Avelumab in Metastatic or Locally Advanced Solid Tumors (JAVELIN Solid Tumor)

• ClinicalTrials.gov Identifier: NCT01772004
• Recruitment Status: Completed
• First Posted: January 21, 2013
• Results First Posted: December 20, 2021
• Last Update Posted: December 20, 2021
• Sponsor: EMD Serono Research & Development Institute, Inc.
• Collaborator: Merck KGaA, Darmstadt, Germany
• Information provided by (Responsible Party): EMD Serono ( EMD Serono Research & Development Institute, Inc. )

• Study Type: Interventional
• Study Design: Allocation: Non-Randomized; Intervention Model: Sequential Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Solid Tumors
• Intervention: Drug: Avelumab
• Enrollment: 1756

Participant Flow

Recruitment Details
Pre-assignment Details	First participant signed informed consent: 31 January 2013, Last Participant Last Visit: 16 December 2019.

Arm/Group Title	Dose Escalation Cohort: Avelumab 1.0 mg/kg	Dose Escalation Cohort: Avelumab 3.0 mg/kg	Dose Escalation Cohort: Avelumab 10.0 mg/kg	Dose Escalation Cohort: Avelumab 20.0 mg/kg	Dose Escalation Cohort: Avelumab 10.0 mg/kg Weekly	Primary Expansion Cohort: NSCLC, Post-platinum Doublet	Primary Expansion Cohort: NSCLC, First Line	Primary Expansion Cohort: Metastatic Breast Cancer	Primary Expansion Cohort: GC/GEJC Progressed	Primary Expansion Cohort: GC/GEJC Non Progressed	Secondary Expansion Cohort: Colorectal Cancer	Secondary Expansion Cohort: Castrate-resistant Prostate Cancer	Secondary Expansion Cohort: Adrenocortical Carcinoma	Secondary Expansion Cohort: Melanoma	Secondary Expansion Cohort: Mesothelioma	Secondary Expansion Cohort: Urothelial Carcinoma	Secondary Expansion Cohort: Ovarian Cancer	Secondary Expansion Cohort: Renal Cell Carcinoma (First Line)	Secondary Expansion Cohort: Renal Cell Carcinoma (Second Line)	Efficacy Expansion Cohort: Ovarian Cancer	Efficacy Expansion Cohort: Urothelial Carcinoma	Efficacy Expansion Cohort: GC/GEJC, Third Line	Efficacy Expansion Cohort: HNSCC
Arm/Group Description	Participants with metastatic or locally advanced solid tumors received intravenous infusion of Avelumab at a dose of 1.0 milligrams per kilogram (mg/kg) once every 2 weeks in dose escalation cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or investigational medicinal product (IMP) occurs.	Participants with metastatic or locally advanced solid tumors received intravenous infusion of Avelumab at a dose of 3.0 mg/kg once every 2 weeks in dose escalation cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with metastatic or locally advanced solid tumors received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in dose escalation cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with metastatic or locally advanced solid tumors received intravenous infusion of Avelumab at a dose of 20.0 mg/kg once every 2 weeks in dose escalation cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with metastatic or locally advanced solid tumors received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once weekly for the first 12 weeks and once every 2 weeks starting Week 13 in dose escalation cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with non-small cell lung cancer (NSCLC), who had progressed after 1 line of platinum-containing doublet chemotherapy received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in primary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with non-small cell lung cancer (NSCLC), first line received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in primary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with metastatic breast cancer received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in primary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with gastric (GC) and gastroesophageal junction cancer (GEJC) who progressed on or after first-line chemotherapy received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in primary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with gastric (GC) and gastroesophageal junction cancer (GEJC) who non-progressed on or after first-line chemotherapy received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in primary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with colorectal cancer received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with castrate-resistant prostate cancer received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with adrenocortical carcinoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with melanoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with mesothelioma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with urothelial carcinoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with ovarian carcinoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with Renal cell carcinoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks as a first-line therapy in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with Renal cell carcinoma who failed 1 prior systemic first-line regimen received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks as a second line treatment in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with ovarian carcinoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in efficacy expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with urothelial carcinoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in efficacy expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with gastric (GC) and gastroesophageal junction cancer (GEJC) who have failed both a first-line chemotherapy regimen and subsequent ramucirumab therapy, received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks as a third-line treatment in efficacy expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with head and neck squamous cell carcinoma (HNSCC) received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in efficacy expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
Period Title: Dose Escalation Phase
Started	4	13	15	21	8	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Completed	4	13	15	21	8	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Not Completed	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Period Title: Dose Expansion Phase
Started	0	0	0	0	0	184	156	168	60	90	21	18	50	51	53	44	125	62	20	103	205	132	153
Completed	0	0	0	0	0	184	156	168	60	90	21	18	50	51	53	44	125	62	20	103	205	132	153
Not Completed	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0

Baseline Characteristics

Arm/Group Title		Dose Escalation Cohort: Avelumab 1.0 mg/kg	Dose Escalation Cohort: Avelumab 3.0 mg/kg	Dose Escalation Cohort: Avelumab 10.0 mg/kg	Dose Escalation Cohort: Avelumab 20.0 mg/kg	Dose Escalation Cohort: Avelumab 10.0 mg/kg Weekly	Primary Expansion Cohort: NSCLC, Post-platinum Doublet	Primary Expansion Cohort: NSCLC, First Line	Primary Expansion Cohort: Metastatic Breast Cancer	Primary Expansion Cohort: GC/GEJC Progressed	Primary Expansion Cohort: GC/GEJC Non Progressed	Secondary Expansion Cohort: Colorectal Cancer	Secondary Expansion Cohort: Castrate-resistant Prostate Cancer	Secondary Expansion Cohort: Adrenocortical Carcinoma	Secondary Expansion Cohort: Melanoma	Secondary Expansion Cohort: Mesothelioma	Secondary Expansion Cohort: Urothelial Carcinoma	Secondary Expansion Cohort: Ovarian Cancer	Secondary Expansion Cohort: Renal Cell Carcinoma (First Line)	Secondary Expansion Cohort: Renal Cell Carcinoma (Second Line)	Efficacy Expansion Cohort: Ovarian Cancer	Efficacy Expansion Cohort: Urothelial Carcinoma	Efficacy Expansion Cohort: GC/GEJC, Third Line	Efficacy Expansion Cohort: HNSCC	Total
Arm/Group Description		Participants with metastatic or locally advanced solid tumors received intravenous infusion of Avelumab at a dose of 1.0 mg/kg once every 2 weeks in dose escalation cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with metastatic or locally advanced solid tumors received intravenous infusion of Avelumab at a dose of 3.0 milligrams per kilogram (mg/kg) once every 2 weeks in dose escalation cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or investigational medicinal product (IMP) occurs.	Participants with metastatic or locally advanced solid tumors received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in dose escalation cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with metastatic or locally advanced solid tumors received intravenous infusion of Avelumab at a dose of 20.0 mg/kg once every 2 weeks in dose escalation cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with metastatic or locally advanced solid tumors received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once weekly for the first 12 weeks and once every 2 weeks starting Week 13 in dose escalation cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with non-small cell lung cancer (NSCLC), who had progressed after 1 line of platinum-containing doublet chemotherapy received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in primary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with non-small cell lung cancer (NSCLC), first line received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in primary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with metastatic breast cancer received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in primary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with gastric and gastroesophageal cancer who progressed on or after first-line chemotherapy received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in primary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with gastric and gastroesophageal cancer who non-progressed on or after first-line chemotherapy received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in primary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with colorectal cancer received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with castrate-resistant prostate cancer received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with adrenocortical carcinoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with melanoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with mesothelioma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with urothelial carcinoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with ovarian carcinoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with Renal cell carcinoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks as a first-line therapy in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with Renal cell carcinoma who failed 1 prior systemic first-line regimen received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks as a second line treatment in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with ovarian carcinoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in efficacy expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with urothelial carcinoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in efficacy expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with gastric (GC) and gastroesophageal junction cancer (GEJC) who have failed both a first-line chemotherapy regimen and subsequent ramucirumab therapy, received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks as a third-line treatment in efficacy expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with head and neck squamous cell carcinoma (HNSCC) received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in efficacy expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Total of all reporting groups
Overall Number of Baseline Participants		4	13	15	21	8	184	156	168	60	90	21	18	50	51	53	44	125	62	20	103	205	132	153	1756
Baseline Analysis Population Description		[Not Specified]
Age, Categorical; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	4 participants	13 participants	15 participants	21 participants	8 participants	184 participants	156 participants	168 participants	60 participants	90 participants	21 participants	18 participants	50 participants	51 participants	53 participants	44 participants	125 participants	62 participants	20 participants	103 participants	205 participants	132 participants	153 participants	1756 participants
	<=18 years	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%
	Between 18 and 65 years	3 75.0%	9 69.2%	10 66.7%	18 85.7%	5 62.5%	90 48.9%	51 32.7%	140 83.3%	38 63.3%	61 67.8%	19 90.5%	7 38.9%	46 92.0%	28 54.9%	20 37.7%	11 25.0%	74 59.2%	37 59.7%	7 35.0%	52 50.5%	66 32.2%	91 68.9%	97 63.4%	980 55.8%
	>=65 years	1 25.0%	4 30.8%	5 33.3%	3 14.3%	3 37.5%	94 51.1%	105 67.3%	28 16.7%	22 36.7%	29 32.2%	2 9.5%	11 61.1%	4 8.0%	23 45.1%	33 62.3%	33 75.0%	51 40.8%	25 40.3%	13 65.0%	51 49.5%	139 67.8%	41 31.1%	56 36.6%	776 44.2%
Sex: Female, Male; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	4 participants	13 participants	15 participants	21 participants	8 participants	184 participants	156 participants	168 participants	60 participants	90 participants	21 participants	18 participants	50 participants	51 participants	53 participants	44 participants	125 participants	62 participants	20 participants	103 participants	205 participants	132 participants	153 participants	1756 participants
	Female	2 50.0%	9 69.2%	8 53.3%	7 33.3%	6 75.0%	84 45.7%	73 46.8%	167 99.4%	14 23.3%	22 24.4%	7 33.3%	0 0.0%	26 52.0%	17 33.3%	21 39.6%	14 31.8%	125 100.0%	19 30.6%	5 25.0%	103 100.0%	57 27.8%	47 35.6%	28 18.3%	861 49.0%
	Male	2 50.0%	4 30.8%	7 46.7%	14 66.7%	2 25.0%	100 54.3%	83 53.2%	1 0.6%	46 76.7%	68 75.6%	14 66.7%	18 100.0%	24 48.0%	34 66.7%	32 60.4%	30 68.2%	0 0.0%	43 69.4%	15 75.0%	0 0.0%	148 72.2%	85 64.4%	125 81.7%	895 51.0%
Race (NIH/OMB); Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	4 participants	13 participants	15 participants	21 participants	8 participants	184 participants	156 participants	168 participants	60 participants	90 participants	21 participants	18 participants	50 participants	51 participants	53 participants	44 participants	125 participants	62 participants	20 participants	103 participants	205 participants	132 participants	153 participants	1756 participants
	American Indian or Alaska Native	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	2	0	0	0	0	2	0	5
	Asian	1	0	2	0	0	5	6	3	13	35	1	0	3	2	0	2	1	6	0	7	15	42	19	163
	Native Hawaiian or Other Pacific Islander	0	0	0	0	0	2	0	0	0	0	0	0	0	0	0	1	0	0	0	0	1	0	0	4
	Black or African American	0	0	2	0	3	12	12	16	4	4	2	4	1	1	0	2	3	1	1	4	9	6	4	91
	White	3	13	11	20	5	159	124	141	36	44	17	12	32	35	43	35	114	35	19	91	155	70	96	1310
	More than one race	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
	Unknown or Not Reported	0	0	0	1	0	6	14	8	7	7	1	2	14	12	10	4	5	20	0	1	25	12	34	183

Outcome Measures

1. Primary Outcome

Title	Dose Escalation Cohort (Excluding Once Weekly Avelumab 10 mg/kg Cohort): Number of Participants Experiencing Dose Limiting Toxicities (DLTs)
Description	DLT: defined using National Cancer Institute Common Toxicity Criteria for Adverse Events Version 4.0, as any one of following: any Grade (Gr) >=3toxicity that is possibly/probably/ definitely related to avelumab, except for any of following: Gr 3 infusion-related reaction resolving within 6 hours and controlled with medical management, Transient Gr 3 flu-like symptoms/fever, which is controlled with medical management, Transient Gr 3 fatigue, local reactions, headache, nausea, emesis that resolves to <= Gr 1, Gr3 diarrhea, Gr 3 skin toxicity, Gr 3 liver function test increase that resolves to <= Gr1 in < 7 days after medical management has been initiated, Single laboratory values out of normal range that were unlikely related to study treatment according to investigator, did not have any clinical correlate, and resolved to <= Gr1 within 7 days with adequate medical management and tumor flare phenomenon defined as local pain, irritation/rash localized at sites of known/suspected tumor.
Time Frame	Dose Escalation: Baseline up to Week 3

Outcome Measure Data

Analysis Population Description

DLT analysis set included all participants with data used for implementing the dose-escalation schedule. These participants should have received all study drug administrations in the DLT evaluation period, or should have stopped treatment because of DLTs in the DLT evaluation period.

Arm/Group Title	Dose Escalation Cohort: Avelumab 1.0 mg/kg	Dose Escalation Cohort: Avelumab 3.0 mg/kg	Dose Escalation Cohort: Avelumab 10.0 mg/kg	Dose Escalation Cohort: Avelumab 20.0 mg/kg
Arm/Group Description:	Participants with metastatic or locally advanced solid tumors received intravenous infusion of Avelumab at a dose of 1.0 milligrams per kilogram (mg/kg) once every 2 weeks in dose escalation cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or investigational medicinal product (IMP) occurs.	Participants with metastatic or locally advanced solid tumors received intravenous infusion of Avelumab at a dose of 3.0 mg/kg once every 2 weeks in dose escalation cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with metastatic or locally advanced solid tumors received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in dose escalation cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with metastatic or locally advanced solid tumors received intravenous infusion of Avelumab at a dose of 20.0 mg/kg once every 2 weeks in dose escalation cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
Overall Number of Participants Analyzed	3	3	6	6
Measure Type: Count of Participants; Unit of Measure: Participants
	0	0	0	1

2. Primary Outcome

Title	Efficacy Expansion Cohort (Ovarian Cancer): Number of Participants With Confirmed Best Overall Response (BOR) as Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1), as Adjudicated by Independent Endpoint Review Committee (IERC)
Description	Confirmed BOR was determined according to RECIST 1.1 and as adjudicated by an Independent Endpoint Review Committee (IERC) and defined as best response of any of complete response (CR), partial response (PR), stable disease (SD) and progressive disease (PD) recorded from date of randomization until disease progression/recurrence (taking smallest measurement recorded since start of treatment as reference). CR: Disappearance of all evidence of target/non-target lesions. PR: At least 30%reduction from baseline in sum of longest diameter (SLD) of all lesions. SD: Neither sufficient increase to qualify for PD nor sufficient shrinkage to qualify for PR. PD: at least a 20% increase in SLD, taking as reference smallest SLD recorded from baseline/appearance of 1or more new lesions and unequivocal progression of non-target lesions.
Time Frame	Ovarian Cancer Efficacy Expansion: Baseline up to Day 620

Outcome Measure Data

Analysis Population Description

Full analysis set (FAS) included all participants who have received at least 1 dose of study treatment.

Arm/Group Title	Efficacy Expansion Cohort: Ovarian Cancer
Arm/Group Description:	Participants with ovarian carcinoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in efficacy expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
Overall Number of Participants Analyzed	103
Measure Type: Count of Participants; Unit of Measure: Participants
Complete response (CR)	3
Partial response (PR)	1
Stable disease (SD)	41
Progressive disease (PD)	39
Non-CR/Non-PD	3
Non-evaluable	16

3. Primary Outcome

Title	Efficacy Expansion Cohort(Urothelial Carcinoma): Number of Participants With Confirmed Best Overall Response (BOR) as Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1), as Adjudicated by Independent Endpoint Review Committee (IERC)
Description	Confirmed BOR was determined according to RECIST 1.1 and as adjudicated by an Independent Endpoint Review Committee (IERC) and defined as best response of any of complete response (CR), partial response (PR), stable disease (SD) and progressive disease (PD) recorded from date of randomization until disease progression/recurrence (taking smallest measurement recorded since start of treatment as reference). CR: Disappearance of all evidence of target/non-target lesions. PR: At least 30% reduction from baseline in sum of longest diameter (SLD) of all lesions. SD: Neither sufficient increase to qualify for PD nor sufficient shrinkage to qualify for PR. PD: at least a 20% increase in SLD, taking as reference smallest SLD recorded from baseline/appearance of 1 or more new lesions and unequivocal progression of non-target lesions.
Time Frame	Urothelial Carcinoma Efficacy Expansion: Baseline up to Day 931

Outcome Measure Data

Analysis Population Description

Full analysis set (FAS) included all participants who have received at least 1 dose of study treatment. Here, "Overall Number of Participants Analyzed" signifies those participants who were evaluable for this outcome measure.

Arm/Group Title	Efficacy Expansion Cohort: Urothelial Carcinoma
Arm/Group Description:	Participants with urothelial carcinoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in efficacy expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
Overall Number of Participants Analyzed	198
Measure Type: Count of Participants; Unit of Measure: Participants
Complete response (CR)	6
Partial response (PR)	26
Stable disease (SD)	51
Progressive disease (PD)	77
Non-CR/Non-PD	1
Non-evaluable	37

4. Primary Outcome

Title	Efficacy Expansion Cohort (GC/GEJC, Third Line): Number of Participants With Confirmed Best Overall Response (BOR) as Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1), as Adjudicated by Independent Endpoint Review Committee (IERC)
Description	Confirmed BOR was determined according to RECIST 1.1 and as adjudicated by an Independent Endpoint Review Committee (IERC) and defined as best response of any of complete response (CR), partial response (PR), stable disease (SD) and progressive disease (PD) recorded from date of randomization until disease progression/recurrence (taking smallest measurement recorded since start of treatment as reference). CR: Disappearance of all evidence of target/non-target lesions. PR: At least 30% reduction from baseline in sum of longest diameter (SLD) of all lesions. SD: Neither sufficient increase to qualify for PD nor sufficient shrinkage to qualify for PR. PD: at least a 20% increase in SLD, taking as reference smallest SLD recorded from baseline/appearance of 1 or more new lesions and unequivocal progression of non-target lesions.
Time Frame	GC/GEJC, Third Line Efficacy Expansion: Baseline up to Day 871

Outcome Measure Data

Analysis Population Description

Full analysis set (FAS) included all participants who have received at least 1 dose of study treatment.

Arm/Group Title	Efficacy Expansion Cohort: GC/GEJC, Third Line
Arm/Group Description:	Participants with gastric (GC) and gastroesophageal junction cancer (GEJC) who have failed both a first-line chemotherapy regimen and subsequent ramucirumab therapy, received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks as a third-line treatment in efficacy expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
Overall Number of Participants Analyzed	132
Measure Type: Count of Participants; Unit of Measure: Participants
Complete response (CR)	2
Partial response (PR)	5
Stable disease (SD)	24
Progressive disease (PD)	72
Non-CR/Non-PD	5
Non-evaluable	24

5. Primary Outcome

Title	Efficacy Expansion Cohort (HNSCC): Number of Participants With Confirmed Best Overall Response (BOR) as Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1), as Adjudicated by Independent Endpoint Review Committee (IERC)
Description	Confirmed BOR was determined according to RECIST 1.1 and as adjudicated by an Independent Endpoint Review Committee (IERC) and defined as best response of any of complete response (CR), partial response (PR), stable disease (SD) and progressive disease (PD) recorded from date of randomization until disease progression/recurrence (taking smallest measurement recorded since start of treatment as reference). CR: Disappearance of all evidence of target/non-target lesions. PR: At least 30%reduction from baseline in sum of longest diameter (SLD) of all lesions. SD: Neither sufficient increase to qualify for PD nor sufficient shrinkage to qualify for PR. PD: at least a 20% increase in SLD, taking as reference smallest SLD recorded from baseline/appearance of 1or more new lesions and unequivocal progression of non-target lesions.
Time Frame	HNSCC Efficacy Expansion: Baseline up to Day 1072

Outcome Measure Data

Analysis Population Description

Full analysis set (FAS) included all participants who have received at least 1 dose of study treatment.

Arm/Group Title	Efficacy Expansion Cohort: HNSCC
Arm/Group Description:	Participants with head and neck squamous cell carcinoma (HNSCC) received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in efficacy expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
Overall Number of Participants Analyzed	153
Measure Type: Count of Participants; Unit of Measure: Participants
Complete response (CR)	2
Partial response (PR)	12
Stable disease (SD)	46
Progressive disease (PD)	67
Non-CR/Non-PD	1
Non-evaluable	25

6. Secondary Outcome

Title	Dose Escalation and Expansion Cohorts: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and TEAEs as Per Severity
Description	Adverse event(AE): any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with use of study drug, whether or not related to study drug. A serious adverse event(SAE) was an AE that resulted in any of following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect or was otherwise considered medically important. Treatment-emergent events were events between first dose of study drug that were absent before treatment or that worsened relative to pre-treatment state up to 30 days after last administration.TEAEs included both Serious TEAEs and non-serious TEAEs. Severity of TEAEs were graded using National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 4.0 toxicity grades, as follows: Grade 1= Mild, Grade 2= Moderate, Grade 3= Severe, Grade 4= Life-threatening and Grade 5= Death.
Time Frame	Up to Day 2511

Outcome Measure Data

Analysis Population Description

Safety analysis set (SAF) included all participants who have received at least 1 dose of study treatment.

Arm/Group Title	Dose Escalation Cohort: Avelumab 1.0 mg/kg	Dose Escalation Cohort: Avelumab 3.0 mg/kg	Dose Escalation Cohort: Avelumab 10.0 mg/kg	Dose Escalation Cohort: Avelumab 20.0 mg/kg	Dose Escalation Cohort: Avelumab 10.0 mg/kg Weekly	Primary Expansion Cohort: NSCLC, Post-platinum Doublet	Primary Expansion Cohort: NSCLC, First Line	Primary Expansion Cohort: Metastatic Breast Cancer	Primary Expansion Cohort: GC/GEJC Progressed	Primary Expansion Cohort: GC/GEJC Non Progressed	Secondary Expansion Cohort: Colorectal Cancer	Secondary Expansion Cohort: Castrate-resistant Prostate Cancer	Secondary Expansion Cohort: Adrenocortical Carcinoma	Secondary Expansion Cohort: Melanoma	Secondary Expansion Cohort: Mesothelioma	Secondary Expansion Cohort: Urothelial Carcinoma	Secondary Expansion Cohort: Ovarian Cancer	Secondary Expansion Cohort: Renal Cell Carcinoma (First Line)	Secondary Expansion Cohort: Renal Cell Carcinoma (Second Line)	Efficacy Expansion Cohort: Ovarian Cancer	Efficacy Expansion Cohort: Urothelial Carcinoma	Efficacy Expansion Cohort: GC/GEJC, Third Line	Efficacy Expansion Cohort: HNSCC
Arm/Group Description:	Participants with metastatic or locally advanced solid tumors received intravenous infusion of Avelumab at a dose of 1.0 milligrams per kilogram (mg/kg) once every 2 weeks in dose escalation cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or investigational medicinal product (IMP) occurs.	Participants with metastatic or locally advanced solid tumors received intravenous infusion of Avelumab at a dose of 3.0 mg/kg once every 2 weeks in dose escalation cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with metastatic or locally advanced solid tumors received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in dose escalation cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with metastatic or locally advanced solid tumors received intravenous infusion of Avelumab at a dose of 20.0 mg/kg once every 2 weeks in dose escalation cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with metastatic or locally advanced solid tumors received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once weekly for the first 12 weeks and once every 2 weeks starting Week 13 in dose escalation cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with non-small cell lung cancer (NSCLC), who had progressed after 1 line of platinum-containing doublet chemotherapy received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in primary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with non-small cell lung cancer (NSCLC), first line received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in primary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with metastatic breast cancer received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in primary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with gastric and gastroesophageal cancer who progressed on or after first-line chemotherapy received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in primary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with gastric and gastroesophageal cancer who non-progressed on or after first-line chemotherapy received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in primary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with colorectal cancer received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with castrate-resistant prostate cancer received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with adrenocortical carcinoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with melanoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with mesothelioma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with urothelial carcinoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with ovarian carcinoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with Renal cell carcinoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks as a first-line therapy in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with Renal cell carcinoma who failed 1 prior systemic first-line regimen received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks as a second line treatment in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with ovarian carcinoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in efficacy expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with urothelial carcinoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in efficacy expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with gastric (GC) and gastroesophageal junction cancer (GEJC) who have failed both a first-line chemotherapy regimen and subsequent ramucirumab therapy, received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks as a third-line treatment in efficacy expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with head and neck squamous cell carcinoma (HNSCC) received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in efficacy expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
Overall Number of Participants Analyzed	4	13	15	21	8	184	156	168	60	90	21	18	50	51	53	44	125	62	20	103	205	132	153
Measure Type: Count of Participants; Unit of Measure: Participants
Participants with TEAEs	4	13	15	21	8	182	156	161	60	88	21	17	50	50	53	44	122	62	19	103	204	130	149
Participants with TEAEs with Grade 1 severity	0	1	1	2	2	11	3	22	5	14	2	5	1	2	2	3	11	7	1	7	15	2	14
Participants with TEAEs with Grade 2 severity	0	4	4	6	3	54	45	58	9	19	9	5	10	17	21	10	52	25	5	30	46	30	43
Participants with TEAEs with Grade 3 severity	2	4	6	11	3	66	68	45	29	41	6	7	25	21	23	18	42	20	10	45	82	51	54
Participants with TEAEs with Grade 4 severity	0	0	2	1	0	19	15	12	7	4	1	0	8	5	3	6	3	6	1	6	16	12	12
Participants with TEAEs with Grade 5 severity	2	4	2	1	0	32	25	24	10	10	3	0	6	5	4	7	14	4	2	15	45	35	25
Participants with TEAEs with missing Grade	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1

7. Secondary Outcome

Title	Dose Escalation and Expansion Cohorts: Number of Participants With Treatment-Related Treatment-Emergent Adverse Events (TEAEs) and Treatment-Related TEAEs as Per Severity
Description	AE was defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of study drug, whether or not related to study drug. Treatment-emergent events were the events between first dose of study drug that were absent before treatment or that worsened relative to pre-treatment state up to 30 days after last administration. TEAEs included both Serious TEAEs and non-serious TEAEs. Treatment related AE was defined as having a "Possible" or "Related" relationship to study treatment, as assessed by the Investigator. Severity of Treatment-Related TEAEs were graded using NCI-CTCAE version 4.0 toxicity grades, as follows: Grade 1= Mild, Grade 2= Moderate, Grade 3= Severe, Grade 4= Life-threatening and Grade 5= Death.
Time Frame	Baseline up to Day 2511

Outcome Measure Data

Analysis Population Description

SAF included all participants who have received at least 1 dose of study treatment.

Arm/Group Title	Dose Escalation Cohort: Avelumab 1.0 mg/kg	Dose Escalation Cohort: Avelumab 3.0 mg/kg	Dose Escalation Cohort: Avelumab 10.0 mg/kg	Dose Escalation Cohort: Avelumab 20.0 mg/kg	Dose Escalation Cohort: Avelumab 10.0 mg/kg Weekly	Primary Expansion Cohort: NSCLC, Post-platinum Doublet	Primary Expansion Cohort: NSCLC, First Line	Primary Expansion Cohort: Metastatic Breast Cancer	Primary Expansion Cohort: GC/GEJC Progressed	Primary Expansion Cohort: GC/GEJC Non Progressed	Secondary Expansion Cohort: Colorectal Cancer	Secondary Expansion Cohort: Castrate-resistant Prostate Cancer	Secondary Expansion Cohort: Adrenocortical Carcinoma	Secondary Expansion Cohort: Melanoma	Secondary Expansion Cohort: Mesothelioma	Secondary Expansion Cohort: Urothelial Carcinoma	Secondary Expansion Cohort: Ovarian Cancer	Secondary Expansion Cohort: Renal Cell Carcinoma (First Line)	Secondary Expansion Cohort: Renal Cell Carcinoma (Second Line)	Efficacy Expansion Cohort: Ovarian Cancer	Efficacy Expansion Cohort: Urothelial Carcinoma	Efficacy Expansion Cohort: GC/GEJC, Third Line	Efficacy Expansion Cohort: HNSCC
Arm/Group Description:	Participants with metastatic or locally advanced solid tumors received intravenous infusion of Avelumab at a dose of 1.0 milligrams per kilogram (mg/kg) once every 2 weeks in dose escalation cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or investigational medicinal product (IMP) occurs.	Participants with metastatic or locally advanced solid tumors received intravenous infusion of Avelumab at a dose of 3.0 mg/kg once every 2 weeks in dose escalation cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with metastatic or locally advanced solid tumors received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in dose escalation cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with metastatic or locally advanced solid tumors received intravenous infusion of Avelumab at a dose of 20.0 mg/kg once every 2 weeks in dose escalation cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with metastatic or locally advanced solid tumors received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once weekly for the first 12 weeks and once every 2 weeks starting Week 13 in dose escalation cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with non-small cell lung cancer (NSCLC), who had progressed after 1 line of platinum-containing doublet chemotherapy received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in primary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with non-small cell lung cancer (NSCLC), first line received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in primary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with metastatic breast cancer received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in primary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with gastric and gastroesophageal cancer who progressed on or after first-line chemotherapy received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in primary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with gastric and gastroesophageal cancer who non-progressed on or after first-line chemotherapy received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in primary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with colorectal cancer received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with castrate-resistant prostate cancer received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with adrenocortical carcinoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with melanoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with mesothelioma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with urothelial carcinoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with ovarian carcinoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with Renal cell carcinoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks as a first-line therapy in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with Renal cell carcinoma who failed 1 prior systemic first-line regimen received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks as a second line treatment in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with ovarian carcinoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in efficacy expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with urothelial carcinoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in efficacy expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with gastric (GC) and gastroesophageal junction cancer (GEJC) who have failed both a first-line chemotherapy regimen and subsequent ramucirumab therapy, received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks as a third-line treatment in efficacy expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with head and neck squamous cell carcinoma (HNSCC) received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in efficacy expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
Overall Number of Participants Analyzed	4	13	15	21	8	184	156	168	60	90	21	18	50	51	53	44	125	62	20	103	205	132	153
Measure Type: Count of Participants; Unit of Measure: Participants
Participants with Treatment-Related TEAEs	3	9	14	17	7	146	109	118	28	57	16	15	41	39	43	32	86	51	14	65	144	71	83
Participants with Treatment-Related TEAEs with Grade 1 severity	1	5	7	6	2	46	29	52	14	27	4	8	12	15	8	11	46	20	4	30	50	25	39
Participants with Treatment-Related TEAEs with Grade 2 severity	1	4	3	8	4	71	60	46	9	22	9	6	21	20	30	18	31	23	9	26	70	33	34
Participants with Treatment-Related TEAEs with Grade 3 severity	1	0	3	2	1	21	17	13	4	7	3	1	8	4	3	2	7	3	1	8	20	11	9
Participants with Treatment-Related TEAEs with Grade 4 severity	0	0	1	1	0	8	3	5	1	0	0	0	0	0	2	1	2	5	0	1	3	1	1
Participants with Treatment-Related TEAEs with Grade 5 severity	0	0	0	0	0	0	0	2	0	1	0	0	0	0	0	0	0	0	0	0	1	1	0
Participants with Treatment-Related TEAEs with missing Grade	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0

8. Secondary Outcome

Title	Dose Escalation Cohort (Excluding Once Weekly Avelumab 10 mg/kg Cohort): Area Under Serum Concentration-Time Curve From the Time of Dosing to the Time of the Last Observation (AUC0-t) of Avelumab
Description	Area under the serum concentration versus time curve from time zero to the last sampling time t at which the concentration is at or above the lower limit of quantification (LLLQ). AUC(0-t) was calculated according to the mixed log-linear trapezoidal rule.
Time Frame	Pre-infusion, at end of 1-hour infusion (Day 1), 0.5, 1, 2, 4, 6,12, 24, 36, 48 hours after end of infusion

Outcome Measure Data

Analysis Population Description

Pharmacokinetic (PK) population included all participants who have completed at least 1 infusion of study drug, and who have provided sufficient concentration measurements.

Arm/Group Title	Dose Escalation Cohort: Avelumab 1.0 mg/kg	Dose Escalation Cohort: Avelumab 3.0 mg/kg	Dose Escalation Cohort: Avelumab 10.0 mg/kg	Dose Escalation Cohort: Avelumab 20.0 mg/kg
Arm/Group Description:	Participants with metastatic or locally advanced solid tumors received intravenous infusion of Avelumab at a dose of 1.0 milligrams per kilogram (mg/kg) once every 2 weeks in dose escalation cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or investigational medicinal product (IMP) occurs.	Participants with metastatic or locally advanced solid tumors received intravenous infusion of Avelumab at a dose of 3.0 mg/kg once every 2 weeks in dose escalation cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with metastatic or locally advanced solid tumors received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in dose escalation cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with metastatic or locally advanced solid tumors received intravenous infusion of Avelumab at a dose of 20.0 mg/kg once every 2 weeks in dose escalation cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
Overall Number of Participants Analyzed	4	13	15	21
Mean (Standard Deviation); Unit of Measure: Hours*micrograms per milliliter
	1040 (443)	6080 (1970)	22749.4 (7857.09)	45100 (15600)

9. Secondary Outcome

Title	Dose Escalation Cohort (Excluding Once Weekly Avelumab 10 mg/kg Cohort): Area Under the Serum Concentration-Time Curve From Time Zero to Infinity (AUC0-infinity) of Avelumab
Description	The AUC(0-inf) was estimated by determining the total area under the curve of the concentration versus time curve extrapolated to infinity.
Time Frame	Pre-infusion, at end of 1-hour infusion (Day 1), 0.5, 1, 2, 4, 6,12, 24, 36, 48 hours after end of infusion

Outcome Measure Data

Analysis Population Description

Pharmacokinetic (PK) population included all participants who have completed at least 1 infusion of study drug, and who have provided sufficient concentration measurements. Here "Overall number of participants analyzed" signifies those who were evaluable for this outcome measure.

Arm/Group Title	Dose Escalation Cohort: Avelumab 1.0 mg/kg	Dose Escalation Cohort: Avelumab 3.0 mg/kg	Dose Escalation Cohort: Avelumab 10.0 mg/kg	Dose Escalation Cohort: Avelumab 20.0 mg/kg
Arm/Group Description:	Participants with metastatic or locally advanced solid tumors received intravenous infusion of Avelumab at a dose of 1.0 milligrams per kilogram (mg/kg) once every 2 weeks in dose escalation cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or investigational medicinal product (IMP) occurs.	Participants with metastatic or locally advanced solid tumors received intravenous infusion of Avelumab at a dose of 3.0 mg/kg once every 2 weeks in dose escalation cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with metastatic or locally advanced solid tumors received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in dose escalation cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with metastatic or locally advanced solid tumors received intravenous infusion of Avelumab at a dose of 20.0 mg/kg once every 2 weeks in dose escalation cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
Overall Number of Participants Analyzed	2	12	13	15
Mean (Standard Deviation); Unit of Measure: Hours*micrograms per milliliter
	1290 (650)	6850 (2100)	25920.9 (6753.76)	46600 (18500)

10. Secondary Outcome

Title	Dose Escalation Cohort (Excluding Once Weekly Avelumab 10 mg/kg Cohort): Maximum Observed Serum Concentration (Cmax) of Avelumab
Description	Cmax is the maximum observed serum concentration obtained directly from the concentration versus time curve.
Time Frame	Pre-infusion, at end of 1-hour infusion (Day 1), 0.5, 1, 2, 4, 6,12, 24, 36, 48 hours after end of infusion

Outcome Measure Data

Analysis Population Description

Pharmacokinetic (PK) population included all participants who have completed at least 1 infusion of study drug, and who have provided sufficient concentration measurements.

Arm/Group Title	Dose Escalation Cohort: Avelumab 1.0 mg/kg	Dose Escalation Cohort: Avelumab 3.0 mg/kg	Dose Escalation Cohort: Avelumab 10.0 mg/kg	Dose Escalation Cohort: Avelumab 20.0 mg/kg
Arm/Group Description:	Participants with metastatic or locally advanced solid tumors received intravenous infusion of Avelumab at a dose of 1.0 milligrams per kilogram (mg/kg) once every 2 weeks in dose escalation cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or investigational medicinal product (IMP) occurs.	Participants with metastatic or locally advanced solid tumors received intravenous infusion of Avelumab at a dose of 3.0 mg/kg once every 2 weeks in dose escalation cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with metastatic or locally advanced solid tumors received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in dose escalation cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with metastatic or locally advanced solid tumors received intravenous infusion of Avelumab at a dose of 20.0 mg/kg once every 2 weeks in dose escalation cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
Overall Number of Participants Analyzed	4	13	15	21
Mean (Standard Deviation); Unit of Measure: Micrograms per milliliter (mcg/mL)
	18.7 (3.96)	81.9 (22.1)	249.048 (55.4697)	489 (140)

11. Secondary Outcome

Title	Dose Escalation Cohort (Excluding Once Weekly Avelumab 10 mg/kg Cohort): Time to Reach Maximum Observed Serum Concentration (Tmax) of Avelumab
Description	Tmax is time to reach maximum observed serum concentration obtained directly from the concentration versus time curve.
Time Frame	Pre-infusion, at end of 1-hour infusion (Day 1), 0.5, 1, 2, 4, 6,12, 24, 36, 48 hours after end of infusion

Outcome Measure Data

Analysis Population Description

Pharmacokinetic (PK) population included all participants who have completed at least 1 infusion of study drug, and who have provided sufficient concentration measurements.

Arm/Group Title	Dose Escalation Cohort: Avelumab 1.0 mg/kg	Dose Escalation Cohort: Avelumab 3.0 mg/kg	Dose Escalation Cohort: Avelumab 10.0 mg/kg	Dose Escalation Cohort: Avelumab 20.0 mg/kg
Arm/Group Description:	Participants with metastatic or locally advanced solid tumors received intravenous infusion of Avelumab at a dose of 1.0 milligrams per kilogram (mg/kg) once every 2 weeks in dose escalation cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or investigational medicinal product (IMP) occurs.	Participants with metastatic or locally advanced solid tumors received intravenous infusion of Avelumab at a dose of 3.0 mg/kg once every 2 weeks in dose escalation cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with metastatic or locally advanced solid tumors received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in dose escalation cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with metastatic or locally advanced solid tumors received intravenous infusion of Avelumab at a dose of 20.0 mg/kg once every 2 weeks in dose escalation cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
Overall Number of Participants Analyzed	4	13	15	21
Median (Full Range); Unit of Measure: Hours
	1.500; (1.02 to 13.00)	1.500; (1.00 to 13.00)	1.500; (1.00 to 7.10)	1.717; (0.95 to 13.00)

12. Secondary Outcome

Title	Dose Escalation Cohort (Excluding Once Weekly Avelumab 10 mg/kg Cohort): Apparent Terminal Half-Life (t1/2) of Avelumab
Description	Apparent terminal half-life was defined as the time required for the serum concentration of drug to decrease 50 percent in the final stage of its elimination.
Time Frame	Pre-infusion, at end of 1-hour infusion (Day 1), 0.5, 1, 2, 4, 6,12, 24, 36, 48 hours after end of infusion

Outcome Measure Data

Analysis Population Description

Pharmacokinetic (PK) population included all participants who have completed at least 1 infusion of study drug, and who have provided sufficient concentration measurements. Here "Overall number of participants analyzed" signifies those who were evaluable for this outcome measure.

Arm/Group Title	Dose Escalation Cohort: Avelumab 1.0 mg/kg	Dose Escalation Cohort: Avelumab 3.0 mg/kg	Dose Escalation Cohort: Avelumab 10.0 mg/kg	Dose Escalation Cohort: Avelumab 20.0 mg/kg
Arm/Group Description:	Participants with metastatic or locally advanced solid tumors received intravenous infusion of Avelumab at a dose of 1.0 milligrams per kilogram (mg/kg) once every 2 weeks in dose escalation cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or investigational medicinal product (IMP) occurs.	Participants with metastatic or locally advanced solid tumors received intravenous infusion of Avelumab at a dose of 3.0 mg/kg once every 2 weeks in dose escalation cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with metastatic or locally advanced solid tumors received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in dose escalation cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with metastatic or locally advanced solid tumors received intravenous infusion of Avelumab at a dose of 20.0 mg/kg once every 2 weeks in dose escalation cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
Overall Number of Participants Analyzed	2	12	13	15
Median (Full Range); Unit of Measure: Hours
	61.425; (46.06 to 76.79)	89.064; (43.09 to 115.95)	97.440; (52.15 to 120.08)	108.671; (55.95 to 133.84)

13. Secondary Outcome

Title	Dose Expansion Phase: Serum Concentration at End of Infusion (CEOI) of Avelumab
Description	Serum concentration at end of infusion (CEOI) of Avelumab is reported.
Time Frame	At Day 1, 15, 29, 43, 85, 127 and 169

Outcome Measure Data

Analysis Population Description

Pharmacokinetic analysis set was used. Here "Overall number of participants analyzed" signifies those who were evaluable for this outcome measure and "Number analyzed" signifies those who were evaluable at specified time points. Data was reported for those arms for which end of infusion sample were collected as per planned analysis.

Arm/Group Title		Primary Expansion Cohort: NSCLC, First Line	Secondary Expansion Cohort: Colorectal Cancer	Secondary Expansion Cohort: Castrate-resistant Prostate Cancer	Secondary Expansion Cohort: Renal Cell Carcinoma (Second Line)	Efficacy Expansion Cohort: Ovarian Cancer	Efficacy Expansion Cohort: Urothelial Carcinoma	Efficacy Expansion Cohort: GC/GEJC, Third Line	Efficacy Expansion Cohort: HNSCC
Arm/Group Description:		Participants with non-small cell lung cancer (NSCLC), first line received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in primary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with colorectal cancer received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with castrate-resistant prostate cancer received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with Renal cell carcinoma (Second line) received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with ovarian carcinoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in efficacy expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with urothelial carcinoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in efficacy expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with gastric and gastroesophageal cancer treated with a first-line chemotherapy received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in efficacy expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with head and neck squamous cell carcinoma (HNSCC) received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in efficacy expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
Overall Number of Participants Analyzed		117	18	13	16	85	84	29	124
Mean (Standard Deviation); Unit of Measure: Microgram per milliliter
Day 1	Number Analyzed	117 participants	18 participants	12 participants	16 participants	85 participants	84 participants	29 participants	124 participants
		246 (87.4)	272 (73.9)	343 (117)	239 (50.2)	247 (77.3)	224 (55.4)	241 (75.0)	212 (47.6)
Day 15	Number Analyzed	0 participants	15 participants	13 participants	0 participants	0 participants	0 participants	0 participants	0 participants
			297 (99.6)	305 (88.1)
Day 29	Number Analyzed	0 participants	17 participants	11 participants	0 participants	0 participants	0 participants	0 participants	0 participants
			287 (89.5)	291 (60.3)
Day 43	Number Analyzed	81 participants	8 participants	7 participants	12 participants	54 participants	46 participants	11 participants	73 participants
		250 (69.8)	306 (108)	294 (57.4)	255 (69.7)	268 (72.0)	241 (58.1)	240 (93.1)	249 (105)
Day 85	Number Analyzed	47 participants	2 participants	6 participants	9 participants	21 participants	40 participants	2 participants	30 participants
		266 (79.5)	216 (24.9)	348 (65.6)	252 (78.9)	263 (66.4)	247 (66.4)	237 (5.54)	255 (57.7)
Day 127	Number Analyzed	0 participants	2 participants	3 participants	0 participants	0 participants	0 participants	0 participants	0 participants
			269 (45.4)	339 (41.4)
Day 169	Number Analyzed	10 participants	1 participants	1 participants	1 participants	2 participants	7 participants	0 participants	6 participants
		304 (64.9)	272	287	235	233 (90.4)	313 (59.3)		245 (51.7)

14. Secondary Outcome

Title	Dose Expansion Phase: Minimum Serum Post-dose (Ctrough) Concentration of Avelumab
Description	Serum Ctrough concentration of Avelumab is reported.
Time Frame	At Day 15, 29, 43, 57, 71, 85, 99, 127 and 169

Outcome Measure Data

Analysis Population Description

Pharmacokinetic analysis set was used. Here "Overall number of participants analyzed" signifies those who were evaluable for this outcome measure and "Number analyzed" signifies those who were evaluable at specified time points. Data for "primary expansion cohort: GC/GEJC Progressed" and "primary expansion cohort: GC/GEJC Non progressed" arms was reported as a single arm "primary expansion cohort: GC/GEJC Progressed/Non progressed" for this outcome measure as per planned analysis.

Arm/Group Title		Primary Expansion Cohort: NSCLC, Post-platinum Doublet	Primary Expansion Cohort: NSCLC, First Line	Primary Expansion Cohort: GC/GEJC (Progressed/Non Progressed)	Primary Expansion Cohort: Metastatic Breast Cancer	Secondary Expansion Cohort: Adrenocortical Carcinoma	Secondary Expansion Cohort: Colorectal Cancer	Secondary Expansion Cohort: Castrate-resistant Prostate Cancer	Secondary Expansion Cohort: Melanoma	Secondary Expansion Cohort: Mesothelioma	Secondary Expansion Cohort: Renal Cell Carcinoma (First Line)	Secondary Expansion Cohort: Renal Cell Carcinoma (Second Line)	Secondary Expansion Cohort: Urothelial Carcinoma	Secondary Expansion Cohort: Ovarian Cancer	Efficacy Expansion Cohort: GC/GEJC, Third Line	Efficacy Expansion Cohort: HNSCC	Efficacy Expansion Cohort: Ovarian Cancer	Efficacy Expansion Cohort: Urothelial Carcinoma
Arm/Group Description:		Participants with non-small cell lung cancer (NSCLC), who had progressed after 1 line of platinum-containing doublet chemotherapy received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in primary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with non-small cell lung cancer (NSCLC), first line received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in primary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with gastric and gastroesophageal cancer who progressed/non-progressed on or after first-line chemotherapy received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in primary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with metastatic breast cancer received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in primary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with adrenocortical carcinoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with colorectal cancer received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with castrate-resistant prostate cancer received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with melanoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with mesothelioma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with Renal cell carcinoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks as a first-line therapy in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with Renal cell carcinoma who failed 1 prior systemic first-line regimen received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks as a second line treatment in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with urothelial carcinoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with ovarian carcinoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with gastric (GC) and gastroesophageal junction cancer (GEJC) who have failed both a first-line chemotherapy regimen and subsequent ramucirumab therapy, received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks as a third-line treatment in efficacy expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with head and neck squamous cell carcinoma (HNSCC) received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in efficacy expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with ovarian carcinoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in efficacy expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with urothelial carcinoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in efficacy expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
Overall Number of Participants Analyzed		163	124	129	154	32	17	13	45	48	57	17	43	118	21	117	87	82
Mean (Standard Deviation); Unit of Measure: Microgram per milliliter
Day 15	Number Analyzed	163 participants	124 participants	129 participants	154 participants	32 participants	17 participants	12 participants	45 participants	48 participants	57 participants	16 participants	43 participants	118 participants	21 participants	117 participants	87 participants	82 participants
		20.4 (16.1)	18.3 (10.3)	22.5 (11.1)	23.7 (24.6)	17.8 (9.51)	22.4 (14.1)	28.8 (14.5)	22.3 (13.4)	21.7 (26.7)	26.9 (14.4)	25.1 (11.6)	21.3 (12.0)	23.1 (14.1)	18.1 (12.4)	20.1 (10.1)	22.3 (11.1)	17.6 (10.7)
Day 29	Number Analyzed	149 participants	109 participants	117 participants	142 participants	28 participants	17 participants	13 participants	41 participants	45 participants	50 participants	15 participants	38 participants	109 participants	20 participants	104 participants	85 participants	74 participants
		23.5 (15.4)	23.5 (15.1)	25.6 (15.2)	26.5 (17.0)	17.3 (13.6)	25.5 (20.1)	31.6 (15.9)	23.8 (17.3)	20.7 (12.4)	35.7 (22.3)	27.4 (16.6)	26.2 (16.9)	27.7 (18.3)	18.6 (16.0)	27.0 (23.9)	23.9 (16.2)	21.3 (13.0)
Day 43	Number Analyzed	126 participants	96 participants	94 participants	96 participants	21 participants	11 participants	8 participants	34 participants	37 participants	51 participants	17 participants	33 participants	93 participants	14 participants	80 participants	62 participants	60 participants
		24.6 (15.6)	23.8 (15.9)	28.3 (18.2)	29.7 (17.8)	20.6 (14.3)	23.2 (24.2)	32.3 (16.3)	29.3 (22.9)	23.6 (18.9)	35.7 (22.6)	29.4 (19.7)	28.1 (18.9)	28.4 (20.9)	19.8 (21.5)	29.0 (17.6)	27.7 (18.1)	25.2 (17.7)
Day 57	Number Analyzed	104 participants	86 participants	86 participants	78 participants	15 participants	0 participants	0 participants	26 participants	36 participants	46 participants	15 participants	30 participants	80 participants	11 participants	55 participants	48 participants	57 participants
		26.2 (17.3)	23.4 (16.1)	26.5 (14.1)	28.9 (14.5)	22.2 (19.8)			29.9 (22.4)	18.2 (11.7)	39.8 (25.5)	25.5 (18.7)	29.7 (22.8)	27.3 (21.5)	16.2 (15.2)	30.6 (18.1)	28.5 (20.3)	24.1 (15.6)
Day 71	Number Analyzed	101 participants	73 participants	83 participants	70 participants	15 participants	0 participants	0 participants	27 participants	33 participants	46 participants	13 participants	24 participants	74 participants	8 participants	48 participants	36 participants	47 participants
		27.9 (36.5)	31.0 (40.1)	28.1 (16.6)	29.9 (15.4)	22.0 (15.5)			28.8 (23.6)	21.0 (14.2)	38.4 (33.4)	27.8 (17.6)	29.4 (22.1)	33.4 (31.8)	19.6 (15.3)	31.1 (18.8)	30.4 (23.0)	24.2 (14.7)
Day 85	Number Analyzed	81 participants	60 participants	67 participants	43 participants	10 participants	4 participants	6 participants	22 participants	24 participants	43 participants	11 participants	23 participants	47 participants	2 participants	31 participants	24 participants	41 participants
		27.8 (18.9)	27.7 (16.7)	29.7 (18.1)	28.9 (16.8)	24.9 (29.0)	8.03 (0.988)	37.9 (18.3)	35.6 (23.7)	23.7 (15.8)	39.7 (27.2)	34.4 (20.2)	34.7 (20.5)	39.1 (28.3)	19.3 (3.60)	35.6 (20.7)	31.2 (22.0)	28.0 (14.6)
Day 99	Number Analyzed	0 participants	32 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants
			28.8 (13.6)
Day 127	Number Analyzed	54 participants	0 participants	45 participants	29 participants	6 participants	1 participants	3 participants	13 participants	13 participants	0 participants	0 participants	13 participants	31 participants	0 participants	0 participants	0 participants	0 participants
		36.9 (24.0)		39.1 (40.2)	33.1 (24.0)	28.8 (22.1)	34.2	44.2 (12.7)	58.6 (76.7)	25.9 (11.3)			35.7 (18.2)	40.7 (25.1)
Day 169	Number Analyzed	49 participants	10 participants	27 participants	19 participants	3 participants	1 participants	0 participants	12 participants	13 participants	34 participants	1 participants	13 participants	22 participants	0 participants	6 participants	3 participants	7 participants
		36.6 (25.8)	39.1 (19.8)	31.4 (18.2)	31.9 (14.0)	24.7 (28.1)	10.5		35.3 (20.2)	28.7 (11.4)	47.1 (26.8)	43.6	38.8 (19.2)	49.3 (27.3)		32.5 (14.7)	28.3 (20.0)	37.3 (31.6)

15. Secondary Outcome

Title	Dose Escalation Cohort (Excluding Once Weekly Avelumab 10 mg/kg Cohort): Number of Participants With Immune Related Best Overall Response (irBOR) According to Modified Immune-Related Response Criteria (irRC)
Description	irBOR defined as best response of any of immune related complete response (irCR), immune related partial response (irPR), immune related stable disease (irSD) and immune related progressive disease (irPD) recorded from baseline until immune related disease progression and determined according to modified irRC per investigator assessment. irCR: Complete disappearance of all tumor lesions (both index and non-index lesions with no new measurable/unmeasurable lesions). irPR: At least 30% reduction from baseline in the sum of the longest diameter (SLD) of all lesions). irSD: SLD of target and new measurable lesions neither irCR, irPR, or irPD. irPD: SLD of target and new measurable lesions increases greater than or equal to [>=] 20%, confirmed by a repeat, consecutive observations at least 4 weeks from the date first documented. Number of participants with immune-related best overall response in each category (irCR, irPR, irSD, irPD) was reported.
Time Frame	Dose Escalation: Baseline up to Day 1023

Outcome Measure Data

Analysis Population Description

Safety analysis set included all participants who have received at least 1 dose of study treatment.

Arm/Group Title	Dose Escalation Cohort: Avelumab 1.0 mg/kg	Dose Escalation Cohort: Avelumab 3.0 mg/kg	Dose Escalation Cohort: Avelumab 10.0 mg/kg	Dose Escalation Cohort: Avelumab 20.0 mg/kg
Arm/Group Description:	Participants with metastatic or locally advanced solid tumors received intravenous infusion of Avelumab at a dose of 1.0 milligrams per kilogram (mg/kg) once every 2 weeks in dose escalation cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or investigational medicinal product (IMP) occurs.	Participants with metastatic or locally advanced solid tumors received intravenous infusion of Avelumab at a dose of 3.0 mg/kg once every 2 weeks in dose escalation cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with metastatic or locally advanced solid tumors received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in dose escalation cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with metastatic or locally advanced solid tumors received intravenous infusion of Avelumab at a dose of 20.0 mg/kg once every 2 weeks in dose escalation cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
Overall Number of Participants Analyzed	4	13	15	21
Measure Type: Count of Participants; Unit of Measure: Participants
Immune-related Complete Response	0	0	0	0
Immune-related Partial Response	0	0	1	1
Immune-related Stable Disease	2	8	8	14
Immune-related Progressive Disease	0	5	4	1
Not Evaluable	2	0	2	5

16. Secondary Outcome

Title	Dose Expansion Cohort: Number of Participants With Immune Related Best Overall Response (irBOR) According to Modified Immune-Related Response Criteria (irRC)
Description	irBOR defined as best response of any of immune related complete response (irCR), immune related partial response (irPR), immune related stable disease (irSD) and immune related progressive disease (irPD) recorded from baseline until immune related disease progression and determined according to modified irRC per investigator assessment. irCR: Complete disappearance of all tumor lesions (both index and non-index lesions with no new measurable/unmeasurable lesions). irPR: At least 30% reduction from baseline in the sum of the longest diameter (SLD) of all lesions). irSD: SLD of target and new measurable lesions neither irCR, irPR, or irPD. irPD: SLD of target and new measurable lesions increases greater than or equal to [>=] 20%, confirmed by a repeat, consecutive observations at least 4 weeks from the date first documented. Number of participants with immune-related best overall response in each category (irCR, irPR, irSD, irPD) was reported.
Time Frame	Dose Expansion: Baseline up to Day 2023

Outcome Measure Data

Analysis Population Description

Full analysis set (FAS) included all participants who have received at least 1 dose of study treatment. Here "Overall Number of Participants Analyzed" signifies those participants who were evaluable for this outcome measure.

Arm/Group Title	Primary Expansion Cohort: NSCLC, Post-platinum Doublet	Primary Expansion Cohort: NSCLC, First Line	Primary Expansion Cohort: Metastatic Breast Cancer	Primary Expansion Cohort: GC/GEJC Progressed	Primary Expansion Cohort: GC/GEJC Non Progressed	Secondary Expansion Cohort: Colorectal Cancer	Secondary Expansion Cohort: Castrate-resistant Prostate Cancer	Secondary Expansion Cohort: Adrenocortical Carcinoma	Secondary Expansion Cohort: Melanoma	Secondary Expansion Cohort: Mesothelioma	Secondary Expansion Cohort: Urothelial Carcinoma	Secondary Expansion Cohort: Ovarian Cancer	Secondary Expansion Cohort: Renal Cell Carcinoma (First Line)	Secondary Expansion Cohort: Renal Cell Carcinoma (Second Line)	Efficacy Expansion Cohort: Ovarian Cancer	Efficacy Expansion Cohort: Urothelial Carcinoma	Efficacy Expansion Cohort: GC/GEJC, Third Line	Efficacy Expansion Cohort: HNSCC
Arm/Group Description:	Participants with non-small cell lung cancer (NSCLC), who had progressed after 1 line of platinum-containing doublet chemotherapy received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in primary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with non-small cell lung cancer (NSCLC), first line received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in primary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with metastatic breast cancer received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in primary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with gastric and gastroesophageal cancer who progressed on or after first-line chemotherapy received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in primary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with gastric and gastroesophageal cancer who non-progressed on or after first-line chemotherapy received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in primary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with colorectal cancer received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with castrate-resistant prostate cancer received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with adrenocortical carcinoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with melanoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with mesothelioma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with urothelial carcinoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with ovarian carcinoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with Renal cell carcinoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks as a first-line therapy in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with Renal cell carcinoma who failed 1 prior systemic first-line regimen received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks as a second line treatment in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with ovarian carcinoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in efficacy expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with urothelial carcinoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in efficacy expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with gastric (GC) and gastroesophageal junction cancer (GEJC) who have failed both a first-line chemotherapy regimen and subsequent ramucirumab therapy, received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks as a third-line treatment in efficacy expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with head and neck squamous cell carcinoma (HNSCC) received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in efficacy expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
Overall Number of Participants Analyzed	184	156	168	60	90	21	18	50	51	53	44	125	62	20	103	198	132	153
Measure Type: Count of Participants; Unit of Measure: Participants
Immune-related Complete Response	2	4	1	0	2	0	0	0	4	1	2	1	1	0	3	10	1	6
Immune-related Partial Response	26	31	6	5	4	0	0	3	7	4	5	15	10	2	4	24	7	15
Immune-related Stable Disease	80	78	60	20	53	9	3	26	20	31	21	61	40	15	44	61	29	61
Immune-related Progressive Disease	36	21	69	0	0	5	1	14	11	10	10	27	6	1	33	62	62	44
Not Evaluable	40	22	32	35	31	7	14	7	9	7	6	21	5	2	19	41	33	27

17. Secondary Outcome

Title	Dose Escalation Cohort: Number of Participants With Best Overall Response (BOR) According to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1
Description	BOR was determined according to RECIST v1.1 and as per investigator assessment. BOR is defined as the best response of any of complete response (CR), partial response (PR), stable disease (SD) and progressive disease (PD) recorded from date of randomization until disease progression or recurrence (taking the smallest measurement recorded since start of treatment as reference). CR: Disappearance of all evidence of target and non-target lesions. PR: At least 30 percent (%) reduction from baseline in the sum of the longest diameter (SLD) of all lesions. SD =Neither sufficient increase to qualify for PD nor sufficient shrinkage to qualify for PR. PD is defined as at least a 20 % increase in the SLD, taking as reference the smallest SLD recorded from baseline or appearance of 1 or more new lesions and unequivocal progression of non-target lesions. Number of participants with best overall response in each category (CR, PR, SD, PD) was reported.
Time Frame	Dose Escalation: Baseline up to Day 2511

Outcome Measure Data

Analysis Population Description

Safety analysis set included all participants who have received at least 1 dose of study treatment.

Arm/Group Title	Dose Escalation Cohort: Avelumab 1.0 mg/kg	Dose Escalation Cohort: Avelumab 3.0 mg/kg	Dose Escalation Cohort: Avelumab 10.0 mg/kg	Dose Escalation Cohort: Avelumab 20.0 mg/kg	Dose Escalation Cohort: Avelumab 10.0 mg/kg Weekly
Arm/Group Description:	Participants with metastatic or locally advanced solid tumors received intravenous infusion of Avelumab at a dose of 1.0 milligrams per kilogram (mg/kg) once every 2 weeks in dose escalation cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or investigational medicinal product (IMP) occurs.	Participants with metastatic or locally advanced solid tumors received intravenous infusion of Avelumab at a dose of 3.0 mg/kg once every 2 weeks in dose escalation cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with metastatic or locally advanced solid tumors received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in dose escalation cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with metastatic or locally advanced solid tumors received intravenous infusion of Avelumab at a dose of 20.0 mg/kg once every 2 weeks in dose escalation cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with metastatic or locally advanced solid tumors received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once weekly for the first 12 weeks and once every 2 weeks starting Week 13 in dose escalation cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
Overall Number of Participants Analyzed	4	13	15	21	8
Measure Type: Count of Participants; Unit of Measure: Participants
Complete Response	0	0	0	0	0
Partial Response	0	0	1	1	1
Stable Disease	2	8	8	14	4
Progressive Disease	0	5	4	3	1
Not Evaluable	2	0	2	3	2

18. Secondary Outcome

Title	Dose Expansion Cohort: Number of Participants With Best Overall Response (BOR) According to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1
Description	BOR was determined according to RECIST v1.1 and as per investigator assessment. BOR is defined as the best response of any of complete response (CR), partial response (PR), stable disease (SD) and progressive disease (PD) recorded from date of randomization until disease progression or recurrence (taking the smallest measurement recorded since start of treatment as reference). CR: Disappearance of all evidence of target and non-target lesions. PR: At least 30 percent (%) reduction from baseline in the sum of the longest diameter (SLD) of all lesions. SD = Neither sufficient increase to qualify for PD nor sufficient shrinkage to qualify for PR. PD is defined as at least a 20 % increase in the SLD, taking as reference the smallest SLD recorded from baseline or appearance of 1 or more new lesions and unequivocal progression of non-target lesions. Number of participants with best overall response in each category (CR, PR, SD, PD) was reported.
Time Frame	Dose Expansion: Baseline up to Day 2023

Outcome Measure Data

Analysis Population Description

Full analysis set (FAS) included all participants who have received at least 1 dose of study treatment. Here "Overall Number of Participants Analyzed" signifies those participants who were evaluable for this outcome measure.

Arm/Group Title	Primary Expansion Cohort: NSCLC, Post-platinum Doublet	Primary Expansion Cohort: NSCLC, First Line	Primary Expansion Cohort: Metastatic Breast Cancer	Primary Expansion Cohort: GC/GEJC Progressed	Primary Expansion Cohort: GC/GEJC Non Progressed	Secondary Expansion Cohort: Colorectal Cancer	Secondary Expansion Cohort: Castrate-resistant Prostate Cancer	Secondary Expansion Cohort: Adrenocortical Carcinoma	Secondary Expansion Cohort: Melanoma	Secondary Expansion Cohort: Mesothelioma	Secondary Expansion Cohort: Urothelial Carcinoma	Secondary Expansion Cohort: Ovarian Cancer	Secondary Expansion Cohort: Renal Cell Carcinoma (First Line)	Secondary Expansion Cohort: Renal Cell Carcinoma (Second Line)	Efficacy Expansion Cohort: Ovarian Cancer	Efficacy Expansion Cohort: Urothelial Carcinoma	Efficacy Expansion Cohort: GC/GEJC, Third Line	Efficacy Expansion Cohort: HNSCC
Arm/Group Description:	Participants with non-small cell lung cancer (NSCLC), who had progressed after 1 line of platinum-containing doublet chemotherapy received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in primary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with non-small cell lung cancer (NSCLC), first line received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in primary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with metastatic breast cancer received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in primary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with gastric and gastroesophageal cancer who progressed on or after first-line chemotherapy received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in primary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with gastric and gastroesophageal cancer who non-progressed on or after first-line chemotherapy received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in primary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with colorectal cancer received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with castrate-resistant prostate cancer received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with adrenocortical carcinoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with melanoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with mesothelioma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with urothelial carcinoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with ovarian carcinoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with Renal cell carcinoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks as a first-line therapy in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with Renal cell carcinoma who failed 1 prior systemic first-line regimen received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks as a second line treatment in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with ovarian carcinoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in efficacy expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with urothelial carcinoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in efficacy expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with gastric (GC) and gastroesophageal junction cancer (GEJC) who have failed both a first-line chemotherapy regimen and subsequent ramucirumab therapy, received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks as a third-line treatment in efficacy expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with head and neck squamous cell carcinoma (HNSCC) received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in efficacy expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
Overall Number of Participants Analyzed	184	156	168	60	90	21	18	50	51	53	44	125	62	20	103	198	132	153
Measure Type: Count of Participants; Unit of Measure: Participants
Complete Response	2	3	1	0	2	0	0	0	4	1	2	1	1	0	3	7	1	5
Partial Response	24	28	4	4	4	0	0	3	7	4	4	11	9	2	4	24	7	15
Stable Disease	66	68	41	13	45	9	10	21	16	26	20	53	38	13	37	45	23	50
Progressive Disease	68	40	107	36	29	9	5	22	17	18	14	51	11	4	46	87	80	66
Not Evaluable	24	17	15	7	10	3	3	4	7	4	4	9	3	1	13	35	21	17

19. Secondary Outcome

Title	Dose Expansion Cohort (Secondary Urothelial Carcinoma Cohort): Number of Participants With Confirmed Best Overall Response According to Response Evaluation Criteria in Solid Tumors Version 1.1 as Adjudicated by an Independent Endpoint Review Committee
Description	Confirmed Best Overall Response (BOR) was determined according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1and as adjudicated by an Independent Endpoint Review Committee (IERC) is defined as best response of any of complete response (CR), partial response (PR), stable disease (SD) and progressive disease (PD) recorded from date of randomization until disease progression/recurrence (taking smallest measurement recorded since start of treatment as reference). CR: Disappearance of all evidence of target/non-target lesions. PR: At least 30% reduction from baseline in sum of longest diameter (SLD) of all lesions. SD: Neither sufficient increase to qualify for PD nor sufficient shrinkage to qualify for PR. PD: at least a 20% increase in SLD, taking as reference smallest SLD recorded from baseline/appearance of 1or more new lesions and unequivocal progression of non-target lesions. Number of participants with BOR in each category (CR, PR, SD, PD) were reported.
Time Frame	Secondary Urothelial Carcinoma Dose Expansion: Baseline up to Day 931

Outcome Measure Data

Analysis Population Description

FAS included all participants who have received at least 1 dose of study treatment. This outcome measure was planned to be analyzed in Secondary Urothelial Carcinoma Cohort only.

Arm/Group Title	Secondary Expansion Cohort: Urothelial Carcinoma
Arm/Group Description:	Participants with urothelial carcinoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
Overall Number of Participants Analyzed	44
Measure Type: Count of Participants; Unit of Measure: Participants
Complete Response	6
Partial Response	1
Stable Disease	16
Non-CR/Non-PD	0
Progressive Disease	16
Not Evaluable	5

20. Secondary Outcome

Title	Dose Expansion Cohort: Progression-Free Survival (PFS) Time According to Response Evaluation Criteria in Solid Tumors Version (RECIST) 1.1
Description	The PFS time (based on investigator assessments), according to the RECIST 1.1, was defined as the time from first administration of study treatment until first documentation of progressive disease (PD) or death when death occurred within 12 weeks of the last tumor assessment or first administration of study treatment (whichever was later). PD was defined as at least a 20% increase in the sum of longest diameter (SLD), taking as reference the smallest SLD recorded from baseline or the appearance of 1 or more new lesions and unequivocal progression of non-target lesions. The analysis of PFS was performed with a Kaplan-Meier method.
Time Frame	Dose Expansion: Baseline up to Day 2023

Outcome Measure Data

Analysis Population Description

FAS included all participants who have received at least 1 dose of study treatment. Here "Overall Number of Participants Analyzed" signifies those participants who were evaluable for this outcome measure.

Arm/Group Title	Primary Expansion Cohort: NSCLC, Post-platinum Doublet	Primary Expansion Cohort: NSCLC, First Line	Primary Expansion Cohort: Metastatic Breast Cancer	Primary Expansion Cohort: GC/GEJC Progressed	Primary Expansion Cohort: GC/GEJC Non Progressed	Secondary Expansion Cohort: Colorectal Cancer	Secondary Expansion Cohort: Castrate-resistant Prostate Cancer	Secondary Expansion Cohort: Adrenocortical Carcinoma	Secondary Expansion Cohort: Melanoma	Secondary Expansion Cohort: Mesothelioma	Secondary Expansion Cohort: Urothelial Carcinoma	Secondary Expansion Cohort: Ovarian Cancer	Secondary Expansion Cohort: Renal Cell Carcinoma (First Line)	Secondary Expansion Cohort: Renal Cell Carcinoma (Second Line)	Efficacy Expansion Cohort: Ovarian Cancer	Efficacy Expansion Cohort: Urothelial Carcinoma	Efficacy Expansion Cohort: GC/GEJC, Third Line	Efficacy Expansion Cohort: HNSCC
Arm/Group Description:	Participants with non-small cell lung cancer (NSCLC), who had progressed after 1 line of platinum-containing doublet chemotherapy received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in primary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with non-small cell lung cancer (NSCLC), first line received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in primary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with metastatic breast cancer received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in primary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with gastric and gastroesophageal cancer who progressed on or after first-line chemotherapy received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in primary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with gastric and gastroesophageal cancer who non-progressed on or after first-line chemotherapy received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in primary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with colorectal cancer received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with castrate-resistant prostate cancer received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with adrenocortical carcinoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with melanoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with mesothelioma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with urothelial carcinoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with ovarian carcinoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with Renal cell carcinoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks as a first-line therapy in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with Renal cell carcinoma who failed 1 prior systemic first-line regimen received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks as a second line treatment in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with ovarian carcinoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in efficacy expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with urothelial carcinoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in efficacy expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with gastric (GC) and gastroesophageal junction cancer (GEJC) who have failed both a first-line chemotherapy regimen and subsequent ramucirumab therapy, received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks as a third-line treatment in efficacy expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with head and neck squamous cell carcinoma (HNSCC) received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in efficacy expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
Overall Number of Participants Analyzed	184	156	168	60	90	21	18	50	51	53	44	125	62	20	103	198	132	153
Median (95% Confidence Interval); Unit of Measure: Months
	2.66; (1.91 to 2.79)	4.04; (2.66 to 5.42)	1.35; (1.35 to 1.38)	1.38; (1.31 to 1.48)	2.76; (2.27 to 4.07)	1.41; (1.38 to 5.52)	5.39; (1.41 to 5.52)	2.56; (1.38 to 3.98)	3.06; (1.41 to 6.28)	4.11; (1.41 to 6.18)	2.69; (1.68 to 4.14)	2.60; (1.41 to 2.76)	8.28; (5.52 to 9.53)	5.55; (2.33 to 9.63)	1.45; (1.38 to 2.60)	1.41; (1.38 to 1.74)	1.31; (1.28 to 1.38)	1.77; (1.38 to 2.69)

21. Secondary Outcome

Title	Dose Expansion Cohort: Immune Related Progression-Free Survival (irPFS) Time According to Modified Immune-Related Response Criteria (irRC)
Description	The irPFS time was defined as the time from first administration of study treatment until first documentation of immune-related progressive disease (irPD) or death when death occurred within 12 weeks of the last tumor assessment or first administration of study treatment (whichever was later). irPD: sum of the longest diameters of target and new measurable lesions increases greater than or equal to [>=] 20%, confirmed by a repeat, consecutive observations at least 4 weeks from the date first documented. The analysis of irPFS will be performed with a Kaplan-Meier method. Data for immune related progression-free survival time has been reported.
Time Frame	Dose Expansion: Baseline up to Day 2023

Outcome Measure Data

Analysis Population Description

FAS included all participants who have received at least 1 dose of study treatment. Here "Overall Number of Participants Analyzed" signifies those participants who were evaluable for this outcome measure.

Arm/Group Title	Primary Expansion Cohort: NSCLC, Post-platinum Doublet	Primary Expansion Cohort: NSCLC, First Line	Primary Expansion Cohort: Metastatic Breast Cancer	Primary Expansion Cohort: GC/GEJC Progressed	Primary Expansion Cohort: GC/GEJC Non Progressed	Secondary Expansion Cohort: Colorectal Cancer	Secondary Expansion Cohort: Castrate-resistant Prostate Cancer	Secondary Expansion Cohort: Adrenocortical Carcinoma	Secondary Expansion Cohort: Melanoma	Secondary Expansion Cohort: Mesothelioma	Secondary Expansion Cohort: Urothelial Carcinoma	Secondary Expansion Cohort: Ovarian Cancer	Secondary Expansion Cohort: Renal Cell Carcinoma (First Line)	Secondary Expansion Cohort: Renal Cell Carcinoma (Second Line)	Efficacy Expansion Cohort: Ovarian Cancer	Efficacy Expansion Cohort: Urothelial Carcinoma	Efficacy Expansion Cohort: GC/GEJC, Third Line	Efficacy Expansion Cohort: HNSCC
Arm/Group Description:	Participants with non-small cell lung cancer (NSCLC), who had progressed after 1 line of platinum-containing doublet chemotherapy received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in primary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with non-small cell lung cancer (NSCLC), first line received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in primary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with metastatic breast cancer received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in primary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with gastric and gastroesophageal cancer who progressed on or after first-line chemotherapy received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in primary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with gastric and gastroesophageal cancer who non-progressed on or after first-line chemotherapy received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in primary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with colorectal cancer received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with castrate-resistant prostate cancer received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with adrenocortical carcinoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with melanoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with mesothelioma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with urothelial carcinoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with ovarian carcinoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with Renal cell carcinoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks as a first-line therapy in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with Renal cell carcinoma who failed 1 prior systemic first-line regimen received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks as a second line treatment in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with ovarian carcinoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in efficacy expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with urothelial carcinoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in efficacy expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with gastric (GC) and gastroesophageal junction cancer (GEJC) who have failed both a first-line chemotherapy regimen and subsequent ramucirumab therapy, received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks as a third-line treatment in efficacy expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with head and neck squamous cell carcinoma (HNSCC) received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in efficacy expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
Overall Number of Participants Analyzed	184	156	168	60	90	21	18	50	51	53	44	125	62	20	103	198	132	153
Median (95% Confidence Interval); Unit of Measure: Months
	4.04; (2.76 to 5.49)	6.93; (5.42 to 9.69)	1.64; (1.38 to 2.50)	1.81; (1.35 to 2.53)	4.14; (2.76 to 5.95)	2.79; (1.41 to 5.82)	NA [1]; (1.38 to NA)	3.81; (2.40 to 5.49)	6.83; (2.79 to 11.04)	6.18; (3.94 to 12.45)	4.07; (2.63 to 9.46)	4.04; (2.69 to 5.42)	8.34; (5.98 to 13.04)	6.90; (2.69 to 11.24)	2.60; (1.51 to 3.84)	2.46; (1.48 to 2.76)	1.35; (1.31 to 1.41)	2.83; (2.66 to 4.14)

[1]

Due to small number of events, estimates (Median and upper limit of 95% confidence interval) from Kaplan-Meier survival curves could not derive.

22. Secondary Outcome

Title	Dose Expansion Cohort: Overall Survival (OS) Time
Description	Overall survival time was measured as time in months first administration of trial treatment to death. The analysis of OS time was performed with a Kaplan-Meier method.
Time Frame	Dose Expansion: Baseline up to Day 2023

Outcome Measure Data

Analysis Population Description

FAS included all participants who have received at least 1 dose of study treatment. Here "Overall Number of Participants Analyzed" signifies those participants who were evaluable for this outcome measure.

Arm/Group Title	Primary Expansion Cohort: NSCLC, Post-platinum Doublet	Primary Expansion Cohort: NSCLC, First Line	Primary Expansion Cohort: Metastatic Breast Cancer	Primary Expansion Cohort: GC/GEJC Progressed	Primary Expansion Cohort: GC/GEJC Non Progressed	Secondary Expansion Cohort: Colorectal Cancer	Secondary Expansion Cohort: Castrate-resistant Prostate Cancer	Secondary Expansion Cohort: Adrenocortical Carcinoma	Secondary Expansion Cohort: Melanoma	Secondary Expansion Cohort: Mesothelioma	Secondary Expansion Cohort: Urothelial Carcinoma	Secondary Expansion Cohort: Ovarian Cancer	Secondary Expansion Cohort: Renal Cell Carcinoma (First Line)	Secondary Expansion Cohort: Renal Cell Carcinoma (Second Line)	Efficacy Expansion Cohort: Ovarian Cancer	Efficacy Expansion Cohort: Urothelial Carcinoma	Efficacy Expansion Cohort: GC/GEJC, Third Line	Efficacy Expansion Cohort: HNSCC
Arm/Group Description:	Participants with non-small cell lung cancer (NSCLC), who had progressed after 1 line of platinum-containing doublet chemotherapy received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in primary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with non-small cell lung cancer (NSCLC), first line received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in primary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with metastatic breast cancer received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in primary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with gastric and gastroesophageal cancer who progressed on or after first-line chemotherapy received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in primary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with gastric and gastroesophageal cancer who non-progressed on or after first-line chemotherapy received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in primary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with colorectal cancer received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with castrate-resistant prostate cancer received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with adrenocortical carcinoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with melanoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with mesothelioma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with urothelial carcinoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with ovarian carcinoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with Renal cell carcinoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks as a first-line therapy in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with Renal cell carcinoma who failed 1 prior systemic first-line regimen received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks as a second line treatment in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with ovarian carcinoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in efficacy expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with urothelial carcinoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in efficacy expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with gastric (GC) and gastroesophageal junction cancer (GEJC) who have failed both a first-line chemotherapy regimen and subsequent ramucirumab therapy, received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks as a third-line treatment in efficacy expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with head and neck squamous cell carcinoma (HNSCC) received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in efficacy expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
Overall Number of Participants Analyzed	184	156	168	60	90	21	18	50	51	53	44	125	62	20	103	198	132	153
Median (95% Confidence Interval); Unit of Measure: Months
	8.57; (7.26 to 11.56)	14.23; (11.33 to 16.85)	8.38; (6.47 to 11.07)	6.64; (5.39 to 9.43)	11.07; (8.94 to 13.67)	11.20; (5.82 to 13.27)	19.32 [1]; (13.73 to NA)	10.55; (7.39 to 15.01)	17.22 [1]; (6.18 to NA)	10.71; (6.44 to 20.24)	13.70; (4.60 to 21.13)	11.17; (8.74 to 15.44)	NA [2]; (NA to NA)	16.85 [1]; (8.34 to NA)	9.13; (6.34 to 11.43)	6.97; (5.85 to 8.41)	3.35; (2.86 to 4.47)	7.98; (6.47 to 10.22)

[1]

Due to small number of events, estimate (upper limit of 95% confidence interval) from Kaplan-Meier survival curves could not derive.

[2]

Due to small number of events, estimates (Median, lower and upper limit of 95% confidence interval) from Kaplan-Meier survival curves could not derive.

23. Secondary Outcome

Title	Dose Escalation Cohort (Excluding Once Weekly Avelumab 10 mg/kg Cohort): Programmed Death Ligand 1 (PD-L1) Receptor Occupancy
Description	Percentage of PD-L1 receptors occupied by avelumab on human lymphocytes (CD3+ T-cells) was assessed by flow cytometry on peripheral blood mononuclear cell (PBMC) samples. Greater than or equal to [>=] 85 percent [%] of cell viability was required for reliable receptor occupancy assessment.
Time Frame	Pre-infusion on Day 1; 48 hours after infusion on Day 3; Pre-infusion on Days 15, 43, and 85

Outcome Measure Data

Analysis Population Description

Safety analysis set included all participants who have received at least 1 dose of study treatment. Here "Overall number of participants analyzed" signifies those who were evaluable for this outcome measure and "number analyzed" signifies those who were evaluable for this outcome measure at specified time points.

Arm/Group Title		Dose Escalation Cohort: Avelumab 1.0 mg/kg	Dose Escalation Cohort: Avelumab 3.0 mg/kg	Dose Escalation Cohort: Avelumab 10.0 mg/kg	Dose Escalation Cohort: Avelumab 20.0 mg/kg
Arm/Group Description:		Participants with metastatic or locally advanced solid tumors received intravenous infusion of Avelumab at a dose of 1.0 milligrams per kilogram (mg/kg) once every 2 weeks in dose escalation cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or investigational medicinal product (IMP) occurs.	Participants with metastatic or locally advanced solid tumors received intravenous infusion of Avelumab at a dose of 3.0 mg/kg once every 2 weeks in dose escalation cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with metastatic or locally advanced solid tumors received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in dose escalation cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with metastatic or locally advanced solid tumors received intravenous infusion of Avelumab at a dose of 20.0 mg/kg once every 2 weeks in dose escalation cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
Overall Number of Participants Analyzed		3	7	4	6
Mean (Standard Deviation); Unit of Measure: Percentage of receptors
Day 1	Number Analyzed	0 participants	5 participants	0 participants	6 participants
			0.0 (0.0)		0.0 (0.0)
Day 3	Number Analyzed	2 participants	6 participants	0 participants	5 participants
		92.5 (1.99)	80.1 (14.43)		84.7 (12.83)
Day 15	Number Analyzed	3 participants	7 participants	4 participants	5 participants
		75.7 (22.12)	90.0 (8.11)	93.2 (1.29)	85.0 (8.73)
Day 43	Number Analyzed	1 participants	1 participants	0 participants	0 participants
		30.3	96.8
Day 85	Number Analyzed	1 participants	0 participants	0 participants	0 participants
		19.8

24. Secondary Outcome

Title	Dose Expansion Cohort: Number of Participants With Positive Programmed Death Receptor-1 Ligand-1 (PD-L1) Biomarker Expression in Tumor Tissue
Description	PD-L1 assessment was performed using immunohistochemistry. PD-L1 expression status was classified as positive or negative based on the following cut-offs: For tumor cells: Participants were considered PD-L1 expression positive (negative): - if at least (less than) 5% of the tumor cells show PD-L1 membrane staining >= 1+, respectively. This was used as the primary cut-off; - if at least (less than) 25% of the tumor cells show PD-L1 membrane staining >=2+, respectively. This was considered as secondary cut-off; - if at least (less than) 1% of the tumor cells show PD-L1 membrane staining >=1+, respectively. This was used as the tertiary cut-off; - if at least (less than) 50% of the tumor cells show PD-L1 membrane staining >=1+, respectively. This was used as the '50% cut-off'; - if at least (less than) 80% of the tumor cells show PD-L1 membrane staining ≥1+, respectively. This was used as the '80% cut-off'.
Time Frame	Dose Expansion: Baseline up to Day 2023

Outcome Measure Data

Analysis Population Description

Safety analysis set included all participants who have received at least 1 dose of study treatment. Here "number analyzed" signifies those participants who were evaluable for this outcome measure at specified category.

Arm/Group Title		Primary Expansion Cohort: NSCLC, Post-platinum Doublet	Primary Expansion Cohort: NSCLC, First Line	Primary Expansion Cohort: Metastatic Breast Cancer	Primary Expansion Cohort: GC/GEJC Progressed	Primary Expansion Cohort: GC/GEJC Non Progressed	Secondary Expansion Cohort: Colorectal Cancer	Secondary Expansion Cohort: Castrate-resistant Prostate Cancer	Secondary Expansion Cohort: Adrenocortical Carcinoma	Secondary Expansion Cohort: Melanoma	Secondary Expansion Cohort: Mesothelioma	Secondary Expansion Cohort: Urothelial Carcinoma	Secondary Expansion Cohort: Ovarian Cancer	Secondary Expansion Cohort: Renal Cell Carcinoma (First Line)	Secondary Expansion Cohort: Renal Cell Carcinoma (Second Line)	Efficacy Expansion Cohort: Ovarian Cancer	Efficacy Expansion Cohort: Urothelial Carcinoma	Efficacy Expansion Cohort: GC/GEJC, Third Line	Efficacy Expansion Cohort: HNSCC
Arm/Group Description:		Participants with non-small cell lung cancer (NSCLC), who had progressed after 1 line of platinum-containing doublet chemotherapy received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in primary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with non-small cell lung cancer (NSCLC), first line received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in primary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with metastatic breast cancer received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in primary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with gastric and gastroesophageal cancer who progressed on or after first-line chemotherapy received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in primary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with gastric and gastroesophageal cancer who non-progressed on or after first-line chemotherapy received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in primary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with colorectal cancer received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with castrate-resistant prostate cancer received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with adrenocortical carcinoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with melanoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with mesothelioma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with urothelial carcinoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with ovarian carcinoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with Renal cell carcinoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks as a first-line therapy in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with Renal cell carcinoma who failed 1 prior systemic first-line regimen received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks as a second line treatment in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with ovarian carcinoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in efficacy expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with urothelial carcinoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in efficacy expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with gastric (GC) and gastroesophageal junction cancer (GEJC) who have failed both a first-line chemotherapy regimen and subsequent ramucirumab therapy, received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks as a third-line treatment in efficacy expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with head and neck squamous cell carcinoma (HNSCC) received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in efficacy expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
Overall Number of Participants Analyzed		184	156	168	60	90	21	18	50	51	53	44	125	62	20	103	205	132	153
Measure Type: Count of Participants; Unit of Measure: Participants
PD-L1 expression status - 1% cutoff	Number Analyzed	184 participants	156 participants	168 participants	60 participants	90 participants	21 participants	18 participants	50 participants	51 participants	53 participants	44 participants	125 participants	62 participants	20 participants	103 participants	205 participants	132 participants	153 participants
		122	88	87	20	26	5	0	15	19	22	14	76	20	4	45	87	39	107
PD-L1 expression status - 5% cutoff	Number Analyzed	184 participants	156 participants	168 participants	0 participants	0 participants	21 participants	18 participants	50 participants	51 participants	53 participants	44 participants	125 participants	62 participants	20 participants	103 participants	205 participants	132 participants	153 participants
		84	76	25			1	0	12	15	16	13	32	11	1	23	72	16	93
PD-L1 expression status - 25% cutoff	Number Analyzed	184 participants	156 participants	168 participants	0 participants	0 participants	21 participants	18 participants	50 participants	51 participants	53 participants	44 participants	125 participants	62 participants	20 participants	103 participants	205 participants	132 participants	153 participants
		53	50	3			0	0	3	7	8	5	3	2	0	6	25	6	48
PD-L1 expression status - 50% cutoff	Number Analyzed	184 participants	156 participants	168 participants	0 participants	0 participants	21 participants	18 participants	50 participants	51 participants	53 participants	44 participants	125 participants	62 participants	20 participants	103 participants	205 participants	0 participants	153 participants
		54	53	13			1	0	5	8	5	5	2	1	0	4	34		51
PD-L1 expression status - 80% cutoff	Number Analyzed	184 participants	156 participants	0 participants	0 participants	0 participants	0 participants	18 participants	50 participants	51 participants	53 participants	44 participants	125 participants	62 participants	20 participants	103 participants	205 participants	0 participants	153 participants
		41	38					0	2	2	2	3	2	0	0	0	25		28

25. Secondary Outcome

Title	Primary Expansion Cohorts: Number of Participants With Unconfirmed Response at Week 13 According to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1
Description	The response criteria evaluation was carried out according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1. CR and PR did not need to be confirmed by a subsequent tumor assessment due to blinded central assessment. CR: Disappearance of all target lesions since baseline; PR: At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum of diameters; SD: Neither sufficient increase to qualify for PD nor sufficient shrinkage to qualify for PR and PD: at least a 20% increase in SLD, taking as reference smallest SLD recorded from baseline/appearance of 1or more new lesions and unequivocal progression of non-target lesions. Number of participants with unconfirmed response at week 13 according to response evaluation criteria in solid tumors (RECIST) version 1.1 were reported.
Time Frame	Week 13

Outcome Measure Data

Analysis Population Description

Efficacy analysis set included all participants who have received at least 1 dose of study treatment and have measurable disease at baseline according to investigator assessment. This outcome measure was planned to be analyzed in Primary expansion cohorts only

Arm/Group Title	Primary Expansion Cohort: NSCLC, Post-platinum Doublet	Primary Expansion Cohort: NSCLC, First Line	Primary Expansion Cohort: Metastatic Breast Cancer	Primary Expansion Cohort: GC/GEJC Progressed	Primary Expansion Cohort: GC/GEJC Non Progressed
Arm/Group Description:	Participants with non-small cell lung cancer (NSCLC), who had progressed after 1 line of platinum-containing doublet chemotherapy received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in primary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with non-small cell lung cancer (NSCLC), first line received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in primary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with metastatic breast cancer received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in primary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with gastric and gastroesophageal cancer who progressed on or after first-line chemotherapy received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in primary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with gastric and gastroesophageal cancer who non-progressed on or after first-line chemotherapy received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in primary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
Overall Number of Participants Analyzed	184	156	168	60	90
Measure Type: Count of Participants; Unit of Measure: Participants
Unconfirmed Complete Response	2	1	1	0	2
Unconfirmed Partial Response	28	24	7	6	5
Unconfirmed Stable Disease	62	54	38	11	44
Unconfirmed Progressive Disease	68	28	107	37	31
Non-evaluable	24	49	15	6	8

26. Secondary Outcome

Title	Dose Expansion Cohort: Duration of Response According to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 Per Investigator Assessment
Description	Duration of response according to RECIST 1.1, per investigator assessment was calculated for each participant with a confirmed response (complete response [CR] or partial response [PR]) as the time from the first observation of response to the first observation of documented disease progression (or death within 12 weeks of the last tumor assessment). CR: Disappearance of all evidence of target and non-target lesions. PR: At least 30 percent (%) reduction from baseline in the sum of the longest diameter (SLD) of all lesions. Results were calculated based on Kaplan-Meier estimates.
Time Frame	Dose Expansion: Baseline up to Day 2023

Outcome Measure Data

Analysis Population Description

FAS included all participants who have received at least 1 dose of study treatment. Data for this outcome measure is reported for the participants with Complete or Partial response.

Arm/Group Title	Primary Expansion Cohort: NSCLC, Post-platinum Doublet	Primary Expansion Cohort: NSCLC, First Line	Primary Expansion Cohort: Metastatic Breast Cancer	Primary Expansion Cohort: GC/GEJC Progressed	Primary Expansion Cohort: GC/GEJC Non Progressed	Secondary Expansion Cohort: Colorectal Cancer	Secondary Expansion Cohort: Castrate-resistant Prostate Cancer	Secondary Expansion Cohort: Adrenocortical Carcinoma	Secondary Expansion Cohort: Melanoma	Secondary Expansion Cohort: Mesothelioma	Secondary Expansion Cohort: Urothelial Carcinoma	Secondary Expansion Cohort: Ovarian Cancer	Secondary Expansion Cohort: Renal Cell Carcinoma (First Line)	Secondary Expansion Cohort: Renal Cell Carcinoma (Second Line)	Efficacy Expansion Cohort: Ovarian Cancer	Efficacy Expansion Cohort: Urothelial Carcinoma	Efficacy Expansion Cohort: GC/GEJC, Third Line	Efficacy Expansion Cohort: HNSCC
Arm/Group Description:	Participants with non-small cell lung cancer (NSCLC), who had progressed after 1 line of platinum-containing doublet chemotherapy received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in primary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with non-small cell lung cancer (NSCLC), first line received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in primary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with metastatic breast cancer received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in primary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with gastric and gastroesophageal cancer who progressed on or after first-line chemotherapy received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in primary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with gastric and gastroesophageal cancer who non-progressed on or after first-line chemotherapy received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in primary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with colorectal cancer received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with castrate-resistant prostate cancer received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with adrenocortical carcinoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with melanoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with mesothelioma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with urothelial carcinoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with ovarian carcinoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with Renal cell carcinoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks as a first-line therapy in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with Renal cell carcinoma who failed 1 prior systemic first-line regimen received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks as a second line treatment in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with ovarian carcinoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in efficacy expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with urothelial carcinoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in efficacy expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with gastric (GC) and gastroesophageal junction cancer (GEJC) who have failed both a first-line chemotherapy regimen and subsequent ramucirumab therapy, received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks as a third-line treatment in efficacy expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with head and neck squamous cell carcinoma (HNSCC) received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in efficacy expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
Overall Number of Participants Analyzed	26	31	5	4	6	0	0	3	11	5	6	12	10	2	7	31	8	20
Median (95% Confidence Interval); Unit of Measure: Months
	17.48; (6.93 to 21.39)	12.02; (6.93 to 21.75)	8.33; (6.60 to 22.67)	3.48; (2.76 to 8.34)	21.42 [1]; (4.04 to NA)			8.41 [1]; (6.80 to NA)	NA [2]; (2.63 to NA)	15.21 [1]; (11.07 to NA)	NA [3]; (NA to NA)	10.38 [1]; (4.17 to NA)	9.94 [1]; (2.79 to NA)	NA [2]; (6.93 to NA)	NA [2]; (2.69 to NA)	NA [3]; (NA to NA)	NA [2]; (2.79 to NA)	NA [2]; (8.31 to NA)

[1]

Due to small number of events, estimate (upper limit of 95% confidence interval) from Kaplan-Meier survival curves could not derive.

[2]

Due to small number of events, estimates (median and upper limit of 95% confidence interval) from Kaplan-Meier survival curves could not derive.

[3]

As per planned analysis, data was analyzed in form of graph and no descriptive analysis was performed.

27. Secondary Outcome

Title	Dose Expansion Cohort: Duration of Response According to Modified Immune-Related Response Criteria (irRC) Per Investigator Assessment
Description	Duration of response according to modified irRC, per investigator assessment was calculated for each participant with a confirmed response (immune-related complete response [irCR] or immune-related partial response [irPR]) as the time from the first observation of response to the first observation of documented disease progression (or death within 12 weeks of the last tumor assessment). irCR: Complete disappearance of all tumor lesions (both index and non-index lesions with no new measurable/unmeasurable lesions). irPR: At least 30% reduction from baseline in the sum of the longest diameter (SLD) of all lesions). Results were calculated based on Kaplan-Meier estimates.
Time Frame	Dose Expansion: Baseline up to Day 2023

Outcome Measure Data

Analysis Population Description

FAS included all participants who have received at least 1 dose of study treatment. Data for this outcome measure is reported for the participants with Complete or Partial response.

Arm/Group Title	Primary Expansion Cohort: NSCLC, Post-platinum Doublet	Primary Expansion Cohort: NSCLC, First Line	Primary Expansion Cohort: Metastatic Breast Cancer	Primary Expansion Cohort: GC/GEJC Progressed	Primary Expansion Cohort: GC/GEJC Non Progressed	Secondary Expansion Cohort: Colorectal Cancer	Secondary Expansion Cohort: Castrate-resistant Prostate Cancer	Secondary Expansion Cohort: Adrenocortical Carcinoma	Secondary Expansion Cohort: Melanoma	Secondary Expansion Cohort: Mesothelioma	Secondary Expansion Cohort: Urothelial Carcinoma	Secondary Expansion Cohort: Ovarian Cancer	Secondary Expansion Cohort: Renal Cell Carcinoma (First Line)	Secondary Expansion Cohort: Renal Cell Carcinoma (Second Line)	Efficacy Expansion Cohort: Ovarian Cancer	Efficacy Expansion Cohort: Urothelial Carcinoma	Efficacy Expansion Cohort: GC/GEJC, Third Line	Efficacy Expansion Cohort: HNSCC
Arm/Group Description:	Participants with non-small cell lung cancer (NSCLC), who had progressed after 1 line of platinum-containing doublet chemotherapy received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in primary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with non-small cell lung cancer (NSCLC), first line received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in primary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with metastatic breast cancer received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in primary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with gastric and gastroesophageal cancer who progressed on or after first-line chemotherapy received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in primary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with gastric and gastroesophageal cancer who non-progressed on or after first-line chemotherapy received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in primary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with colorectal cancer received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with castrate-resistant prostate cancer received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with adrenocortical carcinoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with melanoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with mesothelioma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with urothelial carcinoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with ovarian carcinoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with Renal cell carcinoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks as a first-line therapy in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with Renal cell carcinoma who failed 1 prior systemic first-line regimen received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks as a second line treatment in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with ovarian carcinoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in efficacy expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with urothelial carcinoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in efficacy expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with gastric (GC) and gastroesophageal junction cancer (GEJC) who have failed both a first-line chemotherapy regimen and subsequent ramucirumab therapy, received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks as a third-line treatment in efficacy expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with head and neck squamous cell carcinoma (HNSCC) received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in efficacy expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
Overall Number of Participants Analyzed	28	35	7	5	6	0	0	3	11	5	7	16	11	2	7	34	8	21
Median (95% Confidence Interval); Unit of Measure: Months
	21.13 [1]; (11.07 to NA)	NA [2]; (NA to NA)	8.31; (6.60 to 22.67)	4.14; (2.83 to 8.34)	22.23 [1]; (4.04 to NA)			NA [2]; (NA to NA)	NA [3]; (2.63 to NA)	15.21 [1]; (11.07 to NA)	NA [4]; (NA to NA)	NA [3]; (4.24 to NA)	10.61 [1]; (2.79 to NA)	NA [3]; (6.93 to NA)	NA [2]; (NA to NA)	NA [4]; (NA to NA)	NA [3]; (2.79 to NA)	NA [3]; (12.45 to NA)

[1]

Due to small number of events, estimate (upper limit of 95% confidence interval) from Kaplan-Meier survival curves could not derive.

[2]

Median, lower and upper limit of confidence interval could not be calculated because no participant had an event.

[3]

Due to small number of events, estimates (median and upper limit of 95% confidence interval) from Kaplan-Meier survival curves could not derive.

[4]

As per planned analysis, data was analyzed in form of graph and no descriptive analysis was performed.

28. Secondary Outcome

Title	Efficacy Expansion Cohorts: Duration of Response According to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 as Per Independent Endpoint Review Committee (IERC)
Description	Duration of response according to modified irRC, per investigator assessment was calculated for each participant with a confirmed response (immune-related complete response [irCR] or immune-related partial response [irPR]) as the time from the first observation of response to the first observation of documented disease progression (or death within 12 weeks of the last tumor assessment). irCR: Complete disappearance of all tumor lesions (both index and non-index lesions with no new measurable/unmeasurable lesions). irPR: At least 30% reduction from baseline in the sum of the longest diameter (SLD) of all lesions). Results were calculated based on Kaplan-Meier estimates.
Time Frame	Efficacy Expansion: Baseline up to Day 1072

Outcome Measure Data

Analysis Population Description

FAS included all participants who have received at least 1 dose of study treatment. Here "Overall number of participants analyzed" signifies those who were evaluable for this outcome measure. This outcome measure was planned to be analyzed in Efficacy expansion cohorts only.

Arm/Group Title	Efficacy Expansion Cohort: Ovarian Cancer	Efficacy Expansion Cohort: Urothelial Carcinoma	Efficacy Expansion Cohort: GC/GEJC, Third Line	Efficacy Expansion Cohort: HNSCC
Arm/Group Description:	Participants with ovarian carcinoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in efficacy expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with urothelial carcinoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in efficacy expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with gastric (GC) and gastroesophageal junction cancer (GEJC) who have failed both a first-line chemotherapy regimen and subsequent ramucirumab therapy, received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks as a third-line treatment in efficacy expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with head and neck squamous cell carcinoma (HNSCC) received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in efficacy expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
Overall Number of Participants Analyzed	4	32	7	14
Median (95% Confidence Interval); Unit of Measure: Months
	NA [1]; (NA to NA)	NA [2]; (9.00 to NA)	NA [2]; (4.24 to NA)	NA [2]; (4.17 to NA)

[1]

Median, lower and upper limit of confidence interval could not be calculated because no participant had an event.

[2]

Due to small number of events, estimates (Median and upper limit of 95%confidence interval) from Kaplan-Meier survival curves could not be derived.

29. Secondary Outcome

Title	Efficacy Expansion Cohorts: Progression-Free Survival (PFS) Time According to Response Evaluation Criteria in Solid Tumors Version (RECIST) 1.1 as Per Independent Endpoint Review Committee (IERC)
Description	The PFS time (based on IERC), according to the RECIST 1.1, was defined as the time from first administration of study treatment until first documentation of progressive disease (PD) or death when death occurred within 12 weeks of the last tumor assessment or first administration of study treatment (whichever was later). PD was defined as at least a 20% increase in the sum of longest diameter (SLD), taking as reference the smallest SLD recorded from baseline or the appearance of 1 or more new lesions and unequivocal progression of non-target lesions. The analysis of PFS was performed with a Kaplan-Meier method.
Time Frame	Efficacy Expansion: Baseline up to Day 1072

Outcome Measure Data

Analysis Population Description

FAS included all participants who have received at least 1 dose of study treatment. Here "Overall number of participants analyzed" signifies those who were evaluable for this outcome measure. This outcome measure was planned to be analyzed in Efficacy expansion cohorts only.

Arm/Group Title	Efficacy Expansion Cohort: Ovarian Cancer	Efficacy Expansion Cohort: Urothelial Carcinoma	Efficacy Expansion Cohort: GC/GEJC, Third Line	Efficacy Expansion Cohort: HNSCC
Arm/Group Description:	Participants with ovarian carcinoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in efficacy expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with urothelial carcinoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in efficacy expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with gastric (GC) and gastroesophageal junction cancer (GEJC) who have failed both a first-line chemotherapy regimen and subsequent ramucirumab therapy, received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks as a third-line treatment in efficacy expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with head and neck squamous cell carcinoma (HNSCC) received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in efficacy expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
Overall Number of Participants Analyzed	103	198	132	153
Median (95% Confidence Interval); Unit of Measure: Months
	1.87; (1.41 to 2.66)	1.45; (1.38 to 2.56)	1.31; (1.28 to 1.38)	1.41; (1.38 to 2.63)

30. Secondary Outcome

Title	Dose Escalation Cohort (Excluding Once Weekly Avelumab 10 mg/kg Cohort): Number of Participants With at Least 1 Positive Anti Drug Antibodies (ADA)
Description	Serum samples were analyzed by a validated electrochemiluminescence immunoassay to detect the presence of antidrug antibodies (ADA). Number of participants with ADA positive results for Avelumab were reported.
Time Frame	Dose Escalation: Baseline up to Day 1023

Outcome Measure Data

Analysis Population Description

Safety analysis set included all participants who have received at least 1 dose of study treatment. Here "Overall number of participants analyzed" signifies those who were evaluable for this outcome measure.

Arm/Group Title	Dose Escalation Cohort: Avelumab 1.0 mg/kg	Dose Escalation Cohort: Avelumab 3.0 mg/kg	Dose Escalation Cohort: Avelumab 10.0 mg/kg	Dose Escalation Cohort: Avelumab 20.0 mg/kg
Arm/Group Description:	Participants with metastatic or locally advanced solid tumors received intravenous infusion of Avelumab at a dose of 1.0 milligrams per kilogram (mg/kg) once every 2 weeks in dose escalation cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or investigational medicinal product (IMP) occurs.	Participants with metastatic or locally advanced solid tumors received intravenous infusion of Avelumab at a dose of 3.0 mg/kg once every 2 weeks in dose escalation cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with metastatic or locally advanced solid tumors received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in dose escalation cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with metastatic or locally advanced solid tumors received intravenous infusion of Avelumab at a dose of 20.0 mg/kg once every 2 weeks in dose escalation cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
Overall Number of Participants Analyzed	3	13	9	20
Measure Type: Count of Participants; Unit of Measure: Participants
	0	2	0	0

31. Secondary Outcome

Title	Dose Expansion Cohort: Number of Participants With Atleast 1 Positive Anti Drug Antibodies (ADA) Assay
Description	Serum samples were analyzed by a validated electrochemiluminescence immunoassay to detect the presence of antidrug antibodies (ADA). Number of participants with ADA positive results for Avelumab were reported.
Time Frame	Dose Expansion: Baseline up to Day 2023

Outcome Measure Data

Analysis Population Description

Safety analysis set included all participants who have received at least 1 dose of study treatment. Here "Overall number of participants analyzed" signifies those who were evaluable for this outcome measure.

Arm/Group Title	Primary Expansion Cohort: NSCLC, Post-platinum Doublet	Primary Expansion Cohort: NSCLC, First Line	Primary Expansion Cohort: Metastatic Breast Cancer	Primary Expansion Cohort: GC/GEJC Progressed	Primary Expansion Cohort: GC/GEJC Non Progressed	Secondary Expansion Cohort: Colorectal Cancer	Secondary Expansion Cohort: Castrate-resistant Prostate Cancer	Secondary Expansion Cohort: Adrenocortical Carcinoma	Secondary Expansion Cohort: Melanoma	Secondary Expansion Cohort: Mesothelioma	Secondary Expansion Cohort: Urothelial Carcinoma	Secondary Expansion Cohort: Ovarian Cancer	Secondary Expansion Cohort: Renal Cell Carcinoma (First Line)	Secondary Expansion Cohort: Renal Cell Carcinoma (Second Line)	Efficacy Expansion Cohort: Ovarian Cancer	Efficacy Expansion Cohort: Urothelial Carcinoma	Efficacy Expansion Cohort: GC/GEJC, Third Line	Efficacy Expansion Cohort: HNSCC
Arm/Group Description:	Participants with non-small cell lung cancer (NSCLC), who had progressed after 1 line of platinum-containing doublet chemotherapy received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in primary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with non-small cell lung cancer (NSCLC), first line received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in primary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with metastatic breast cancer received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in primary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with gastric and gastroesophageal cancer who progressed on or after first-line chemotherapy received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in primary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with gastric and gastroesophageal cancer who non-progressed on or after first-line chemotherapy received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in primary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with colorectal cancer received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with castrate-resistant prostate cancer received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with adrenocortical carcinoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with melanoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with mesothelioma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with urothelial carcinoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with ovarian carcinoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with Renal cell carcinoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks as a first-line therapy in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with Renal cell carcinoma who failed 1 prior systemic first-line regimen received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks as a second line treatment in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with ovarian carcinoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in efficacy expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with urothelial carcinoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in efficacy expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with gastric (GC) and gastroesophageal junction cancer (GEJC) who have failed both a first-line chemotherapy regimen and subsequent ramucirumab therapy, received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks as a third-line treatment in efficacy expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with head and neck squamous cell carcinoma (HNSCC) received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in efficacy expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
Overall Number of Participants Analyzed	184	155	168	60	90	21	18	50	51	53	43	125	61	20	103	201	130	151
Measure Type: Count of Participants; Unit of Measure: Participants
	17	9	17	3	6	0	0	4	5	3	2	5	5	3	5	17	6	5

Adverse Events

Time Frame

Baseline up to Day 2511

Adverse Event Reporting Description

[Not Specified]

Arm/Group Title

Dose Escalation Cohort: Avelumab 1.0 mg/kg

Dose Escalation Cohort: Avelumab 3.0 mg/kg

Dose Escalation Cohort: Avelumab 10.0 mg/kg

Dose Escalation Cohort: Avelumab 20.0 mg/kg

Dose Escalation Cohort: Avelumab 10.0 mg/kg Weekly

Primary Expansion Cohort: NSCLC, Post-platinum Doublet

Primary Expansion Cohort: NSCLC, First Line

Primary Expansion Cohort: Metastatic Breast Cancer

Primary Expansion Cohort: GC/GEJC Progressed

Primary Expansion Cohort: GC/GEJC Non Progressed

Secondary Expansion Cohort: Colorectal Cancer

Secondary Expansion Cohort: Castrate-resistant Prostate Cancer

Secondary Expansion Cohort: Adrenocortical Carcinoma

Secondary Expansion Cohort: Melanoma

Secondary Expansion Cohort: Mesothelioma

Secondary Expansion Cohort: Urothelial Carcinoma

Secondary Expansion Cohort: Ovarian Cancer

Secondary Expansion Cohort: Renal Cell Carcinoma (First Line)

Secondary Expansion Cohort: Renal Cell Carcinoma (Second Line)

Efficacy Expansion Cohort: Ovarian Cancer

Efficacy Expansion Cohort: Urothelial Carcinoma

Efficacy Expansion Cohort: GC/GEJC, Third Line

Efficacy Expansion Cohort: HNSCC

Arm/Group Description

Participants with metastatic or locally advanced solid tumors received intravenous infusion of Avelumab at a dose of 1.0 mg/kg once every 2 weeks in dose escalation cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.

Participants with metastatic or locally advanced solid tumors received intravenous infusion of Avelumab at a dose of 3.0 milligrams per kilogram (mg/kg) once every 2 weeks in dose escalation cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or investigational medicinal product (IMP) occurs.

Participants with metastatic or locally advanced solid tumors received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in dose escalation cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.

Participants with metastatic or locally advanced solid tumors received intravenous infusion of Avelumab at a dose of 20.0 mg/kg once every 2 weeks in dose escalation cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.

Participants with metastatic or locally advanced solid tumors received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once weekly for the first 12 weeks and once every 2 weeks starting Week 13 in dose escalation cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.

Participants with non-small cell lung cancer (NSCLC), who had progressed after 1 line of platinum-containing doublet chemotherapy received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in primary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.

Participants with non-small cell lung cancer (NSCLC), first line received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in primary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.

Participants with metastatic breast cancer received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in primary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.

Participants with gastric and gastroesophageal cancer who progressed on or after first-line chemotherapy received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in primary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.

Participants with gastric and gastroesophageal cancer who non-progressed on or after first-line chemotherapy received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in primary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.

Participants with colorectal cancer received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.

Participants with castrate-resistant prostate cancer received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.

Participants with adrenocortical carcinoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.

Participants with melanoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.

Participants with mesothelioma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.

Participants with urothelial carcinoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.

Participants with ovarian carcinoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.

Participants with Renal cell carcinoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks as a first-line therapy in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.

Participants with Renal cell carcinoma who failed 1 prior systemic first-line regimen received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks as a second line treatment in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.

Participants with ovarian carcinoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in efficacy expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.

Participants with urothelial carcinoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in efficacy expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.

Participants with gastric (GC) and gastroesophageal junction cancer (GEJC) who have failed both a first-line chemotherapy regimen and subsequent ramucirumab therapy, received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks as a third-line treatment in efficacy expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.

Participants with head and neck squamous cell carcinoma (HNSCC) received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in efficacy expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.

All-Cause Mortality

Dose Escalation Cohort: Avelumab 1.0 mg/kg

Dose Escalation Cohort: Avelumab 3.0 mg/kg

Dose Escalation Cohort: Avelumab 10.0 mg/kg

Dose Escalation Cohort: Avelumab 20.0 mg/kg

Dose Escalation Cohort: Avelumab 10.0 mg/kg Weekly

Primary Expansion Cohort: NSCLC, Post-platinum Doublet

Primary Expansion Cohort: NSCLC, First Line

Primary Expansion Cohort: Metastatic Breast Cancer

Primary Expansion Cohort: GC/GEJC Progressed

Primary Expansion Cohort: GC/GEJC Non Progressed

Secondary Expansion Cohort: Colorectal Cancer

Secondary Expansion Cohort: Castrate-resistant Prostate Cancer

Secondary Expansion Cohort: Adrenocortical Carcinoma

Secondary Expansion Cohort: Melanoma

Secondary Expansion Cohort: Mesothelioma

Secondary Expansion Cohort: Urothelial Carcinoma

Secondary Expansion Cohort: Ovarian Cancer

Secondary Expansion Cohort: Renal Cell Carcinoma (First Line)

Secondary Expansion Cohort: Renal Cell Carcinoma (Second Line)

Efficacy Expansion Cohort: Ovarian Cancer

Efficacy Expansion Cohort: Urothelial Carcinoma

Efficacy Expansion Cohort: GC/GEJC, Third Line

Efficacy Expansion Cohort: HNSCC

Affected / at Risk (%)

Affected / at Risk (%)

Affected / at Risk (%)

Affected / at Risk (%)

Affected / at Risk (%)

Affected / at Risk (%)

Affected / at Risk (%)

Affected / at Risk (%)

Affected / at Risk (%)

Affected / at Risk (%)

Affected / at Risk (%)

Affected / at Risk (%)

Affected / at Risk (%)

Affected / at Risk (%)

Affected / at Risk (%)

Affected / at Risk (%)

Affected / at Risk (%)

Affected / at Risk (%)

Affected / at Risk (%)

Affected / at Risk (%)

Affected / at Risk (%)

Affected / at Risk (%)

Affected / at Risk (%)

Total

4/4 (100.00%)

11/13 (84.62%)

11/15 (73.33%)

16/21 (76.19%)

2/8 (25.00%)

161/184 (87.50%)

124/156 (79.49%)

141/168 (83.93%)

50/60 (83.33%)

75/90 (83.33%)

18/21 (85.71%)

7/18 (38.89%)

27/50 (54.00%)

25/51 (49.02%)

34/53 (64.15%)

31/44 (70.45%)

87/125 (69.60%)

17/62 (27.42%)

14/20 (70.00%)

71/103 (68.93%)

129/205 (62.93%)

118/132 (89.39%)

129/153 (84.31%)

Serious Adverse Events

Dose Escalation Cohort: Avelumab 1.0 mg/kg

Dose Escalation Cohort: Avelumab 3.0 mg/kg

Dose Escalation Cohort: Avelumab 10.0 mg/kg

Dose Escalation Cohort: Avelumab 20.0 mg/kg

Dose Escalation Cohort: Avelumab 10.0 mg/kg Weekly

Primary Expansion Cohort: NSCLC, Post-platinum Doublet

Primary Expansion Cohort: NSCLC, First Line

Primary Expansion Cohort: Metastatic Breast Cancer

Primary Expansion Cohort: GC/GEJC Progressed

Primary Expansion Cohort: GC/GEJC Non Progressed

Secondary Expansion Cohort: Colorectal Cancer

Secondary Expansion Cohort: Castrate-resistant Prostate Cancer

Secondary Expansion Cohort: Adrenocortical Carcinoma

Secondary Expansion Cohort: Melanoma

Secondary Expansion Cohort: Mesothelioma

Secondary Expansion Cohort: Urothelial Carcinoma

Secondary Expansion Cohort: Ovarian Cancer

Secondary Expansion Cohort: Renal Cell Carcinoma (First Line)

Secondary Expansion Cohort: Renal Cell Carcinoma (Second Line)

Efficacy Expansion Cohort: Ovarian Cancer

Efficacy Expansion Cohort: Urothelial Carcinoma

Efficacy Expansion Cohort: GC/GEJC, Third Line

Efficacy Expansion Cohort: HNSCC

Affected / at Risk (%)

# Events

Affected / at Risk (%)

# Events

Affected / at Risk (%)

# Events

Affected / at Risk (%)

# Events

Affected / at Risk (%)

# Events

Affected / at Risk (%)

# Events

Affected / at Risk (%)

# Events

Affected / at Risk (%)

# Events

Affected / at Risk (%)

# Events

Affected / at Risk (%)

# Events

Affected / at Risk (%)

# Events

Affected / at Risk (%)

# Events

Affected / at Risk (%)

# Events

Affected / at Risk (%)

# Events

Affected / at Risk (%)

# Events

Affected / at Risk (%)

# Events

Affected / at Risk (%)

# Events

Affected / at Risk (%)

# Events

Affected / at Risk (%)

# Events

Affected / at Risk (%)

# Events

Affected / at Risk (%)

# Events

Affected / at Risk (%)

# Events

Affected / at Risk (%)

# Events

Total

3/4 (75.00%)

6/13 (46.15%)

6/15 (40.00%)

8/21 (38.10%)

0/8 (0.00%)

95/184 (51.63%)

80/156 (51.28%)

66/168 (39.29%)

36/60 (60.00%)

44/90 (48.89%)

8/21 (38.10%)

2/18 (11.11%)

32/50 (64.00%)

24/51 (47.06%)

22/53 (41.51%)

19/44 (43.18%)

42/125 (33.60%)

14/62 (22.58%)

7/20 (35.00%)

48/103 (46.60%)

114/205 (55.61%)

87/132 (65.91%)

73/153 (47.71%)

Blood and lymphatic system disorders

Anaemia * 1

0/4 (0.00%)

0/13 (0.00%)

0/15 (0.00%)

0/21 (0.00%)

0/8 (0.00%)

3/184 (1.63%)

0/156 (0.00%)

3/168 (1.79%)

3/60 (5.00%)

3/90 (3.33%)

0/21 (0.00%)

0/18 (0.00%)

0/50 (0.00%)

1/51 (1.96%)

0/53 (0.00%)

1/44 (2.27%)

1/125 (0.80%)

0/62 (0.00%)

0/20 (0.00%)

0/103 (0.00%)

3/205 (1.46%)

2/132 (1.52%)

1/153 (0.65%)

Autoimmune neutropenia * 1

0/4 (0.00%)

0/13 (0.00%)

0/15 (0.00%)

0/21 (0.00%)

0/8 (0.00%)

1/184 (0.54%)

0/156 (0.00%)

0/168 (0.00%)

0/60 (0.00%)

0/90 (0.00%)

0/21 (0.00%)

0/18 (0.00%)

0/50 (0.00%)

0/51 (0.00%)

0/53 (0.00%)

0/44 (0.00%)

0/125 (0.00%)

0/62 (0.00%)

0/20 (0.00%)

0/103 (0.00%)

0/205 (0.00%)

0/132 (0.00%)

0/153 (0.00%)

Blood loss anaemia * 1

0/4 (0.00%)

0/13 (0.00%)

0/15 (0.00%)

0/21 (0.00%)

0/8 (0.00%)

1/184 (0.54%)

0/156 (0.00%)

0/168 (0.00%)

0/60 (0.00%)

0/90 (0.00%)

0/21 (0.00%)

0/18 (0.00%)

0/50 (0.00%)

0/51 (0.00%)

0/53 (0.00%)

0/44 (0.00%)

0/125 (0.00%)

0/62 (0.00%)

0/20 (0.00%)

0/103 (0.00%)

0/205 (0.00%)

0/132 (0.00%)

0/153 (0.00%)

Pancytopenia * 1

0/4 (0.00%)

0/13 (0.00%)

0/15 (0.00%)

0/21 (0.00%)

0/8 (0.00%)

1/184 (0.54%)

0/156 (0.00%)

0/168 (0.00%)

1/60 (1.67%)

0/90 (0.00%)

0/21 (0.00%)

0/18 (0.00%)

0/50 (0.00%)

0/51 (0.00%)

0/53 (0.00%)

0/44 (0.00%)

0/125 (0.00%)

0/62 (0.00%)

0/20 (0.00%)

0/103 (0.00%)

0/205 (0.00%)

0/132 (0.00%)

0/153 (0.00%)

Coagulopathy * 1

0/4 (0.00%)

0/13 (0.00%)

0/15 (0.00%)

0/21 (0.00%)

0/8 (0.00%)

0/184 (0.00%)

1/156 (0.64%)

0/168 (0.00%)

0/60 (0.00%)

0/90 (0.00%)

0/21 (0.00%)

0/18 (0.00%)

0/50 (0.00%)

0/51 (0.00%)

0/53 (0.00%)

0/44 (0.00%)

0/125 (0.00%)

0/62 (0.00%)

0/20 (0.00%)

1/103 (0.97%)

0/205 (0.00%)

0/132 (0.00%)

0/153 (0.00%)

Thrombocytopenia * 1

0/4 (0.00%)

0/13 (0.00%)

0/15 (0.00%)

0/21 (0.00%)

0/8 (0.00%)

0/184 (0.00%)

0/156 (0.00%)

1/168 (0.60%)

0/60 (0.00%)

0/90 (0.00%)

0/21 (0.00%)

0/18 (0.00%)

0/50 (0.00%)

0/51 (0.00%)

0/53 (0.00%)

0/44 (0.00%)

0/125 (0.00%)

0/62 (0.00%)

0/20 (0.00%)

1/103 (0.97%)

0/205 (0.00%)

0/132 (0.00%)

0/153 (0.00%)

Leukocytosis * 1

0/4 (0.00%)

0/13 (0.00%)

0/15 (0.00%)

0/21 (0.00%)

0/8 (0.00%)

0/184 (0.00%)

0/156 (0.00%)

0/168 (0.00%)

1/60 (1.67%)

0/90 (0.00%)

0/21 (0.00%)

0/18 (0.00%)

0/50 (0.00%)

0/51 (0.00%)

0/53 (0.00%)

0/44 (0.00%)

0/125 (0.00%)

0/62 (0.00%)

0/20 (0.00%)

0/103 (0.00%)

0/205 (0.00%)

0/132 (0.00%)

0/153 (0.00%)

Thrombotic microangiopathy * 1

0/4 (0.00%)

0/13 (0.00%)

0/15 (0.00%)

0/21 (0.00%)

0/8 (0.00%)

0/184 (0.00%)

0/156 (0.00%)

0/168 (0.00%)

0/60 (0.00%)

0/90 (0.00%)

0/21 (0.00%)

0/18 (0.00%)

0/50 (0.00%)

0/51 (0.00%)

0/53 (0.00%)

0/44 (0.00%)

0/125 (0.00%)

0/62 (0.00%)