A Trial of Intratumoral Injections of SD-101 in Combination With Pembrolizumab in Patients With Metastatic Melanoma or Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma

• ClinicalTrials.gov Identifier: NCT02521870
• Recruitment Status: Terminated
• First Posted: August 13, 2015
• Results First Posted: August 3, 2021
• Last Update Posted: August 3, 2021
• Sponsor: Dynavax Technologies Corporation
• Collaborator: Merck Sharp & Dohme Corp.
• Information provided by (Responsible Party): Dynavax Technologies Corporation

• Study Type: Interventional
• Study Design: Allocation: Non-Randomized; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Conditions: Metastatic Melanoma; Head Neck Cancer
• Interventions: Drug: SD-101(1); Biological: Pembrolizumab; Drug: SD-101(2); Biological: SD-101(3)
• Enrollment: 241

Participant Flow

Recruitment Details
Pre-assignment Details

Arm/Group Title	SD-101 1 mg	SD-101 2 mg	SD-101 4 mg	SD-101 8 mg	SD-101 8 mg in Anti-PD-1/L1-Naïve Melanoma	SD-101 8 mg in Anti-PD-1/L1-Experienced Melanoma	SD-101 8 mg in Anti-PD-1/L1-Naïve HNSCC	SD-101 8 mg in Anti-PD-1/L1-Experienced HNSCC	SD-101 2 mg in Anti-PD-1/L1-Naïve Melanoma	SD-101 2 mg in Anti-PD-1/L1-Naïve HNSCC	SD-101 2 mg in Anti-PD-1/L1 Refractory or Resistant HNSCC	SD-101 2 mg in Anti-PD-1/L1 Refractory or Resistant Melanoma
Arm/Group Description	Dose Escalation Cohort 4: Participants were administered SD-101 1 mg intratumorally as 4 weekly doses followed by 1 dose Q3W for 7 additional doses. Participants were also administered Pembrolizumab 200 mg intravenously Q3W starting on Day 1 for up to 35 treatments or until disease progression.	Dose Escalation Cohort 1: Participants were administered SD-101 2 mg intratumorally as 4 weekly doses followed by 1 dose Q3W for 7 additional doses. Participants were also administered Pembrolizumab 200 mg intravenously Q3W starting on Day 1 for up to 35 treatments or until disease progression.	Dose Escalation Cohort 2: Participants were administered SD-101 4 mg intratumorally as 4 weekly doses followed by 1 dose Q3W for 7 additional doses. Participants were also administered Pembrolizumab 200 mg intravenously Q3W starting on Day 1 for up to 35 treatments or until disease progression.	Dose Escalation Cohort 3: Participants were administered SD-101 8 mg intratumorally as 4 weekly doses followed by 1 dose Q3W for 7 additional doses. Participants were also administered Pembrolizumab 200 mg intravenously Q3W starting on Day 1 for up to 35 treatments or until disease progression.	Dose Expansion Cohort 1: Participants with melanoma who are anti-PD-1/L1-naïve were administered SD-101 8 mg intratumorally starting on Day 22 dose Q1W for 4 weeks followed by dose Q3W for 7 doses, then 9 weeks off, then dose Q1W for 4 weeks followed by dose Q3W for 7 doses (up to 22 total doses). Participants were also administered Pembrolizumab 200 mg intravenously Q3W starting on Day 1 for up to 35 treatments or until disease progression.	Dose Expansion Cohort 2: Participants with melanoma who are anti-PD-1/L1-experienced were administered SD-101 8 mg intratumorally starting on Day 1 dose Q1W for 4 weeks followed by dose Q3W for 7 doses, then 9 weeks off, then dose Q1W for 4 weeks followed by dose Q3W for 7 doses (up to 22 total doses). Participants were also administered Pembrolizumab 200 mg intravenously Q3W starting on Day 1 for up to 35 treatments or until disease progression.	Dose Expansion Cohort 3: Participants with HNSCC who are anti-PD-1/L1-naïve were administered SD-101 8 mg intratumorally starting on Day 22 dose Q1W for 4 weeks followed by dose Q3W for 7 doses, then 9 weeks off, then dose Q1W for 4 weeks followed by dose Q3W for 7 doses (up to 22 total doses). Participants were also administered Pembrolizumab 200 mg intravenously Q3W starting on Day 1 for up to 35 treatments or until disease progression.	Dose Expansion Cohort 4: Participants with HNSCC who are anti-PD-1/L1-experienced were administered SD-101 8 mg intratumorally starting on Day 1 dose Q1W for 4 weeks followed by dose Q3W for 7 doses, then 9 weeks off, then dose Q1W for 4 weeks followed by dose Q3W for 7 doses (up to 22 total doses). Participants were also administered Pembrolizumab 200 mg intravenously Q3W starting on Day 1 for up to 35 treatments or until disease progression.	Dose Expansion Cohort 5: Participants with melanoma who are anti-PD-1/L1-naïve were administered SD-101 2 mg intratumorally starting on Day 1 dose Q1W for 4 weeks followed by dose Q3W for 16 doses (up to 20 total doses). Participants were also administered Pembrolizumab 200 mg intravenously Q3W starting on Day 1 for up to 35 treatments or until disease progression.	Dose Expansion Cohort 6: Participants with HNSCC who are anti-PD-1/L1-naïve were administered SD-101 2 mg intratumorally starting on Day 1 dose Q1W for 4 weeks followed by dose Q3W for 16 doses (up to 20 total doses). Participants were also administered Pembrolizumab 200 mg intravenously Q3W starting on Day 1 for up to 35 treatments or until disease progression.	Dose Expansion Cohort 7: Participants with HNSCC who are anti-PD-1/L1 refractory or resistant were administered SD-101 2 mg intratumorally starting on Day 1 dose Q1W for 4 weeks followed by dose Q3W for 16 doses (up to 20 total doses). Participants were also administered Pembrolizumab 200 mg intravenously Q3W starting on Day 1 for up to 35 treatments or until disease progression.	Dose Expansion Cohort 8: Participants with melanoma who are anti-PD-1/L1 refractory or resistant were administered SD-101 2 mg intratumorally starting on Day 1 dose Q1W for 4 weeks followed by dose Q3W for 16 doses (up to 20 total doses). Participants were also administered Pembrolizumab 200 mg intravenously Q3W starting on Day 1 for up to 35 treatments or until disease progression.
Period Title: Phase 1: Dose Escalation
Started	6	5	5	6	0	0	0	0	0	0	0	0
Completed SD-101 Treatment (up to 11 Doses)	3	3	0	1	0	0	0	0	0	0	0	0
Completed [1]	1	1	1	0	0	0	0	0	0	0	0	0
Not Completed	5	4	4	6	0	0	0	0	0	0	0	0
Reason Not Completed
Withdrawal by Subject	0	1	0	0	0	0	0	0	0	0	0	0
Adverse Event	2	1	0	0	0	0	0	0	0	0	0	0
Progressive Disease	3	2	4	6	0	0	0	0	0	0	0	0
[1] Completed Pembrolizumab Treatment (up to 35 doses)
Period Title: Phase 2: Dose Expansion
Started	0	0	0	0	57	25	23	9	24	28	23	30
Completed SD-101 Treatment (up to 11 Doses)	0	0	0	0	25	7	3	2	9	5	1	11
Completed SD-101 Treatment Cycle 2 (up to 22 Doses)	0	0	0	0	7	1	0	0	0	0	0	0
Completed [1]	0	0	0	0	5	0	0	0	2 [2]	0	0	0
Not Completed	0	0	0	0	52	25	23	9	22	28	23	30
Reason Not Completed
Withdrawal by Subject	0	0	0	0	5	1	1	0	1	1	2	0
Adverse Event	0	0	0	0	11	2	0	1	5	0	1	0
Progressive Disease	0	0	0	0	22	18	17	7	5	17	17	21
Death	0	0	0	0	1	1	3	1	1	5	2	2
Other	0	0	0	0	10	3	2	0	10	5	1	7
Lost to Follow-up	0	0	0	0	1	0	0	0	0	0	0	0
Non-Compliance with Study Drug	0	0	0	0	2	0	0	0	0	0	0	0
[1] Completed Pembrolizumab Treatment (up to 35 doses); [2] 4 participants completed pembrolizumab treatment (up to 35 cycles).

Baseline Characteristics

Arm/Group Title		Melanoma Anti-PD-1/L1 Naïve SD-101 2 mg	Melanoma Anti-PD-1/L1 Naïve SD-101 8 mg	Melanoma Anti-PD-1/L1 Experienced SD-101 2 mg	Melanoma Anti-PD-1/L1 Experienced SD-101 8 mg	HNSCC Anti-PD-1/L1 Naïve SD-101 2 mg	HNSCC Anti-PD-1/L1 Naïve SD-101 8 mg	HNSCC Anti-PD-1/L1 Experienced SD-101 2 mg	HNSCC Anti-PD-1/L1 Experienced SD-101 8 mg	Total
Arm/Group Description		Phase 1 Dose Escalation cohorts and Phase 2 Dose Expansion cohorts were rearranged as analysis groups for analyses to assess study objectives, based on tumor indications, anti-PD-1/L1 experience, and dose of SD-101. The participants in this analysis group include participants in Phase 1 Dose Escalation Cohort 1 (SD-101 2 mg) and participants in Phase 2 Dose Expansion Cohort 1 and Cohort 5.	Phase 1 Dose Escalation cohorts and Phase 2 Dose Expansion cohorts were rearranged as analysis groups for analyses to assess study objectives, based on tumor indications, anti-PD-1/L1 experience, and dose of SD-101. The participants in this analysis group include participants in Phase 1 Dose Escalation Cohort 3 (SD-101 8 mg) and participants in Phase 2 Dose Expansion Cohort 1.	Phase 1 Dose Escalation cohorts and Phase 2 Dose Expansion cohorts were rearranged as analysis groups for analyses to assess study objectives, based on tumor indications, anti-PD-1/L1 experience, and dose of SD-101. The participants in this analysis group include participants in Phase 1 Dose Escalation Cohort 1 (SD-101 2 mg) and participants in Phase 2 Dose Expansion Cohort 2 and Cohort 8.	Phase 1 Dose Escalation cohorts and Phase 2 Dose Expansion cohorts were rearranged as analysis groups for analyses to assess study objectives, based on tumor indications, anti-PD-1/L1 experience, and dose of SD-101. The participants in this analysis group include participants in Phase 1 Dose Escalation Cohort 3 (SD-101 8 mg) and participants in Phase 2 Dose Expansion Cohort 2.	Phase 1 Dose Escalation cohorts and Phase 2 Dose Expansion cohorts were rearranged as analysis groups for analyses to assess study objectives, based on tumor indications, anti-PD-1/L1 experience, and dose of SD-101. The participants in this analysis group include participants in Phase 2 Dose Expansion Cohort 3 and Cohort 6.	Phase 1 Dose Escalation cohorts and Phase 2 Dose Expansion cohorts were rearranged as analysis groups for analyses to assess study objectives, based on tumor indications, anti-PD-1/L1 experience, and dose of SD-101. The participants in this analysis group include participants in Phase 2 Dose Expansion Cohort 3.	Phase 1 Dose Escalation cohorts and Phase 2 Dose Expansion cohorts were rearranged as analysis groups for analyses to assess study objectives, based on tumor indications, anti-PD-1/L1 experience, and dose of SD-101. The participants in this analysis group include participants in Phase 2 Dose Expansion Cohort 4 and Cohort 7.	Phase 1 Dose Escalation cohorts and Phase 2 Dose Expansion cohorts were rearranged as analysis groups for analyses to assess study objectives, based on tumor indications, anti-PD-1/L1 experience, and dose of SD-101. The participants in this analysis group include participants in Phase 2 Dose Expansion Cohort 4.	Total of all reporting groups
Overall Number of Baseline Participants		45	41	31	30	28	23	23	9	230
Baseline Analysis Population Description		The intent-to-treat (ITT) population comprises all participants who received at least one dose of SD-101. Phase 1 Dose Escalation cohorts and Phase 2 Dose Expansion cohorts were rearranged as analysis groups for analyses to assess study objectives, based on tumor indications, anti-PD-1/L1 experience, and dose of SD-101, as specified by the statistical analysis plan. Participants who received 1 mg or 4 mg of SD-101 in Phase 1: Dose Escalation of the study are not included in the analysis groups.
Age, Categorical; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	45 participants	41 participants	31 participants	30 participants	28 participants	23 participants	23 participants	9 participants	230 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%
	Between 18 and 65 years	16 35.6%	18 43.9%	13 41.9%	17 56.7%	16 57.1%	10 43.5%	15 65.2%	4 44.4%	109 47.4%
	>=65 years	29 64.4%	23 56.1%	18 58.1%	13 43.3%	12 42.9%	13 56.5%	8 34.8%	5 55.6%	121 52.6%
Age, Continuous; Mean (Standard Deviation); Unit of measure: Years
	Number Analyzed	45 participants	41 participants	31 participants	30 participants	28 participants	23 participants	23 participants	9 participants	230 participants
		66.2 (13.34)	65.3 (12.44)	65.6 (12.99)	62.4 (15.25)	62.6 (10.66)	67.2 (9.59)	61.0 (12.94)	65.2 (12.35)	64.4 (12.45)
Sex: Female, Male; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	45 participants	41 participants	31 participants	30 participants	28 participants	23 participants	23 participants	9 participants	230 participants
	Female	13 28.9%	14 34.1%	10 32.3%	7 23.3%	9 32.1%	2 8.7%	8 34.8%	1 11.1%	64 27.8%
	Male	32 71.1%	27 65.9%	21 67.7%	23 76.7%	19 67.9%	21 91.3%	15 65.2%	8 88.9%	166 72.2%
Ethnicity (NIH/OMB); Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	45 participants	41 participants	31 participants	30 participants	28 participants	23 participants	23 participants	9 participants	230 participants
	Hispanic or Latino	0 0.0%	2 4.9%	1 3.2%	4 13.3%	0 0.0%	0 0.0%	2 8.7%	1 11.1%	10 4.3%
	Not Hispanic or Latino	43 95.6%	37 90.2%	28 90.3%	26 86.7%	28 100.0%	22 95.7%	20 87.0%	8 88.9%	212 92.2%
	Unknown or Not Reported	2 4.4%	2 4.9%	2 6.5%	0 0.0%	0 0.0%	1 4.3%	1 4.3%	0 0.0%	8 3.5%
Race/Ethnicity, Customized; Measure Type: Count of Participants; Unit of measure: Participants	Number Analyzed	45 participants	41 participants	31 participants	30 participants	28 participants	23 participants	23 participants	9 participants	230 participants
White		44 97.8%	41 100.0%	30 96.8%	25 83.3%	24 85.7%	20 87.0%	19 82.6%	9 100.0%	212 92.2%
Black or African American		1 2.2%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	2 8.7%	2 8.7%	0 0.0%	5 2.2%
Asian		0 0.0%	0 0.0%	1 3.2%	1 3.3%	2 7.1%	1 4.3%	2 8.7%	0 0.0%	7 3.0%
Other		0 0.0%	0 0.0%	0 0.0%	4 13.3%	2 7.1%	0 0.0%	0 0.0%	0 0.0%	6 2.6%
ECOG Performance Status [1]; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	45 participants	41 participants	31 participants	30 participants	28 participants	23 participants	23 participants	9 participants	230 participants
	0	28 62.2%	30 73.2%	19 61.3%	16 53.3%	5 17.9%	6 26.1%	4 17.4%	2 22.2%	110 47.8%
	1	17 37.8%	11 26.8%	12 38.7%	14 46.7%	23 82.1%	17 73.9%	19 82.6%	7 77.8%	120 52.2%
		[1] Measure Description: ECOG PS = Eastern Cooperative Oncology Group Performance Status; 0 = Fully active, able to carry on all pre-disease performance without restriction (better outcome) 1 = Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work (worse outcome)
PDL1 Expression; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	45 participants	41 participants	31 participants	30 participants	28 participants	23 participants	23 participants	9 participants	230 participants
	Positive	21 46.7%	13 31.7%	9 29.0%	13 43.3%	14 50.0%	15 65.2%	4 17.4%	7 77.8%	96 41.7%
	Negative	14 31.1%	15 36.6%	8 25.8%	11 36.7%	2 7.1%	4 17.4%	5 21.7%	1 11.1%	60 26.1%
	Unknown	10 22.2%	13 31.7%	14 45.2%	6 20.0%	12 42.9%	4 17.4%	14 60.9%	1 11.1%	74 32.2%

Outcome Measures

1. Primary Outcome

Title	Phase 1 Dose Escalation Only - Number of Participants With DLTs
Description	Dose-limiting toxicities (DLTs) are defined per protocol as specific AEs occurring from the time of the first injection (Day 1) through Day 29.
Time Frame	Day 1 through Day 29

Outcome Measure Data

Analysis Population Description

The safety population is defined as comprising of participants who received at least 1 dose of SD-101.

Arm/Group Title	SD-101 1 mg	SD-101 2 mg	SD-101 4 mg	SD-101 8 mg	SD-101 8 mg in Anti-PD-1/L1-Naïve Melanoma	SD-101 8 mg in Anti-PD-1/L1-Experienced Melanoma	SD-101 8 mg in Anti-PD-1/L1-Naïve HNSCC	SD-101 8 mg in Anti-PD-1/L1-Experienced HNSCC	SD-101 2 mg in Anti-PD-1/L1-Naïve Melanoma	SD-101 2 mg in Anti-PD-1/L1-Naïve HNSCC	SD-101 2 mg in Anti-PD-1/L1 Refractory or Resistant HNSCC	SD-101 2 mg in Anti-PD-1/L1 Refractory or Resistant Melanoma
Arm/Group Description:	Dose Escalation Cohort 4: Participants were administered SD-101 1 mg intratumorally as 4 weekly doses followed by 1 dose Q3W for 7 additional doses. Participants were also administered Pembrolizumab 200 mg intravenously Q3W starting on Day 1 for up to 35 treatments or until disease progression.	Dose Escalation Cohort 1: Participants were administered SD-101 2 mg intratumorally as 4 weekly doses followed by 1 dose Q3W for 7 additional doses. Participants were also administered Pembrolizumab 200 mg intravenously Q3W starting on Day 1 for up to 35 treatments or until disease progression.	Dose Escalation Cohort 2: Participants were administered SD-101 4 mg intratumorally as 4 weekly doses followed by 1 dose Q3W for 7 additional doses. Participants were also administered Pembrolizumab 200 mg intravenously Q3W starting on Day 1 for up to 35 treatments or until disease progression.	Dose Escalation Cohort 3: Participants were administered SD-101 8 mg intratumorally as 4 weekly doses followed by 1 dose Q3W for 7 additional doses. Participants were also administered Pembrolizumab 200 mg intravenously Q3W starting on Day 1 for up to 35 treatments or until disease progression.	Dose Expansion Cohort 1: Participants with melanoma who are anti-PD-1/L1-naïve were administered SD-101 8 mg intratumorally starting on Day 22 dose Q1W for 4 weeks followed by dose Q3W for 7 weeks, then 9 weeks off, then dose Q1W for 4 weeks followed by dose Q3W for 7 weeks (up to 22 total doses). Participants were also administered Pembrolizumab 200 mg intravenously Q3W starting on Day 1 for up to 35 treatments or until disease progression.	Dose Expansion Cohort 2: Participants with melanoma who are anti-PD-1/L1-experienced were administered SD-101 8 mg intratumorally starting on Day 1 dose Q1W for 4 weeks followed by dose Q3W for 7 weeks, then 9 weeks off, then dose Q1W for 4 weeks followed by dose Q3W for 7 weeks (up to 22 total doses). Participants were also administered Pembrolizumab 200 mg intravenously Q3W starting on Day 1 for up to 35 treatments or until disease progression.	Dose Expansion Cohort 3: Participants with HNSCC who are anti-PD-1/L1-naïve were administered SD-101 8 mg intratumorally starting on Day 22 dose Q1W for 4 weeks followed by dose Q3W for 7 weeks, then 9 weeks off, then dose Q1W for 4 weeks followed by dose Q3W for 7 weeks (up to 22 total doses). Participants were also administered Pembrolizumab 200 mg intravenously Q3W starting on Day 1 for up to 35 treatments or until disease progression.	Dose Expansion Cohort 4: Participants with HNSCC who are anti-PD-1/L1-experienced were administered SD-101 8 mg intratumorally starting on Day 1 dose Q1W for 4 weeks followed by dose Q3W for 7 weeks, then 9 weeks off, then dose Q1W for 4 weeks followed by dose Q3W for 7 weeks (up to 22 total doses). Participants were also administered Pembrolizumab 200 mg intravenously Q3W starting on Day 1 for up to 35 treatments or until disease progression.	Dose Expansion Cohort 5: Participants with melanoma who are anti-PD-1/L1-naïve were administered SD-101 2 mg intratumorally starting on Day 1 dose Q1W for 4 weeks followed by dose Q3W for 16 weeks (up to 20 total doses). Participants were also administered Pembrolizumab 200 mg intravenously Q3W starting on Day 1 for up to 35 treatments or until disease progression.	Dose Expansion Cohort 6: Participants with HNSCC who are anti-PD-1/L1-naïve were administered SD-101 2 mg intratumorally starting on Day 1 dose Q1W for 4 weeks followed by dose Q3W for 16 weeks (up to 20 total doses). Participants were also administered Pembrolizumab 200 mg intravenously Q3W starting on Day 1 for up to 35 treatments or until disease progression.	Dose Expansion Cohort 7: Participants with HNSCC who are anti-PD-1/L1 refractory or resistant were administered SD-101 2 mg intratumorally starting on Day 1 dose Q1W for 4 weeks followed by dose Q3W for 16 weeks (up to 20 total doses). Participants were also administered Pembrolizumab 200 mg intravenously Q3W starting on Day 1 for up to 35 treatments or until disease progression.	Dose Expansion Cohort 8: Participants with melanoma who are anti-PD-1/L1 refractory or resistant were administered SD-101 2 mg intratumorally starting on Day 1 dose Q1W for 4 weeks followed by dose Q3W for 16 weeks (up to 20 total doses). Participants were also administered Pembrolizumab 200 mg intravenously Q3W starting on Day 1 for up to 35 treatments or until disease progression.
Overall Number of Participants Analyzed	6	5	5	6	0	0	0	0	0	0	0	0
Measure Type: Count of Participants; Unit of Measure: Participants
	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0	0	0	0	0	0	0	0

2. Primary Outcome

Title	Phase 1 Dose Escalation and Phase 2 Dose Expansion - Overall Response Rate (ORR) by Analysis Group
Description	Overall response rate (ORR) by analysis group based on investigator assessment using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 was evaluated from Baseline (Day 1) through Day 743 or End of Study (EOS).
Time Frame	Day 1 through Day 743

Outcome Measure Data

Analysis Population Description

The intent-to-treat (ITT) population comprises of all participants who were enrolled in the study.

Arm/Group Title	Melanoma Anti-PD-1/L1 Naïve SD-101 2 mg	Melanoma Anti-PD-1/L1 Naïve SD-101 8 mg	Melanoma Anti-PD-1/L1 Experienced SD-101 2 mg	Melanoma Anti-PD-1/L1 Experienced SD-101 8 mg	HNSCC Anti-PD-1/L1 Naïve SD-101 2 mg	HNSCC Anti-PD-1/L1 Naïve SD-101 8 mg	HNSCC Anti-PD-1/L1 Experienced SD-101 2 mg	HNSCC Anti-PD-1/L1 Experienced SD-101 8 mg
Arm/Group Description:	Phase 1 Dose Escalation cohorts and Phase 2 Dose Expansion cohorts were rearranged as analysis groups for analyses to assess study objectives, based on tumor indications, anti-PD-1/L1 experience, and dose of SD-101. The participants in this analysis group include participants in Phase 1 Dose Escalation Cohort 1 (SD-101 2 mg) and participants in Phase 2 Dose Expansion Cohort 1 and Cohort 5.	Phase 1 Dose Escalation cohorts and Phase 2 Dose Expansion cohorts were rearranged as analysis groups for analyses to assess study objectives, based on tumor indications, anti-PD-1/L1 experience, and dose of SD-101. The participants in this analysis group include participants in Phase 1 Dose Escalation Cohort 3 (SD-101 8 mg) and participants in Phase 2 Dose Expansion Cohort 1.	Phase 1 Dose Escalation cohorts and Phase 2 Dose Expansion cohorts were rearranged as analysis groups for analyses to assess study objectives, based on tumor indications, anti-PD-1/L1 experience, and dose of SD-101. The participants in this analysis group include participants in Phase 1 Dose Escalation Cohort 1 (SD-101 2 mg) and participants in Phase 2 Dose Expansion Cohort 2 and Cohort 8.	Phase 1 Dose Escalation cohorts and Phase 2 Dose Expansion cohorts were rearranged as analysis groups for analyses to assess study objectives, based on tumor indications, anti-PD-1/L1 experience, and dose of SD-101. The participants in this analysis group include participants in Phase 1 Dose Escalation Cohort 3 (SD-101 8 mg) and participants in Phase 2 Dose Expansion Cohort 2.	Phase 1 Dose Escalation cohorts and Phase 2 Dose Expansion cohorts were rearranged as analysis groups for analyses to assess study objectives, based on tumor indications, anti-PD-1/L1 experience, and dose of SD-101. The participants in this analysis group include participants in Phase 2 Dose Expansion Cohort 3 and Cohort 6.	Phase 1 Dose Escalation cohorts and Phase 2 Dose Expansion cohorts were rearranged as analysis groups for analyses to assess study objectives, based on tumor indications, anti-PD-1/L1 experience, and dose of SD-101. The participants in this analysis group include participants in Phase 2 Dose Expansion Cohort 3.	Phase 1 Dose Escalation cohorts and Phase 2 Dose Expansion cohorts were rearranged as analysis groups for analyses to assess study objectives, based on tumor indications, anti-PD-1/L1 experience, and dose of SD-101. The participants in this analysis group include participants in Phase 2 Dose Expansion Cohort 4 and Cohort 7.	Phase 1 Dose Escalation cohorts and Phase 2 Dose Expansion cohorts were rearranged as analysis groups for analyses to assess study objectives, based on tumor indications, anti-PD-1/L1 experience, and dose of SD-101. The participants in this analysis group include participants in Phase 2 Dose Expansion Cohort 4.
Overall Number of Participants Analyzed	45	41	31	30	28	23	23	9
Measure Type: Count of Participants; Unit of Measure: Participants
Complete Response	9 20.0%	4 9.8%	0 0.0%	1 3.3%	2 7.1%	0 0.0%	0 0.0%	1 11.1%
Partial Response	25 55.6%	16 39.0%	7 22.6%	3 10.0%	4 14.3%	6 26.1%	2 8.7%	0 0.0%
Stable Disease	2 4.4%	8 19.5%	8 25.8%	8 26.7%	7 25.0%	5 21.7%	3 13.0%	2 22.2%
Progressive Disease	5 11.1%	8 19.5%	12 38.7%	11 36.7%	10 35.7%	9 39.1%	10 43.5%	4 44.4%
Not Evaluable	4 8.9%	5 12.2%	4 12.9%	7 23.3%	5 17.9%	3 13.0%	8 34.8%	2 22.2%

3. Secondary Outcome

Title	Phase 1 Dose Escalation and Phase 2 Dose Expansion - Time to Objective Response by Analysis Group
Description	Time to objective response by analysis group based on investigator assessment using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 was evaluated from Baseline (Day 1) through Day 743 or End of Study (EOS).
Time Frame	Day 1 through Day 743

Outcome Measure Data

Analysis Population Description

The intent-to-treat (ITT) population comprises of all participants who were enrolled in the study. This subset of participants analyzed comprises of participants with objective response.

Arm/Group Title	Melanoma Anti-PD-1/L1 Naïve SD-101 2 mg	Melanoma Anti-PD-1/L1 Naïve SD-101 8 mg	Melanoma Anti-PD-1/L1 Experienced SD-101 2 mg	Melanoma Anti-PD-1/L1 Experienced SD-101 8 mg	HNSCC Anti-PD-1/L1 Naïve SD-101 2 mg	HNSCC Anti-PD-1/L1 Naïve SD-101 8 mg	HNSCC Anti-PD-1/L1 Experienced SD-101 2 mg	HNSCC Anti-PD-1/L1 Experienced SD-101 8 mg
Arm/Group Description:	Phase 1 Dose Escalation cohorts and Phase 2 Dose Expansion cohorts were rearranged as analysis groups for analyses to assess study objectives, based on tumor indications, anti-PD-1/L1 experience, and dose of SD-101. The participants in this analysis group include participants in Phase 1 Dose Escalation Cohort 1 (SD-101 2 mg) and participants in Phase 2 Dose Expansion Cohort 1 and Cohort 5.	Phase 1 Dose Escalation cohorts and Phase 2 Dose Expansion cohorts were rearranged as analysis groups for analyses to assess study objectives, based on tumor indications, anti-PD-1/L1 experience, and dose of SD-101. The participants in this analysis group include participants in Phase 1 Dose Escalation Cohort 3 (SD-101 8 mg) and participants in Phase 2 Dose Expansion Cohort 1.	Phase 1 Dose Escalation cohorts and Phase 2 Dose Expansion cohorts were rearranged as analysis groups for analyses to assess study objectives, based on tumor indications, anti-PD-1/L1 experience, and dose of SD-101. The participants in this analysis group include participants in Phase 1 Dose Escalation Cohort 1 (SD-101 2 mg) and participants in Phase 2 Dose Expansion Cohort 2 and Cohort 8.	Phase 1 Dose Escalation cohorts and Phase 2 Dose Expansion cohorts were rearranged as analysis groups for analyses to assess study objectives, based on tumor indications, anti-PD-1/L1 experience, and dose of SD-101. The participants in this analysis group include participants in Phase 1 Dose Escalation Cohort 3 (SD-101 8 mg) and participants in Phase 2 Dose Expansion Cohort 2.	Phase 1 Dose Escalation cohorts and Phase 2 Dose Expansion cohorts were rearranged as analysis groups for analyses to assess study objectives, based on tumor indications, anti-PD-1/L1 experience, and dose of SD-101. The participants in this analysis group include participants in Phase 2 Dose Expansion Cohort 3 and Cohort 6.	Phase 1 Dose Escalation cohorts and Phase 2 Dose Expansion cohorts were rearranged as analysis groups for analyses to assess study objectives, based on tumor indications, anti-PD-1/L1 experience, and dose of SD-101. The participants in this analysis group include participants in Phase 2 Dose Expansion Cohort 3.	Phase 1 Dose Escalation cohorts and Phase 2 Dose Expansion cohorts were rearranged as analysis groups for analyses to assess study objectives, based on tumor indications, anti-PD-1/L1 experience, and dose of SD-101. The participants in this analysis group include participants in Phase 2 Dose Expansion Cohort 4 and Cohort 7.	Phase 1 Dose Escalation cohorts and Phase 2 Dose Expansion cohorts were rearranged as analysis groups for analyses to assess study objectives, based on tumor indications, anti-PD-1/L1 experience, and dose of SD-101. The participants in this analysis group include participants in Phase 2 Dose Expansion Cohort 4.
Overall Number of Participants Analyzed	34	20	7	4	6	6	2	1
Mean (Standard Deviation); Unit of Measure: months
	3.2 (1.6)	4.1 (2.96)	5.1 (3.06)	4.3 (2.98)	2.3 (.92)	2.4 (0.87)	2.7 (1.09)	2.1 (0)

4. Secondary Outcome

Title	Phase 1 Dose Escalation and Phase 2 Dose Expansion - Duration of Response by Analysis Group
Description	Duration of response by analysis group based on investigator assessment using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 was evaluated from Baseline (Day 1) through Day 743 or End of Study (EOS).
Time Frame	Day 1 through Day 743

Outcome Measure Data

Analysis Population Description

The intent-to-treat (ITT) population comprises of all participants who were enrolled in the study. This subset of participants analyzed comprises of participants with objective response.

Arm/Group Title	Melanoma Anti-PD-1/L1 Naïve SD-101 2 mg	Melanoma Anti-PD-1/L1 Naïve SD-101 8 mg	Melanoma Anti-PD-1/L1 Experienced SD-101 2 mg	Melanoma Anti-PD-1/L1 Experienced SD-101 8 mg	HNSCC Anti-PD-1/L1 Naïve SD-101 2 mg	HNSCC Anti-PD-1/L1 Naïve SD-101 8 mg	HNSCC Anti-PD-1/L1 Experienced SD-101 2 mg	HNSCC Anti-PD-1/L1 Experienced SD-101 8 mg
Arm/Group Description:	Phase 1 Dose Escalation cohorts and Phase 2 Dose Expansion cohorts were rearranged as analysis groups for analyses to assess study objectives, based on tumor indications, anti-PD-1/L1 experience, and dose of SD-101. The participants in this analysis group include participants in Phase 1 Dose Escalation Cohort 1 (SD-101 2 mg) and participants in Phase 2 Dose Expansion Cohort 1 and Cohort 5.	Phase 1 Dose Escalation cohorts and Phase 2 Dose Expansion cohorts were rearranged as analysis groups for analyses to assess study objectives, based on tumor indications, anti-PD-1/L1 experience, and dose of SD-101. The participants in this analysis group include participants in Phase 1 Dose Escalation Cohort 3 (SD-101 8 mg) and participants in Phase 2 Dose Expansion Cohort 1.	Phase 1 Dose Escalation cohorts and Phase 2 Dose Expansion cohorts were rearranged as analysis groups for analyses to assess study objectives, based on tumor indications, anti-PD-1/L1 experience, and dose of SD-101. The participants in this analysis group include participants in Phase 1 Dose Escalation Cohort 1 (SD-101 2 mg) and participants in Phase 2 Dose Expansion Cohort 2 and Cohort 8.	Phase 1 Dose Escalation cohorts and Phase 2 Dose Expansion cohorts were rearranged as analysis groups for analyses to assess study objectives, based on tumor indications, anti-PD-1/L1 experience, and dose of SD-101. The participants in this analysis group include participants in Phase 1 Dose Escalation Cohort 3 (SD-101 8 mg) and participants in Phase 2 Dose Expansion Cohort 2.	Phase 1 Dose Escalation cohorts and Phase 2 Dose Expansion cohorts were rearranged as analysis groups for analyses to assess study objectives, based on tumor indications, anti-PD-1/L1 experience, and dose of SD-101. The participants in this analysis group include participants in Phase 2 Dose Expansion Cohort 3 and Cohort 6.	Phase 1 Dose Escalation cohorts and Phase 2 Dose Expansion cohorts were rearranged as analysis groups for analyses to assess study objectives, based on tumor indications, anti-PD-1/L1 experience, and dose of SD-101. The participants in this analysis group include participants in Phase 2 Dose Expansion Cohort 3.	Phase 1 Dose Escalation cohorts and Phase 2 Dose Expansion cohorts were rearranged as analysis groups for analyses to assess study objectives, based on tumor indications, anti-PD-1/L1 experience, and dose of SD-101. The participants in this analysis group include participants in Phase 2 Dose Expansion Cohort 4 and Cohort 7.	Phase 1 Dose Escalation cohorts and Phase 2 Dose Expansion cohorts were rearranged as analysis groups for analyses to assess study objectives, based on tumor indications, anti-PD-1/L1 experience, and dose of SD-101. The participants in this analysis group include participants in Phase 2 Dose Expansion Cohort 4.
Overall Number of Participants Analyzed	34	20	7	4	6	6	2	1
Mean (Standard Deviation); Unit of Measure: months
	11.1 (6.42)	11.7 (5.96)	4.6 (6.57)	7.6 (7.28)	5.9 (4.93)	6.3 (3.96)	2.1 (0.07)	8.1 (0)

5. Secondary Outcome

Title	Phase 1 Dose Escalation and Phase 2 Dose Expansion - Disease Control Rate (DCR) by Analysis Group
Description	Disease Control Rate (DCR) by analysis group based on investigator assessment using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 was evaluated from Baseline (Day 1) through Day 743 or End of Study (EOS).
Time Frame	Day 1 through Day 743

Outcome Measure Data

Analysis Population Description

The intent-to-treat (ITT) population comprises of all participants who were enrolled in the study.

Arm/Group Title	Melanoma Anti-PD-1/L1 Naïve SD-101 2 mg	Melanoma Anti-PD-1/L1 Naïve SD-101 8 mg	Melanoma Anti-PD-1/L1 Experienced SD-101 2 mg	Melanoma Anti-PD-1/L1 Experienced SD-101 8 mg	HNSCC Anti-PD-1/L1 Naïve SD-101 2 mg	HNSCC Anti-PD-1/L1 Naïve SD-101 8 mg	HNSCC Anti-PD-1/L1 Experienced SD-101 2 mg	HNSCC Anti-PD-1/L1 Experienced SD-101 8 mg
Arm/Group Description:	Phase 1 Dose Escalation cohorts and Phase 2 Dose Expansion cohorts were rearranged as analysis groups for analyses to assess study objectives, based on tumor indications, anti-PD-1/L1 experience, and dose of SD-101. The participants in this analysis group include participants in Phase 1 Dose Escalation Cohort 1 (SD-101 2 mg) and participants in Phase 2 Dose Expansion Cohort 1 and Cohort 5.	Phase 1 Dose Escalation cohorts and Phase 2 Dose Expansion cohorts were rearranged as analysis groups for analyses to assess study objectives, based on tumor indications, anti-PD-1/L1 experience, and dose of SD-101. The participants in this analysis group include participants in Phase 1 Dose Escalation Cohort 3 (SD-101 8 mg) and participants in Phase 2 Dose Expansion Cohort 1.	Phase 1 Dose Escalation cohorts and Phase 2 Dose Expansion cohorts were rearranged as analysis groups for analyses to assess study objectives, based on tumor indications, anti-PD-1/L1 experience, and dose of SD-101. The participants in this analysis group include participants in Phase 1 Dose Escalation Cohort 1 (SD-101 2 mg) and participants in Phase 2 Dose Expansion Cohort 2 and Cohort 8.	Phase 1 Dose Escalation cohorts and Phase 2 Dose Expansion cohorts were rearranged as analysis groups for analyses to assess study objectives, based on tumor indications, anti-PD-1/L1 experience, and dose of SD-101. The participants in this analysis group include participants in Phase 1 Dose Escalation Cohort 3 (SD-101 8 mg) and participants in Phase 2 Dose Expansion Cohort 2.	Phase 1 Dose Escalation cohorts and Phase 2 Dose Expansion cohorts were rearranged as analysis groups for analyses to assess study objectives, based on tumor indications, anti-PD-1/L1 experience, and dose of SD-101. The participants in this analysis group include participants in Phase 2 Dose Expansion Cohort 3 and Cohort 6.	Phase 1 Dose Escalation cohorts and Phase 2 Dose Expansion cohorts were rearranged as analysis groups for analyses to assess study objectives, based on tumor indications, anti-PD-1/L1 experience, and dose of SD-101. The participants in this analysis group include participants in Phase 2 Dose Expansion Cohort 3.	Phase 1 Dose Escalation cohorts and Phase 2 Dose Expansion cohorts were rearranged as analysis groups for analyses to assess study objectives, based on tumor indications, anti-PD-1/L1 experience, and dose of SD-101. The participants in this analysis group include participants in Phase 2 Dose Expansion Cohort 4 and Cohort 7.	Phase 1 Dose Escalation cohorts and Phase 2 Dose Expansion cohorts were rearranged as analysis groups for analyses to assess study objectives, based on tumor indications, anti-PD-1/L1 experience, and dose of SD-101. The participants in this analysis group include participants in Phase 2 Dose Expansion Cohort 4.
Overall Number of Participants Analyzed	45	41	31	30	28	23	23	9
Measure Type: Count of Participants; Unit of Measure: Participants
	36 80.0%	28 68.3%	15 48.4%	12 40.0%	13 46.4%	11 47.8%	5 21.7%	3 33.3%

6. Secondary Outcome

Title	Phase 1 Dose Escalation and Phase 2 Dose Expansion - Progression-Free Survival Rate by Analysis Group
Description	Progression-Free Survival (PFS) rate by analysis group based on investigator assessment using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 was evaluated from Baseline (Day 1) through Day 743 or End of Study (EOS).
Time Frame	Day 1 through Day 743

Outcome Measure Data

Analysis Population Description

The intent-to-treat (ITT) population comprises of all participants who were enrolled in the study.

Arm/Group Title	Melanoma Anti-PD-1/L1 Naïve SD-101 2 mg	Melanoma Anti-PD-1/L1 Naïve SD-101 8 mg	Melanoma Anti-PD-1/L1 Experienced SD-101 2 mg	Melanoma Anti-PD-1/L1 Experienced SD-101 8 mg	HNSCC Anti-PD-1/L1 Naïve SD-101 2 mg	HNSCC Anti-PD-1/L1 Naïve SD-101 8 mg	HNSCC Anti-PD-1/L1 Experienced SD-101 2 mg	HNSCC Anti-PD-1/L1 Experienced SD-101 8 mg
Arm/Group Description:	Phase 1 Dose Escalation cohorts and Phase 2 Dose Expansion cohorts were rearranged as analysis groups for analyses to assess study objectives, based on tumor indications, anti-PD-1/L1 experience, and dose of SD-101. The participants in this analysis group include participants in Phase 1 Dose Escalation Cohort 1 (SD-101 2 mg) and participants in Phase 2 Dose Expansion Cohort 1 and Cohort 5.	Phase 1 Dose Escalation cohorts and Phase 2 Dose Expansion cohorts were rearranged as analysis groups for analyses to assess study objectives, based on tumor indications, anti-PD-1/L1 experience, and dose of SD-101. The participants in this analysis group include participants in Phase 1 Dose Escalation Cohort 3 (SD-101 8 mg) and participants in Phase 2 Dose Expansion Cohort 1.	Phase 1 Dose Escalation cohorts and Phase 2 Dose Expansion cohorts were rearranged as analysis groups for analyses to assess study objectives, based on tumor indications, anti-PD-1/L1 experience, and dose of SD-101. The participants in this analysis group include participants in Phase 1 Dose Escalation Cohort 1 (SD-101 2 mg) and participants in Phase 2 Dose Expansion Cohort 2 and Cohort 8.	Phase 1 Dose Escalation cohorts and Phase 2 Dose Expansion cohorts were rearranged as analysis groups for analyses to assess study objectives, based on tumor indications, anti-PD-1/L1 experience, and dose of SD-101. The participants in this analysis group include participants in Phase 1 Dose Escalation Cohort 3 (SD-101 8 mg) and participants in Phase 2 Dose Expansion Cohort 2.	Phase 1 Dose Escalation cohorts and Phase 2 Dose Expansion cohorts were rearranged as analysis groups for analyses to assess study objectives, based on tumor indications, anti-PD-1/L1 experience, and dose of SD-101. The participants in this analysis group include participants in Phase 2 Dose Expansion Cohort 3 and Cohort 6.	Phase 1 Dose Escalation cohorts and Phase 2 Dose Expansion cohorts were rearranged as analysis groups for analyses to assess study objectives, based on tumor indications, anti-PD-1/L1 experience, and dose of SD-101. The participants in this analysis group include participants in Phase 2 Dose Expansion Cohort 3.	Phase 1 Dose Escalation cohorts and Phase 2 Dose Expansion cohorts were rearranged as analysis groups for analyses to assess study objectives, based on tumor indications, anti-PD-1/L1 experience, and dose of SD-101. The participants in this analysis group include participants in Phase 2 Dose Expansion Cohort 4 and Cohort 7.	Phase 1 Dose Escalation cohorts and Phase 2 Dose Expansion cohorts were rearranged as analysis groups for analyses to assess study objectives, based on tumor indications, anti-PD-1/L1 experience, and dose of SD-101. The participants in this analysis group include participants in Phase 2 Dose Expansion Cohort 4.
Overall Number of Participants Analyzed	45	41	31	30	28	23	23	9
Measure Type: Number; Number (95% Confidence Interval); Unit of Measure: percentage of participants
3 months	85.7; (70.9 to 93.3)	71.9; (54 to 83.8)	46.7; (28.4 to 63)	48; (27.8 to 65.6)	46.4; (26.6 to 64.1)	43.5; (23.3 to 62.1)	31.6; (12.9 to 52.2)	37.5; (8.7 to 67.4)
6 months	78.4; (62.6 to 88.1)	63.3; (45.2 to 76.8)	33; (17.2 to 49.8)	24; (9.8 to 41.7)	26.5; (10.5 to 45.7)	17.4; (5.4 to 35)	0; (0 to 0)	25; (3.7 to 55.8)
9 months	70.8; (54.3 to 82.3)	60.4; (42.4 to 74.4)	21.4; (8.6 to 37.9)	14.4; (3.9 to 31.4)	21.2; (7.1 to 40.3)	17.4; (5.4 to 35)	0; (0 to 0)	12.5; (0.7 to 42.3)
12 months	70.8; (54.3 to 82.3)	53.7; (35.7 to 68.7)	21.4; (8.6 to 37.9)	9.6; (1.7 to 25.7)	15.9; (4.2 to 34.4)	8.7; (1.5 to 24.2)	00; (0 to 0)	0; (0 to 0)
15 months	65.1; (48.2 to 77.8)	49.9; (31.9 to 65.5)	0; (0 to 0)	9.6; (1.7 to 25.7)	15.9; (4.2 to 34.4)	4.3; (0.3 to 18.2)	00; (0 to 0)	0; (0 to 0)
18 months	61.5; (44 to 75)	40.3; (22.3 to 57.7)	0; (0 to 0)	9.6; (1.7 to 25.7)	0; (0 to 0)	0; (0 to 0)	0; (0 to 0)	0; (0 to 0)
21 months	61.5; (44 to 75)	40.3; (22.3 to 57.7)	0; (0 to 0)	0; (0 to 0)	0; (0 to 0)	0; (0 to 0)	0; (0 to 0)	0; (0 to 0)
24 months	0; (0 to 0)	0; (0 to 0)	0; (0 to 0)	0; (0 to 0)	0; (0 to 0)	0; (0 to 0)	0; (0 to 0)	0; (0 to 0)

Adverse Events

Time Frame	From informed consent through Day 743
Adverse Event Reporting Description	[Not Specified]
Arm/Group Title	Melanoma Anti-PD-1/L1 Naïve SD-101 2 mg	Melanoma Anti-PD-1/L1 Naïve SD-101 8 mg	Melanoma Anti-PD-1/L1 Experienced SD-101 2 mg	Melanoma Anti-PD-1/L1 Experienced SD-101 8 mg	HNSCC Anti-PD-1/L1 Naïve SD-101 2 mg	HNSCC Anti-PD-1/L1 Naïve SD-101 8 mg	HNSCC Anti-PD-1/L1 Experienced SD-101 2 mg	HNSCC Anti-PD-1/L1 Experienced SD-101 8 mg
Arm/Group Description	Some of the Phase 1 dose escalation cohorts and the 8 Phase 2 dose expansion cohorts were rearranged as analysis groups for analyses to assess the Phase 2 objectives as specified by the statistical analysis plan, based on tumor indications, anti-PD-1/L1 experience, and dose of SD-101. Results for Phase 2 objectives, using combined Phases 1 and 2 data, are presented by 2mg/lesion and 8mg/lesion doses. The participants in this analysis group include participants in Phase 1 Dose Escalation Cohort 1 (SD-101 2 mg) and participants in Phase 2 Dose Expansion Cohort 5.	Some of the Phase 1 dose escalation cohorts and the 8 Phase 2 dose expansion cohorts were rearranged as analysis groups for analyses to assess the Phase 2 objectives as specified by the statistical analysis plan, based on tumor indications, anti-PD-1/L1 experience, and dose of SD-101. Results for Phase 2 objectives, using combined Phases 1 and 2 data, are presented by 2mg/lesion and 8mg/lesion doses. The participants in this analysis group include participants in Phase 1 Dose Escalation Cohort 3 (SD-101 8 mg) and participants in Phase 2 Dose Expansion Cohort 1.	Some of the Phase 1 dose escalation cohorts and the 8 Phase 2 dose expansion cohorts were rearranged as analysis groups for analyses to assess the Phase 2 objectives as specified by the statistical analysis plan, based on tumor indications, anti-PD-1/L1 experience, and dose of SD-101. Results for Phase 2 objectives, using combined Phases 1 and 2 data, are presented by 2mg/lesion and 8mg/lesion doses. The participants in this analysis group include participants in Phase 1 Dose Escalation Cohort 1 (SD-101 2 mg) and participants in Phase 2 Dose Expansion Cohort 8.	Some of the Phase 1 dose escalation cohorts and the 8 Phase 2 dose expansion cohorts were rearranged as analysis groups for analyses to assess the Phase 2 objectives as specified by the statistical analysis plan, based on tumor indications, anti-PD-1/L1 experience, and dose of SD-101. Results for Phase 2 objectives, using combined Phases 1 and 2 data, are presented by 2mg/lesion and 8mg/lesion doses. The participants in this analysis group include participants in Phase 1 Dose Escalation Cohort 3 (SD-101 8 mg) and participants in Phase 2 Dose Expansion Cohort 2.	Some of the Phase 1 dose escalation cohorts and the 8 Phase 2 dose expansion cohorts were rearranged as analysis groups for analyses to assess the Phase 2 objectives as specified by the statistical analysis plan, based on tumor indications, anti-PD-1/L1 experience, and dose of SD-101. Results for Phase 2 objectives, using combined Phases 1 and 2 data, are presented by 2mg/lesion and 8mg/lesion doses. The participants in this analysis group include participants in Phase 2 Dose Expansion Cohort 6.	Some of the Phase 1 dose escalation cohorts and the 8 Phase 2 dose expansion cohorts were rearranged as analysis groups for analyses to assess the Phase 2 objectives as specified by the statistical analysis plan, based on tumor indications, anti-PD-1/L1 experience, and dose of SD-101. Results for Phase 2 objectives, using combined Phases 1 and 2 data, are presented by 2mg/lesion and 8mg/lesion doses. The participants in this analysis group include participants in Phase 2 Dose Expansion Cohort 3.	Some of the Phase 1 dose escalation cohorts and the 8 Phase 2 dose expansion cohorts were rearranged as analysis groups for analyses to assess the Phase 2 objectives as specified by the statistical analysis plan, based on tumor indications, anti-PD-1/L1 experience, and dose of SD-101. Results for Phase 2 objectives, using combined Phases 1 and 2 data, are presented by 2mg/lesion and 8mg/lesion doses. The participants in this analysis group include participants in Phase 2 Dose Expansion and Cohort 7.	Some of the Phase 1 dose escalation cohorts and the 8 Phase 2 dose expansion cohorts were rearranged as analysis groups for analyses to assess the Phase 2 objectives as specified by the statistical analysis plan, based on tumor indications, anti-PD-1/L1 experience, and dose of SD-101. Results for Phase 2 objectives, using combined Phases 1 and 2 data, are presented by 2mg/lesion and 8mg/lesion doses. The participants in this analysis group include participants in Phase 2 Dose Expansion Cohort 4.
All-Cause Mortality
	Melanoma Anti-PD-1/L1 Naïve SD-101 2 mg	Melanoma Anti-PD-1/L1 Naïve SD-101 8 mg	Melanoma Anti-PD-1/L1 Experienced SD-101 2 mg	Melanoma Anti-PD-1/L1 Experienced SD-101 8 mg	HNSCC Anti-PD-1/L1 Naïve SD-101 2 mg	HNSCC Anti-PD-1/L1 Naïve SD-101 8 mg	HNSCC Anti-PD-1/L1 Experienced SD-101 2 mg	HNSCC Anti-PD-1/L1 Experienced SD-101 8 mg
	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	2/44 (4.55%)	3/39 (7.69%)	5/31 (16.13%)	7/30 (23.33%)	6/27 (22.22%)	13/23 (56.52%)	7/23 (30.43%)	3/9 (33.33%)
Serious Adverse Events
	Melanoma Anti-PD-1/L1 Naïve SD-101 2 mg	Melanoma Anti-PD-1/L1 Naïve SD-101 8 mg	Melanoma Anti-PD-1/L1 Experienced SD-101 2 mg	Melanoma Anti-PD-1/L1 Experienced SD-101 8 mg	HNSCC Anti-PD-1/L1 Naïve SD-101 2 mg	HNSCC Anti-PD-1/L1 Naïve SD-101 8 mg	HNSCC Anti-PD-1/L1 Experienced SD-101 2 mg	HNSCC Anti-PD-1/L1 Experienced SD-101 8 mg
	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	15/44 (34.09%)	17/39 (43.59%)	6/31 (19.35%)	9/30 (30.00%)	8/27 (29.63%)	5/23 (21.74%)	10/23 (43.48%)	4/9 (44.44%)
Blood and lymphatic system disorders
Anaemia † 1	1/44 (2.27%)	0/39 (0.00%)	0/31 (0.00%)	0/30 (0.00%)	0/27 (0.00%)	0/23 (0.00%)	0/23 (0.00%)	0/9 (0.00%)
Eosinophilia † 1	0/44 (0.00%)	1/39 (2.56%)	0/31 (0.00%)	0/30 (0.00%)	0/27 (0.00%)	0/23 (0.00%)	0/23 (0.00%)	0/9 (0.00%)
Febrile neutropenia † 1	1/44 (2.27%)	0/39 (0.00%)	0/31 (0.00%)	0/30 (0.00%)	0/27 (0.00%)	0/23 (0.00%)	0/23 (0.00%)	0/9 (0.00%)
Iron deficiency anaemia † 1	0/44 (0.00%)	0/39 (0.00%)	0/31 (0.00%)	0/30 (0.00%)	0/27 (0.00%)	0/23 (0.00%)	0/23 (0.00%)	1/9 (11.11%)
Thrombocytopenia † 1	0/44 (0.00%)	0/39 (0.00%)	0/31 (0.00%)	0/30 (0.00%)	1/27 (3.70%)	0/23 (0.00%)	0/23 (0.00%)	0/9 (0.00%)
Cardiac disorders
Angina pectoris † 1	0/44 (0.00%)	0/39 (0.00%)	1/31 (3.23%)	0/30 (0.00%)	0/27 (0.00%)	0/23 (0.00%)	0/23 (0.00%)	0/9 (0.00%)
Aortic valve stenosis † 1	0/44 (0.00%)	0/39 (0.00%)	0/31 (0.00%)	1/30 (3.33%)	0/27 (0.00%)	0/23 (0.00%)	0/23 (0.00%)	0/9 (0.00%)
Atrial fibrillation † 1	0/44 (0.00%)	0/39 (0.00%)	0/31 (0.00%)	1/30 (3.33%)	0/27 (0.00%)	1/23 (4.35%)	0/23 (0.00%)	0/9 (0.00%)
Atrial flutter † 1	0/44 (0.00%)	0/39 (0.00%)	0/31 (0.00%)	1/30 (3.33%)	0/27 (0.00%)	0/23 (0.00%)	0/23 (0.00%)	0/9 (0.00%)
Atrioventricular block complete † 1	0/44 (0.00%)	0/39 (0.00%)	0/31 (0.00%)	1/30 (3.33%)	0/27 (0.00%)	0/23 (0.00%)	0/23 (0.00%)	0/9 (0.00%)
Autoimmune myocarditis † 1	0/44 (0.00%)	1/39 (2.56%)	0/31 (0.00%)	0/30 (0.00%)	0/27 (0.00%)	0/23 (0.00%)	0/23 (0.00%)	0/9 (0.00%)
Cardiac failure † 1	0/44 (0.00%)	0/39 (0.00%)	0/31 (0.00%)	1/30 (3.33%)	0/27 (0.00%)	0/23 (0.00%)	0/23 (0.00%)	0/9 (0.00%)
Mitral valve stenosis † 1	0/44 (0.00%)	0/39 (0.00%)	0/31 (0.00%)	1/30 (3.33%)	0/27 (0.00%)	0/23 (0.00%)	0/23 (0.00%)	0/9 (0.00%)
Pericardial effusion † 1	0/44 (0.00%)	0/39 (0.00%)	0/31 (0.00%)	0/30 (0.00%)	0/27 (0.00%)	1/23 (4.35%)	0/23 (0.00%)	0/9 (0.00%)
Pulseless electrical activity † 1	0/44 (0.00%)	0/39 (0.00%)	0/31 (0.00%)	0/30 (0.00%)	1/27 (3.70%)	0/23 (0.00%)	0/23 (0.00%)	0/9 (0.00%)
Endocrine disorders
Hypophysitis † 1	1/44 (2.27%)	0/39 (0.00%)	0/31 (0.00%)	0/30 (0.00%)	0/27 (0.00%)	0/23 (0.00%)	0/23 (0.00%)	0/9 (0.00%)
Inappropriate antidiuretic hormone secretion † 1	0/44 (0.00%)	0/39 (0.00%)	0/31 (0.00%)	0/30 (0.00%)	0/27 (0.00%)	0/23 (0.00%)	1/23 (4.35%)	0/9 (0.00%)
Eye disorders
Autoimmune retinopathy † 1	0/44 (0.00%)	1/39 (2.56%)	0/31 (0.00%)	0/30 (0.00%)	0/27 (0.00%)	0/23 (0.00%)	0/23 (0.00%)	0/9 (0.00%)
Gastrointestinal disorders
Constipation † 1	0/44 (0.00%)	0/39 (0.00%)	1/31 (3.23%)	0/30 (0.00%)	0/27 (0.00%)	0/23 (0.00%)	0/23 (0.00%)	0/9 (0.00%)
Diarrhoea † 1	1/44 (2.27%)	0/39 (0.00%)	0/31 (0.00%)	1/30 (3.33%)	0/27 (0.00%)	0/23 (0.00%)	0/23 (0.00%)	0/9 (0.00%)
Intussusception † 1	0/44 (0.00%)	0/39 (0.00%)	1/31 (3.23%)	0/30 (0.00%)	0/27 (0.00%)	0/23 (0.00%)	0/23 (0.00%)	0/9 (0.00%)
Lower gastrointestinal haemorrhage † 1	0/44 (0.00%)	0/39 (0.00%)	0/31 (0.00%)	1/30 (3.33%)	0/27 (0.00%)	0/23 (0.00%)	0/23 (0.00%)	0/9 (0.00%)
Mouth haemorrhage † 1	0/44 (0.00%)	0/39 (0.00%)	0/31 (0.00%)	0/30 (0.00%)	0/27 (0.00%)	0/23 (0.00%)	1/23 (4.35%)	0/9 (0.00%)
Nausea † 1	0/44 (0.00%)	0/39 (0.00%)	0/31 (0.00%)	1/30 (3.33%)	0/27 (0.00%)	0/23 (0.00%)	0/23 (0.00%)	0/9 (0.00%)
Pancreatitis † 1	1/44 (2.27%)	0/39 (0.00%)	0/31 (0.00%)	1/30 (3.33%)	0/27 (0.00%)	0/23 (0.00%)	0/23 (0.00%)	0/9 (0.00%)
Upper gastrointestinal haemorrhage † 1	1/44 (2.27%)	0/39 (0.00%)	0/31 (0.00%)	0/30 (0.00%)	0/27 (0.00%)	0/23 (0.00%)	0/23 (0.00%)	0/9 (0.00%)
Vomiting † 1	0/44 (0.00%)	0/39 (0.00%)	1/31 (3.23%)	2/30 (6.67%)	0/27 (0.00%)	0/23 (0.00%)	0/23 (0.00%)	0/9 (0.00%)
General disorders
Asthenia † 1	0/44 (0.00%)	0/39 (0.00%)	1/31 (3.23%)	0/30 (0.00%)	0/27 (0.00%)	0/23 (0.00%)	0/23 (0.00%)	0/9 (0.00%)
Generalised oedema † 1	0/44 (0.00%)	0/39 (0.00%)	0/31 (0.00%)	1/30 (3.33%)	0/27 (0.00%)	0/23 (0.00%)	0/23 (0.00%)	0/9 (0.00%)
Influenza like illness † 1	0/44 (0.00%)	1/39 (2.56%)	0/31 (0.00%)	1/30 (3.33%)	0/27 (0.00%)	0/23 (0.00%)	0/23 (0.00%)	0/9 (0.00%)
Localised oedema † 1	0/44 (0.00%)	0/39 (0.00%)	0/31 (0.00%)	0/30 (0.00%)	0/27 (0.00%)	0/23 (0.00%)	1/23 (4.35%)	0/9 (0.00%)
Oedema peripheral † 1	0/44 (0.00%)	1/39 (2.56%)	0/31 (0.00%)	0/30 (0.00%)	0/27 (0.00%)	0/23 (0.00%)	0/23 (0.00%)	0/9 (0.00%)
Pyrexia † 1	1/44 (2.27%)	0/39 (0.00%)	2/31 (6.45%)	1/30 (3.33%)	0/27 (0.00%)	0/23 (0.00%)	0/23 (0.00%)	0/9 (0.00%)
Systemic inflammatory response syndrome † 1	0/44 (0.00%)	0/39 (0.00%)	0/31 (0.00%)	1/30 (3.33%)	1/27 (3.70%)	0/23 (0.00%)	0/23 (0.00%)	0/9 (0.00%)
Hepatobiliary disorders
Autoimmune hepatitis † 1	0/44 (0.00%)	1/39 (2.56%)	0/31 (0.00%)	0/30 (0.00%)	0/27 (0.00%)	0/23 (0.00%)	0/23 (0.00%)	0/9 (0.00%)
Bile duct stone † 1	0/44 (0.00%)	0/39 (0.00%)	0/31 (0.00%)	1/30 (3.33%)	0/27 (0.00%)	0/23 (0.00%)	0/23 (0.00%)	0/9 (0.00%)
Immune system disorders
Contrast media allergy † 1	0/44 (0.00%)	1/39 (2.56%)	0/31 (0.00%)	0/30 (0.00%)	0/27 (0.00%)	0/23 (0.00%)	0/23 (0.00%)	0/9 (0.00%)
Infections and infestations
Abscess † 1	0/44 (0.00%)	0/39 (0.00%)	0/31 (0.00%)	0/30 (0.00%)	1/27 (3.70%)	0/23 (0.00%)	0/23 (0.00%)	0/9 (0.00%)
Cellulitis † 1	2/44 (4.55%)	0/39 (0.00%)	0/31 (0.00%)	0/30 (0.00%)	1/27 (3.70%)	0/23 (0.00%)	0/23 (0.00%)	1/9 (11.11%)
Clostridium difficile colitis † 1	0/44 (0.00%)	1/39 (2.56%)	0/31 (0.00%)	0/30 (0.00%)	0/27 (0.00%)	0/23 (0.00%)	0/23 (0.00%)	0/9 (0.00%)
Erysipelas † 1	0/44 (0.00%)	0/39 (0.00%)	1/31 (3.23%)	0/30 (0.00%)	0/27 (0.00%)	0/23 (0.00%)	0/23 (0.00%)	0/9 (0.00%)
Gastroenteritis † 1	1/44 (2.27%)	0/39 (0.00%)	0/31 (0.00%)	0/30 (0.00%)	0/27 (0.00%)	0/23 (0.00%)	0/23 (0.00%)	0/9 (0.00%)
Influenza † 1	0/44 (0.00%)	1/39 (2.56%)	0/31 (0.00%)	0/30 (0.00%)	0/27 (0.00%)	0/23 (0.00%)	0/23 (0.00%)	0/9 (0.00%)
Meningitis aseptic † 1	0/44 (0.00%)	1/39 (2.56%)	0/31 (0.00%)	0/30 (0.00%)	0/27 (0.00%)	0/23 (0.00%)	0/23 (0.00%)	0/9 (0.00%)
Osteomyelitis † 1	0/44 (0.00%)	0/39 (0.00%)	0/31 (0.00%)	0/30 (0.00%)	0/27 (0.00%)	0/23 (0.00%)	1/23 (4.35%)	0/9 (0.00%)
Pneumonia † 1	0/44 (0.00%)	1/39 (2.56%)	1/31 (3.23%)	3/30 (10.00%)	2/27 (7.41%)	1/23 (4.35%)	1/23 (4.35%)	0/9 (0.00%)
Sepsis † 1	2/44 (4.55%)	0/39 (0.00%)	0/31 (0.00%)	0/30 (0.00%)	2/27 (7.41%)	1/23 (4.35%)	1/23 (4.35%)	0/9 (0.00%)
Septic shock † 1	0/44 (0.00%)	0/39 (0.00%)	0/31 (0.00%)	0/30 (0.00%)	0/27 (0.00%)	0/23 (0.00%)	1/23 (4.35%)	0/9 (0.00%)
Skin infection † 1	1/44 (2.27%)	0/39 (0.00%)	0/31 (0.00%)	0/30 (0.00%)	0/27 (0.00%)	0/23 (0.00%)	0/23 (0.00%)	0/9 (0.00%)
Soft tissue infection † 1	0/44 (0.00%)	1/39 (2.56%)	0/31 (0.00%)	0/30 (0.00%)	0/27 (0.00%)	0/23 (0.00%)	0/23 (0.00%)	0/9 (0.00%)
Streptococcal infection † 1	0/44 (0.00%)	1/39 (2.56%)	0/31 (0.00%)	0/30 (0.00%)	0/27 (0.00%)	0/23 (0.00%)	0/23 (0.00%)	0/9 (0.00%)
Urinary tract infection † 1	0/44 (0.00%)	1/39 (2.56%)	0/31 (0.00%)	0/30 (0.00%)	0/27 (0.00%)	0/23 (0.00%)	0/23 (0.00%)	0/9 (0.00%)
Urosepsis † 1	0/44 (0.00%)	1/39 (2.56%)	0/31 (0.00%)	0/30 (0.00%)	0/27 (0.00%)	0/23 (0.00%)	0/23 (0.00%)	0/9 (0.00%)
Injury, poisoning and procedural complications
Cervical vertebral fracture † 1	0/44 (0.00%)	0/39 (0.00%)	0/31 (0.00%)	0/30 (0.00%)	0/27 (0.00%)	1/23 (4.35%)	0/23 (0.00%)	0/9 (0.00%)
Fall † 1	0/44 (0.00%)	1/39 (2.56%)	0/31 (0.00%)	0/30 (0.00%)	0/27 (0.00%)	1/23 (4.35%)	0/23 (0.00%)	0/9 (0.00%)
Humerus fracture † 1	1/44 (2.27%)	0/39 (0.00%)	0/31 (0.00%)	0/30 (0.00%)	0/27 (0.00%)	0/23 (0.00%)	0/23 (0.00%)	0/9 (0.00%)
Infusion related reaction † 1	0/44 (0.00%)	0/39 (0.00%)	0/31 (0.00%)	0/30 (0.00%)	0/27 (0.00%)	1/23 (4.35%)	0/23 (0.00%)	0/9 (0.00%)
Investigations
Alanine aminotransferase increased † 1	0/44 (0.00%)	1/39 (2.56%)	0/31 (0.00%)	0/30 (0.00%)	0/27 (0.00%)	0/23 (0.00%)	0/23 (0.00%)	0/9 (0.00%)
Aspartate aminotransferase increased † 1	0/44 (0.00%)	1/39 (2.56%)	0/31 (0.00%)	0/30 (0.00%)	0/27 (0.00%)	0/23 (0.00%)	0/23 (0.00%)	0/9 (0.00%)
Blood creatine phosphokinase increased † 1	0/44 (0.00%)	0/39 (0.00%)	0/31 (0.00%)	1/30 (3.33%)	0/27 (0.00%)	0/23 (0.00%)	0/23 (0.00%)	0/9 (0.00%)
Blood creatinine increased † 1	1/44 (2.27%)	0/39 (0.00%)	0/31 (0.00%)	0/30 (0.00%)	0/27 (0.00%)	0/23 (0.00%)	0/23 (0.00%)	0/9 (0.00%)
Metabolism and nutrition disorders
Dehydration † 1	0/44 (0.00%)	3/39 (7.69%)	0/31 (0.00%)	1/30 (3.33%)	1/27 (3.70%)	1/23 (4.35%)	0/23 (0.00%)	0/9 (0.00%)
Failure to thrive † 1	0/44 (0.00%)	0/39 (0.00%)	0/31 (0.00%)	0/30 (0.00%)	1/27 (3.70%)	0/23 (0.00%)	0/23 (0.00%)	0/9 (0.00%)
Fluid overload † 1	0/44 (0.00%)	0/39 (0.00%)	0/31 (0.00%)	1/30 (3.33%)	0/27 (0.00%)	0/23 (0.00%)	0/23 (0.00%)	0/9 (0.00%)
Hyponatraemia † 1	0/44 (0.00%)	1/39 (2.56%)	1/31 (3.23%)	0/30 (0.00%)	0/27 (0.00%)	0/23 (0.00%)	0/23 (0.00%)	0/9 (0.00%)
Malnutrition † 1	0/44 (0.00%)	0/39 (0.00%)	0/31 (0.00%)	0/30 (0.00%)	1/27 (3.70%)	0/23 (0.00%)	2/23 (8.70%)	0/9 (0.00%)
Musculoskeletal and connective tissue disorders
Muscular weakness † 1	0/44 (0.00%)	1/39 (2.56%)	0/31 (0.00%)	1/30 (3.33%)	0/27 (0.00%)	0/23 (0.00%)	0/23 (0.00%)	0/9 (0.00%)
Musculoskeletal chest pain † 1	0/44 (0.00%)	0/39 (0.00%)	0/31 (0.00%)	1/30 (3.33%)	0/27 (0.00%)	0/23 (0.00%)	0/23 (0.00%)	0/9 (0.00%)
Myositis † 1	0/44 (0.00%)	1/39 (2.56%)	0/31 (0.00%)	0/30 (0.00%)	0/27 (0.00%)	0/23 (0.00%)	0/23 (0.00%)	0/9 (0.00%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma † 1	1/44 (2.27%)	0/39 (0.00%)	0/31 (0.00%)	0/30 (0.00%)	0/27 (0.00%)	0/23 (0.00%)	0/23 (0.00%)	0/9 (0.00%)
Infected neoplasm † 1	0/44 (0.00%)	0/39 (0.00%)	0/31 (0.00%)	1/30 (3.33%)	0/27 (0.00%)	0/23 (0.00%)	0/23 (0.00%)	1/9 (11.11%)
Squamous cell carcinoma † 1	1/44 (2.27%)	1/39 (2.56%)	0/31 (0.00%)	0/30 (0.00%)	0/27 (0.00%)	0/23 (0.00%)	0/23 (0.00%)	0/9 (0.00%)
Tumour haemorrhage † 1	0/44 (0.00%)	0/39 (0.00%)	0/31 (0.00%)	0/30 (0.00%)	2/27 (7.41%)	0/23 (0.00%)	1/23 (4.35%)	0/9 (0.00%)
Nervous system disorders
Cerebrovascular accident † 1	1/44 (2.27%)	0/39 (0.00%)	0/31 (0.00%)	0/30 (0.00%)	0/27 (0.00%)	0/23 (0.00%)	0/23 (0.00%)	0/9 (0.00%)
Embolic stroke † 1	1/44 (2.27%)	0/39 (0.00%)	0/31 (0.00%)	0/30 (0.00%)	0/27 (0.00%)	0/23 (0.00%)	0/23 (0.00%)	0/9 (0.00%)
Headache † 1	1/44 (2.27%)	0/39 (0.00%)	0/31 (0.00%)	0/30 (0.00%)	0/27 (0.00%)	0/23 (0.00%)	0/23 (0.00%)	0/9 (0.00%)
Hepatic encephalopathy † 1	0/44 (0.00%)	1/39 (2.56%)	0/31 (0.00%)	0/30 (0.00%)	0/27 (0.00%)	0/23 (0.00%)	0/23 (0.00%)	0/9 (0.00%)
Ischaemic stroke † 1	0/44 (0.00%)	0/39 (0.00%)	0/31 (0.00%)	0/30 (0.00%)	0/27 (0.00%)	0/23 (0.00%)	0/23 (0.00%)	1/9 (11.11%)
Metabolic encephalopathy † 1	0/44 (0.00%)	1/39 (2.56%)	0/31 (0.00%)	0/30 (0.00%)	0/27 (0.00%)	0/23 (0.00%)	0/23 (0.00%)	0/9 (0.00%)
Myasthenia gravis † 1	0/44 (0.00%)	1/39 (2.56%)	0/31 (0.00%)	0/30 (0.00%)	0/27 (0.00%)	0/23 (0.00%)	0/23 (0.00%)	0/9 (0.00%)
Parkinson's disease † 1	1/44 (2.27%)	0/39 (0.00%)	0/31 (0.00%)	0/30 (0.00%)	0/27 (0.00%)	0/23 (0.00%)	0/23 (0.00%)	0/9 (0.00%)
Seizure † 1	0/44 (0.00%)	1/39 (2.56%)	0/31 (0.00%)	0/30 (0.00%)	0/27 (0.00%)	0/23 (0.00%)	0/23 (0.00%)	0/9 (0.00%)
Syncope † 1	1/44 (2.27%)	0/39 (0.00%)	0/31 (0.00%)	0/30 (0.00%)	0/27 (0.00%)	1/23 (4.35%)	0/23 (0.00%)	0/9 (0.00%)
Psychiatric disorders
Mental status changes † 1	0/44 (0.00%)	0/39 (0.00%)	0/31 (0.00%)	0/30 (0.00%)	0/27 (0.00%)	1/23 (4.35%)	0/23 (0.00%)	0/9 (0.00%)
Violence-related symptom † 1	0/44 (0.00%)	0/39 (0.00%)	0/31 (0.00%)	0/30 (0.00%)	0/27 (0.00%)	0/23 (0.00%)	1/23 (4.35%)	0/9 (0.00%)
Renal and urinary disorders
Acute kidney injury † 1	0/44 (0.00%)	1/39 (2.56%)	0/31 (0.00%)	1/30 (3.33%)	0/27 (0.00%)	0/23 (0.00%)	0/23 (0.00%)	0/9 (0.00%)
Nephrolithiasis † 1	0/44 (0.00%)	1/39 (2.56%)	0/31 (0.00%)	0/30 (0.00%)	0/27 (0.00%)	0/23 (0.00%)	0/23 (0.00%)	0/9 (0.00%)
Urinary tract obstruction † 1	0/44 (0.00%)	1/39 (2.56%)	0/31 (0.00%)	0/30 (0.00%)	0/27 (0.00%)	0/23 (0.00%)	0/23 (0.00%)	0/9 (0.00%)
Respiratory, thoracic and mediastinal disorders
Bronchial hyperreactivity † 1	1/44 (2.27%)	0/39 (0.00%)	0/31 (0.00%)	0/30 (0.00%)	0/27 (0.00%)	0/23 (0.00%)	0/23 (0.00%)	0/9 (0.00%)
Chronic obstructive pulmonary disease † 1	0/44 (0.00%)	0/39 (0.00%)	1/31 (3.23%)	0/30 (0.00%)	0/27 (0.00%)	0/23 (0.00%)	0/23 (0.00%)	0/9 (0.00%)
Cough † 1	1/44 (2.27%)	0/39 (0.00%)	0/31 (0.00%)	0/30 (0.00%)	0/27 (0.00%)	0/23 (0.00%)	0/23 (0.00%)	0/9 (0.00%)
Dyspnoea † 1	0/44 (0.00%)	0/39 (0.00%)	0/31 (0.00%)	0/30 (0.00%)	1/27 (3.70%)	0/23 (0.00%)	0/23 (0.00%)	0/9 (0.00%)
Haemoptysis † 1	0/44 (0.00%)	0/39 (0.00%)	0/31 (0.00%)	0/30 (0.00%)	1/27 (3.70%)	0/23 (0.00%)	0/23 (0.00%)	0/9 (0.00%)
Hypoxia † 1	1/44 (2.27%)	0/39 (0.00%)	0/31 (0.00%)	0/30 (0.00%)	0/27 (0.00%)	0/23 (0.00%)	0/23 (0.00%)	0/9 (0.00%)
Pleural effusion † 1	1/44 (2.27%)	0/39 (0.00%)	0/31 (0.00%)	0/30 (0.00%)	0/27 (0.00%)	0/23 (0.00%)	0/23 (0.00%)	0/9 (0.00%)
Pneumonia aspiration † 1	0/44 (0.00%)	0/39 (0.00%)	0/31 (0.00%)	0/30 (0.00%)	1/27 (3.70%)	0/23 (0.00%)	1/23 (4.35%)	0/9 (0.00%)
Pneumonitis † 1	0/44 (0.00%)	1/39 (2.56%)	0/31 (0.00%)	0/30 (0.00%)	0/27 (0.00%)	0/23 (0.00%)	0/23 (0.00%)	0/9 (0.00%)
Pneumothorax † 1	0/44 (0.00%)	0/39 (0.00%)	0/31 (0.00%)	1/30 (3.33%)	0/27 (0.00%)	0/23 (0.00%)	0/23 (0.00%)	0/9 (0.00%)
Pulmonary embolism † 1	0/44 (0.00%)	2/39 (5.13%)	0/31 (0.00%)	0/30 (0.00%)	0/27 (0.00%)	0/23 (0.00%)	0/23 (0.00%)	0/9 (0.00%)
Respiratory depression † 1	0/44 (0.00%)	0/39 (0.00%)	0/31 (0.00%)	0/30 (0.00%)	0/27 (0.00%)	0/23 (0.00%)	0/23 (0.00%)	1/9 (11.11%)
Respiratory failure † 1	0/44 (0.00%)	0/39 (0.00%)	0/31 (0.00%)	0/30 (0.00%)	0/27 (0.00%)	0/23 (0.00%)	0/23 (0.00%)	1/9 (11.11%)
Skin and subcutaneous tissue disorders
Angioedema † 1	0/44 (0.00%)	0/39 (0.00%)	0/31 (0.00%)	1/30 (3.33%)	0/27 (0.00%)	0/23 (0.00%)	0/23 (0.00%)	0/9 (0.00%)
Vascular disorders
Aortic aneurysm † 1	0/44 (0.00%)	1/39 (2.56%)	0/31 (0.00%)	0/30 (0.00%)	0/27 (0.00%)	0/23 (0.00%)	0/23 (0.00%)	0/9 (0.00%)
Arterial rupture † 1	0/44 (0.00%)	0/39 (0.00%)	0/31 (0.00%)	0/30 (0.00%)	1/27 (3.70%)	0/23 (0.00%)	0/23 (0.00%)	0/9 (0.00%)
Deep vein thrombosis † 1	0/44 (0.00%)	1/39 (2.56%)	0/31 (0.00%)	0/30 (0.00%)	0/27 (0.00%)	0/23 (0.00%)	0/23 (0.00%)	0/9 (0.00%)
Hypotension † 1	0/44 (0.00%)	2/39 (5.13%)	0/31 (0.00%)	0/30 (0.00%)	0/27 (0.00%)	0/23 (0.00%)	0/23 (0.00%)	0/9 (0.00%)
Orthostatic hypotension † 1	0/44 (0.00%)	0/39 (0.00%)	0/31 (0.00%)	0/30 (0.00%)	1/27 (3.70%)	0/23 (0.00%)	0/23 (0.00%)	0/9 (0.00%)
1 Term from vocabulary, MedDRA 18_1; † Indicates events were collected by systematic assessment
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	2%
	Melanoma Anti-PD-1/L1 Naïve SD-101 2 mg	Melanoma Anti-PD-1/L1 Naïve SD-101 8 mg	Melanoma Anti-PD-1/L1 Experienced SD-101 2 mg	Melanoma Anti-PD-1/L1 Experienced SD-101 8 mg	HNSCC Anti-PD-1/L1 Naïve SD-101 2 mg	HNSCC Anti-PD-1/L1 Naïve SD-101 8 mg	HNSCC Anti-PD-1/L1 Experienced SD-101 2 mg	HNSCC Anti-PD-1/L1 Experienced SD-101 8 mg
	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	44/44 (100.00%)	39/39 (100.00%)	31/31 (100.00%)	30/30 (100.00%)	25/27 (92.59%)	23/23 (100.00%)	22/23 (95.65%)	9/9 (100.00%)
Blood and lymphatic system disorders
Anaemia † 1	7/44 (15.91%)	10/39 (25.64%)	4/31 (12.90%)	4/30 (13.33%)	4/27 (14.81%)	5/23 (21.74%)	3/23 (13.04%)	2/9 (22.22%)
Neutropenia † 1	1/44 (2.27%)	2/39 (5.13%)	0/31 (0.00%)	0/30 (0.00%)	0/27 (0.00%)	0/23 (0.00%)	0/23 (0.00%)	0/9 (0.00%)
Thrombocytopenia † 1	0/44 (0.00%)	0/39 (0.00%)	0/31 (0.00%)	0/30 (0.00%)	1/27 (3.70%)	2/23 (8.70%)	0/23 (0.00%)	0/9 (0.00%)
Cardiac disorders
Sinus tachycardia † 1	0/44 (0.00%)	0/39 (0.00%)	1/31 (3.23%)	1/30 (3.33%)	0/27 (0.00%)	0/23 (0.00%)	0/23 (0.00%)	0/9 (0.00%)
Endocrine disorders
Hypothyroidism † 1	11/44 (25.00%)	3/39 (7.69%)	1/31 (3.23%)	1/30 (3.33%)	2/27 (7.41%)	2/23 (8.70%)	0/23 (0.00%)	0/9 (0.00%)
Eye disorders
Dry eye † 1	1/44 (2.27%)	1/39 (2.56%)	0/31 (0.00%)	0/30 (0.00%)	0/27 (0.00%)	0/23 (0.00%)	0/23 (0.00%)	0/9 (0.00%)
Vision blurred † 1	0/44 (0.00%)	0/39 (0.00%)	1/31 (3.23%)	1/30 (3.33%)	0/27 (0.00%)	0/23 (0.00%)	0/23 (0.00%)	0/9 (0.00%)
Gastrointestinal disorders
Abdominal pain † 1	5/44 (11.36%)	4/39 (10.26%)	2/31 (6.45%)	1/30 (3.33%)	0/27 (0.00%)	0/23 (0.00%)	0/23 (0.00%)	0/9 (0.00%)
Constipation † 1	8/44 (18.18%)	3/39 (7.69%)	2/31 (6.45%)	6/30 (20.00%)	4/27 (14.81%)	4/23 (17.39%)	0/23 (0.00%)	0/9 (0.00%)
Diarrhoea † 1	21/44 (47.73%)	11/39 (28.21%)	6/31 (19.35%)	7/30 (23.33%)	2/27 (7.41%)	7/23 (30.43%)	0/23 (0.00%)	0/9 (0.00%)
Dry mouth † 1	2/44 (4.55%)	3/39 (7.69%)	0/31 (0.00%)	0/30 (0.00%)	0/27 (0.00%)	0/23 (0.00%)	0/23 (0.00%)	0/9 (0.00%)
Dyspepsia † 1	0/44 (0.00%)	0/39 (0.00%)	1/31 (3.23%)	1/30 (3.33%)	0/27 (0.00%)	0/23 (0.00%)	0/23 (0.00%)	0/9 (0.00%)
Dysphagia † 1	1/44 (2.27%)	2/39 (5.13%)	0/31 (0.00%)	0/30 (0.00%)	5/27 (18.52%)	6/23 (26.09%)	0/23 (0.00%)	0/9 (0.00%)
Nausea † 1	13/44 (29.55%)	15/39 (38.46%)	9/31 (29.03%)	10/30 (33.33%)	8/27 (29.63%)	8/23 (34.78%)	0/23 (0.00%)	0/9 (0.00%)
Stomatitis † 1	1/44 (2.27%)	2/39 (5.13%)	0/31 (0.00%)	0/30 (0.00%)	0/27 (0.00%)	0/23 (0.00%)	0/23 (0.00%)	0/9 (0.00%)
Vomiting † 1	6/44 (13.64%)	6/39 (15.38%)	6/31 (19.35%)	6/30 (20.00%)	5/27 (18.52%)	3/23 (13.04%)	0/23 (0.00%)	0/9 (0.00%)
General disorders
Asthenia † 1	2/44 (4.55%)	4/39 (10.26%)	0/31 (0.00%)	0/30 (0.00%)	0/27 (0.00%)	0/23 (0.00%)	0/23 (0.00%)	0/9 (0.00%)
Chest pain † 1	1/44 (2.27%)	1/39 (2.56%)	0/31 (0.00%)	0/30 (0.00%)	1/27 (3.70%)	1/23 (4.35%)	0/23 (0.00%)	0/9 (0.00%)
Chills † 1	19/44 (43.18%)	20/39 (51.28%)	6/31 (19.35%)	16/30 (53.33%)	3/27 (11.11%)	10/23 (43.48%)	2/23 (8.70%)	1/9 (11.11%)
Face oedema † 1	1/44 (2.27%)	1/39 (2.56%)	0/31 (0.00%)	0/30 (0.00%)	0/27 (0.00%)	0/23 (0.00%)	0/23 (0.00%)	0/9 (0.00%)
Fatigue † 1	33/44 (75.00%)	31/39 (79.49%)	13/31 (41.94%)	22/30 (73.33%)	15/27 (55.56%)	17/23 (73.91%)	7/23 (30.43%)	5/9 (55.56%)
Gait disturbance † 1	1/44 (2.27%)	1/39 (2.56%)	0/31 (0.00%)	0/30 (0.00%)	0/27 (0.00%)	0/23 (0.00%)	0/23 (0.00%)	0/9 (0.00%)
Influenza like illness † 1	13/44 (29.55%)	7/39 (17.95%)	10/31 (32.26%)	4/30 (13.33%)	2/27 (7.41%)	2/23 (8.70%)	0/23 (0.00%)	0/9 (0.00%)
Injection site erythema † 1	17/44 (38.64%)	9/39 (23.08%)	4/31 (12.90%)	13/30 (43.33%)	1/27 (3.70%)	4/23 (17.39%)	2/23 (8.70%)	1/9 (11.11%)
Injection site induration † 1	1/44 (2.27%)	3/39 (7.69%)	1/31 (3.23%)	1/30 (3.33%)	0/27 (0.00%)	0/23 (0.00%)	0/23 (0.00%)	0/9 (0.00%)
Injection site pain † 1	11/44 (25.00%)	6/39 (15.38%)	4/31 (12.90%)	8/30 (26.67%)	0/27 (0.00%)	0/23 (0.00%)	2/23 (8.70%)	1/9 (11.11%)
Injection site pruritus † 1	3/44 (6.82%)	3/39 (7.69%)	0/31 (0.00%)	0/30 (0.00%)	0/27 (0.00%)	0/23 (0.00%)	0/23 (0.00%)	0/9 (0.00%)
Injection site reaction † 1	0/44 (0.00%)	0/39 (0.00%)	2/31 (6.45%)	1/30 (3.33%)	0/27 (0.00%)	0/23 (0.00%)	0/23 (0.00%)	0/9 (0.00%)
Injection site swelling † 1	9/44 (20.45%)	5/39 (12.82%)	0/31 (0.00%)	0/30 (0.00%)	2/27 (7.41%)	3/23 (13.04%)	1/23 (4.35%)	1/9 (11.11%)
Malaise † 1	14/44 (31.82%)	20/39 (51.28%)	4/31 (12.90%)	11/30 (36.67%)	0/27 (0.00%)	0/23 (0.00%)	2/23 (8.70%)	2/9 (22.22%)
Non-cardiac chest pain † 1	2/44 (4.55%)	1/39 (2.56%)	0/31 (0.00%)	0/30 (0.00%)	0/27 (0.00%)	0/23 (0.00%)	0/23 (0.00%)	0/9 (0.00%)
Oedema peripheral † 1	4/44 (9.09%)	5/39 (12.82%)	2/31 (6.45%)	2/30 (6.67%)	1/27 (3.70%)	2/23 (8.70%)	0/23 (0.00%)	0/9 (0.00%)
Pain † 1	5/44 (11.36%)	3/39 (7.69%)	2/31 (6.45%)	2/30 (6.67%)	1/27 (3.70%)	1/23 (4.35%)	0/23 (0.00%)	0/9 (0.00%)
Pyrexia † 1	10/44 (22.73%)	15/39 (38.46%)	7/31 (22.58%)	7/30 (23.33%)	6/27 (22.22%)	6/23 (26.09%)	6/23 (26.09%)	4/9 (44.44%)
Secretion discharge † 1	0/44 (0.00%)	0/39 (0.00%)	0/31 (0.00%)	0/30 (0.00%)	0/27 (0.00%)	0/23 (0.00%)	1/23 (4.35%)	1/9 (11.11%)
Infections and infestations
Candida infection † 1	1/44 (2.27%)	1/39 (2.56%)	0/31 (0.00%)	0/30 (0.00%)	2/27 (7.41%)	2/23 (8.70%)	0/23 (0.00%)	0/9 (0.00%)
Cellulitis † 1	5/44 (11.36%)	3/39 (7.69%)	0/31 (0.00%)	0/30 (0.00%)	0/27 (0.00%)	0/23 (0.00%)	0/23 (0.00%)	0/9 (0.00%)
Folliculitis † 1	1/44 (2.27%)	1/39 (2.56%)	0/31 (0.00%)	0/30 (0.00%)	0/27 (0.00%)	0/23 (0.00%)	0/23 (0.00%)	0/9 (0.00%)
Gastroenteritis viral † 1	1/44 (2.27%)	2/39 (5.13%)	0/31 (0.00%)	0/30 (0.00%)	0/27 (0.00%)	0/23 (0.00%)	0/23 (0.00%)	0/9 (0.00%)
Lower respiratory tract infection † 1	0/44 (0.00%)	0/39 (0.00%)	1/31 (3.23%)	1/30 (3.33%)	0/27 (0.00%)	0/23 (0.00%)	0/23 (0.00%)	0/9 (0.00%)
Nasopharyngitis † 1	1/44 (2.27%)	1/39 (2.56%)	2/31 (6.45%)	1/30 (3.33%)	0/27 (0.00%)	0/23 (0.00%)	0/23 (0.00%)	0/9 (0.00%)
Oral candidiasis † 1	3/44 (6.82%)	2/39 (5.13%)	0/31 (0.00%)	0/30 (0.00%)	1/27 (3.70%)	1/23 (4.35%)	0/23 (0.00%)	0/9 (0.00%)
Pneumonia † 1	0/44 (0.00%)	0/39 (0.00%)	0/31 (0.00%)	0/30 (0.00%)	2/27 (7.41%)	1/23 (4.35%)	0/23 (0.00%)	0/9 (0.00%)
Sinusitis † 1	2/44 (4.55%)	2/39 (5.13%)	1/31 (3.23%)	1/30 (3.33%)	0/27 (0.00%)	0/23 (0.00%)	0/23 (0.00%)	0/9 (0.00%)
Skin infection † 1	3/44 (6.82%)	1/39 (2.56%)	0/31 (0.00%)	0/30 (0.00%)	0/27 (0.00%)	0/23 (0.00%)	0/23 (0.00%)	0/9 (0.00%)
Upper respiratory tract infection † 1	5/44 (11.36%)	3/39 (7.69%)	1/31 (3.23%)	1/30 (3.33%)	1/27 (3.70%)	2/23 (8.70%)	0/23 (0.00%)	0/9 (0.00%)
Urinary tract infection † 1	4/44 (9.09%)	3/39 (7.69%)	2/31 (6.45%)	3/30 (10.00%)	1/27 (3.70%)	2/23 (8.70%)	0/23 (0.00%)	0/9 (0.00%)
Injury, poisoning and procedural complications
Fall † 1	1/44 (2.27%)	5/39 (12.82%)	0/31 (0.00%)	0/30 (0.00%)	0/27 (0.00%)	0/23 (0.00%)	0/23 (0.00%)	0/9 (0.00%)
Investigations
Alanine aminotransferase increased † 1	4/44 (9.09%)	2/39 (5.13%)	1/31 (3.23%)	2/30 (6.67%)	2/27 (7.41%)	2/23 (8.70%)	0/23 (0.00%)	0/9 (0.00%)
Aspartate aminotransferase increased † 1	6/44 (13.64%)	5/39 (12.82%)	2/31 (6.45%)	4/30 (13.33%)	2/27 (7.41%)	1/23 (4.35%)	0/23 (0.00%)	0/9 (0.00%)
Blood alkaline phosphatase increased † 1	3/44 (6.82%)	2/39 (5.13%)	1/31 (3.23%)	1/30 (3.33%)	0/27 (0.00%)	0/23 (0.00%)	0/23 (0.00%)	0/9 (0.00%)
Blood bilirubin increased † 1	1/44 (2.27%)	5/39 (12.82%)	0/31 (0.00%)	0/30 (0.00%)	0/27 (0.00%)	0/23 (0.00%)	0/23 (0.00%)	0/9 (0.00%)
Blood creatinine increased † 1	7/44 (15.91%)	8/39 (20.51%)	0/31 (0.00%)	0/30 (0.00%)	1/27 (3.70%)	2/23 (8.70%)	0/23 (0.00%)	0/9 (0.00%)
Blood lactate dehydrogenase increased † 1	0/44 (0.00%)	0/39 (0.00%)	1/31 (3.23%)	1/30 (3.33%)	0/27 (0.00%)	0/23 (0.00%)	0/23 (0.00%)	0/9 (0.00%)
C-reactive protein increased † 1	0/44 (0.00%)	0/39 (0.00%)	3/31 (9.68%)	1/30 (3.33%)	0/27 (0.00%)	0/23 (0.00%)	0/23 (0.00%)	0/9 (0.00%)
Gamma-glutamyltransferase increased † 1	0/44 (0.00%)	0/39 (0.00%)	1/31 (3.23%)	1/30 (3.33%)	0/27 (0.00%)	0/23 (0.00%)	0/23 (0.00%)	0/9 (0.00%)
Lymphocyte count decreased † 1	1/44 (2.27%)	3/39 (7.69%)	1/31 (3.23%)	1/30 (3.33%)	0/27 (0.00%)	0/23 (0.00%)	0/23 (0.00%)	0/9 (0.00%)
Neutrophil count decreased † 1	2/44 (4.55%)	2/39 (5.13%)	1/31 (3.23%)	3/30 (10.00%)	2/27 (7.41%)	1/23 (4.35%)	0/23 (0.00%)	0/9 (0.00%)
Platelet count decreased † 1	3/44 (6.82%)	4/39 (10.26%)	0/31 (0.00%)	0/30 (0.00%)	0/27 (0.00%)	0/23 (0.00%)	0/23 (0.00%)	0/9 (0.00%)
Tri-iodothyronine free decreased † 1	0/44 (0.00%)	0/39 (0.00%)	1/31 (3.23%)	1/30 (3.33%)	0/27 (0.00%)	0/23 (0.00%)	0/23 (0.00%)	0/9 (0.00%)
Weight decreased † 1	3/44 (6.82%)	4/39 (10.26%)	2/31 (6.45%)	1/30 (3.33%)	0/27 (0.00%)	0/23 (0.00%)	0/23 (0.00%)	0/9 (0.00%)
White blood cell count decreased † 1	3/44 (6.82%)	5/39 (12.82%)	0/31 (0.00%)	0/30 (0.00%)	0/27 (0.00%)	0/23 (0.00%)	0/23 (0.00%)	0/9 (0.00%)
Metabolism and nutrition disorders
Decreased appetite † 1	11/44 (25.00%)	11/39 (28.21%)	3/31 (9.68%)	9/30 (30.00%)	3/27 (11.11%)	3/23 (13.04%)	0/23 (0.00%)	0/9 (0.00%)
Dehydration † 1	4/44 (9.09%)	4/39 (10.26%)	0/31 (0.00%)	0/30 (0.00%)	1/27 (3.70%)	2/23 (8.70%)	0/23 (0.00%)	0/9 (0.00%)
Hypercalcaemia † 1	0/44 (0.00%)	0/39 (0.00%)	0/31 (0.00%)	0/30 (0.00%)	2/27 (7.41%)	2/23 (8.70%)	0/23 (0.00%)	0/9 (0.00%)
Hyperglycaemia † 1	2/44 (4.55%)	1/39 (2.56%)	0/31 (0.00%)	0/30 (0.00%)	0/27 (0.00%)	0/23 (0.00%)	0/23 (0.00%)	0/9 (0.00%)
Hyperkalaemia † 1	0/44 (0.00%)	0/39 (0.00%)	1/31 (3.23%)	1/30 (3.33%)	0/27 (0.00%)	0/23 (0.00%)	0/23 (0.00%)	0/9 (0.00%)
Hypoalbuminaemia † 1	2/44 (4.55%)	4/39 (10.26%)	0/31 (0.00%)	0/30 (0.00%)	0/27 (0.00%)	0/23 (0.00%)	0/23 (0.00%)	0/9 (0.00%)
Hypokalaemia † 1	2/44 (4.55%)	4/39 (10.26%)	2/31 (6.45%)	1/30 (3.33%)	0/27 (0.00%)	0/23 (0.00%)	0/23 (0.00%)	0/9 (0.00%)
Hypomagnesaemia † 1	2/44 (4.55%)	1/39 (2.56%)	0/31 (0.00%)	0/30 (0.00%)	1/27 (3.70%)	1/23 (4.35%)	0/23 (0.00%)	0/9 (0.00%)
Hyponatraemia † 1	5/44 (11.36%)	3/39 (7.69%)	1/31 (3.23%)	2/30 (6.67%)	3/27 (11.11%)	2/23 (8.70%)	0/23 (0.00%)	0/9 (0.00%)
Increased appetite † 1	1/44 (2.27%)	1/39 (2.56%)	0/31 (0.00%)	0/30 (0.00%)	0/27 (0.00%)	0/23 (0.00%)	0/23 (0.00%)	0/9 (0.00%)
Malnutrition † 1	0/44 (0.00%)	0/39 (0.00%)	0/31 (0.00%)	0/30 (0.00%)	1/27 (3.70%)	1/23 (4.35%)	0/23 (0.00%)	0/9 (0.00%)
Musculoskeletal and connective tissue disorders
Arthralgia † 1	16/44 (36.36%)	8/39 (20.51%)	3/31 (9.68%)	4/30 (13.33%)	0/27 (0.00%)	0/23 (0.00%)	0/23 (0.00%)	0/9 (0.00%)
Back pain † 1	4/44 (9.09%)	2/39 (5.13%)	2/31 (6.45%)	3/30 (10.00%)	0/27 (0.00%)	0/23 (0.00%)	0/23 (0.00%)	0/9 (0.00%)
Groin pain † 1	1/44 (2.27%)	1/39 (2.56%)	0/31 (0.00%)	0/30 (0.00%)	0/27 (0.00%)	0/23 (0.00%)	0/23 (0.00%)	0/9 (0.00%)
Joint swelling † 1	1/44 (2.27%)	1/39 (2.56%)	0/31 (0.00%)	0/30 (0.00%)	0/27 (0.00%)	0/23 (0.00%)	0/23 (0.00%)	0/9 (0.00%)
Muscular weakness † 1	2/44 (4.55%)	4/39 (10.26%)	0/31 (0.00%)	0/30 (0.00%)	0/27 (0.00%)	0/23 (0.00%)	0/23 (0.00%)	0/9 (0.00%)
Musculoskeletal pain † 1	2/44 (4.55%)	1/39 (2.56%)	0/31 (0.00%)	0/30 (0.00%)	0/27 (0.00%)	0/23 (0.00%)	0/23 (0.00%)	0/9 (0.00%)
Myalgia † 1	18/44 (40.91%)	17/39 (43.59%)	2/31 (6.45%)	16/30 (53.33%)	1/27 (3.70%)	9/23 (39.13%)	1/23 (4.35%)	2/9 (22.22%)
Neck pain † 1	1/44 (2.27%)	2/39 (5.13%)	0/31 (0.00%)	0/30 (0.00%)	0/27 (0.00%)	0/23 (0.00%)	2/23 (8.70%)	2/9 (22.22%)
Pain in extremity † 1	4/44 (9.09%)	4/39 (10.26%)	1/31 (3.23%)	1/30 (3.33%)	0/27 (0.00%)	0/23 (0.00%)	0/23 (0.00%)	0/9 (0.00%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour haemorrhage † 1	0/44 (0.00%)	0/39 (0.00%)	0/31 (0.00%)	0/30 (0.00%)	0/27 (0.00%)	0/23 (0.00%)	1/23 (4.35%)	1/9 (11.11%)
Tumour pain † 1	3/44 (6.82%)	1/39 (2.56%)	4/31 (12.90%)	2/30 (6.67%)	4/27 (14.81%)	2/23 (8.70%)	0/23 (0.00%)	0/9 (0.00%)
Nervous system disorders
Dizziness † 1	7/44 (15.91%)	5/39 (12.82%)	3/31 (9.68%)	4/30 (13.33%)	5/27 (18.52%)	1/23 (4.35%)	0/23 (0.00%)	0/9 (0.00%)
Dysaesthesia † 1	1/44 (2.27%)	1/39 (2.56%)	0/31 (0.00%)	0/30 (0.00%)	0/27 (0.00%)	0/23 (0.00%)	0/23 (0.00%)	0/9 (0.00%)
Dysgeusia † 1	2/44 (4.55%)	1/39 (2.56%)	1/31 (3.23%)	2/30 (6.67%)	0/27 (0.00%)	0/23 (0.00%)	0/23 (0.00%)	0/9 (0.00%)
Headache † 1	23/44 (52.27%)	25/39 (64.10%)	9/31 (29.03%)	14/30 (46.67%)	3/27 (11.11%)	10/23 (43.48%)	2/23 (8.70%)	4/9 (44.44%)
Hypoaesthesia † 1	2/44 (4.55%)	1/39 (2.56%)	1/31 (3.23%)	2/30 (6.67%)	0/27 (0.00%)	0/23 (0.00%)	1/23 (4.35%)	1/9 (11.11%)
Memory impairment † 1	1/44 (2.27%)	2/39 (5.13%)	0/31 (0.00%)	0/30 (0.00%)	0/27 (0.00%)	0/23 (0.00%)	0/23 (0.00%)	0/9 (0.00%)
Paraesthesia † 1	1/44 (2.27%)	2/39 (5.13%)	2/31 (6.45%)	1/30 (3.33%)	0/27 (0.00%)	0/23 (0.00%)	0/23 (0.00%)	0/9 (0.00%)
Peripheral sensory neuropathy † 1	1/44 (2.27%)	1/39 (2.56%)	0/31 (0.00%)	0/30 (0.00%)	0/27 (0.00%)	0/23 (0.00%)	0/23 (0.00%)	0/9 (0.00%)
Presyncope † 1	2/44 (4.55%)	3/39 (7.69%)	1/31 (3.23%)	1/30 (3.33%)	0/27 (0.00%)	0/23 (0.00%)	0/23 (0.00%)	0/9 (0.00%)
Sinus headache † 1	1/44 (2.27%)	1/39 (2.56%)	0/31 (0.00%)	0/30 (0.00%)	0/27 (0.00%)	0/23 (0.00%)	0/23 (0.00%)	0/9 (0.00%)
Somnolence † 1	0/44 (0.00%)	0/39 (0.00%)	0/31 (0.00%)	0/30 (0.00%)	1/27 (3.70%)	1/23 (4.35%)	0/23 (0.00%)	0/9 (0.00%)
Syncope † 1	0/44 (0.00%)	0/39 (0.00%)	0/31 (0.00%)	0/30 (0.00%)	1/27 (3.70%)	2/23 (8.70%)	0/23 (0.00%)	0/9 (0.00%)
Tremor † 1	1/44 (2.27%)	2/39 (5.13%)	0/31 (0.00%)	0/30 (0.00%)	0/27 (0.00%)	0/23 (0.00%)	0/23 (0.00%)	0/9 (0.00%)
Psychiatric disorders
Anxiety † 1	0/44 (0.00%)	0/39 (0.00%)	0/31 (0.00%)	0/30 (0.00%)	1/27 (3.70%)	3/23 (13.04%)	1/23 (4.35%)	2/9 (22.22%)
Insomnia † 1	4/44 (9.09%)	4/39 (10.26%)	3/31 (9.68%)	1/30 (3.33%)	3/27 (11.11%)	2/23 (8.70%)	0/23 (0.00%)	0/9 (0.00%)
Renal and urinary disorders
Proteinuria † 1	1/44 (2.27%)	3/39 (7.69%)	0/31 (0.00%)	0/30 (0.00%)	0/27 (0.00%)	0/23 (0.00%)	0/23 (0.00%)	0/9 (0.00%)
Respiratory, thoracic and mediastinal disorders
Cough † 1	8/44 (18.18%)	4/39 (10.26%)	3/31 (9.68%)	6/30 (20.00%)	3/27 (11.11%)	2/23 (8.70%)	1/23 (4.35%)	2/9 (22.22%)
Dysphonia † 1	1/44 (2.27%)	1/39 (2.56%)	1/31 (3.23%)	1/30 (3.33%)	2/27 (7.41%)	2/23 (8.70%)	0/23 (0.00%)	0/9 (0.00%)
Dyspnoea † 1	5/44 (11.36%)	9/39 (23.08%)	6/31 (19.35%)	4/30 (13.33%)	0/27 (0.00%)	0/23 (0.00%)	2/23 (8.70%)	1/9 (11.11%)
Epistaxis † 1	0/44 (0.00%)	0/39 (0.00%)	1/31 (3.23%)	1/30 (3.33%)	0/27 (0.00%)	0/23 (0.00%)	0/23 (0.00%)	0/9 (0.00%)
Haemoptysis † 1	0/44 (0.00%)	0/39 (0.00%)	0/31 (0.00%)	0/30 (0.00%)	1/27 (3.70%)	1/23 (4.35%)	0/23 (0.00%)	0/9 (0.00%)
Nasal congestion † 1	1/44 (2.27%)	1/39 (2.56%)	2/31 (6.45%)	3/30 (10.00%)	0/27 (0.00%)	0/23 (0.00%)	0/23 (0.00%)	0/9 (0.00%)
Oropharyngeal pain † 1	4/44 (9.09%)	2/39 (5.13%)	0/31 (0.00%)	0/30 (0.00%)	2/27 (7.41%)	1/23 (4.35%)	0/23 (0.00%)	0/9 (0.00%)
Pleural effusion † 1	1/44 (2.27%)	1/39 (2.56%)	0/31 (0.00%)	0/30 (0.00%)	0/27 (0.00%)	0/23 (0.00%)	0/23 (0.00%)	0/9 (0.00%)
Pneumonia aspiration † 1	0/44 (0.00%)	0/39 (0.00%)	0/31 (0.00%)	0/30 (0.00%)	1/27 (3.70%)	1/23 (4.35%)	0/23 (0.00%)	0/9 (0.00%)
Pneumonitis † 1	2/44 (4.55%)	2/39 (5.13%)	0/31 (0.00%)	0/30 (0.00%)	0/27 (0.00%)	0/23 (0.00%)	0/23 (0.00%)	0/9 (0.00%)
Productive cough † 1	3/44 (6.82%)	1/39 (2.56%)	0/31 (0.00%)	0/30 (0.00%)	0/27 (0.00%)	0/23 (0.00%)	1/23 (4.35%)	1/9 (11.11%)
Sinus congestion † 1	3/44 (6.82%)	1/39 (2.56%)	0/31 (0.00%)	0/30 (0.00%)	0/27 (0.00%)	0/23 (0.00%)	0/23 (0.00%)	0/9 (0.00%)
Skin and subcutaneous tissue disorders
Alopecia † 1	1/44 (2.27%)	1/39 (2.56%)	0/31 (0.00%)	0/30 (0.00%)	0/27 (0.00%)	0/23 (0.00%)	0/23 (0.00%)	0/9 (0.00%)
Dermatitis † 1	1/44 (2.27%)	1/39 (2.56%)	1/31 (3.23%)	2/30 (6.67%)	0/27 (0.00%)	0/23 (0.00%)	0/23 (0.00%)	0/9 (0.00%)
Dermatitis acneiform † 1	1/44 (2.27%)	1/39 (2.56%)	0/31 (0.00%)	0/30 (0.00%)	0/27 (0.00%)	0/23 (0.00%)	0/23 (0.00%)	0/9 (0.00%)
Dry skin † 1	1/44 (2.27%)	1/39 (2.56%)	0/31 (0.00%)	0/30 (0.00%)	0/27 (0.00%)	0/23 (0.00%)	0/23 (0.00%)	0/9 (0.00%)
Ecchymosis † 1	1/44 (2.27%)	1/39 (2.56%)	0/31 (0.00%)	0/30 (0.00%)	0/27 (0.00%)	0/23 (0.00%)	0/23 (0.00%)	0/9 (0.00%)
Erythema † 1	5/44 (11.36%)	3/39 (7.69%)	4/31 (12.90%)	3/30 (10.00%)	0/27 (0.00%)	0/23 (0.00%)	0/23 (0.00%)	0/9 (0.00%)
Hyperhidrosis † 1	3/44 (6.82%)	1/39 (2.56%)	0/31 (0.00%)	0/30 (0.00%)	0/27 (0.00%)	0/23 (0.00%)	0/23 (0.00%)	0/9 (0.00%)
Night sweats † 1	0/44 (0.00%)	0/39 (0.00%)	1/31 (3.23%)	2/30 (6.67%)	0/27 (0.00%)	0/23 (0.00%)	1/23 (4.35%)	1/9 (11.11%)
Pruritus † 1	14/44 (31.82%)	6/39 (15.38%)	3/31 (9.68%)	7/30 (23.33%)	2/27 (7.41%)	4/23 (17.39%)	0/23 (0.00%)	0/9 (0.00%)
Rash † 1	11/44 (25.00%)	7/39 (17.95%)	1/31 (3.23%)	1/30 (3.33%)	2/27 (7.41%)	1/23 (4.35%)	0/23 (0.00%)	0/9 (0.00%)
Rash erythematous † 1	1/44 (2.27%)	4/39 (10.26%)	0/31 (0.00%)	0/30 (0.00%)	0/27 (0.00%)	0/23 (0.00%)	0/23 (0.00%)	0/9 (0.00%)
Rash maculo-papular † 1	5/44 (11.36%)	5/39 (12.82%)	3/31 (9.68%)	3/30 (10.00%)	0/27 (0.00%)	0/23 (0.00%)	0/23 (0.00%)	0/9 (0.00%)
Rash pruritic † 1	3/44 (6.82%)	1/39 (2.56%)	0/31 (0.00%)	0/30 (0.00%)	0/27 (0.00%)	0/23 (0.00%)	0/23 (0.00%)	0/9 (0.00%)
Scab † 1	1/44 (2.27%)	1/39 (2.56%)	0/31 (0.00%)	0/30 (0.00%)	0/27 (0.00%)	0/23 (0.00%)	0/23 (0.00%)	0/9 (0.00%)
Skin hypopigmentation † 1	1/44 (2.27%)	3/39 (7.69%)	0/31 (0.00%)	0/30 (0.00%)	0/27 (0.00%)	0/23 (0.00%)	0/23 (0.00%)	0/9 (0.00%)
Skin lesion † 1	1/44 (2.27%)	1/39 (2.56%)	0/31 (0.00%)	0/30 (0.00%)	0/27 (0.00%)	0/23 (0.00%)	0/23 (0.00%)	0/9 (0.00%)
Vitiligo † 1	5/44 (11.36%)	4/39 (10.26%)	0/31 (0.00%)	0/30 (0.00%)	0/27 (0.00%)	0/23 (0.00%)	0/23 (0.00%)	0/9 (0.00%)
Vascular disorders
Flushing † 1	2/44 (4.55%)	2/39 (5.13%)	0/31 (0.00%)	0/30 (0.00%)	0/27 (0.00%)	0/23 (0.00%)	0/23 (0.00%)	0/9 (0.00%)
Haematoma † 1	1/44 (2.27%)	1/39 (2.56%)	0/31 (0.00%)	0/30 (0.00%)	0/27 (0.00%)	0/23 (0.00%)	0/23 (0.00%)	0/9 (0.00%)
Hypertension † 1	4/44 (9.09%)	13/39 (33.33%)	1/31 (3.23%)	2/30 (6.67%)	1/27 (3.70%)	2/23 (8.70%)	0/23 (0.00%)	0/9 (0.00%)
Hypotension † 1	1/44 (2.27%)	1/39 (2.56%)	0/31 (0.00%)	0/30 (0.00%)	2/27 (7.41%)	1/23 (4.35%)	1/23 (4.35%)	1/9 (11.11%)
Lymphoedema † 1	2/44 (4.55%)	1/39 (2.56%)	3/31 (9.68%)	1/30 (3.33%)	0/27 (0.00%)	0/23 (0.00%)	0/23 (0.00%)	0/9 (0.00%)
1 Term from vocabulary, MedDRA 18_1; † Indicates events were collected by systematic assessment

Limitations and Caveats

The sponsor terminated the trial early due to strategic restructuring, including the planned conclusion of clinical oncology development programs and no further sponsoring of the development of SD-101.

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact

• Name/Title: Robert Janssen MD \ VP & Chief Medical Officer
• Organization: Dynavax Technologies, Inc.
• Phone: 510-665-0414
• EMail: rjanssen@dynavax.com

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Ribas A, Medina T, Kummar S, Amin A, Kalbasi A, Drabick JJ, Barve M, Daniels GA, Wong DJ, Schmidt EV, Candia AF, Coffman RL, Leung ACF, Janssen RS. SD-101 in Combination with Pembrolizumab in Advanced Melanoma: Results of a Phase Ib, Multicenter Study. Cancer Discov. 2018 Oct;8(10):1250-1257. doi: 10.1158/2159-8290.CD-18-0280. Epub 2018 Aug 28.

• Responsible Party: Dynavax Technologies Corporation
• ClinicalTrials.gov Identifier: NCT02521870
• Other Study ID Numbers: DV3-MEL-01; Keynote 184 ( Other Identifier: Merck ); SYNERGY-001 ( Other Identifier: Dynavax )
• First Submitted: July 30, 2015
• First Posted: August 13, 2015
• Results First Submitted: April 30, 2021
• Results First Posted: August 3, 2021
• Last Update Posted: August 3, 2021