Ipilimumab vs Ipilimumab Plus Nivolumab in Patients With Stage III-IV Melanoma Who Have Progressed or Relapsed on PD-1 Inhibitor Therapy

• ClinicalTrials.gov Identifier: NCT02731729
• Recruitment Status: Completed
• First Posted: April 7, 2016
• Results First Posted: February 21, 2021
• Last Update Posted: December 23, 2022
• Sponsor: Parker Institute for Cancer Immunotherapy
• Collaborator: Bristol-Myers Squibb
• Information provided by (Responsible Party): Parker Institute for Cancer Immunotherapy

• Study Type: Interventional
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Melanoma
• Interventions: Drug: ipilimumab; Drug: nivolumab
• Enrollment: 20

Participant Flow

Recruitment Details	Participants were recruited at four institutions in the United States. Recruitment occurred between June 2016 to May 2018.
Pre-assignment Details	33 participants were assessed for eligibility. Out of the 33 participants, 20 patients met the inclusion/exclusion criteria and were randomized to the study arms.

Arm/Group Title	Ipilimumab and Nivolumab	Ipilimumab
Arm/Group Description	For patients in the combination arm, nivolumab will first be administered intravenously at a dose of 1 mg/kg of body weight over a period of 60 minutes, once every 3 weeks for four doses. Thirty minutes after the completion of each nivolumab infusion, patients will receive 3 mg/kg of ipilimumab over a period of 30 minutes. ipilimumab nivolumab	In the ipilimumab monotherapy group, patients will receive 3 mg/kg of ipilimumab over a period of 30 minutes once every 3 weeks for four doses. ipilimumab
Period Title: Overall Study
Started	10	10
Completed	1	2
Not Completed	9	8
Reason Not Completed
Death	2	2
Study terminated by Sponsor	6	6
Withdrawal by Subject	1	0

Baseline Characteristics

Arm/Group Title		Ipilimumab and Nivolumab	Ipilimumab	Total
Arm/Group Description		For patients in the combination arm, nivolumab will first be administered intravenously at a dose of 1 mg/kg of body weight over a period of 60 minutes, once every 3 weeks for four doses. Thirty minutes after the completion of each nivolumab infusion, patients will receive 3 mg/kg of ipilimumab over a period of 30 minutes. ipilimumab nivolumab	In the ipilimumab monotherapy group, patients will receive 3 mg/kg of ipilimumab over a period of 30 minutes once every 3 weeks for four doses. ipilimumab	Total of all reporting groups
Overall Number of Baseline Participants		10	9	19
Baseline Analysis Population Description		Out of the 20 patients randomized, one participant randomized to the ipilimumab monotherapy arm withdrew consent before starting treatment. The remaining 19 patients were evaluated for efficacy and safety analysis.
Age, Continuous; Median (Full Range); Unit of measure: Years
	Number Analyzed	10 participants	9 participants	19 participants
		66; (35 to 83)	56; (39 to 66)	60; (35 to 83)
Sex: Female, Male; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	10 participants	9 participants	19 participants
	Female	1 10.0%	3 33.3%	4 21.1%
	Male	9 90.0%	6 66.7%	15 78.9%
Race/Ethnicity, Customized; Measure Type: Count of Participants; Unit of measure: Participants	Number Analyzed	10 participants	9 participants	19 participants
Asian		1 10.0%	0 0.0%	1 5.3%
White		7 70.0%	9 100.0%	16 84.2%
Other		2 20.0%	0 0.0%	2 10.5%
Region of Enrollment; Measure Type: Number; Unit of measure: Participants
United States	Number Analyzed	10 participants	9 participants	19 participants
		10	9	19
ECOG Performance Status [1]; Measure Type: Count of Participants; Unit of measure: Participants	Number Analyzed	10 participants	9 participants	19 participants
ECOG Score = 0		7 70.0%	6 66.7%	13 68.4%
ECOG Score = 1		3 30.0%	3 33.3%	6 31.6%
		[1] Measure Description: The Eastern Cooperative Oncology Group (ECOG) Scale of Performance Status is one such measurement. It describes a patient's level of functioning in terms of their ability to care for themself, daily activity, and physical ability (walking, working, etc.). The ECOG Performance Status ranges from 0 (fully active, able to carry on all pre-disease performance without restriction) to 5 (dead).
M stage [1]; Measure Type: Count of Participants; Unit of measure: Participants	Number Analyzed	10 participants	9 participants	19 participants
M0		1 10.0%	3 33.3%	4 21.1%
M1a		2 20.0%	1 11.1%	3 15.8%
M1b		3 30.0%	2 22.2%	5 26.3%
M1c - without brain metastases		4 40.0%	3 33.3%	7 36.8%
		[1] Measure Description: The letter "M" indicates whether the cancer has spread to other parts of the body, called distant metastasis. If the cancer has not spread, it is labeled M0. If the cancer has spread, it is considered M1. M1a: The cancer has spread to 1 other part of the body beyond the colon or rectum. M1b: The cancer has spread to more than 1 part of the body other than the colon or rectum. M1c: The cancer has spread to the peritoneal surface.
Type of Melanoma; Measure Type: Count of Participants; Unit of measure: Participants	Number Analyzed	10 participants	9 participants	19 participants
Acral		1 10.0%	1 11.1%	2 10.5%
Cutaneous		8 80.0%	7 77.8%	15 78.9%
Mucosal		1 10.0%	1 11.1%	2 10.5%
Genomic Driver; Measure Type: Count of Participants; Unit of measure: Participants	Number Analyzed	10 participants	9 participants	19 participants
v-RAF murine sarcoma viral oncogene homolog B1 (BRAF)		3 30.0%	2 22.2%	5 26.3%
Neuroblastoma RAS viral oncogene homolog (NRAS)		2 20.0%	4 44.4%	6 31.6%
Other/Unknown		5 50.0%	3 33.3%	8 42.1%
Prior Treatment; Measure Type: Count of Participants; Unit of measure: Participants	Number Analyzed	10 participants	9 participants	19 participants
Anti-PD-1		10 100.0%	9 100.0%	19 100.0%
Other		3 30.0%	1 11.1%	4 21.1%
Best response to prior anti-PD-1 treatment; Measure Type: Count of Participants; Unit of measure: Participants	Number Analyzed	10 participants	9 participants	19 participants
Stable Disease		0 0.0%	1 11.1%	1 5.3%
Progressive Disease		9 90.0%	6 66.7%	15 78.9%
Unknown		1 10.0%	2 22.2%	3 15.8%
Median lactate dehydrogenase; Median (Full Range); Unit of measure: units/L
	Number Analyzed	10 participants	9 participants	19 participants
		214; (157 to 310)	208; (152 to 1800)	211; (152 to 1800)
Median time since last anti-PD-1 treatment; Median (Full Range); Unit of measure: Weeks
	Number Analyzed	10 participants	9 participants	19 participants
		4.3; (2 to 36)	6.0; (3 to 55)	5.1; (2 to 54.7)

Outcome Measures

1. Primary Outcome

Title	Overall Response Rate (ORR) as Defined by RECIST v1.1 at Week 18
Description	Overall Response Rate was defined as any participant who had a Complete Response (CR) or Partial Response (PR) as defined by RECIST v1.1 by week 18 of treatment.
Time Frame	Week 18

Outcome Measure Data

Analysis Population Description

Efficacy-Evaluable Population. The efficacy-evaluable population includes all participants who were randomly allocated to receive either combination ipilimumab/nivolumab or ipilimumab alone and received at least one dose of any study intervention (ipilimumab or nivolumab). For analyses based on this population, participant treatment groups are defined according to the treatment that was assigned at randomization.

Arm/Group Title	Ipilimumab and Nivolumab	Ipilimumab
Arm/Group Description:	For patients in the combination arm, nivolumab will first be administered intravenously at a dose of 1 mg/kg of body weight over a period of 60 minutes, once every 3 weeks for four doses. Thirty minutes after the completion of each nivolumab infusion, patients will receive 3 mg/kg of ipilimumab over a period of 30 minutes. ipilimumab nivolumab	In the ipilimumab monotherapy group, patients will receive 3 mg/kg of ipilimumab over a period of 30 minutes once every 3 weeks for four doses. ipilimumab
Overall Number of Participants Analyzed	10	9
Measure Type: Number; Number (95% Confidence Interval); Unit of Measure: percentage of participants
	20; (3 to 56)	56; (21 to 86)

2. Secondary Outcome

Title	Disease Control Rate (DCR) Status at Week 18
Description	Disease Control Rate was defined as any participant who achieved a complete response (CR), partial response (PR), or who remained stable (SD) as defined in Recist v1.1 at week 18.
Time Frame	Week 18

Outcome Measure Data

Analysis Population Description

Efficacy-Evaluable Population. The efficacy-evaluable population includes all participants who were randomly allocated to receive either combination ipilimumab/nivolumab or ipilimumab alone and received at least one dose of any study intervention (ipilimumab or nivolumab). For analyses based on this population, participant treatment groups are defined according to the treatment that was assigned at randomization.

Arm/Group Title	Ipilimumab and Nivolumab	Ipilimumab
Arm/Group Description:	For patients in the combination arm, nivolumab will first be administered intravenously at a dose of 1 mg/kg of body weight over a period of 60 minutes, once every 3 weeks for four doses. Thirty minutes after the completion of each nivolumab infusion, patients will receive 3 mg/kg of ipilimumab over a period of 30 minutes. ipilimumab nivolumab	In the ipilimumab monotherapy group, patients will receive 3 mg/kg of ipilimumab over a period of 30 minutes once every 3 weeks for four doses. ipilimumab
Overall Number of Participants Analyzed	10	9
Measure Type: Number; Number (95% Confidence Interval); Unit of Measure: percentage of participants
	60; (26 to 88)	67; (30 to 93)

3. Secondary Outcome

Title	Time to Treatment Failure (TTF)
Description	Time to Treatment Failure is defined as the time from treatment initiation until the participant starts a subsequent therapy or death, whichever comes first.
Time Frame	The time from treatment initiation until a subsequent therapy is started or death.

Outcome Measure Data

Analysis Population Description

Efficacy-Evaluable Population. The efficacy-evaluable population includes all participants who were randomly allocated to receive either combination ipilimumab/nivolumab or ipilimumab alone and received at least one dose of any study intervention (ipilimumab or nivolumab). For analyses based on this population, participant treatment groups are defined according to the treatment that was assigned at randomization.

Arm/Group Title	Ipilimumab and Nivolumab	Ipilimumab
Arm/Group Description:	For patients in the combination arm, nivolumab will first be administered intravenously at a dose of 1 mg/kg of body weight over a period of 60 minutes, once every 3 weeks for four doses. Thirty minutes after the completion of each nivolumab infusion, patients will receive 3 mg/kg of ipilimumab over a period of 30 minutes. ipilimumab nivolumab	In the ipilimumab monotherapy group, patients will receive 3 mg/kg of ipilimumab over a period of 30 minutes once every 3 weeks for four doses. ipilimumab
Overall Number of Participants Analyzed	10	9
Median (95% Confidence Interval); Unit of Measure: months
	26.9 [1]; (0.7 to NA)	13.6 [1]; (2.8 to NA)

[1]

The upper confidence limit is not evaluable based on the available data

4. Secondary Outcome

Title	Overall Survival (OS)
Description	Overall Survival is defined as the time of treatment initiation to death by any cause
Time Frame	Death

Outcome Measure Data

Analysis Population Description

Efficacy-Evaluable Population. The efficacy-evaluable population includes all participants who were randomly allocated to receive either combination ipilimumab/nivolumab or ipilimumab alone and received at least one dose of any study intervention (ipilimumab or nivolumab). For analyses based on this population, participant treatment groups are defined according to the treatment that was assigned at randomization.

Arm/Group Title	Ipilimumab and Nivolumab	Ipilimumab
Arm/Group Description:	For patients in the combination arm, nivolumab will first be administered intravenously at a dose of 1 mg/kg of body weight over a period of 60 minutes, once every 3 weeks for four doses. Thirty minutes after the completion of each nivolumab infusion, patients will receive 3 mg/kg of ipilimumab over a period of 30 minutes. ipilimumab nivolumab	In the ipilimumab monotherapy group, patients will receive 3 mg/kg of ipilimumab over a period of 30 minutes once every 3 weeks for four doses. ipilimumab
Overall Number of Participants Analyzed	10	9
Measure Type: Count of Participants; Unit of Measure: Participants
	2 20.0%	1 11.1%

5. Secondary Outcome

Title	Number of Participants With Grade 3 or 4 Adverse Events
Description	The occurrence of Grade 3 and Grade 4 adverse events (AE) assessed according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
Time Frame	AE were monitored during each treatment cycle and could be reported until 30 days after the last dose of study treatment had been administered.

Outcome Measure Data

Analysis Population Description

Safety-Evaluable Population. The safety-evaluable population includes all participants who received at least one dose of any study intervention. For analyses based on this population, participant treatment groups will be defined according to the treatment that was assigned at randomization. However, if a participant received the incorrect study drug for the entire period of treatment, the participant's treatment group will be defined as the treatment the participant actually received.

Arm/Group Title	Ipilimumab and Nivolumab	Ipilimumab
Arm/Group Description:	For patients in the combination arm, nivolumab will first be administered intravenously at a dose of 1 mg/kg of body weight over a period of 60 minutes, once every 3 weeks for four doses. Thirty minutes after the completion of each nivolumab infusion, patients will receive 3 mg/kg of ipilimumab over a period of 30 minutes. ipilimumab nivolumab	In the ipilimumab monotherapy group, patients will receive 3 mg/kg of ipilimumab over a period of 30 minutes once every 3 weeks for four doses. ipilimumab
Overall Number of Participants Analyzed	10	9
Measure Type: Count of Participants; Unit of Measure: Participants
	4 40.0%	5 55.6%

6. Secondary Outcome

Title	Disease Control Rate (DCR) Status at Week 12
Description	Disease Control Rate was defined as any participant who achieved a complete response (CR), partial response (PR), or who remained stable (SD) as defined in Recist v1.1 at week 12.
Time Frame	Week 12

Outcome Measure Data

Analysis Population Description

Efficacy-Evaluable Population. The efficacy-evaluable population includes all participants who were randomly allocated to receive either combination ipilimumab/nivolumab or ipilimumab alone and received at least one dose of any study intervention (ipilimumab or nivolumab). For analyses based on this population, participant treatment groups are defined according to the treatment that was assigned at randomization.

Arm/Group Title	Ipilimumab and Nivolumab	Ipilimumab
Arm/Group Description:	For patients in the combination arm, nivolumab will first be administered intravenously at a dose of 1 mg/kg of body weight over a period of 60 minutes, once every 3 weeks for four doses. Thirty minutes after the completion of each nivolumab infusion, patients will receive 3 mg/kg of ipilimumab over a period of 30 minutes. ipilimumab nivolumab	In the ipilimumab monotherapy group, patients will receive 3 mg/kg of ipilimumab over a period of 30 minutes once every 3 weeks for four doses. ipilimumab
Overall Number of Participants Analyzed	10	9
Measure Type: Number; Number (95% Confidence Interval); Unit of Measure: Percentage of participants
	60.0; (26.2 to 87.8)	55.6; (21.2 to 86.3)

Adverse Events

Time Frame	Adverse events were monitored during each cycle. Adverse events were reported until 30 days after the last dose of study treatment had been administered.
Adverse Event Reporting Description	[Not Specified]
Arm/Group Title	Ipilimumab and Nivolumab	Ipilimumab
Arm/Group Description	For patients in the combination arm, nivolumab will first be administered intravenously at a dose of 1 mg/kg of body weight over a period of 60 minutes, once every 3 weeks for four doses. Thirty minutes after the completion of each nivolumab infusion, patients will receive 3 mg/kg of ipilimumab over a period of 30 minutes. ipilimumab nivolumab	In the ipilimumab monotherapy group, patients will receive 3 mg/kg of ipilimumab over a period of 30 minutes once every 3 weeks for four doses. ipilimumab
All-Cause Mortality
	Ipilimumab and Nivolumab	Ipilimumab
	Affected / at Risk (%)	Affected / at Risk (%)
Total	2/10 (20.00%)	1/9 (11.11%)
Serious Adverse Events
	Ipilimumab and Nivolumab	Ipilimumab
	Affected / at Risk (%)	Affected / at Risk (%)
Total	2/10 (20.00%)	4/9 (44.44%)
Cardiac disorders
Pericardial effusion † 1	1/10 (10.00%)	0/9 (0.00%)
Endocrine disorders
Adrenal insufficiency † 1	0/10 (0.00%)	1/9 (11.11%)
Gastrointestinal disorders
Colitis † 1	0/10 (0.00%)	2/9 (22.22%)
Diarrhoea † 1	1/10 (10.00%)	1/9 (11.11%)
Abdominal pain † 1	0/10 (0.00%)	1/9 (11.11%)
Vomiting † 1	1/10 (10.00%)	0/9 (0.00%)
Nausea † 1	1/10 (10.00%)	1/9 (11.11%)
Infections and infestations
Urinary tract infection † 1	0/10 (0.00%)	1/9 (11.11%)
Injury, poisoning and procedural complications
Hip fracture † 1	0/10 (0.00%)	1/9 (11.11%)
Investigations
Neutrophil count decreased † 1	0/10 (0.00%)	1/9 (11.11%)
White blood cell count decreased † 1	0/10 (0.00%)	1/9 (11.11%)
Nervous system disorders
Headache † 1	0/10 (0.00%)	1/9 (11.11%)
Psychiatric disorders
Confusional state † 1	0/10 (0.00%)	2/9 (22.22%)
Reproductive system and breast disorders
Pleural effusion † 1	1/10 (10.00%)	0/9 (0.00%)
Respiratory, thoracic and mediastinal disorders
Dyspnoea † 1	1/10 (10.00%)	0/9 (0.00%)
Vascular disorders
Hypertension † 1	0/10 (0.00%)	1/9 (11.11%)
Hypotension † 1	1/10 (10.00%)	0/9 (0.00%)
1 Term from vocabulary, MedDRA (19.1); † Indicates events were collected by systematic assessment
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	5%
	Ipilimumab and Nivolumab	Ipilimumab
	Affected / at Risk (%)	Affected / at Risk (%)
Total	10/10 (100.00%)	9/9 (100.00%)
Blood and lymphatic system disorders
Anaemia † 1	1/10 (10.00%)	1/9 (11.11%)
Cardiac disorders
Bundle branch block left † 1	0/10 (0.00%)	1/9 (11.11%)
Sinus bradycardia † 1	0/10 (0.00%)	1/9 (11.11%)
Sinus tachycardia † 1	0/10 (0.00%)	1/9 (11.11%)
Ventricular tachycardia † 1	1/10 (10.00%)	0/9 (0.00%)
Endocrine disorders
Hypophysitis † 1	3/10 (30.00%)	1/9 (11.11%)
Hypothyroidism † 1	1/10 (10.00%)	1/9 (11.11%)
Hyperthyroidism † 1	1/10 (10.00%)	0/9 (0.00%)
Eye disorders
Vision blurred † 1	1/10 (10.00%)	0/9 (0.00%)
Gastrointestinal disorders
Diarrhoea † 1	5/10 (50.00%)	4/9 (44.44%)
Abdominal pain † 1	2/10 (20.00%)	4/9 (44.44%)
Nausea † 1	5/10 (50.00%)	0/9 (0.00%)
Constipation † 1	2/10 (20.00%)	1/9 (11.11%)
Dry mouth † 1	1/10 (10.00%)	2/9 (22.22%)
Vomiting † 1	1/10 (10.00%)	1/9 (11.11%)
Abdominal distension † 1	1/10 (10.00%)	0/9 (0.00%)
Abdominal pain upper † 1	0/10 (0.00%)	1/9 (11.11%)
Colitis † 1	1/10 (10.00%)	0/9 (0.00%)
Faecaloma † 1	0/10 (0.00%)	1/9 (11.11%)
Flatulence † 1	0/10 (0.00%)	1/9 (11.11%)
Gastrooesophageal reflux disease † 1	0/10 (0.00%)	1/9 (11.11%)
Haemorrhoids † 1	1/10 (10.00%)	0/9 (0.00%)
General disorders
Pyrexia † 1	3/10 (30.00%)	3/9 (33.33%)
Fatigue † 1	2/10 (20.00%)	3/9 (33.33%)
Chills † 1	0/10 (0.00%)	2/9 (22.22%)
Oedema peripheral † 1	1/10 (10.00%)	1/9 (11.11%)
Influenza like illness † 1	0/10 (0.00%)	1/9 (11.11%)
Hepatobiliary disorders
Biliary colic † 1	0/10 (0.00%)	1/9 (11.11%)
Cholelithiasis † 1	0/10 (0.00%)	1/9 (11.11%)
Infections and infestations
Skin infection † 1	1/10 (10.00%)	1/9 (11.11%)
Lung infection † 1	1/10 (10.00%)	0/9 (0.00%)
Oral herpes † 1	1/10 (10.00%)	0/9 (0.00%)
Proteus infection † 1	1/10 (10.00%)	0/9 (0.00%)
Sinusitis † 1	0/10 (0.00%)	1/9 (11.11%)
Injury, poisoning and procedural complications
Post procedural swelling † 1	1/10 (10.00%)	0/9 (0.00%)
Investigations
Alanine aminotransferase increased † 1	5/10 (50.00%)	2/9 (22.22%)
Aspartate aminotransferase increased † 1	4/10 (40.00%)	1/9 (11.11%)
White blood cell count decreased † 1	2/10 (20.00%)	2/9 (22.22%)
Platelet count decreased † 1	2/10 (20.00%)	1/9 (11.11%)
Weight decreased † 1	1/10 (10.00%)	2/9 (22.22%)
Neutrophil count decreased † 1	1/10 (10.00%)	1/9 (11.11%)
Amylase increased † 1	0/10 (0.00%)	1/9 (11.11%)
Blood alkaline phosphatase increased † 1	0/10 (0.00%)	1/9 (11.11%)
Blood bilirubin increased † 1	1/10 (10.00%)	0/9 (0.00%)
Lipase increased † 1	0/10 (0.00%)	1/9 (11.11%)
Lymphocyte count decreased † 1	0/10 (0.00%)	1/9 (11.11%)
Metabolism and nutrition disorders
Hypoalbuminaemia † 1	3/10 (30.00%)	5/9 (55.56%)
Hyponatraemia † 1	2/10 (20.00%)	2/9 (22.22%)
Decreased appetite † 1	1/10 (10.00%)	2/9 (22.22%)
Hypokalaemia † 1	1/10 (10.00%)	2/9 (22.22%)
Hypocalcaemia † 1	0/10 (0.00%)	2/9 (22.22%)
Hypercalcaemia † 1	0/10 (0.00%)	1/9 (11.11%)
Hyperglycaemia † 1	0/10 (0.00%)	1/9 (11.11%)
Hyperkalaemia † 1	0/10 (0.00%)	1/9 (11.11%)
Hypernatraemia † 1	1/10 (10.00%)	0/9 (0.00%)
Hypoglycaemia † 1	1/10 (10.00%)	0/9 (0.00%)
Musculoskeletal and connective tissue disorders
Arthralgia † 1	1/10 (10.00%)	2/9 (22.22%)
Pain in extremity † 1	0/10 (0.00%)	2/9 (22.22%)
Back pain † 1	0/10 (0.00%)	1/9 (11.11%)
Myalgia † 1	0/10 (0.00%)	1/9 (11.11%)
Nervous system disorders
Headache † 1	3/10 (30.00%)	1/9 (11.11%)
Hypoaesthesia † 1	1/10 (10.00%)	0/9 (0.00%)
Peripheral sensory neuropathy † 1	1/10 (10.00%)	0/9 (0.00%)
Syncope † 1	0/10 (0.00%)	1/9 (11.11%)
Renal and urinary disorders
Pollakiuria † 1	0/10 (0.00%)	1/9 (11.11%)
Reproductive system and breast disorders
Pelvic pain † 1	0/10 (0.00%)	1/9 (11.11%)
Vulval disorder † 1	0/10 (0.00%)	1/9 (11.11%)
Respiratory, thoracic and mediastinal disorders
Cough † 1	4/10 (40.00%)	2/9 (22.22%)
Nasal congestion † 1	2/10 (20.00%)	2/9 (22.22%)
Dysphonia † 1	1/10 (10.00%)	0/9 (0.00%)
Oropharyngeal pain † 1	1/10 (10.00%)	0/9 (0.00%)
Rhonchi † 1	0/10 (0.00%)	1/9 (11.11%)
Upper-airway cough syndrome † 1	0/10 (0.00%)	1/9 (11.11%)
Skin and subcutaneous tissue disorders
Pruritus † 1	7/10 (70.00%)	5/9 (55.56%)
Rash maculo-papular † 1	5/10 (50.00%)	3/9 (33.33%)
Dry skin † 1	0/10 (0.00%)	1/9 (11.11%)
Erythema multiforme † 1	1/10 (10.00%)	0/9 (0.00%)
Hair color changes † 1	0/10 (0.00%)	1/9 (11.11%)
Lichenoid keratosis † 1	1/10 (10.00%)	0/9 (0.00%)
Skin hypopigmentation † 1	1/10 (10.00%)	0/9 (0.00%)
Stasis dermatitis † 1	0/10 (0.00%)	1/9 (11.11%)
Vascular disorders
Hypertension † 1	4/10 (40.00%)	4/9 (44.44%)
Hypotension † 1	1/10 (10.00%)	0/9 (0.00%)
1 Term from vocabulary, MedDRA (19.1); † Indicates events were collected by systematic assessment

Limitations and Caveats

[Not Specified]

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.

Trial Site and/or Co-Principal Investigators may publish or present Study Data and other results of the Study from the Trial Site individually upon the first to occur of: (i) twelve (12) months after conclusion, abandonment, or termination of the Study at all Affiliated Research Institutions, or (ii) after Parker Institute for Cancer Immunotherapy [PICI] confirms in writing there will not be a multi-site Study publication.

Results Point of Contact

• Name/Title: Ute Dugan
• Organization: Parker Institute for Cancer Immunotherapy
• Phone: 203-379-6757
• EMail: udugan@parkerici.org

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

Friedman CF, Spencer C, Cabanski CR, Panageas KS, Wells DK, Ribas A, Tawbi H, Tsai K, Postow M, Shoushtari A, Chapman P, Karakunnel J, Bucktrout S, Gherardini P, Hollmann TJ, Chen RO, Callahan M, LaVallee T, Ibrahim R, Wolchok J. Ipilimumab alone or in combination with nivolumab in patients with advanced melanoma who have progressed or relapsed on PD-1 blockade: clinical outcomes and translational biomarker analyses. J Immunother Cancer. 2022 Jan;10(1):e003853. doi: 10.1136/jitc-2021-003853.

• Responsible Party: Parker Institute for Cancer Immunotherapy
• ClinicalTrials.gov Identifier: NCT02731729
• Other Study ID Numbers: PICI0001; 16-043 ( Other Identifier: Memorial Sloan Kettering Cancer Center )
• First Submitted: April 4, 2016
• First Posted: April 7, 2016
• Results First Submitted: January 12, 2021
• Results First Posted: February 21, 2021
• Last Update Posted: December 23, 2022