A Study to Assess Safety of Relatlimab With Ipilimumab in Participants With Advanced Melanoma Who Progressed on Anti-Programmed Cell Death Protein 1 (Anti-PD-1) Treatment

Study Overview
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Brief Summary
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The primary purpose of this study is to characterize the safety, tolerability, and dose-limiting toxicities (DLTs) of relatlimab in combination with ipilimumab.

Official Title
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A Phase 1/2a Study to Evaluate the Safety, Tolerability, and Efficacy of Relatlimab Administered in Combination With Ipilimumab or Ipilimumab Alone in Participants With Unresectable or Metastatic Melanoma Who Have Progressed on Anti-PD-1 Therapy

Conditions
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Melanoma

Intervention / Treatment
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* Drug: Relatlimab
* Drug: Ipilimumab


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Must have documented progression while on a prior anti-programmed cell death protein 1 (PD-1) containing regimen limited to Nivolumab or Pembrolizumab Must have histologically confirmed advanced unresectable (Stage III) or metastatic (Stage IV) melanoma, as per (AJCC) staging system Tumor tissue from an unresectable or metastatic site of disease must be provided for biomarker analyses Eastern Cooperative Oncology Group (ECOG) 0-1 Exclusion Criteria: History of uveal melanoma Known history of positive test for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome Prior treatment with ipilimumab, relatlimab, or any other cytotoxic T-lymphocyte-associated antigen 4 (CTLA-4) or lymphocyte-activation gene 3 (LAG-3) targeted agents

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Part 1: Dose Escalation Phase<br> | Drug: Relatlimab<br>* Specified dose on specified days<br>* Other names: BMS-986016;Drug: Ipilimumab<br>* Specified dose on specified days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants with Adverse Events (AEs) |  | Up to Follow-up Period (100 days after 34 cycles [1 cycle is of 3 weeks]) | 
| Number of Participants with Serious Adverse Events (SAEs) |  | Up to Follow-up Period (100 days after 34 cycles [1 cycle is of 3 weeks]) | 
| Number of Participants With Adverse Events Including Dose Limiting Toxicity |  | Up to 28 days after last study drug dose (approximately up to 2 years) | 
| Number of Participants with AEs resulting in Discontinuation |  | Up to end of study (approximately 2.4 years) | 
| Number of Participants with AEs resulting in Death |  | Up to end of study (approximately 2.4 years) | 
| Number of Participants with AEs resulting in Laboratory Abnormalities |  | Up to end of study (approximately 2.4 years) |