A Study of Relatlimab Plus Nivolumab Versus Nivolumab Alone in Participants With Advanced Melanoma

Study Overview
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Brief Summary
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The purpose of this study is to determine whether relatlimab in combination with nivolumab is more effective than nivolumab by itself in treating unresectable melanoma or melanoma that has spread.

Official Title
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A Randomized, Double-Blind Phase 2/3 Study of Relatlimab Combined With Nivolumab Versus Nivolumab in Participants With Previously Untreated Metastatic or Unresectable Melanoma

Conditions
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Melanoma

Intervention / Treatment
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* Biological: Relatlimab
* Biological: Nivolumab


Participation Criteria
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Eligibility Criteria
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For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com Inclusion Criteria: Participants must have histologically confirmed Stage III (unresectable) or Stage IV melanoma, per the AJCC staging system Participants must not have had prior systemic anticancer therapy for unresectable or metastatic melanoma Tumor tissue from an unresectable or metastatic site of disease must be provided for biomarker analyses Exclusion Criteria: Participants must not have active brain metastases or leptomeningeal metastases Participants must not have uveal melanoma Participants must not have an active, known, or suspected autoimmune disease Other protocol defined inclusion/exclusion criteria could apply

Ages Eligible for Study
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Minimum Age: 12 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: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm A: Relatlimab + Nivolumab<br>Combination | Biological: Relatlimab<br>* Specified dose on specified day<br>Biological: Nivolumab<br>* Specified dose on specified days<br>|
| Experimental: Arm B: Nivolumab<br>Monotherapy | Biological: Nivolumab<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 |
| --- | --- | --- |
| Progression Free Survival (PFS) | Progression Free Survival (PFS) is defined as the time between the date of randomization and the date of first documented tumor progression, assessed by a blinded independent central review (BICR) (per RECIST v1.1 criteria), or death due to any cause, whichever occurs first. Subjects who die without a reported progression will be considered to have progressed on the date of their death. | From randomization to date of first documented tumor progression or death (up to approximately 33 months) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Survival (OS) | Overall Survival (OS) is defined as the time between the date of randomization and the date of death due to any cause. For subjects that are alive, their survival time will be censored at the date of last contact (last known alive date). | From randomization to the date of death (up to approximately 3 years) | 
| Overall Response Rate (ORR) | Objective response rate (ORR) is defined as the number of randomized subjects who achieve a best response of complete response (CR) or partial response (PR) based on BICR assessments (using RECIST v1.1 criteria). | From randomization up to approximately 3 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cancer, Advanced Cancer