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

Phase 2

Active, not recruiting

• Conditions: Melanoma
• Interventions: Biological: Relatlimab; Biological: Nivolumab

• Registration Number: NCT03470922
• Lead Sponsor: Bristol-Myers Squibb

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-03-14
• Study First Submitted QC: 2018-03-14
• Study First Posted: 2018-03-20
• Study Start: 2018-04-11
• Primary Completion: 2021-01-25
• Results First Submitted: 2022-01-25
• Results First Submitted QC: 2022-03-02
• Results First Posted: 2022-03-29
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-06
• Last Update Posted: 2025-03-17
• Study Completion: 2030-12-15

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 714

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm A: Relatlimab + Nivolumab	Nivolumab	Combination
Arm A: Relatlimab + Nivolumab	Relatlimab	Combination
Arm B: Nivolumab	Nivolumab	Monotherapy

Primary Outcome Measures

Name	Time	Method
Progression Free Survival (PFS)	From randomization to date of first documented tumor progression or death (up to approximately 33 months)	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.

Secondary Outcome Measures

Name	Time	Method
Overall Response Rate (ORR)	From randomization up to approximately 3 years	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).
Overall Survival (OS)	From randomization to the date of death (up to approximately 3 years)	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").

Trial Locations

Locations (127)

Local Institution - 0010; 🇺🇸 Tucson, Arizona, United States

Local Institution - 0020; 🇺🇸 Los Angeles, California, United States

Coastal Integrative Cancer Care; 🇺🇸 San Luis Obispo, California, United States

Local Institution - 0116; 🇺🇸 Santa Barbara, California, United States

Local Institution - 0012; 🇺🇸 Washington, District of Columbia, United States

Local Institution - 0013; 🇺🇸 Jacksonville, Florida, United States

Local Institution - 0117; 🇺🇸 Orlando, Florida, United States

Local Institution - 0007; 🇺🇸 Tampa, Florida, United States

Local Institution - 0038; 🇺🇸 Atlanta, Georgia, United States

Local Institution - 0016; 🇺🇸 Chicago, Illinois, United States

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