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

Running, not enrolling · Phase 2/Phase 3

Conditions studied: Melanoma

In brief

The purpose of this study is to determine whether relatlimab in combination with nivolumab is more effective than nivolumab monotherapy in treating unresectable melanoma or melanoma that has spread.

Key facts

Study ID

NCT03470922

Run by

Bristol-Myers Squibb

People needed

714

Starts

2018-04-11

Expected to finish

2030-12-15

Last updated by the study team

2025-09-09

Who can join

Age: 12 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• 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 D.C., 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
• Local Institution - 0114 — Fort Wayne, Indiana, United States
• Local Institution - 0077 — Baltimore, Maryland, United States
• Local Institution - 0120 — Baltimore, Maryland, United States
• Local Institution - 0014 — Boston, Massachusetts, United States
• Local Institution - 0134 — Boston, Massachusetts, United States
• Local Institution - 0015 — Ann Arbor, Michigan, United States
• Local Institution - 0009 — Minneapolis, Minnesota, United States
• Local Institution - 0011 — Rochester, Minnesota, United States
• Local Institution - 0018 — Charlotte, North Carolina, United States
• Local Institution - 0019 — Allentown, Pennsylvania, United States
• Local Institution - 0076 — Dallas, Texas, United States
• Local Institution - 0008 — Houston, Texas, United States
• Local Institution - 0135 — Buenos Aires, Distrito Federal, Argentina
• Local Institution - 0002 — Capital Federal, Distrito Federal, Argentina
• Local Institution - 0004 — Buenos Aires, Argentina
• Local Institution - 0010 — Tucson, Arizona, United States

Full record on ClinicalTrials.gov

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