A Study To Assess the Safety, and Tolerability of Nivolumab + Relatlimab Fixed-Dose Combination (FDC) In Untreated, Unresectable or Metastatic Melanoma Participants In India

Starting soon · Phase 4

Conditions studied: Untreated Melanoma, Unresectable Melanoma, Metastatic Melanoma

In brief

The purpose of this study is to assess the safety and tolerability of Nivolumab + Relatlimab Fixed-Dose Combination (FDC) in untreated, unresectable or metastatic melanoma participants in India

Key facts

Study ID

NCT07459543

Run by

Bristol-Myers Squibb

People needed

30

Starts

2026-11-15

Expected to finish

2029-05-28

Last updated by the study team

2026-03-09

Who can join

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

You may qualify if…

• Participants must have an Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 1/Lansky Performance Score ≥ 80% for minors (ages 12-17) ONLY.
• Participants must have histologically confirmed Stage III (unresectable) or Stage IV melanoma, per the American Joint Committee on Cancer (AJCC) staging system (8th edition).
• Participants must be treatment-naïve (ie, no prior systemic anticancer therapy for unresectable or metastatic melanoma).
• Participants must have measurable disease by Computed Tomography (CT) or Magnetic Resonance Imaging (MRI) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria.
• Participants must have completed prior radiotherapy at least 2 weeks prior to study treatment administration.
• Individuals of Childbearing Potential (IOCBP) must not be pregnant or breastfeeding.

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.
• Participants must not have a condition requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days of start of study treatment.
• Participants must not have a history of myocarditis.
• Participants must not have had prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T-cell costimulation or immune checkpoint pathways. Prior treatment with relatlimab or any other with LAG-3 targeted agents.
• Other protocol-defined Inclusion/Exclusion criteria apply.

Where it is running

• Local Institution - 0009 — Navi Mumbai, Maharashtra, India
• Local Institution - 0008 — Pune, Maharashtra, India
• Local Institution - 0003 — Bhubaneswar, Odisha, India
• Local Institution - 0002 — Chennai, India
• Local Institution - 0006 — Mumbai, India
• Local Institution - 0005 — Nagpur, India
• Local Institution - 0004 — New Delhi, India
• Local Institution - 0001 — New Delhi, India

Full record on ClinicalTrials.gov

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