A Study of Subcutaneous Nivolumab + Relatlimab Fixed-dose Combination (FDC) in Previously Untreated Metastatic or Unresectable Melanoma

Running, not enrolling · Phase 3

Conditions studied: Melanoma

In brief

The purpose of this study is to demonstrate that the study drug exposure level of the nivolumab + relatlimab FDC subcutaneous (SC) formulation is not worse than nivolumab + relatlimab FDC intravenous (IV) administration in participants with previously untreated metastatic or unresectable melanoma.

Key facts

Study ID

NCT05625399

Run by

Bristol-Myers Squibb

People needed

579

Starts

2023-03-06

Expected to finish

2027-11-18

Last updated by the study team

2026-06-03

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 adolescents (≥ 12 to < 18 years of age).
• Participants must have histologically confirmed Stage III (unresectable) or Stage IV (metastatic) melanoma, per the American Joint Committee for Cancer (AJCC) staging system.
• Participants must have measurable disease by computed tomography (CT) or magnetic resonance imaging (MRI) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1).
• Participants must be ≥ 12 years of age. Participants who are ≥ 12 years of age and < 18 years of age (adolescents) must weigh ≥ 40 kg at the time of signing the informed consent (assent).
• Participants must have histologically confirmed Stage III (unresectable) or Stage IV (metastatic) melanoma, per the AJCC staging system (8th edition).

You may not qualify if…

• Participants must not have ocular melanoma.
• Participants must not have a history of myocarditis, regardless of etiology.
• Participants must not have a condition requiring systemic treatment with either corticosteroids (>10 milligrams [mg] daily prednisone equivalent) or other immunosuppressive medications within 14 days of start of study treatment. Inhaled or topical steroids, and adrenal replacement steroid doses >10 mg daily prednisone equivalent, are permitted in the absence of active autoimmune disease.
• Other protocol-defined Inclusion/Exclusion criteria apply.

Where it is running

• Local Institution - 0125 — Phoenix, Arizona, United States
• Local Institution - 0189 — Springdale, Arkansas, United States
• Local Institution - 0098 — Los Angeles, California, United States
• Local Institution - 0093 — Orange, California, United States
• Local Institution - 0123 — Stanford, California, United States
• Local Institution - 0113 — Englewood, Colorado, United States
• Local Institution - 0114 — Jacksonville, Florida, United States
• Local Institution - 0146 — Baltimore, Maryland, United States
• Local Institution - 0071 — Rochester, Minnesota, United States
• Local Institution - 0013 — Omaha, Nebraska, United States
• Local Institution - 0169 — Cleveland, Ohio, United States
• Local Institution - 0139 — Easton, Pennsylvania, United States
• Local Institution - 0124 — Philadelphia, Pennsylvania, United States
• Local Institution - 0153 — Jaén, Spain
• Local Institution - 0122 — Murray, Utah, United States
• Local Institution - 0115 — Fairfax, Virginia, United States
• Local Institution - 0050 — Coffs Harbour, New South Wales, Australia
• Local Institution - 0175 — Orange, New South Wales, Australia
• Local Institution - 0172 — Port Macquarie, New South Wales, Australia
• Local Institution - 0118 — Wagga Wagga, New South Wales, Australia
• Local Institution - 0184 — Waratah, New South Wales, Australia
• Local Institution - 0033 — Westmead, New South Wales, Australia
• Local Institution - 0055 — Wollstonecraft, New South Wales, Australia
• Local Institution - 0090 — Birtinya, Queensland, Australia
• Local Institution - 0162 — Turku, Finland

Full record on ClinicalTrials.gov

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