🏛️ Verified NIH Record • Updated 2026-08-03

A Study of Subcutaneous Nivolumab + Relatlimab Fixed-dose Combination (FDC) in Previously Untreated Metastatic or Unresectable Melanoma (NCT05625399)

🔵 Active, Not Recruiting Phase3 💊 Investigational Drug / Biologic Sponsor: Bristol-Myers Squibb

🩺 Plain-English Summary (8th-Grade Level)

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.

Who can join: To join this study, participants generally need to meet the listed inclusion criteria (5 items) and avoid the listed exclusions (5 items).

Location: Local Institution - 0125 — Phoenix, Arizona

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

Usually NOT eligible if any of the following apply:

  • Exclusion Criteria
  • 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.

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (149 Sites)

  • Local Institution - 0125 — Phoenix, Arizona
  • Local Institution - 0189 — Springdale, Arkansas
  • Local Institution - 0098 — Los Angeles, California
  • Local Institution - 0093 — Orange, California
  • Local Institution - 0123 — Stanford, California
  • Local Institution - 0113 — Englewood, Colorado
  • Local Institution - 0114 — Jacksonville, Florida
  • Local Institution - 0146 — Baltimore, Maryland
  • Local Institution - 0071 — Rochester, Minnesota
  • Local Institution - 0013 — Omaha, Nebraska
  • Local Institution - 0169 — Cleveland, Ohio
  • Local Institution - 0139 — Easton, Pennsylvania
  • Local Institution - 0124 — Philadelphia, Pennsylvania
  • Local Institution - 0122 — Murray, Utah
  • Local Institution - 0115 — Fairfax, Virginia
  • Local Institution - 0050 — Coffs Harbour, New South Wales
  • Local Institution - 0175 — Orange, New South Wales
  • Local Institution - 0172 — Port Macquarie, New South Wales
  • Local Institution - 0118 — Wagga Wagga, New South Wales
  • Local Institution - 0184 — Waratah, New South Wales
  • Local Institution - 0033 — Westmead, New South Wales
  • Local Institution - 0055 — Wollstonecraft, New South Wales
  • Local Institution - 0090 — Birtinya, Queensland
  • Local Institution - 0008 — Bendigo, Victoria
  • Local Institution - 0059 — Box Hill, Victoria

💰 Cost, Insurance & Patient Rights

  • 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
  • Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
  • Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
🏛️ View Official NIH Record ↗