๐Ÿ›๏ธ Verified NIH Record โ€ข Updated 2026-08-03

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

A Phase 3, Randomized, Open-label, Study of Subcutaneous Nivolumab + Relatlimab Fixed-dose Combination Versus Intravenous Nivolumab + Relatlimab Fixed-dose Combination in Participants With Previously Untreated Metastatic or Unresectable Melanoma

๐Ÿ”ต Active, Not Recruiting Phase3 ๐Ÿ’Š Investigational Drug / Biologic Sponsor: Bristol-Myers Squibb

๐Ÿฉบ 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: Review the eligibility criteria below.

Location: Local Institution - 0125 โ€” Phoenix, Arizona

Age range: 12 Years

๐Ÿงช Interventions in This Study

๐Ÿ“‹ "Do I Qualify?" โ€” 1-Minute Self Screener

Instant Checklist

Full eligibility criteria are available on the official NIH protocol. View the criteria โ†—

๐Ÿ“ All Participating Trial Locations (149 Sites)

Showing the first 25 of 149 sites.

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

๐Ÿ’ฐ 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 ยง 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.

Explore by condition: All Melanoma clinical trials

๐Ÿ’ก How to Participate

  1. Check the checklist above to see if you may qualify.
  2. Review the official NIH record below to find the coordinating site.
  3. Ask about the visit schedule, what is covered at no cost, and any travel support.
  4. Confirm with your own doctor before making a decision.
๐Ÿ›๏ธ View Official NIH Record โ†—