for people ages 12 years and up (full criteria)
at Orange, California and other locations
study started
completion around



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.

Official Title

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


Melanoma, Nivolumab, Relatlimab, FDC, rHuPH20, OPDUALAG, Nivolumab + Relatlimab, Nivolumab + Relatlimab FDC SC, Nivolumab + Relatlimab FDC IV


You can join if…

Open to people ages 12 years and up

  • 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 CAN'T join 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.


  • UC Irvine Health accepting new patients
    Orange California 92868-3201 United States
  • The Angeles Clinic and Research Institute accepting new patients
    Los Angeles California 90025 United States


accepting new patients
Start Date
Completion Date
Bristol-Myers Squibb
BMS Clinical Trial Information BMS Clinical Trial Patient Recruiting
Phase 3 Skin Cancer/Melanoma Research Study
Study Type
Expecting 570 study participants
Last Updated