for people ages 12 years and up (full criteria)
at Orange, California and other locations
end: about



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.


  • 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 FDA Safety Alerts and Recalls BMS Clinical Trial Patient Recruiting Investigator Inquiry Form
Phase 3 Skin Cancer/Melanoma Research Study
Study Type
Expecting 570 study participants
Last Updated