PhIII Subcutaneous Nivolumab+Relatlimab Fixeddose Comb vsIntravenous Nivolumab+Relatlimab Melanoma

Cancer
Warren A Chow
A Phase III, 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 skin

Study Description

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.

Eligibility

You can participate in this study 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 have histologically confirmed Stage III (unresectable) or Stage IV (metastatic) melanoma, per the AJCC staging system (8th edition).
  • 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.
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