PhIII Subcutaneous Nivolumab+Relatlimab Fixeddose Comb vsIntravenous Nivolumab+Relatlimab Melanoma
UCI Specialty Area: Cancer
Principal Investigator:
Warren A Chow
Official Title:
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
A Study On:
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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