A Study of Subcutaneous Nivolumab + Relatlimab Fixed-dose Combination (FDC) in Previously Untreated Metastatic or Unresectable Melanoma
About the study
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 take part
You may be eligible to participate in the study if you meet the following criteria:
INCLUSION CRITERIA
Inclusion Criteria:
- 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).
EXCLUSION CRITERIA
Exclusion Criteria:
- 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.
Study Locations
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How to Apply
Contact the study center to learn if this study is a good match for you.
Study’s details
Contition
Melanoma
Age (in years)
12+
Phase
Phase 3
Participants needed
570
Est. Completion Date
Feb 28, 2025
Treatment type
Interventional
Sponsor
Bristol-Myers Squibb
ClinicalTrials.gov identifier
NCT05625399
Study number
CA224127
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