A Study of Subcutaneous Nivolumab + Relatlimab Fixed-dose Combination (FDC) in Previously Untreated Metastatic or Unresectable Melanoma (RELATIVITY-127)
Melanoma
About this trial
This is an interventional treatment trial for Melanoma focused on measuring Nivolumab, Relatlimab, FDC, Melanoma, rHuPH20, OPDUALAG
Eligibility 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: 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.
Sites / Locations
- Dignity Health - St. Josephs Hospital and Medical CenterRecruiting
- The Angeles Clinic and Research InstituteRecruiting
- UC Irvine HealthRecruiting
- Stanford Univ Med School Dept of DermatologyRecruiting
- The Melanoma and Skin Cancer InstituteRecruiting
- Mayo Clinic - JacksonvilleRecruiting
- Ft. Wayne Medical Oncology and Hematology
- Greenebaum Cancer Center University of Maryland
- Mayo ClinicRecruiting
- Oncology Hematology West P.C. dba Nebraska Cancer SpecialistRecruiting
- Rutgers CINJ
- Cleveland Clinic
- St. Lukes University Health NetworkRecruiting
- Thomas Jefferson University HospitalRecruiting
- Intermountain Medical Center Campus Location
- Inova Health Care ServicesRecruiting
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Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
Nivolumab + Relatlimab FDC SC
Nivolumab + Relatlimab FDC IV