BMS CA224-098 Melanoma study

Full Name

CA224-098: A Phase 3, Randomized, Double-blind Study of Adjuvant Immunotherapy With Relatlimab and Nivolumab Fixed-dose Combination Versus Nivolumab Monotherapy After Complete Resection of Stage III-IV Melanoma

Eligibility

Inclusion Criteria

Must have been diagnosed with either Stage IIIA (> 1 mm tumor in lymph node)/B/C/D or Stage IV melanoma by American Joint Committee on Cancer (AJCC) v8 and have histologically confirmed melanoma that is completely surgically resected (free of disease) with negative margins in order to be eligible
Participants must have an Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 1
Complete resection must be performed within 12 weeks prior to randomization
All participants must have disease-free status documented by a complete physical examination within 14 days prior to randomization and imaging studies within 35 days prior to randomization
Tumor tissue must be provided for biomarker analyses

Exclusion Criteria

History of uveal melanoma
Untreated/unresected CNS metastases or leptomeningeal metastases
Active, known, or suspected autoimmune disease
Participants with serious or uncontrolled medical disorder
Prior immunotherapy treatment for any prior malignancy: No prior immunotherapies are permitted
Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection 4 weeks prior to screening

Other protocol-defined inclusion/exclusion criteria apply.