Adjuvant Immunotherapy with Nivolumab + Relatlimab Fixed-dose Combination versus Nivolumab Monotherapy after Complete Resection of Stage III-IV Melanoma

Prior treatment

• Prior treatment with LAG-3 targeted agents
• Prior therapy for melanoma except surgery for the melanoma lesion(s) and/or adjuvant radiation therapy for central nervous system lesions.
• Prior treatment with BRAF/MEK targeted agents.

Other illness

• Prior immunotherapy treatment for any prior malignancy: No prior immunotherapies are permitted (such as, but not limited to, antiprogrammed death-1 (anti-PD-1), anti-programmed death ligand-1 (anti-PD-L1), anti-programmed death ligand-2 (PD-L2), or any other antibody or drug specifically targeting T-cell costimulation or immune checkpoint pathways).
• Participants with an active, known, or suspected autoimmune disease. Participants with type I diabetes mellitus, hypothyroidism only requiring hormone replacement, skin disorders (such as vitiligo, psoriasis, or alopecia) not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enroll.
• Participants with a history of myocarditis, regardless of etiology.

• All participants must have been diagnosed with either Stage IIIA (> 1 mm tumor in lymph node)/B/C/D or Stage IV melanoma by AJCC v8 and have histologically confirmed melanoma that is completely surgically resected (free of disease) with negative margins in order to be eligible. All melanomas, except ocular melanoma, regardless of primary site of disease, will be allowed. Note: Conjunctival melanoma is not considered to be ocular melanoma and is to be classified as mucosal melanoma.
• 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 obtained from surgical specimen or biopsy during resection collected within 90 days prior to randomization, with an associated pathology report, must be submitted to the central laboratory (preferably prior to randomization).
• Participant must be ≥ 12 years of age inclusive at the time of signing the informed consent. Except: Where local regulations and/or institutional policies do not allow for participants < 18 years of age (adolescent population) to participate. For those sites, the eligible participant population is ≥ 18 years of age.
• Participants ≥ 18 years of age must have an Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1. Adolescent participants between 12 and <18 years of age must have a Lansky/Karnofsky performance score ≥ 80%.