A Study to Evaluate the Superiority of the Fianlimab and Cemiplimab Combination Compared to Pembrolizumab in Adult and Adolescent Patients With Completely Resected High-Risk Skin Cancer

The primary objective of the study is To demonstrate superiority of fianlimab + cemiplimab compared to pembrolizumab, as measured by relapse free survival (RFS)The secondary objectives of the study are:To demonstrate superiority of fianlimab + cemiplimab compared to pembrolizumab, as measured by overall survival (OS)To demonstrate superiority of fianlimab + cemiplimab compared to pembrolizumab, as measured by melanoma specific survival (MSS)To evaluate whether post-operative adjuvant therapy improves distant metastasis-free survival (DMFS), in stage IIC or III patients receiving fianlimab + cemiplimab compared to pembrolizumabTo assess impact of fianlimab + cemiplimab on quality of life as compared to pembrolizumab in adultsTo assess safety and tolerability of fianlimab + cemiplimab compared to pembrolizumabTo characterize pharmacokinetics (PK) of fianlimab + cemiplimab using sparse PK sampling in patients 12 years of age and olderTo assess immunogenicity of fianlimab and against cemiplimab

Key Inclusion Criteria:All patients must be either stage IIC, III, or stage IV per American Joint Committee on Cancer (AJCC) 8th edition and have histologically confirmed melanoma that is completely surgically resected in order to be eligible as defined by the protocolComplete surgical resection must be performed within 12 weeks prior to randomization, and enrollment may occur only after satisfactory wound healing from the surgeryAll patients must have disease-free status documented by a complete physical examination and imaging studies within 4 weeks prior to randomization, as described in the protocolKey Exclusion Criteria:Uveal melanomaAny evidence of residual disease after surgery by imaging, pathology, or cytology.Ongoing or recent (within 2 years) evidence of clinically significant autoimmune disease that required systemic treatment with immunosuppressive agentsUncontrolled infection with human immunodeficiency virus (HIV), hepatitis B virus (HBV), or hepatitis C (HCV) infection; or diagnosis of immunodeficiency that is related to, or results in chronic infection, as described in the protocolAnother malignancy that is currently progressing or that required active treatment in the past 5 years, as described in the protocolAdolescent patients (≥12 to <18 years old) with body weight <40 kgNote: Other Protocol Defined Inclusion/ Exclusion Criteria Apply