A PK Study to Compare GME751 (Proposed Pembrolizumab Biosimilar) and US-licensed and EU-authorized Keytruda® in Participants With Stage II and III Melanoma

Inclusion Criteria:

• At least 18 years of age

• Advanced Melanoma

• Completely removed melanoma by surgery performed within 13 weeks of randomization

• Adequate organ function

• Subject has an Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1

Exclusion Criteria:

• Known history or evidence of ocular or uveal melanoma

• Known history of hypersensitivity (grade ≥3) to pembrolizumab or its excipients

• Known History of auto-immune disease

• Received live vaccine ≤30 days before the first study treatment

• Prior treatment with anti-PD-1 agents or agent against another stimulatory orco-inhibitory T cell receptor

• Active autoimmune disease that has necessitated chronic systemic treatment within 2years before the first study treatment

Other protocol-defined inclusion/exclusion criteria apply