A Study to Compare Nivolumab Administered Subcutaneously vs Intravenous in Melanoma Participants Following Complete Resection

A Phase 3, Open Label, Randomized, Non-Inferiority Pharmacokinetic Study of Nivolumab Subcutaneous (Nivo SC) Versus Intravenous (Nivo IV) Administration in Participants With Stage IIIA/B/C/D or Stage IV Adjuvant Melanoma Following Complete Resection

The purpose of this study is to assess the safety and tolerability of subcutaneous nivolumab vs intravenous nivolumab in participants with completely resected Stage IIIA/B/C/D or Stage IV melanoma.

Inclusion Criteria:

• Stage IIIA/B/C/D or Stage IV melanoma and have histologically confirmed melanoma that is completely surgically resected (free of disease) with negative margins
• Complete resection performed within 12 weeks prior to randomization or treatment assignment
• Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 1

Exclusion Criteria:

• History of uveal or mucosal melanoma
• Untreated/unresected CNS metastases or leptomeningeal metastases
• Active, known or suspected autoimmune disease
• Serious or uncontrolled medical disorder 4 weeks prior to screening
• Concurrent malignancy (present during screening) requiring treatment or history of prior malignancy active within 2 years prior to randomization or treatment assignment. Participants with history of prior early stage basal/squamous cell skin cancer or non-invasive or in situ cancers that have undergone definitive treatment at any time are eligible
• Prior immunotherapy treatments for any prior malignancies are not permitted

Other protocol-defined inclusion/exclusion criteria apply