A Study to Evaluate ABP 206 Compared With OPDIVO® (Nivolumab) in Subjects With Unresectable or Metastatic Melanoma

Prior treatment

• Subject has had any prior systemic anti-cancer therapy for the treatment of advanced melanoma.
• Subject has active central nervous system (CNS) metastases not previously treated.
• Subject has medical conditions requiring systemic immunosuppression with either corticosteroids or other immunosuppressive medications within 14 days of the first dose of investigational product.
  • Other protocol-defined inclusion/exclusion criteria apply.

Other illness

• Known hypersensitivity to monoclonal antibodies or to any of the excipients of the study drug.
• Subject has active or known immune-mediated disorders.

Lab values

• Subject has had prior treatment with PD-1/PD-L1 and cytotoxic T lymphocyte- associated protein 4 inhibitors, or other antibodies targeting immune checkpoint pathways.

Other

• Ocular melanoma.

• At least 18 years of age.
• Histologically confirmed unresectable or metastatic melanoma.
• Subject has no prior systemic treatment for advanced disease.
• Subject must have measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST version 1.1).
• Tumor tissue from site of unresectable or metastatic melanoma must be available for biomarker analyses in order to be randomized.
• Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1.