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

• Status: Recruiting
• Trial end date: 2027-01-25
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to assess the efficacy, safety, and immunogenicity of ABP 206 compared with Nivolumab in Subjects with Treatment-Naïve Unresectable or Metastatic Melanoma.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Amgen
• Treatments: Nivolumab

Criteria

Key Inclusion Criteria:

• 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 RECIST (version 1.1).

• Tumor tissue from the resected site of disease must be available for biomarker analyses in order to be randomized.

• Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1.

Key Exclusion Criteria:

• Subject has had any prior systemic anti-cancer therapy for the treatment of advanced melanoma.

• Known hypersensitivity to monoclonal antibodies or to any of the excipients of the study drug.

• Subject has active central nervous system (CNS) metastases not previously treated.

• Ocular melanoma.

• Subject has active or known immune-mediated disorders.

• 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.

• 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.