A Study to Evaluate ABP 206 Compared With OPDIVO® (Nivolumab) in Subjects With Unresectable or Metastatic Melanoma
Melanoma
About this trial
This is an interventional treatment trial for Melanoma focused on measuring Treatment-naive, Unresectable melanoma, Metastatic melanoma
Eligibility 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.
Sites / Locations
- Oncology Hematology AssociatesRecruiting
- Dr. Everett Chalmers HospitalRecruiting
- LLC "Todua Clinic"Recruiting
- ISR-GEO Med Res Clin HealthycoreRecruiting
- JSC KE Nat Ctr of Exp and Clin SurgRecruiting
- Multprofil Clinic Consilium MedullaRecruiting
- Hospital Universitario Virgen De La MacarenaRecruiting
- Hospital Jerez Puerta Del SurRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
ABP 206
Nivolumab
Subjects will receive Dose A of ABP 206 via intravenous (IV) infusion.
Subjects will receive Dose A of Nivolumab via IV infusion.