Melanoma Clinical Trial
A Study to Evaluate ABP 206 Compared With OPDIVO® (Nivolumab) in Subjects With Unresectable or Metastatic Melanoma
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.
Eligible subjects will be randomized (1:1) to receive investigational product (ABP 206 or nivolumab).
All subjects will be treated until disease progression, unacceptable toxicity, or subject withdrawal of consent for a maximum of 24 months of treatment.
The total duration of study participation for each subject will be approximately 26 months.
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.
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.
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There are 11 Locations for this study
Fort Wayne Indiana, 46804, United States
Springfield Missouri, 65807, United States
Fredericton New Brunswick, E3B 5, Canada
Tbilisi , 0112;, Georgia
Tbilisi , 0112, Georgia
Tbilisi , 0159, Georgia
Tbilisi , 0186, Georgia
Vilnius , LT-08, Lithuania
Sevilla Andalucía, 41009, Spain
El Palmar Murcia, Región De, 30120, Spain
Málaga , 29011, Spain
Sevilla , 41009, Spain
Valencia , 46014, Spain
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