Overview
The purpose of this study is to investigate the pharmacokinetic (PK) similarity and efficacy, safety, and immunogenicity of ABP 206 compared with OPDIVO® (nivolumab) in subjects with resected advanced melanoma.
Description
Eligible subjects will be randomized in a 1:1:1 ratio to receive either ABP 206, Food and Drug Administration (FDA)-licensed nivolumab, or European Union (EU)-authorized nivolumab.
The treatment period is in alignment with the maximum treatment duration for OPDIVO® (nivolumab, reference product) in the adjuvant setting for melanoma.
All subjects will be treated until recurrence of disease, unacceptable toxicity, or subject withdrawal of consent with a maximum of 1 year of treatment.
The total duration of study participation for each subject will be approximately 13 months.
Eligibility
Inclusion Criteria:
- At least 18 years of age
- Completely removed melanoma by surgery performed within 12 weeks of randomization
- Advanced Melanoma
- Tumor tissue from the resected site of the disease must be available for biomarker analyses in order to be randomized
- Subject has an Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1
Exclusion Criteria:
- Previous anti-cancer treatment
- Known hypersensitivity to monoclonal antibodies or to any of the excipients of the study drug
- Ocular or uveal melanoma or history of carcinomatosis meningitis
- History of auto-immune disease
- Subject has medical conditions requiring systemic immunosuppression with either corticosteroids or other immunosuppressive medications within 14 days of the first dose of the investigational product
Other protocol-defined inclusion/exclusion criteria apply