About this trial
Last updated 6 months ago
Study ID
Status
Type
Phase
Placebo
Accepting
Not accepting
Trial Timing
Started 2 years ago
What is this trial about?
What are the Participation Requirements?
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 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.
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.