Clinical Research Directory

Inclusion Criteria: * Male or female subjects, aged 18 years or older with unresectable or metastatic melanoma. * A life expectancy of \>12 weeks. * Laboratory ranges and medical criteria met, as defined within the protocol. * Subject may have received more than 1 prior regimen of systematic treatment for unresectable or metastatic melanoma. * For Phase 2 period of the study only, Subjects must have archival tumor tissue available and collected with the prior 6 months or accessible disease for pre-treatment, study biopsy. Exclusion Criteria: * Pregnant or nursing women. * Current investigational trial participation with another investigational product or subjects who have received any anticancer medications within 21 days prior to screening (6 weeks for mitomycin-C or nitrosoureas.) * Subjects receiving monoamine oxidase inhibitors (MAOI)s; subjects who have ever had Serotonin Syndrome after receiving one or more serotonergic drugs. * Subjects who have received prior immune checkpoint inhibitors (eg anti-CTLA-4, anti-programmed death 1 (PD-1), anti-programmed death-ligand 1 (PD-L1) and others) who have had Grade 3 or 4 hepatotoxicity, immune colitis requiring infliximab, endocrine toxicity not controlled by replacement, any other Grade 4 immune adverse events (AEs) or ocular toxicity * Subjects with protocol-specified active autoimmune process except vitiligo or thyroiditis. * Subjects with concurrent conditions that would jeopardize the safety of the safety of the subject or compliance with the protocol.