A Phase 1/2 Randomized, Blinded, Placebo Controlled Study of Ipilimumab in Combination With Epacadostat or Placebo in Subjects With Unresectable or Metastatic Melanoma

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.