Clinical Trials

Inclusion Criteria:

• Have histologically- or cytologically-confirmed unresectable stage III or stage IV melanoma not amenable to local therapy
• At least one radiologically measurable lesion as per RECIST 1.1
• Have documentation of V600-activating BRAF mutation status or consent to BRAF V600 mutation testing during the screening period.
• ECOG performance status 0 or 1
• Ability to ingest oral medications

Exclusion Criteria:

• Has Ocular Melanoma
• Has received prior systemic treatment for unresectable or metastatic melanoma (except BRAF directed therapy).
• Has received prior therapy with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or IDO1 inhibitor or any other antibody or drug specifically targeting checkpoint pathways other than anti-CTLA-4 which is permitted in the adjuvant setting.
• Has received prior adjuvant therapy, monoclonal antibody or an investigational agent or device within 4 weeks or 5 half-lives (whichever is longer)
• Has received prior radiotherapy within 2 weeks of therapy.
• Is pregnant or breast-feeding or expecting to conceive or father children within the projected duration of the study, starting with the screening visit through 120 days after the last dose of study treatment.
• Patients who have active, chronic, or on active treatment for Hep B or Hep C are excluded.
• Patients who have received a live attenuated vaccine with in 30 days of randomization
• Patients who take a MAOI or drug with significant MAOI activity
• Patients who have had Serotonin Syndrome after receiving a serotonergic drug