A Study of Indoximod or Placebo Plus Pembrolizumab or Nivolumab for Subjects With Unresectable or Metastatic Melanoma

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.