A Study of Epacadostat (INCB024360) in Combination With Durvalumab (MEDI4736) in Subjects With Selected Advanced Solid Tumors (ECHO-203)

Inclusion Criteria

• Male or female subjects, age 18 years or older
• Histologically or cytologically confirmed diagnosis of selected locally advanced or metastatic solid tumors
• Must have failed at least 1 prior treatment regimen for locally advanced or metastatic disease or be intolerant to treatment or refuse standard treatment

Exclusion Criteria

• Laboratory and medical history parameters not within protocol-defined range
• Participation in any other study in which receipt of an investigational study drug occurred within 28 days or 5 half-lives (whichever is longer) prior to first dose
• Prior treatment with immune checkpoint inhibitors (eg, anti-CTLA-4, anti-PD-1, anti-PD-L1, and any other antibody or drug specifically targeting T-cell co-stimulation) or an IDO inhibitor (exception is tumor types in which a PD-1 pathway targeted agent is approved, e.g. melanoma, non-small cell lung cancer.)
• Receipt of any anticancer medication in the 21 days prior to receiving the first dose of study medication
• Has an active or inactive autoimmune process
• Evidence of interstitial lung disease or active, non-infectious pneumonitis
• Prior radiotherapy within 2 weeks of initiating treatment; Must have recovered from all radiation-related toxicities, not require corticosteroids, and not have had radiation pneumonitis
• Untreated central nervous system (CNS) metastases or CNS metastases that have progressed
• Currently pregnant or breastfeeding