This phase 1/2 trial aims to study the safety and effectiveness of the treatment with different targeted therapy in patients with advanced lung or colorectal cancer. The main outcome to be measured is the response rate of the tumor to the treatment and the negative side effects. This trial is recruiting in California, Illinois and Texas, United States.

Epacadostat and azacitidine (Vidaza) block tumor growth by inhibiting enzymes necessary for cell growth. The combination of these agents with the immunotherapy agent pembrolizumab (Keytruda) to treat advanced cancers could increase the activity against cancer cells.

The current trial will investigate the effectiveness of increasing doses of treatment with these agents. The main outcome will be measured through response rate and negative side effects.

The trial will recruit 142 participants with advanced or metastatic (spread to other parts of the body) lung cancer and colorectal cancer. Patients must have normal to near normal blood levels. Participants must not have received prior anti-cancer treatment within a defined interval before the start of this trial. Patients must not have any autoimmune disease, active infection, brain metastasis, or abnormal heart rhythms. 

Patients will receive increasing doses, by injection, of azacitidine over days 1 and 7, pembrolizumab over 30 minutes every 3 weeks on day 1 and epacadostat tablets twice daily. Treatment will repeat until disease progression or unacceptable side effects. Participants will be followed for up to 18 months.

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