A Phase 1/2 Study Exploring the Safety, Tolerability, and Efficacy of MK-3475 in Combination With INCB024360 in Subjects With Selected Cancers (ECHO-202/KEYNOTE-037)

Trial ID # NCT02178722
Phase II
Drug Class Immunotherapy: Immune Cell Stimulators/IDO
Drug Name Epacadostat
Alternate Drug Names IDO1 Inhibitor INCB024360, INCB024360, Indoleamine-2,3-dioxygenase Inhibitor INCB024360, 3-dioxygenase Inhibitor INCB024360
Drugs in Trial Epacadostat, Pembrolizumab
Eligible Participant

Recurrent or persistent cancer

Patients Enrolled

463 (Phase II: 37 ovarian; median ≥3 prior therapies)

Therapy Setting


Study Design

Open-Label, Non-randomized


ORR, DCR, evaluated per RECIST


Exploratory: PD-L1 protein


ORR: 8% (3PR, n=37)
DCR: 35% (3PR, 10SD, n=37)

Exploratory analysis PD-L1+ patients:
ORR: 5% (1PR, n=20)
DCR: 30% (1PR, 5SD, n=20)

Clinically Significant Adverse Events

Serious AE: none
Grade 3-4 AE: rash (8%)


Encouraging anti-tumor activity with acceptable safety profile


Spira AI et al. Efficacy/Safety of Epacadostat Plus Pembrolizumab in Triple-Negative Breast Cancer and Ovarian Cancer: Phase 1/2 ECHO-202 Study. J Clin Oncol (2017) 35 (suppl; abstr 1103)

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