Epacadostat in Combination With Pembrolizumab and Azacitidine in Subjects With Metastatic Colorectal Cancer
Status:
Withdrawn
Trial end date:
2020-07-30
Target enrollment:
Participant gender:
Summary
Trial Design This is an open label, single-arm, phase IB/II trial to evaluate the safety,
tolerability and anti-tumor efficacy of epacadostat (INCB024360) in combination with
pembrolizumab (MK-3475) plus azacitidine in patients with chemo-refractory MSS mCRC.
The phase 1B portion of the study will evaluate the safety, tolerability and RP2D of
epacadostat (INCB024360) in combination with pembrolizumab plus azacitidine in subjects with
chemo-refractory MSS mCRC without any further standard treatment options.
The phase 2 portion of the study will evaluate the efficacy and safety of epacadostat
(INCB024360) in combination with pembrolizumab plus azacitidine in subjects with
chemo-refractory MSS mCRC without any further standard treatment options.
In both phase IB and phase 2 portions, patients will receive the combination of azacitidine,
pembrolizumab and epacadostat (INCB024360) for the first 18 cycles (Cycles 1-18). Beginning
with Cycle 19 through Cycle 35, patients will receive the combination of pembrolizumab and
epacadostat (INCB024360).