Phase I Study MK-3475 With Chemotherapy in Patients With Advanced GI Cancers
Status:
Terminated
Trial end date:
2017-06-26
Target enrollment:
Participant gender:
Summary
This is a Phase I dose escalation trial to assess MTD of MK-3475 in combination with mFOLFOX6
followed by a safety expansion open label, nonrandomized trial with MK-3475 at MTD in
combination with mFOLFOX6 and supplemental celecoxib in 4 cohorts of advanced/metastatic GI
malignancies (pancreatic, gastro esophageal, colorectal/appendiceal adenocarcinoma and
biliary carcinoma) to assess response rate, clinical benefit rate, progression free survival
and overall survival. The safety expansion cohort will assess the effect of the addition of
celecoxib to patients that do not respond to combination MK-3475/mFOLFOX treatment.