Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional
Official Title: A Phase I/IIA Study of MK-3475 in Combination With Chemotherapy and Supplemental Celecoxib in Patients With Advanced GI Cancers (Colorectal/Appendiceal Adenocarcinoma, Gas
Brief Summary: This is a Phase I dose escalation trial to assess MTD of MK-3475 in combination with mFOLFOX6 followed by a Phase II 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 Phase II expansion cohort will assess the effect of the addition of celecoxib to patients that do not respond to combination MK-3475/mFOLFOX treatment.