Clinical Trial: Phase I/IIA Study MK-3475 With Chemotherapy in Patients With Advanced GI Cancers

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.

Detailed Summary:
Sponsor: University of Utah

Current Primary Outcome: Safety of combination mFOLFOX and MK-3475 [ Time Frame: Patient safety will be evaluated throughout the treatment period (treatment with MK-3475 and FOLFOX) which is expected to last 4-6 months for each patient. ]

Routine safety and tolerability will be evaluated from the results of reported signs and symptoms, scheduled physical examinations, vital sign measurements, and clinical laboratory test results. More frequent safety evaluations may be performed if clinically indicated or at the discretion of the investigator.


Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: University of Utah

Dates:
Date Received: October 15, 2014
Date Started: January 2015
Date Completion: January 2020
Last Updated: November 21, 2016
Last Verified: November 2016