Clinical Trial: Study of Pembrolizumab (MK-3475) vs Standard Therapy in Participants With Microsatellite Instability-High (MSI-H) or Mismatch Repair Deficient (dMMR) Stage IV Colorectal Carcinoma (MK-3475-177/KEYNOTE-177)
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional
Official Title: A Phase III Study of Pembrolizumab (MK-3475) vs. Chemotherapy in Microsatellite Instability-High (MSI-H) or Mismatch Repair Deficient (dMMR) Stage IV Colorectal Carcinoma
Brief Summary: In this study, participants with MSI-H or dMMR advanced colorectal carcinoma will be randomly assigned to receive either pembrolizumab or the Investigator's choice of 1 of 6 standard of care (SOC) chemotherapy regimens for the treatment of advanced colorectal carcinoma. The primary study hypothesis is that pembrolizumab will prolong progression-free survival (PFS) compared to current SOC chemotherapy.
Detailed Summary:
Sponsor: Merck Sharp & Dohme Corp.
Current Primary Outcome: Progression-free Survival (PFS) [ Time Frame: Up to 57 months ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Overall Response Rate (ORR) [ Time Frame: Up to 57 months ]
- Overall Survival (OS) [ Time Frame: Up to 57 months ]
Original Secondary Outcome: Same as current
Information By: Merck Sharp & Dohme Corp.
Dates:
Date Received: September 28, 2015
Date Started: November 30, 2015
Date Completion: September 18, 2019
Last Updated: April 26, 2017
Last Verified: April 2017
