Protocol #: 14-166
Status
Active, not recruiting
Description
The purpose of this study is to examine if Nivolumab by itself, or Nivolumab in combination with other anti-cancer drugs, will result in meaningful tumor size reduction, in patients with colon cancer that has come back or has spread, and who have a specific biomarker in their tumors.
Condition
Microsatellite Unstable Colorectal Cancer
Microsatellite Stable Colorectal Cancer
Mismatch Repair Proficient Colorectal Cancer
Mismatch Repair Deficient Colorectal Cancer
Interventions
Ipilimumab
Nivolumab
Cobimetinib
Daratumumab
anti-LAG-3 antibody
Phase
Phase 2
Study Type
Interventional
Further Study Details
Primary Outcome:
Objective response rate (ORR) in all MSI-High and non-MSI-High subjects as determined by Investigators
Secondary Outcome:
ORR in all MSI-H and non-MSI-H subjects based on IRRC determination
Estimated Enrollment
340
Study Start Date
March 7, 2014
Eligibility
Gender: All
Minimum Age: 18 Years
Maximum Age: N/A
Health Volunteers: No
Criteria
Bristol-Myers Squibb
Information Provided By
Bristol-Myers Squibb
Official Title
A Phase 2 Clinical Trial of Nivolumab, or Nivolumab Combinations in Recurrent and Metastatic Microsatellite High (MSI-H) and Non-MSI-H Colon Cancer
Clinicaltrials.gov Identifier
NCT02060188

 

 

Source: Clinicaltrials.gov. Through our founding membership in the Dana-Farber/Harvard Cancer Center, an NCI-designated Comprehensive Cancer Center, these clinical trials are conducted at the Massachusetts General Hospital Cancer Center and may be available at other partner institutions.

Back to Top