A Study of Nivolumab, Nivolumab Plus Ipilimumab, or Investigator's Choice Chemotherapy for the Treatment of Participants With Deficient Mismatch Repair (dMMR)/Microsatellite Instability High (MSI-H) Metastatic Colorectal Cancer (mCRC) (CheckMate 8HW) identifier:
NCT04008030 (

People with metastatic colorectal cancer that is MSI-High

Study Contact Information:

For more information please email [email protected] 
Reference NCT04008030 in the subject line and email body. 

About the Study

The purpose of this study is to compare the benefit of the combination of immunotherapy agents nivolumab (Opdivo) plus ipilimumab (Yervoy) in patients who have Microsatellite Instability High (MSI-H) or Mismatch Repair Deficient (dMMR) metastatic colorectal cancer versus using nivolumab as a single therapy or chemotherapy. 


Type of Study

This is a 3-arm, randomized, open-label, phase 3 study.  

What the Study Entails

Group 1 treatment

People in Group 1 will receive nivolumab as a single therapy.   

Group 2 treatment

Patients in Group 2 will receive a combination of nivolumab plus ipilimumab.

Group 3 treatment

Patients in group 3 will receive their doctor's choice of chemotherapy agents. Patients in this group would also be allowed to receive the nivolumab + ipilimumab combination therapy if their disease progresses.


Patients will be followed up to five years.

Study Sites

California Colorado Illinois New York Oregon
Pennsylvania Texas Virginia    





New York





This Study is Open To:

People age 18 years or older, are eligible if they have:


This Study is Not Open To:

People with a history of the following cannot participate


FORCE is a national nonprofit organization, established in 1999. Our mission is to improve the lives of individuals and families affected by adult hereditary cancers.