About the study

The main purpose of this study is to compare the clinical benefit, as measured by Progression-Free Survival (PFS), Objective Response Rate (ORR), and Overall Survival (OS), achieved by nivolumab in combination with ipilimumab or by nivolumab monotherapy in participants with Microsatellite Instability High (MSI-H) or Mismatch Repair Deficient (dMMR) metastatic colorectal cancer (mCRC). This study will also compare nivolumab plus ipilimumab combination vs chemotherapy for treatment of MSI-H/dMMR mCRC participants.

Who can take part?

You may be eligible to participate in the study if you meet the following criteria:

Inclusion criteria

1. Histologically confirmed recurrent or metastatic colorectal cancer (CRC) irrespective of prior treatment history with chemotherapy and/or targeted agents not amenable to surgery (Applicable only during Part 1 enrollment of the study)
2. Histologically confirmed recurrent or metastatic CRC with no prior treatment history with chemotherapy and/or targeted agents for metastatic disease and not amenable to surgery (Applicable during Part 2 enrollment of the study)
3. Known tumor microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) status per local standard of practice
4. Eastern cooperative oncology group (ECOG) performance status lower than or equal to 1

Exclusion criteria

1. An active, known or suspected autoimmune disease
2. History of interstitial lung disease or pneumonitis
3. Known history of positive test for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS) Other protocol-defined inclusion/exclusion criteria apply

For a full list of inclusion/exclusion criteria, please visit ClinicalTrials.gov

Study locations

Enter your ZIP code/Postal code/PIN code to locate study sites near you:

How to apply

Determine if a study site for this clinical trial is near you. Contact the study to apply.