Overview

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)

Status:
Recruiting
Trial end date:
2025-08-05
Target enrollment:
0
Participant gender:
All
Summary
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.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Bristol-Myers Squibb
Collaborator:
Ono Pharmaceutical Co. Ltd
Treatments:
Bevacizumab
Cetuximab
Fluorouracil
Ipilimumab
Irinotecan
Leucovorin
Nivolumab
Oxaliplatin
Criteria
For more information regarding Bristol-Myers Squibb Clinical Trial participation, please
visit www.BMSStudyConnect.com

Inclusion Criteria:

- 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)

- 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)

- Known tumor MSI-H or dMMR status per local standard of practice

- Eastern cooperative oncology group (ECOG) performance status lower than or equal to 1

Exclusion Criteria:

- Participants with an active, known or suspected autoimmune disease

- History of interstitial lung disease or pneumonitis

- Known history of positive test for human immunodeficiency virus (HIV) or known
acquired immunodeficiency syndrome (AIDS)

Other protocol-defined inclusion/exclusion criteria apply