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)

Running, not enrolling · Phase 3

Conditions studied: Metastatic Colorectal Cancer

In brief

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.

Key facts

Study ID

NCT04008030

Run by

Bristol-Myers Squibb

People needed

839

Starts

2019-08-05

Expected to finish

2026-06-10

Last updated by the study team

2025-10-03

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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 microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) status per local standard of practice
• Eastern cooperative oncology group (ECOG) performance status lower than or equal to 1

You may not qualify if…

• 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

Where it is running

• Local Institution - 0130 — Sacramento, California, United States
• Local Institution - 0103 — Denver, Colorado, United States
• Local Institution - 0119 — Arlington Heights, Illinois, United States
• Local Institution - 0060 — New York, New York, United States
• Local Institution - 0105 — Portland, Oregon, United States
• Local Institution - 0121 — Pittsburgh, Pennsylvania, United States
• Local Institution - 0106 — Dallas, Texas, United States
• Local Institution - 0104 — Roanoke, Virginia, United States
• Local Institution - 0073 — Ciudad Autonoma Beunos Aires, Buenos Aires, Argentina
• Local Institution - 0074 — Viedma, Río Negro Province, Argentina
• Local Institution - 0084 — Buenos Aires, Argentina
• Local Institution - 0100 — CABA, Argentina
• Local Institution - 0072 — CABA, Argentina
• Local Institution - 0019 — Westmead, New South Wales, Australia
• Local Institution - 0053 — Woolloongabba, Queensland, Australia
• Local Institution - 0018 — Elizabeth Vale, South Australia, Australia
• Local Institution - 0041 — Clayton, Victoria, Australia
• Local Institution - 0017 — Heidelberg, Victoria, Australia
• Local Institution - 0064 — Graz, Austria
• Local Institution - 0068 — Linz, Austria
• Local Institution - 0120 — Salzburg, Austria
• Local Institution - 0065 — Vienna, Austria
• Local Institution - 0067 — Wiener Neustadt, Austria
• Local Institution - 0045 — Bonheiden, Antwerpen, Belgium
• Local Institution - 0059 — Los Angeles, California, United States

Full record on ClinicalTrials.gov

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