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)

NCT04008030 · tracked via the Priya Life Science UK tracker

Sponsor

Bristol-Myers Squibb

Phase

Phase 3

Started

2019-08-05

Last updated

2026-08-20

Condition(s) studied

Metastatic Colorectal Cancer

Investigational drug(s) / intervention(s)

IpilimumabOxaliplatinLeucovorinFluorouracilIrinotecanBevacizumabCetuximabNivolumab

Ipilimumab: Specified dose on specified days

Oxaliplatin: Specified dose on specified days

Leucovorin: Specified dose on specified days

Fluorouracil: Specified dose on specified days

Irinotecan: Specified dose on specified days

Bevacizumab: Specified dose on specified days

Cetuximab: Specified dose on specified days

Nivolumab: Specified dose on specified days

Study 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.

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

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 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 Exclusion Criteria: * 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

Primary outcome measure(s)

Progression-free Survival (PFS) by Blinded Independent Review Center (BICR) - Arm B vs. Arm A All Lines Centrally Confirmed MSI-H/dMMR — From date of randomization to the date of first objectively documented disease progression or death due to any cause, whichever occurs first (Up to approximately 60 months)
BICR-assessed Progression-free survival (PFS) is defined as the time from the randomization date to the date of first objectively documented disease progression per RECIST 1.1 (i.e, radiologic) or death due to any cause, whichever occurs first.
Progression-free Survival (PFS) by Blinded Independent Review Center (BICR) - Arm B vs. Arm C 1L Participants Centrally Confirmed MSI-H/dMMR — From date of randomization to the date of first objectively documented disease progression or death due to any cause, whichever occurs first (Up to approximately 32 months)
BICR-assessed Progression-free survival (PFS) is defined as the time from the randomization date to the date of first objectively documented disease progression per RECIST 1.1 (i.e, radiologic) or death due to any cause, whichever occurs first.

Trial sites (157)

Facility	City	Region
Local Institution - 0059	Los Angeles	California
Local Institution - 0130	Sacramento	California
Local Institution - 0103	Denver	Colorado
Local Institution - 0119	Arlington Heights	Illinois
Local Institution - 0060	New York	New York
Local Institution - 0105	Portland	Oregon
Local Institution - 0121	Pittsburgh	Pennsylvania
Local Institution - 0106	Dallas	Texas
Local Institution - 0104	Roanoke	Virginia
Local Institution - 0073	Ciudad Autonoma Beunos Aires	Buenos Aires
Local Institution - 0074	Viedma	Río Negro Province
Local Institution - 0084	Buenos Aires	Argentina
Local Institution - 0100	CABA	Argentina
Local Institution - 0072	CABA	Argentina
Local Institution - 0019	Westmead	New South Wales
Local Institution - 0053	Woolloongabba	Queensland
Local Institution - 0018	Elizabeth Vale	South Australia
Local Institution - 0041	Clayton	Victoria
Local Institution - 0017	Heidelberg	Victoria
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
Local Institution - 0025	Anderlecht	Bruxelles-Capitale, Région de
Local Institution - 0024	Leuven	Belgium
Local Institution - 0096	Ipatinga	Minas Gerais
Local Institution - 0200	Natal	Rio Grande do Norte
Local Institution - 0192	Porto Alegre	Rio Grande do Sul
Local Institution - 0102	Barretos	São Paulo
Local Institution - 0094	São José do Rio Preto	São Paulo
Local Institution - 0095	São Paulo	São Paulo
Local Institution - 0199	Rio de Janeiro	Brazil
Local Institution - 0193	São Paulo	Brazil
Local Institution - 0011	Edmonton	Alberta
Local Institution - 0039	Vancouver	British Columbia
Local Institution - 0013	Toronto	Ontario
Local Institution - 0016	Montreal	Quebec
Local Institution - 0015	Sherbrooke	Quebec

+ 117 more sites — see the full list on the official registry below.

On this site

📄 Avastin (bevacizumab) drug profile → 📄 Opdivo (nivolumab) drug profile →

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04008030 on ClinicalTrials.gov ↗ ← All trials in the UK