At a glance

ClinicalIndex Comparison Record

Phase 3Active· 839 enrolled

Drug / intervention

Ipilimumab +7 morebiological

Likely dose

Nivolumab dose specified on protocol; investigator's choice chemotherapy includes oxaliplatin, leucovorin, fluorouracil, irinotecan, bevacizumab, or cetuximab at specified dosesAI-extracted

Key inclusion· 4

✓Histologically confirmed recurrent or metastatic colorectal cancer
✓MSI-H or mismatch repair deficient (dMMR) tumor status confirmed by local standard of practice
✓ECOG performance status 0 or 1
✓Disease not amenable to curative surgery

Key exclusion· 3

✕Active, known, or suspected autoimmune disease
✕History of interstitial lung disease or pneumonitis
✕Known HIV-positive or AIDS

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04008030

NCT04008030Phase 3Active

Compare CT.gov

A Phase 3 Randomized Clinical Trial of Nivolumab Alone, Nivolumab in Combination With Ipilimumab, or Investigator's Choice Chemotherapy in Participants With Microsatellite Instability High (MSI-H) or Mismatch Repair Deficient (dMMR) Metastatic Colorectal Cancer

Bristol-Myers Squibb·interventional·Posted Jul 5, 2019·Updated Oct 3, 2025

In Brief

A Phase 3 clinical trial evaluating Ipilimumab, Oxaliplatin, and 6 other interventions for Metastatic Colorectal Cancer. Active but no longer recruiting, targeting 839 participants across 157 sites in 24 countries.

Detailed 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.

Study Details

Study Typeinterventional

Allocation--

Masking--

Primary Purpose--

ConditionsMetastatic Colorectal Cancer

CountriesArgentina, Australia, Austria, Belgium, Brazil, Canada, Chile, China, Czechia, Denmark, France, Germany, Greece, Ireland, Italy, Japan, Netherlands, Norway, Puerto Rico, Romania, Spain, Turkey (Türkiye), United Kingdom, United States

CollaboratorsOno Pharmaceutical Co., Ltd.

Timeline

Phase 3ActiveOverdue

2020202120222023202420252026

First PostedJul 2019

Enrollment StartAug 2019

Primary CompletionAug 2024

Study CompletionJun 2026

TodayJul 2026

First PostedJul 5, 2019

Enrollment StartAug 5, 2019

Primary CompletionAug 28, 2024

Study CompletionJun 10, 2026

TodayJul 2, 2026

Enrollment to primary: 5.1 yearsPosted 7.0 years ago