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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)

Active, not recruiting · Phase 3 · NCT04008030

Conditions: Metastatic Colorectal Cancer

At a glance

Research payments reported, 2025
$17,109
U.S. investigators named
4
Sites paid
4
Planned or actual enrollment
839

About the trial

Sponsor
Bristol-Myers Squibb (with Ono Pharmaceutical Co., Ltd.)
Tested
Ipilimumab (biological), Oxaliplatin (drug), Leucovorin (drug), Fluorouracil (drug), Irinotecan (drug), Bevacizumab (drug), Cetuximab (drug), Nivolumab (biological)
Dates
Started 2019-08-05; completion 2027-03-23
Results posted
Yes

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.

From ClinicalTrials.gov, last updated 2026-08-20. Full record, eligibility and contacts (opens in a new tab)

Industry funding

E.r. Squibb & Sons, L.l.c. reported $17,109 in research payments for this study in 2025 (8 payments).

Products named: Opdivo

Research payments usually go to hospitals, universities and research sites to run a study, not to the investigators personally. A payment is not evidence of wrongdoing.

U.S. investigators named on this study

Clinicians the company named as principal investigators in its Open Payments reports.

Sites paid to run it

  • Rocky Mountain Cancer Centers LLP $8,645
  • Blue Ridge Cancer Care $3,514
  • Texas Onco Southwest Fort Worth $2,475
  • Northwest Cancer Specialists, PC $2,475

Sources: CMS Open Payments research payments (program year 2025) and ClinicalTrials.gov, U.S. National Library of Medicine.