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
- Allen L. Cohn, MD Hematology & Oncology · Denver, CO
- Spencer H. Shao, M.D. Medical Oncology · Portland, OR
- Andrew S. Paulson, MD Medical Oncology · Dallas, TX
- Mark D. Kochenderfer, MD Hematology & Oncology · Roanoke, VA
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.