Trials / Active Not Recruiting
Active Not RecruitingNCT04008030
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)
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
- Status
- Active Not Recruiting
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 839 (actual)
- Sponsor
- Bristol-Myers Squibb · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Ipilimumab | Specified dose on specified days |
| DRUG | Oxaliplatin | Specified dose on specified days |
| DRUG | Leucovorin | Specified dose on specified days |
| DRUG | Fluorouracil | Specified dose on specified days |
| DRUG | Irinotecan | Specified dose on specified days |
| DRUG | Bevacizumab | Specified dose on specified days |
| DRUG | Cetuximab | Specified dose on specified days |
| BIOLOGICAL | Nivolumab | Specified dose on specified days |
Timeline
- Start date
- 2019-08-05
- Primary completion
- 2024-08-28
- Completion
- 2026-06-10
- First posted
- 2019-07-05
- Last updated
- 2025-10-03
- Results posted
- 2025-09-22
Locations
157 sites across 24 countries: United States, Argentina, 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
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04008030. Inclusion in this directory is not an endorsement.