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)
← catalyst calendarSponsored by Bristol-Myers Squibb (industry) · BMY — their whole pipeline →. With Ono Pharmaceutical Co., Ltd..
Phase
Phase 3
Status
Active, not recruiting
Study type
Interventional
Design
Randomized · None · Treatment
Enrollment
839actual
Sites
157
Countries
Argentina, Australia, Austria +21
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2019-08-05 | actual | When the study began enrolling |
| Primary completion | 2024-08-28 | actual | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2026-06-10 | estimated | The whole study's end, after follow-up |
| First posted | 2019-07-05 | actual | When this record first appeared on the registry |
| Results posted | 2025-09-22 | actual | When the sponsor posted results to the registry |
| Record updated | 2025-10-03 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Condition
- Metastatic Colorectal Cancer
Interventions
- Biological: Ipilimumab
- Drug: Oxaliplatin
- Drug: Leucovorin
- Drug: Fluorouracil
- Drug: Irinotecan
- Drug: Bevacizumab
- Drug: Cetuximab
- Biological: Nivolumab
Primary outcomes
what the primary-completion date above is the date OFProgression-free Survival (PFS) by Blinded Independent Review Center (BICR) - Arm B vs. Arm A All Lines Centrally Confirmed MSI-H/dMMR
measured 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)
Progression-free Survival (PFS) by Blinded Independent Review Center (BICR) - Arm B vs. Arm C 1L Participants Centrally Confirmed MSI-H/dMMR
measured 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)
Posted documents
hosted by the registry — we link, never re-serveStudy Protocol and Statistical Analysis Planposted 2024-07-01 · 6.4 MB · Prot_SAP_000.pdf
Publications
- PMID 39874977 — linked by the registry
- PMID 39602630 — linked by the registry
Linked on the registry record. A “linked by the registry” entry is NLM's own automated PubMed match, not a claim by the sponsor that the paper reports this study.
Permalink · BMY's whole pipeline · Catalyst calendar · Every registered study · What changed