Practice-entering research
CheckMate 8HW — nivo±ipi vs chemotherapy in MSI-H/dMMR mCRC
A Study of Nivolumab, Nivolumab Plus Ipilimumab, or Investigator's Choice Chemotherapy for the Treatment of Participants With Microsatellite Instability High (MSI-H) or Mismatch Repair Deficient (dMMR) Metastatic Colorectal Cancer
- Phase
- Phase III
- Recruitment
- Active, not recruiting
- Results maturity
- Primary analysis
- Publication
- Congress + peer-reviewed
- Regulatory approval
- FDA approval — 8 April 2025 (US; nivo+ipi, MSI-H/dMMR mCRC)
- NCT
- NCT04008030
- Registry checked
- 2026-10-29
- Editorial update
- 2026-10-29
Not a treatment recommendation. Experimental or ongoing research does not by itself replace standard care.
For patients
What is being studied? Dual immunotherapy can delay progression versus chemotherapy in metastatic, genetically defined colorectal cancer. US approval exists; access may differ by country.
Why promising? In metastatic MSI-H/dMMR CRC, nivolumab+ipilimumab improved progression-free survival versus chemotherapy and is FDA-approved in the US.
What is not proven? Do not confuse with adjuvant dMMR (ATOMIC); no generalization to all CRC; Türkiye license; mature OS read per sub-question.
Is this standard care today? This listing alone does not replace standard care; approval and guideline context require clinician judgment.
For clinicians
Phase III; enrollment closed. Nivo+ipi MSI-H/dMMR mCRC — FDA 8 Apr 2025 (US). Related to Landmark KEYNOTE-177; Ufuk does not award or change stars.
Cancer / population: Colon, Rectum — MSI-H/dMMR metastatik kolorektal kanser
Intervention: Nivolumab ± ipilimumab
Primary endpoint: PFS (BICR; protokol kollarına göre)
Source-verified summary: FDA 8 Nisan 2025 (ABD) nivo+ipi MSI-H/dMMR mCRC. Primer PFS kolları birincil yayınla okunur.
Limitations: Metastatik; adjuvan/organ koruma sorularından ayrı; Türkiye erişimi ayrı.
Landmark Atlas links
Cross-links are informational only; this module does not award or change gold stars.