# CheckMate 8HW

Source: https://onco.cc/trials/checkmate-8hw/  
OnCo record `checkmate-8hw` (Trial). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

Showed that a two-drug immunotherapy combination controls mismatch-repair-deficient bowel cancer for over four years on average, and beats immunotherapy alone.

## Summary

First-line nivolumab + ipilimumab vs chemotherapy: PFS HR 0.21 (NEJM 2024); at 47 months' follow-up median PFS 54.1 vs 5.9 months. Across all lines, nivolumab + ipilimumab beat nivolumab alone on PFS (Lancet 2025, HR 0.62), the first phase 3 to show the CTLA-4 add-on matters in this setting. FDA approved the combination first line in April 2025. Overall survival is not yet mature.

## Fields

- Kind: Trial
- Status: positive
- Last checked: 2026-09-07
- Registry id: NCT04008030
- Phase: 3
- Setting: MSI-H/dMMR metastatic colorectal cancer, all lines: nivolumab + ipilimumab vs nivolumab vs chemotherapy
- Sponsor: BMS
- Enrolled: 839
- Result: First-line PFS 54.1 vs 5.9 months (HR 0.21); combination vs nivolumab PFS HR 0.62.
- Outcomes: Progression-free survival, first line: Nivolumab + ipilimumab 54.1 months vs Chemotherapy 5.9 months, HR 0.21; Progression-free survival, all lines: combination vs nivolumab: Nivolumab + ipilimumab vs Nivolumab, HR 0.62
- Replication: Consistent with KEYNOTE-177 for PD-1 monotherapy; the doublet-over-monotherapy result is so far unique to this trial.

## Sources

- ClinicalTrials.gov NCT04008030: https://clinicaltrials.gov/study/NCT04008030
- NEJM 2024: https://www.nejm.org/doi/abs/10.1056/NEJMoa2402141
- Lancet 2025: https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(24)02848-4/abstract

## Connected records

- cancers: [BRAF V600E-mutant colorectal cancer](https://onco.cc/cancers/braf-v600e-colorectal/), [Colorectal cancer](https://onco.cc/cancers/colorectal/), [Mismatch-repair deficient (MSI-high) colorectal cancer](https://onco.cc/cancers/msi-high-colorectal/)
- technologies: [Immune checkpoint inhibitors](https://onco.cc/technologies/checkpoint-inhibitor/)
- targets: [CTLA-4](https://onco.cc/targets/ctla4/), [PD-1](https://onco.cc/targets/pd1/)
- drugs: [Ipilimumab](https://onco.cc/drugs/ipilimumab/), [Nivolumab](https://onco.cc/drugs/nivolumab/)
- terms: [Microsatellite instability (MSI-H) / mismatch repair deficiency (dMMR)](https://onco.cc/terms/msi/), [Microsatellite-stable (MSS) / mismatch-repair proficient (pMMR)](https://onco.cc/terms/mss-pmmr/)
- trials: [CheckMate 142](https://onco.cc/trials/checkmate-142/), [Study of Perioperative Dostarlimab in Participants With Untreated T4N0 or Stage III dMMR/MSI-H Resectable Colon Cancer](https://onco.cc/trials/nct05855200/)
- people: [Heinz-Josef Lenz](https://onco.cc/people/heinz-josef-lenz/), [Thierry André](https://onco.cc/people/thierry-andre/)
- key papers: [CheckMate 8HW: nivolumab plus ipilimumab versus nivolumab alone in MSI-high metastatic colorectal cancer](https://onco.cc/key-papers/paper-checkmate-8hw-lancet-2025/), [Le 2015: PD-1 blockade works in tumours with mismatch-repair deficiency, whatever the organ](https://onco.cc/key-papers/paper-le-mmr-deficiency-pd1-nejm-2015/), [Le 2017: mismatch-repair deficiency predicts response to PD-1 blockade across twelve tumour types, leading to the first tissue-agnostic drug approval](https://onco.cc/key-papers/paper-le-mmr-deficiency-science-2017/), [Nivolumab in patients with metastatic DNA mismatch repair-deficient or microsatellite instability-high colorectal cancer (CheckMate 142)](https://onco.cc/key-papers/paper-overman-checkmate-142-nivolumab-dmmr-colorectal-lancet-oncol-2017/), [Nivolumab plus ipilimumab in microsatellite-instability-high metastatic colorectal cancer (CheckMate 8HW)](https://onco.cc/key-papers/paper-andre-checkmate-8hw-nivolumab-ipilimumab-nejm-2024/)
- ideas: [Making microsatellite-stable colorectal cancer immunotherapy-responsive](https://onco.cc/ideas/idea-immunotherapy-mss-crc/)
- roadmaps: [Colorectal cancer roadmap: from the adenoma-carcinoma sequence and the first screening trials to total mesorectal excision, oxaliplatin, RAS testing, immunotherapy for mismatch repair-deficient disease, ctDNA-guided treatment and organ preservation](https://onco.cc/roadmaps/colorectal-roadmap/)
- bottlenecks: [Cold tumours and the immunosuppressive microenvironment](https://onco.cc/bottlenecks/b-tme-immunosuppression/)

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