This research was in patients with advanced or metastatic bowel (colon and rectal) cancer whose tumour had a particular feature (MSI-H or dMMR). A combination of two immunotherapy drugs (nivolumab and ipilimumab) was compared with nivolumab alone. The two-drug combination kept the disease from getting worse for longer. Side effects were slightly more common with the two-drug combination, but overall they were reported to be manageable.
MSI-H/dMMR metastatic colorectal cancer; preferred option in ESMO 2026
| Drug | Dose | Route | Schedule |
|---|---|---|---|
| Phase 1: up to 4 doses, every 3 weeks | |||
| Nivolumab | 240 mg | IV | Day 1 |
| Ipilimumab | 1 mg/kg | IV (same day, after nivolumab) | Day 1 |
| Phase 2: maintenance | |||
| Nivolumab | 240 mg every 2 weeks or 480 mg every 4 weeks | IV | |
Doses from the FDA label for nivolumab; evidence: CheckMate 8HW.
On the page “Colorectal cancer” · MSI-H/dMMR metastatic colorectal cancer: first-line
Adults and children aged 12 and over; MSI-H/dMMR by an approved test
| Drug | Dose | Route | Schedule |
|---|---|---|---|
| Combination: up to 4 doses | |||
| Nivolumab | 240 mg (below 40 kg: 3 mg/kg) | IV, 30-minute infusion | Day 1 every 3 weeks (given first) |
| Ipilimumab | 1 mg/kg | IV, 30-minute infusion | Same day, after nivolumab |
| Maintenance | |||
| Nivolumab | 240 mg every 2 weeks or 480 mg every 4 weeks (below 40 kg: 3 mg/kg every 2 weeks or 6 mg/kg every 4 weeks) | IV, 30-minute infusion | After the combination doses |
On the page “Ipilimumab (Yervoy)” · Other cancers, with nivolumab (FDA label, revised 08/2026)
Doses follow the trial protocol, guideline or official drug label (source given in the notes of each regimen). Before prescribing, check blood counts, renal and hepatic function, drug interactions and the patient’s condition, and adjust the dose according to the drug label.
Nivolumab 240 mg + ipilimumab 1 mg/kg IV every 3 weeks, up to 4 doses; then nivolumab 480 mg IV every 4 weeks; until disease progression, unacceptable toxicity or a maximum of 2 years. Patients who stopped the combination because of an adverse event attributed to ipilimumab could continue nivolumab alone.
Nivolumab 240 mg IV every 2 weeks for 6 doses, then 480 mg every 4 weeks; until disease progression, unacceptable toxicity or a maximum of 2 years.
At the investigator's choice, every 2 weeks: mFOLFOX6 (oxaliplatin 85 mg/m², leucovorin 400 mg/m², fluorouracil 400 mg/m² bolus then 2400 mg/m² over 46 hours) or FOLFIRI (irinotecan 180 mg/m² with the same leucovorin and fluorouracil doses), with or without bevacizumab 5 mg/kg or cetuximab 500 mg/m² before chemotherapy every 2 weeks. Patients could receive nivolumab + ipilimumab after progression. This group is not analysed in the comparison reported in this paper (nivolumab + ipilimumab versus nivolumab).
Source of the regimen details: Abstract of the paper and the FDA label for nivolumab (OPDIVO; Clinical Studies section, CHECKMATE-8HW)
Doses are given for the information of specialists, as in this study’s protocol, and are not a prescription. Every drug must be prescribed by the treating physician for the individual patient.
Immunotherapy-naive adults with unresectable or metastatic colorectal cancer, in any line of therapy, with microsatellite instability-high (MSI-H) or mismatch repair-deficient (dMMR) status by local testing. The primary endpoints were assessed in patients with centrally confirmed MSI-H/dMMR status.
Dual independent primary endpoints: progression-free survival (PFS) by blinded independent central review for nivolumab plus ipilimumab versus chemotherapy (first line), and PFS by blinded independent central review for nivolumab plus ipilimumab versus nivolumab (all lines of therapy), in patients with centrally confirmed MSI-H/dMMR. This paper reports the prespecified interim analysis of the second endpoint.
Treatment-related adverse events of any grade: 285 (81%) of 352 patients in the nivolumab plus ipilimumab group and 249 (71%) of 351 patients in the nivolumab group. Grade 3 or 4 treatment-related adverse events: 78 (22%) and 50 (14%), respectively. Three treatment-related deaths occurred: one myocarditis and one pneumonitis in the nivolumab plus ipilimumab group and one pneumonitis in the nivolumab group.
Based on the abstract, nivolumab plus ipilimumab gave better progression-free survival than nivolumab alone in MSI-H/dMMR metastatic colorectal cancer, and the authors regard it as a potential new standard of care. Treatment choice should take into account the greater immune toxicity of the doublet and each patient's situation. Drug approval status and formal guideline recommendations should be checked separately, as they are not given in the abstract.
The trial was open-label. The reported results are from a prespecified interim analysis, and no overall survival data are given in the abstract. The primary endpoints were assessed in patients with centrally confirmed MSI-H/dMMR status. Other limitations should be checked in the full text of the paper.
This summary was prepared by the editorial team from the published paper; the original paper is the final reference. Read the original abstract on PubMed.
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