NICHE-2
In NICHE-2, four weeks of immunotherapy before surgery wiped out most mismatch-repair-deficient colon cancers, and nobody had relapsed three years later.
Pathologic response in 98%, major pathologic response 95%, pathologic complete response 68% (NEJM 2024). Three-year disease-free survival 100% (ESMO 2024). No patient needed chemotherapy. NICHE-3 (nivolumab + relatlimab) and the ATOMIC adjuvant trial extend the evidence; organ-preservation trials in rectal cancer (AZUR-1) follow the same logic.
- 68 out of 100 people had no cancer left at surgery with Neoadjuvant nivolumab + ipilimumab.
- 100 out of 100 people alive without the cancer coming back at 3 years with Neoadjuvant nivolumab + ipilimumab.
- There was no comparison group, so this number cannot tell you how much of the effect is due to the treatment.
- This is a surrogate endpoint: it measures the cancer being controlled or absent on scans and tests, which often, but not always, translates into living longer.
- These results apply to the people the trial enrolled: Locally advanced (mostly stage III) dMMR colon cancer: 4 weeks of neoadjuvant nivolumab + one dose ipilimumab, then surgery. People in a different situation may not see the same effect.
- The trial selected people by a biomarker (dMMR); the result should not be assumed for people whose cancer does not have it.
Numbers are from the trial as recorded here; see the source links in the table below. This is orientation, not medical advice: ask your team how closely the trial population matches you.
115 participants enrolled.
| Endpoint | Arm | n | Value | HR (95% CI) | p | Source |
|---|---|---|---|---|---|---|
| Pathologic complete responseprimary | Neoadjuvant nivolumab + ipilimumab | 111 | 68 percent | — | — | link |
| 3-year disease-free survival | Neoadjuvant nivolumab + ipilimumab | 111 | 100 percent | — | — | link |
Pages like this
not linked directly; found by shared links- Key paperNICHE-2: a month of nivolumab and ipilimumab before surgery clears mismatch-repair-deficient colon cancer in most patients
Shares Myriam Chalabi, Netherlands Cancer Institute (NKI-AvL), Pathologic complete response (pCR), Microsatellite instability (MSI-H) / mismatch repair deficiency (dMMR).
- PersonChristian Blank
Shares Use pre-surgery immunotherapy windows as the field's biomarker engine, Netherlands Cancer Institute (NKI-AvL), Neoadjuvant / adjuvant / perioperative, Ipilimumab.
- TrialCheckMate 816
Shares Use pre-surgery immunotherapy windows as the field's biomarker engine, Pathologic complete response (pCR), Neoadjuvant / adjuvant / perioperative, Nivolumab.
- TrialATOMIC (Alliance A021502)
Shares Neoadjuvant checkpoint inhibitor → surgery (or no surgery) in dMMR colorectal cancer, Microsatellite instability (MSI-H) / mismatch repair deficiency (dMMR), Neoadjuvant / adjuvant / perioperative, Colorectal cancer.
- TrialCheckMate 8HW
Shares Microsatellite instability (MSI-H) / mismatch repair deficiency (dMMR), Ipilimumab, Cold tumours and the immunosuppressive microenvironment, Nivolumab.
- TrialNADINA
Shares Use pre-surgery immunotherapy windows as the field's biomarker engine, Netherlands Cancer Institute (NKI-AvL), Neoadjuvant / adjuvant / perioperative, Ipilimumab.
- IdeaA funded programme of organ-preservation trials to avoid radical surgery
Shares Myriam Chalabi, Microsatellite instability (MSI-H) / mismatch repair deficiency (dMMR), Neoadjuvant / adjuvant / perioperative, Colorectal cancer.
- Key paperNADINA: two doses of ipilimumab plus nivolumab before surgery beat a year of nivolumab after surgery in stage III melanoma
Shares Netherlands Cancer Institute (NKI-AvL), Pathologic complete response (pCR), Neoadjuvant / adjuvant / perioperative, Ipilimumab.