# NICHE-2

Source: https://onco.cc/trials/niche-2/  
OnCo record `niche-2` (Trial). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

In NICHE-2, four weeks of immunotherapy before surgery wiped out most mismatch-repair-deficient colon cancers, and nobody had relapsed three years later.

## Summary

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.

## Fields

- Kind: Trial
- Status: positive
- Last checked: 2026-09-07
- Registry id: NCT03026140
- Phase: 2
- Setting: Locally advanced (mostly stage III) dMMR colon cancer: 4 weeks of neoadjuvant nivolumab + one dose ipilimumab, then surgery
- Sponsor: Netherlands Cancer Institute
- Enrolled: 115
- Result: pCR 68%, major pathologic response 95%; 3-year DFS 100%.
- Outcomes: Pathologic complete response: Neoadjuvant nivolumab + ipilimumab 68 percent; 3-year disease-free survival: Neoadjuvant nivolumab + ipilimumab 100 percent
- Replication: Single-arm; the ATOMIC phase 3 (adjuvant atezolizumab) and NICHE-3 corroborate dMMR immunotherapy benefit in the curative setting, but no randomised neoadjuvant trial has yet reported.

## Sources

- ClinicalTrials.gov NCT03026140: https://clinicaltrials.gov/study/NCT03026140
- NEJM 2024: https://www.nejm.org/doi/abs/10.1056/NEJMoa2400634

## Connected records

- cancers: [Colon cancer (adenocarcinoma of the colon)](https://onco.cc/cancers/colon-cancer/), [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/)
- drugs: [Ipilimumab](https://onco.cc/drugs/ipilimumab/), [Nivolumab](https://onco.cc/drugs/nivolumab/)
- institutions: [Netherlands Cancer Institute (NKI-AvL)](https://onco.cc/institutions/nki/)
- terms: [Microsatellite instability (MSI-H) / mismatch repair deficiency (dMMR)](https://onco.cc/terms/msi/), [Neoadjuvant / adjuvant / perioperative](https://onco.cc/terms/neoadjuvant-adjuvant/), [Pathologic complete response (pCR)](https://onco.cc/terms/pcr/)
- trials: [FOxTROT](https://onco.cc/trials/foxtrot/), [Study of Perioperative Dostarlimab in Participants With Untreated T4N0 or Stage III dMMR/MSI-H Resectable Colon Cancer](https://onco.cc/trials/nct05855200/)
- people: [Myriam Chalabi](https://onco.cc/people/myriam-chalabi/)
- key papers: [Identification of Lynch syndrome among patients with colorectal cancer](https://onco.cc/key-papers/paper-moreira-lynch-syndrome-identification-jama-2012/), [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/), [Neoadjuvant immunotherapy leads to pathological responses in MMR-proficient and MMR-deficient early-stage colon cancers](https://onco.cc/key-papers/paper-niche-2-nat-med-2020/), [NICHE-2: a month of nivolumab and ipilimumab before surgery clears mismatch-repair-deficient colon cancer in most patients](https://onco.cc/key-papers/paper-niche-2-nejm-2024/)
- pairings: [Neoadjuvant checkpoint inhibitor → surgery (or no surgery) in dMMR colorectal cancer](https://onco.cc/pairings/neoadjuvant-io-dmmr/)
- 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/), [Surgery roadmap: radical operations → less surgery → no surgery when a drug has done the work](https://onco.cc/roadmaps/surgery-roadmap/), [Trial modernisation roadmap: the randomised trial → platforms and adaptive designs → decentralised, pragmatic and always-on](https://onco.cc/roadmaps/trial-modernisation-roadmap/)
- bottlenecks: [Cold tumours and the immunosuppressive microenvironment](https://onco.cc/bottlenecks/b-tme-immunosuppression/)
- ideas: [Use pre-surgery immunotherapy windows as the field's biomarker engine](https://onco.cc/ideas/idea-bio2-neoadjuvant-biomarker-engine/)

---
JSON: https://onco.cc/api/v1/entities/niche-2.json