# Study of Perioperative Dostarlimab in Participants With Untreated T4N0 or Stage III dMMR/MSI-H Resectable Colon Cancer

Source: https://onco.cc/trials/nct05855200/  
OnCo record `nct05855200` (Trial). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

A phase 3 trial of Dostarlimab in colorectal cancer, run by GlaxoSmithKline, now recruiting.

## Summary

Study of Perioperative Dostarlimab in Participants With Untreated T4N0 or Stage III dMMR/MSI-H Resectable Colon Cancer is a phase 3 interventional study registered as NCT05855200 by GlaxoSmithKline, with 892 participants planned, started 2023-08-01 and due to reach its primary completion in 2029-03-19. Interventions recorded: Dostarlimab, CAPEOX and FOLFOX.

## Fields

- Kind: Trial
- Status: recruiting
- Last checked: 2026-09-16
- Also known as: AZUR-2
- Tags: pipeline; ctgov-ingest
- Registry id: NCT05855200
- Phase: 3
- Setting: A Phase 3, Open-Label, Randomized Study of Perioperative Dostarlimab Monotherapy Versus Standard of Care in Participants With Untreated T4N0 or Stage III dMMR/MSI-H Resectable Colon Cancer
- Sponsor: GlaxoSmithKline
- Enrolled: 892

## Notes

- AZUR-2 is the phase 3 test of perioperative dostarlimab in untreated T4N0 or stage III mismatch-repair deficient, MSI-high resectable colon cancer, against surgery with standard adjuvant chemotherapy. The registry lists 892 participants, a start date of 1 August 2023, recruitment continuing and primary completion due 19 March 2029. It is the trial that would turn the NICHE-2 pathological complete response rate into a change in the standard of care.

## Sources

- ClinicalTrials.gov NCT05855200: https://clinicaltrials.gov/study/NCT05855200

## 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: [Dostarlimab](https://onco.cc/drugs/dostarlimab/)
- companies: [GSK](https://onco.cc/companies/gsk/)
- trials: [ATOMIC (Alliance A021502)](https://onco.cc/trials/atomic/), [AZUR-1](https://onco.cc/trials/azur-1/), [CheckMate 8HW](https://onco.cc/trials/checkmate-8hw/), [NICHE-2](https://onco.cc/trials/niche-2/)
- ideas: [A funded programme of organ-preservation trials to avoid radical surgery](https://onco.cc/ideas/idea-fund-organ-preservation-programme/), [Making microsatellite-stable colorectal cancer immunotherapy-responsive](https://onco.cc/ideas/idea-immunotherapy-mss-crc/)

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