{"entity":{"id":"nct05855200","kind":"trial","name":"Study of Perioperative Dostarlimab in Participants With Untreated T4N0 or Stage III dMMR/MSI-H Resectable Colon Cancer","aka":["AZUR-2"],"tldr":"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.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05855200","url":"https://clinicaltrials.gov/study/NCT05855200"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["colorectal","msi-high-colorectal","colon-cancer"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["dostarlimab"],"companies":["gsk"],"institutions":[],"pathways":[],"terms":[],"trials":["niche-2","azur-1","atomic"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"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."],"nct":"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","participation":[{"nct":"NCT05855200","source":"https://clinicaltrials.gov/study/NCT05855200","fetchedAt":"2026-10-07T16:53:58.081Z","studySha256":"c3a1efb2360b763c62be2fbe945735ce54459e0d445a8b719355c4c365da38f4","overallStatus":"RECRUITING","lastUpdatePosted":"2026-01-23","leadSponsor":"GlaxoSmithKline","collaboratorCount":0,"minimumAge":"18 Years","sex":"ALL","healthyVolunteers":false,"hasEligibility":true,"enrolment":892,"enrolmentType":"ESTIMATED","siteCount":266,"recruitingSiteCount":229,"countries":["Argentina","Australia","Belgium","Brazil","Canada","China","Czechia","Estonia","Finland","France","Germany","Greece","India","Italy","Japan","Mexico","Netherlands","Norway","Panama","Poland","Portugal","South Korea","Spain","Sweden","Taiwan","Turkey (Türkiye)","United Kingdom","United States"]}],"started":"2023-08-01","startedType":"actual","enrolled":892,"enrolledBasis":"registry","outcomes":[]},"route":"/trials/nct05855200/","neighbours":{"cancer":[{"id":"colon-cancer","kind":"cancer","name":"Colon cancer (adenocarcinoma of the colon)","route":"/cancers/colon-cancer/"},{"id":"colorectal","kind":"cancer","name":"Colorectal cancer","route":"/cancers/colorectal/"},{"id":"msi-high-colorectal","kind":"cancer","name":"Mismatch-repair deficient (MSI-high) colorectal cancer","route":"/cancers/msi-high-colorectal/"}],"technology":[{"id":"checkpoint-inhibitor","kind":"technology","name":"Immune checkpoint inhibitors","route":"/technologies/checkpoint-inhibitor/"}],"drug":[{"id":"dostarlimab","kind":"drug","name":"Dostarlimab","route":"/drugs/dostarlimab/"}],"company":[{"id":"gsk","kind":"company","name":"GSK","route":"/companies/gsk/"}],"trial":[{"id":"atomic","kind":"trial","name":"ATOMIC (Alliance A021502)","route":"/trials/atomic/"},{"id":"azur-1","kind":"trial","name":"AZUR-1","route":"/trials/azur-1/"},{"id":"checkmate-8hw","kind":"trial","name":"CheckMate 8HW","route":"/trials/checkmate-8hw/"},{"id":"niche-2","kind":"trial","name":"NICHE-2","route":"/trials/niche-2/"}],"idea":[{"id":"idea-fund-organ-preservation-programme","kind":"idea","name":"A funded programme of organ-preservation trials to avoid radical surgery","route":"/ideas/idea-fund-organ-preservation-programme/"},{"id":"idea-immunotherapy-mss-crc","kind":"idea","name":"Making microsatellite-stable colorectal cancer immunotherapy-responsive","route":"/ideas/idea-immunotherapy-mss-crc/"}]}}