CI

At a glance

ClinicalIndex Comparison Record
Phase 3Recruiting· 892 target
Drug / intervention
Dostarlimab +2 morebiological
Likely dose
Not stated in record
Key inclusion· 4
  • ✓Untreated pathologically confirmed colon adenocarcinoma
  • ✓Resectable colon adenocarcinoma defined as clinically T4N0 or Stage III
  • ✓Radiologically evaluable disease
  • ✓Tumor with dMMR status or MSI-H
Key exclusion· 12
  • ✕Distant metastatic disease
  • ✕Prior chemotherapy, immunotherapy, biologic, targeted therapy, radiation, or surgery for current colon cancer
  • ✕Symptomatic bowel obstruction or requires urgent/emergent surgery at screening
  • ✕Colonic obstruction treated with stents

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05855200
NCT05855200Phase 3RecruitingHigh MomentumUpdated 5mo ago
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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

GlaxoSmithKline·interventional·Posted May 11, 2023·Updated Jan 23, 2026

In Brief

A Phase 3 clinical trial evaluating Dostarlimab, CAPEOX, and 1 other intervention for Colonic Neoplasms and Neoplasms, Colon. Currently recruiting, targeting 892 participants across 266 sites in 28 countries.

Signals

Enrolling ahead of pace

Detailed Summary

The primary purpose of this study is to evaluate the efficacy of perioperative dostarlimab compared with standard of care (SOC) in participants with untreated T4N0 or Stage III (resectable), defective mismatch repair/ microsatellite instability high (dMMR/MSI-H) colon cancer.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsColonic Neoplasms, Neoplasms, Colon
CountriesArgentina, 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
Collaborators--

Timeline

Phase 3Recruiting
20242025202620272028202920302031
First PostedMay 11, 2023
Enrollment StartAug 1, 2023
Primary CompletionMar 19, 2029
Study CompletionMar 27, 2031
TodayJul 2, 2026
Enrollment to primary: 5.6 yearsPosted 3.1 years agoPrimary completion in 2.7 years

Interventions

Dostarlimabbiological

Dostarlimab will be administered.

CAPEOXdrug

CAPEOX will be administered.

FOLFOXdrug

FOLFOX will be administered.