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

NCT05855200 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 892

Last updated 2026-01-23

No results posted yet for this study

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.

Conditions

  • Colonic Neoplasms
  • Neoplasms, Colon

Interventions

BIOLOGICAL

Dostarlimab

Dostarlimab will be administered.

DRUG

CAPEOX

CAPEOX will be administered.

DRUG

FOLFOX

FOLFOX will be administered.

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-08-01
Primary Completion
2029-03-19
Completion
2031-03-27
FDA Drug
Yes

Countries

  • United States
  • 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

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05855200 on ClinicalTrials.gov