Back to search results

Study of Dostarlimab for Resectable Colon Cancer

This study is looking at a new way to treat colon cancer that can be removed by surgery (resectable). It's for people with untreated T4N0 or Stage III colon cancer that has specific markers called dMMR or MSI-H. The study compares dostarlimab, an immunotherapy, with standard treatments like CAPEOX or FOLFOX. Researchers want to see if dostarlimab helps people live longer without their cancer returning or getting worse (Event-free Survival). You could be eligible if you have this type of colon cancer and are at least 18 years old. The study plans to enroll 892 participants, but its current recruitment status is unclear.

Study design
This interventional study plans to enroll 892 participants. It is comparing dostarlimab with standard treatments like CAPEOX or FOLFOX.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for Event-free Survival for up to approximately 5 years.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05855200

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

Recruiting
PHASE3Ages 18+InterventionalTreatment
GlaxoSmithKline
~892 participants
Updated 2026-01-23 on ClinicalTrials.gov
What's tested:DostarlimabCAPEOXFOLFOX

At a glance

Recruiting sites
229 of 266 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Event-free Survival (EFS) Assessed by Blinded Independent Central Review (BICR)
Measured over Up to approximately 5 years

Conditions

Colonic Neoplasms
Neoplasms, Colon

Explore related trials

Colon CarcinomaMRC1 wt AlleleMSI1 GeneProgrammed Cell Death Protein 1

Where it's being run

266 sites across 59 states
Spain30
China29
Japan18
Brazil12
France11
Argentina10
Italy10
United Kingdom10

Study leadership

  • GSK Clinical Trials · STUDY_DIRECTOR · GlaxoSmithKline

Who to contact

US GSK Clinical Trials Call Center
[email protected]
877-379-3718
Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

Do you actually qualify for this trial?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

Check eligibility for this trial ~2 min · HIPAA-protected · delete anytime
Eligibility criteria

Inclusion

Has untreated pathologically confirmed colon adenocarcinoma
Has resectable colon adenocarcinoma defined as clinically T4N0 or Stage III
Has radiologically evaluable disease
Has a tumor demonstrating the presence of either dMMR status or MSI-H

Exclusion

Has distant metastatic disease.
Has received prior medical therapy (chemotherapy, immunotherapy, biologic, or targeted therapy), radiation therapy or surgery for management of the current diagnosis of colon cancer
Has a tumor that, in the investigator's judgment is causing symptomatic bowel obstruction or otherwise requires urgent/emergent surgery at the time of screening. Participants with a history of colonic obstruction are eligible after obstruction is relieved by a diverting stoma (defunctioning ileostomy or colostomy). Patients with a history of colonic obstruction in the context of current colon cancer diagnosis and treated with colonic stents are not eligible.
Has undergone any major surgical procedure, open biopsy, or experienced significant traumatic injury within 28 days prior to randomization
Has any history of interstitial lung disease or pneumonitis and/or history of radiation induced enteritis.
Has cirrhosis or current unstable liver or biliary disease per investigator assessment defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminemia, esophageal/gastric varices, or persistent jaundice
Has a history of allogenic stem cell transplantation or organ transplantation
Is receiving any other anticancer or experimental therapy. No other experimental therapies (including but not limited to chemotherapy, radiation, hormonal treatment, antibody therapy, immunotherapy, gene therapy, vaccine therapy, or other experimental drugs) of any kind are permitted while the participant is receiving study intervention
Is pregnant, breastfeeding, or expecting to conceive children within the projected duration of the study
Has a history of severe allergic and/or anaphylactic reactions to chimeric, human or humanized antibodies, fusion proteins, or known allergies to dostarlimab, or its excipients, or any components of FOLFOX or CAPEOX

What this trial measures

  • Event-free Survival (EFS) Assessed by Blinded Independent Central Review (BICR)Up to approximately 5 years

    EFS is defined as the time from randomization to either disease recurrence or death due to any cause or treatment related toxicity that results in the participant not being suitable for surgery