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

RecruitingPhase 3

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

Who can join

Ages 18 and older · All sexes

Full eligibility criteria
Inclusion Criteria:

* 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 Criteria:

* 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

About the study

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.

What is being tested

Sponsor: GlaxoSmithKline · Participants: 892 · Started: Aug 1, 2023

Contact the study team

Official record on ClinicalTrials.gov — NCT05855200

Locations in the U.S.

ArizonaGSK Investigational Site, Tucson
CaliforniaGSK Investigational Site, Los Angeles
ConnecticutGSK Investigational Site, New Haven
IllinoisGSK Investigational Site, Chicago
GSK Investigational Site, Chicago
GSK Investigational Site, Naperville
GSK Investigational Site, Naperville
KansasGSK Investigational Site, Westwood
MarylandGSK Investigational Site, Bethesda
MichiganGSK Investigational Site, Detroit
MinnesotaGSK Investigational Site, Minneapolis
NebraskaGSK Investigational Site, Grand Island
GSK Investigational Site, Omaha
New YorkGSK Investigational Site, New York
GSK Investigational Site, New York
GSK Investigational Site, New York
GSK Investigational Site, New York
GSK Investigational Site, The Bronx
North CarolinaGSK Investigational Site, Durham
OhioGSK Investigational Site, Akron
GSK Investigational Site, Cincinnati
South DakotaGSK Investigational Site, Sioux Falls
GSK Investigational Site, Sioux Falls
GSK Investigational Site, Sioux Falls
GSK Investigational Site, Sioux Falls
VirginiaGSK Investigational Site, Richmond
WisconsinGSK Investigational Site, Appleton

Conditions

From ClinicalTrials.gov, data retrieved Sep 29, 2026. Each study sets its own eligibility; the study team decides who can join.