🇮🇪Ireland
16°C Partly Cloudy · Dublin
Live Updates
--:--:-- IST
Writer Login
Latest
Clinical Trials in the UK / NCT05855200
Recruiting Phase 3

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

NCT05855200 · tracked via the Priya Life Science UK tracker
Sponsor
GlaxoSmithKline
Phase
Phase 3
Started
2023-08-01
Last updated
2026-01-23

Condition(s) studied

Colonic NeoplasmsNeoplasms, Colon

Investigational drug(s) / intervention(s)

DostarlimabCAPEOXFOLFOX

Dostarlimab: Dostarlimab will be administered.

CAPEOX: CAPEOX will be administered.

FOLFOX: FOLFOX will be administered.

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
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

Primary outcome measure(s)

Trial sites (266)

FacilityCityRegionStatus
GSK Investigational Site Tucson Arizona Recruiting
GSK Investigational Site Los Angeles California Recruiting
GSK Investigational Site New Haven Connecticut Recruiting
GSK Investigational Site Washington D.C. District of Columbia Withdrawn
GSK Investigational Site Deerfield Beach Florida Withdrawn
GSK Investigational Site Fort Lauderdale Florida Withdrawn
GSK Investigational Site Marietta Georgia Withdrawn
GSK Investigational Site Chicago Illinois Recruiting
GSK Investigational Site Chicago Illinois Recruiting
GSK Investigational Site Chicago Illinois Withdrawn
GSK Investigational Site Naperville Illinois Recruiting
GSK Investigational Site Naperville Illinois Recruiting
GSK Investigational Site Westwood Kansas Recruiting
GSK Investigational Site Lexington Kentucky Withdrawn
GSK Investigational Site Louisville Kentucky Withdrawn
GSK Investigational Site Baton Rouge Louisiana Withdrawn
GSK Investigational Site Bethesda Maryland Recruiting
GSK Investigational Site Ann Arbor Michigan Withdrawn
GSK Investigational Site Detroit Michigan Recruiting
GSK Investigational Site Minneapolis Minnesota Recruiting
GSK Investigational Site Joplin Missouri Withdrawn
GSK Investigational Site St Louis Missouri Withdrawn
GSK Investigational Site St Louis Missouri Withdrawn
GSK Investigational Site Grand Island Nebraska Recruiting
GSK Investigational Site Omaha Nebraska Recruiting
GSK Investigational Site Omaha Nebraska Withdrawn
GSK Investigational Site Lebanon New Hampshire Withdrawn
GSK Investigational Site New York New York Recruiting
GSK Investigational Site New York New York Recruiting
GSK Investigational Site New York New York Recruiting
GSK Investigational Site New York New York Recruiting
GSK Investigational Site The Bronx New York Recruiting
GSK Investigational Site Durham North Carolina Recruiting
GSK Investigational Site Akron Ohio Recruiting
GSK Investigational Site Cincinnati Ohio Recruiting
GSK Investigational Site Cleveland Ohio Withdrawn
GSK Investigational Site Cleveland Ohio Withdrawn
GSK Investigational Site Cleveland Ohio Withdrawn
GSK Investigational Site Oklahoma City Oklahoma Withdrawn
GSK Investigational Site Oklahoma City Oklahoma Withdrawn

+ 226 more sites — see the full list on the official registry below.

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05855200 on ClinicalTrials.gov ↗ ← All trials in the UK