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Looking for participantsPhase3

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

Sponsor: GlaxoSmithKline

NCT ID: NCT05855200

View on ClinicalTrials.gov ↗

At a glance

What the study gets you
Access to the study treatment being tested
Type of study
Interventional (receives a drug or procedure)
Time in hospital
In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention
Dostarlimab (biological), CAPEOX (drug), FOLFOX (drug)
How long the study runs
Study runs about 91 months (dates as stated)
About the drug or intervention
Dostarlimab — biological: Dostarlimab will be administered. · CAPEOX — drug: CAPEOX will be administered. · FOLFOX — drug: FOLFOX will be administered.
Patient visit burden
Not specified by the sponsor

In plain English

This study, run by GlaxoSmithKline, is looking at dostarlimab (a type of immunotherapy) given around the time of surgery in people with untreated colon cancer that can be removed by surgery. It is for people whose cancer is clinically T4N0 or Stage III and whose tumour shows either mismatch repair deficiency (dMMR) or high microsatellite instability (MSI-H) — changes that can affect how cancer grows.

Who can take part

  • Has colon adenocarcinoma (a type of bowel cancer) confirmed by testing tissue, that has not been treated yet
  • The cancer can be removed by surgery and is classed as clinically T4N0 or Stage III
  • The cancer can be measured on scans
  • The tumour shows either dMMR or MSI-H status

Who may not be able to

  • The cancer has spread to distant parts of the body
  • Has already had treatment for this colon cancer, including chemotherapy, immunotherapy, biologic or targeted therapy, radiotherapy, or surgery
  • The tumour is causing a blockage of the bowel that needs urgent surgery, although people whose blockage was relieved with a stoma may still join. People treated with a bowel stent cannot join
  • Has had major surgery, an open biopsy, or a serious injury in the 28 days before joining
  • Has ever had lung disease called interstitial lung disease or pneumonitis, or radiation-induced bowel inflammation
  • Has cirrhosis or unstable liver or bile disease, based on certain signs the doctor looks for
  • Has had a stem cell transplant or organ transplant from another person
  • Is having any other anti-cancer or experimental treatment while in the study
  • Is pregnant, breastfeeding, or planning to conceive during the study
  • Has had severe allergic reactions to antibodies, fusion proteins, dostarlimab, or any parts of FOLFOX or CAPEOX (chemotherapy drug combinations)

What taking part involves

  • • Taking dostarlimab (an immunotherapy drug) around the time of surgery — exact details of doses and schedule are not stated — ask the trial team

Time commitment: Not stated — ask the trial team.

Plain-English summary (AI-generated) from registry data. Not eligibility advice — only the trial team can confirm whether you can take part. Use the eligibility checker to see how your health profile matches this trial.

Type of study
Testing a treatment
Ages
18 Years and over
Who
All
Number of participants
892
Started
2023-08-01
Last checked
2026-01

Plain English Summary

What is this study?

  • • Testing a new treatment for colonic neoplasms
  • • Phase3 - 892 participants
  • • 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

Who can take part?

  • • Ages 18 Years and over
  • • Diagnosed with colonic neoplasms

Where?

  • • Birmingham - GSK Investigational Site
  • • Chelmsford - GSK Investigational Site
  • • Cheltenham - GSK Investigational Site
  • • Edinburgh - GSK Investigational Site
  • • +6 more UK sites

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

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.

Colonic NeoplasmsNeoplasms, Colon

How this trial compares with your answers

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What we know so far

Condition· Matched your search
Age· Tell us your age for better matching
Gender· Tell us your sex for better matching

Still need:

  • • Tell us your age for better matching
  • • Tell us your sex for better matching

Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

  • Age: 18 Years and over
  • Who can join: All genders

Biomarkers mentioned

MSI

What the study is looking for

  • ✓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

Who cannot take part

  • ✗Has distant that has spread disease.
  • ✗Has received prior medical therapy (drug treatment, treatment that helps your immune system fight cancer, biologic, or treatment that targets specific changes in the cancer), radiotherapy...
  • ✗Has undergone any major surgical procedure, open biopsy, or experienced significant traumatic injury within 28 days...
  • ✗Has any history of interstitial lung disease or pneumonitis and/or history of radiation induced enteritis.
  • ✗Has a history of allogenic stem cell transplantation or organ transplantation
See the full 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

Where Is This Study? (10 UK sites)

GSK Investigational Site

Birmingham B9 5SS, United Kingdom

Recruiting
Site contact (verified)
Shobhit BaijalPrincipal Investigator
US GSK Clinical Trials Call Center877-379-3718GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre+44 (0) 20 8990 4466GSKClinicalSupportHD@gsk.com

GSK Investigational Site

Chelmsford CM1 7ET, United Kingdom

Recruiting
Site contact (verified)
Rafiqul IslamPrincipal Investigator
US GSK Clinical Trials Call Center877-379-3718GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre+44 (0) 20 8990 4466GSKClinicalSupportHD@gsk.com

GSK Investigational Site

Cheltenham GL53 7AN, United Kingdom

Recruiting
Site contact (verified)
Nick ReedPrincipal Investigator
US GSK Clinical Trials Call Center877-379-3718GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre+44 (0) 20 8990 4466GSKClinicalSupportHD@gsk.com

GSK Investigational Site

Edinburgh EH4 2XU, United Kingdom

Recruiting
Site contact (verified)
Faye RobertsonPrincipal Investigator
US GSK Clinical Trials Call Center877-379-3718GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre+44 (0) 20 8990 4466GSKClinicalSupportHD@gsk.com

GSK Investigational Site

Hull HU16 5JQ, United Kingdom

Recruiting
Site contact (verified)
Rajarshi RoyPrincipal Investigator
US GSK Clinical Trials Call Center877-379-3718GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre+44 (0) 20 8990 4466GSKClinicalSupportHD@gsk.com

GSK Investigational Site

Leeds West Yorkshire LS9 7TF, United Kingdom

Recruiting
Site contact (verified)
Jenny SeligmannPrincipal Investigator
US GSK Clinical Trials Call Center877-379-3718GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre+44 (0) 20 8990 4466GSKClinicalSupportHD@gsk.com

GSK Investigational Site

London NW3 2QG, United Kingdom

Recruiting
Site contact (verified)
Robert GoldsteinPrincipal Investigator
US GSK Clinical Trials Call Center877-379-3718GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre+44 (0) 20 8990 4466GSKClinicalSupportHD@gsk.com

GSK Investigational Site

London SW3 6JJ, United Kingdom

Recruiting
Site contact (verified)
Naureen StarlingPrincipal Investigator
US GSK Clinical Trials Call Center877-379-3718GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre+44 (0) 20 8990 4466GSKClinicalSupportHD@gsk.com

GSK Investigational Site

Manchester M20 4BX, United Kingdom

Recruiting
Site contact (verified)
Michael BraunPrincipal Investigator
US GSK Clinical Trials Call Center877-379-3718GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre+44 (0) 20 8990 4466GSKClinicalSupportHD@gsk.com

GSK Investigational Site

Sutton SM2 5PT, United Kingdom

Recruiting
Site contact (verified)
Naureen StarlingPrincipal Investigator
US GSK Clinical Trials Call Center877-379-3718GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre+44 (0) 20 8990 4466GSKClinicalSupportHD@gsk.com

How to Get in Touch

US GSK Clinical Trials Call Center

Sponsor contact

CONTACT

877-379-3718 GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Center

Sponsor contact

CONTACT

+44 (0) 20 89904466 GSKClinicalSupportHD@gsk.com
Data sourced from ClinicalTrials.gov · Last verified: 2026-01