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.
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
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
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
Where Is This Study? (10 UK sites)
GSK Investigational Site
Birmingham B9 5SS, United Kingdom
GSK Investigational Site
Chelmsford CM1 7ET, United Kingdom
GSK Investigational Site
Cheltenham GL53 7AN, United Kingdom
GSK Investigational Site
Edinburgh EH4 2XU, United Kingdom
GSK Investigational Site
Hull HU16 5JQ, United Kingdom
GSK Investigational Site
Leeds West Yorkshire LS9 7TF, United Kingdom
GSK Investigational Site
London NW3 2QG, United Kingdom
GSK Investigational Site
London SW3 6JJ, United Kingdom
GSK Investigational Site
Manchester M20 4BX, United Kingdom
GSK Investigational Site
Sutton SM2 5PT, United Kingdom
How to Get in Touch
US GSK Clinical Trials Call Center
Sponsor contactCONTACT
EU GSK Clinical Trials Call Center
Sponsor contactCONTACT
