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)
- How long the study runs
- Study runs about 44 months (dates as stated)
- About the drug or intervention
- Dostarlimab — biological: Dostarlimab will be administered. · CAPEOX — drug: CAPEOX chemotherapy consisting of capecitabine and oxaliplatin will be administered.
- Patient visit burden
- Not specified by the sponsor
In plain English
This study looks at colon cancer that has not yet been treated and can be removed with surgery. It compares two treatment approaches before surgery: dostarlimab (an immunotherapy) given together with CAPEOX chemotherapy (capecitabine plus oxaliplatin), versus CAPEOX chemotherapy alone. The trial is for people whose cancer is mismatch repair proficient (MMRp) or microsatellite stable (MSS), which means the cancer is unlikely to respond well to immunotherapy on its own. It is funded by GlaxoSmithKline.
Who can take part
- Colon cancer (adenocarcinoma) that has been confirmed by testing and has not been treated before
- Cancer that can be removed by surgery, defined as clinically T4N0 or Stage III
- A tumour that tests show is MMRp (all mismatch repair proteins present), or MSS / MSI-L (microsatellite stable or low instability)
- Willing to give a fresh tumour tissue sample taken during a colonoscopy (a camera test of the bowel)
- Willing to use reliable contraception, for men and women
- Able to carry out normal daily activity with little or no restriction (performance status 0 or 1)
- Good enough organ function (such as liver and kidneys)
Who may not be able to
- Cancer that has spread to distant parts of the body
- Any previous treatment for colon cancer (chemotherapy, immunotherapy, targeted therapy, radiotherapy or surgery)
- A tumour that cannot be operated on, or any other reason surgery is not safe
- Certain serious past reactions to immunotherapy, including severe immune-related side effects, serious skin reactions, or heart inflammation (myocarditis)
- A history of lung disease called interstitial lung disease or immune-related pneumonitis
- Any other medical condition, treatment or test result that could affect the study or make taking part unsafe, in the doctor's opinion
- A serious uncontrolled illness or active infection needing treatment
- Treatment with an experimental drug within 4 weeks of the first study dose
- Pregnancy or breastfeeding
- Severe allergic reactions to antibodies or fusion proteins, or known allergy to dostarlimab or any part of CAPEOX
What taking part involves
- • Participants are placed into one of two groups: dostarlimab plus CAPEOX chemotherapy (capecitabine and oxaliplatin), or CAPEOX chemotherapy alone
- • Treatment is given before surgery to remove the cancer (this is called neoadjuvant treatment)
- • A fresh tumour biopsy (tissue sample) is required, taken during a colonoscopy
- • Contraception is required during the study for both men and women
Time commitment: Not stated — ask the trial team about how long the study lasts, how many hospital visits are needed, and exactly what tests and procedures are involved.
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
- 120
- Started
- 2025-02-18
- Last checked
- 2026-05
Plain English Summary
What is this study?
- • Testing a new treatment for neoplasms, colon
- • Phase2 - 120 participants
- • The main goal of this study is to test a new treatment approach for colon cancer
Who can take part?
- • Ages 18 Years and over
- • Diagnosed with neoplasms, colon
Where?
- • Glasgow - GSK Investigational Site
- • Leeds West Yorkshire - GSK Investigational Site
- • London - GSK Investigational Site
- • Sutton - GSK Investigational Site
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
The main goal of this study is to test a new treatment approach for colon cancer. The treatment involves dostarlimab along with a specific type of chemotherapy called CAPEOX (short for "capecitabine + oxaliplatin") to check if using these two together works better than using just CAPEOX by itself. This treatment is given before any surgery takes place; a method referred to as "neoadjuvant therapy." . The aim is to see if this new approach can show early signs of effectiveness in treating participants with a specific type of colon cancer known as mismatch repair proficient/ microsatellite stable (MMRp/MSS), where the cells have normal repair systems and stable DNA sequences. This study will also look at specific signs in the blood and tumor to see if they can help predict how well the treatment is working. This could help better understand how dostarlimab contributes to the response of the disease to treatment.
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 a tumor demonstrating the presence of either-
- ✓MSS or Microsatellite Instability-L (MSI-L) phenotype as determined by polymerase chain reaction (PCR) or by tissue...
- ✓Provides fresh tumor tissue obtained during either the pre-screening or screening period via colonoscopy performed...
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, in the investigator's opinion, a tumor that is not amenable to surgery or has any other safety concern to surgery
- ✗Has any history of interstitial lung disease or immune-related pneumonitis
- ✗Is considered, in investigator's opinion, a poor medical risk due to a serious, uncontrolled medical disorder,...
See the full criteria
Where Is This Study? (4 UK sites)
GSK Investigational Site
Glasgow G12 0YN, United Kingdom
GSK Investigational Site
Leeds West Yorkshire LS9 7TF, United Kingdom
GSK Investigational Site
London NW1 2PG, 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
