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Looking for participantsPhase2

A Study of Neoadjuvant Dostarlimab Plus Capecitabine Plus Oxaliplatin (CAPEOX) Vs CAPEOX With Previously Untreated T4N0 or Stage III Mismatch Repair Proficient (MMRp)/Microsatellite Stable (MSS) Colon Cancer

Sponsor: GlaxoSmithKline

NCT ID: NCT06567782

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)
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.

Neoplasms, Colon

How this trial compares with your answers

Answer 2 more questions to improve match

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

MMRMSI

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
Inclusion Criteria: * 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- 1. MMR status: MMR status must be assessed by Immunohistochemistry (IHC) for MMR protein expression (MLH1, MSH2, MSH6, PMS2) where all proteins are present indicates MMRp; MMR status may be determined local laboratory; or 2. MSS or Microsatellite Instability-L (MSI-L) phenotype as determined by polymerase chain reaction (PCR) or by tissue next generation sequencing (NGS), determined by local laboratory * Provides fresh tumor tissue obtained during either the pre-screening or screening period via colonoscopy performed per procedure manual. Tissue biopsy is required * Is willing to use adequate contraception male and/or female participants * Has an Eastern Cooperative Oncology Group - Performance status (ECOG-PS) of 0 or 1 * Has adequate organ function Exclusion Criteria: * Has distant metastatic disease * Has received prior medical therapy (chemotherapy, immunotherapy, biologic, or targeted therapy), radiation therapy or surgery for management of colon cancer * Has, in the investigator's opinion, a tumor that is not amenable to surgery or has any other contraindication to surgery * Has experienced any of the following with prior immunotherapy: any imAE ≥ Grade 3, immune-mediated severe neurologic events of any-grade (e.g., myasthenic syndrome/myasthenia gravis, encephalitis, Guillain Barré Syndrome, or transverse myelitis), exfoliative dermatitis of any grade \[Stevens-Johnson Syndrome (SJS), Toxic Epidermal Necrolysis (TEN), or Drug rash with eosinophilia and systemic symptoms (DRESS) syndrome\], or myocarditis of any grade. Non-clinically significant laboratory abnormalities are not exclusionary * Has any history of interstitial lung disease or immune-related pneumonitis * Has a history or current evidence of any medical condition, therapy, or laboratory abnormality that might confound the study results, interfere with their participation for the full duration of the study intervention, or indicate it is not in the best interest of the participant to participate, in the opinion of the investigator * Is considered, in investigator's opinion, a poor medical risk due to a serious, uncontrolled medical disorder, non-malignant systemic disease, or active infection requiring systemic therapy * Has received treatment with an investigational agent within \[4 weeks\] of the first dose of study intervention * Is pregnant or breastfeeding * 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 CAPEOX

Where Is This Study? (4 UK sites)

GSK Investigational Site

Glasgow G12 0YN, United Kingdom

Recruiting
Site contact (verified)
Janet GrahamPrincipal 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 NW1 2PG, United Kingdom

Recruiting
Site contact (verified)
Kai-Keen ShiuPrincipal 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: 2026-05