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New drug combo shows promise in early colon cancer trial

NCT ID NCT06567782

Disease control Sponsor: GlaxoSmithKline Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether adding the immunotherapy drug dostarlimab to standard chemotherapy (CAPEOX) before surgery works better than chemotherapy alone for a common type of colon cancer (MMRp/MSS). About 120 people with stage III or T4N0 colon cancer that has not been treated yet will take part. The goal is to see if the combination shrinks tumors more and helps doctors understand which patients benefit most.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 120 people

The number the study aims to enrol. It can still change while the study runs.

Started

Feb 2025

Expected to finish

Oct 2028

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

colon adenocarcinoma colonic neoplasm

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Neoplasms, colon

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    32 sites in 6 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • GSK Investigational Site

    RECRUITING

    Aalst, 9300, Belgium

  • GSK Investigational Site

    RECRUITING

    Bonheiden, 2820, Belgium

  • GSK Investigational Site

    RECRUITING

    Brussels, 1070, Belgium

  • GSK Investigational Site

    RECRUITING

    Brussels, 1200, Belgium

  • GSK Investigational Site

    RECRUITING

    Ghent, 9000, Belgium

  • GSK Investigational Site

    RECRUITING

    Leuven, 3000, Belgium

  • GSK Investigational Site

    RECRUITING

    Liège, 4000, Belgium

  • GSK Investigational Site

    RECRUITING

    Liège, 4000, Belgium

  • GSK Investigational Site

    RECRUITING

    Ostend, 8400, Belgium

  • GSK Investigational Site

    RECRUITING

    Roeselare, 8800, Belgium

  • GSK Investigational Site

    RECRUITING

    Turnhout, 2300, Belgium

  • GSK Investigational Site

    RECRUITING

    Milan, 20162, Italy

  • GSK Investigational Site

    RECRUITING

    Roma, 00168, Italy

  • GSK Investigational Site

    RECRUITING

    Udine, 33100, Italy

  • GSK Investigational Site

    RECRUITING

    Osaka, 565-0871, Japan

  • GSK Investigational Site

    RECRUITING

    Osaka, 5731191, Japan

  • GSK Investigational Site

    WITHDRAWN

    Tokyo, 104-0045, Japan

  • GSK Investigational Site

    RECRUITING

    Tokyo, 135-8550, Japan

  • GSK Investigational Site

    RECRUITING

    Barcelona, 8025, Spain

  • GSK Investigational Site

    RECRUITING

    Barcelona, 8035, Spain

  • GSK Investigational Site

    RECRUITING

    Barcelona, 8036, Spain

  • GSK Investigational Site

    RECRUITING

    Madrid, 28007, Spain

  • GSK Investigational Site

    RECRUITING

    Madrid, 28034, Spain

  • GSK Investigational Site

    RECRUITING

    Madrid, 28041, Spain

  • GSK Investigational Site

    RECRUITING

    Madrid, 28222, Spain

  • GSK Investigational Site

    RECRUITING

    Oviedo, 33011, Spain

  • GSK Investigational Site

    RECRUITING

    Valencia, 46010, Spain

  • GSK Investigational Site

    RECRUITING

    Bern, 3010, Switzerland

  • GSK Investigational Site

    RECRUITING

    Geneva, 1205, Switzerland

  • GSK Investigational Site

    RECRUITING

    Glasgow, G12 0YN, United Kingdom

  • GSK Investigational Site

    RECRUITING

    Leeds West Yorkshire, LS9 7TF, United Kingdom

  • GSK Investigational Site

    RECRUITING

    London, NW1 2PG, United Kingdom

  • GSK Investigational Site

    RECRUITING

    Sutton, SM2 5PT, United Kingdom

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