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NCT06567782RecruitingPhase 2

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

A Phase 2, Open Label, Randomized Study of Neoadjuvant Dostarlimab Plus CAPEOX Versus CAPEOX in Participants With Previously Untreated T4N0 or Stage III MMRp/ MSS Colon Cancer

Source: ClinicalTrials.gov · Last updated 22 May 2026

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Phase (registry)
Phase 2
Study type
Interventional
Enrollment
120 (estimated)
First submitted
20 Aug 2024
Start date
18 Feb 2025
Primary completion date
23 Nov 2026
Lead sponsor
GlaxoSmithKline
NCT number
NCT06567782
EudraCT number
2024-513441-36

What you commit to

  • Study type: Interventional · Phase 2
  • Planned participants: 120
  • From 18 Feb 2025 to the primary completion date, 23 Nov 2026
  • 24 sites in 6 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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 received treatment with an investigational agent within \[4 weeks\] of the first dose of study intervention

Other illness

  • Has distant metastatic disease
  • 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, non-malignant systemic disease, or active infection requiring systemic therapy
  • 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

Lab values

  • 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 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

Other

  • Is pregnant or breastfeeding

Who 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-
    • 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
    • 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

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (24)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
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AalstBelgiumRecruiting
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BonheidenBelgiumRecruiting
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BrusselsBelgiumRecruiting
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GhentBelgiumRecruiting
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LeuvenBelgiumRecruiting
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LiègeBelgiumRecruiting
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OstendBelgiumRecruiting
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RoeselareBelgiumRecruiting
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TurnhoutBelgiumRecruiting
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BernSwitzerlandRecruiting
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GenevaSwitzerlandRecruiting
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BarcelonaSpainRecruiting
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MadridSpainRecruiting
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OviedoSpainRecruiting
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ValenciaSpainRecruiting
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GlasgowUnited KingdomRecruiting
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Leeds West YorkshireUnited KingdomRecruiting
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LondonUnited KingdomRecruiting
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SuttonUnited KingdomRecruiting
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MilanItalyRecruiting
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RomaItalyRecruiting
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UdineItalyRecruiting
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OsakaJapanRecruiting
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TokyoJapanWithdrawn

This page is information, not medical advice. Discuss any trial with your doctor.