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Clinical Trials in the UK / NCT06567782
Recruiting Phase 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

NCT06567782 · tracked via the Priya Life Science UK tracker
Sponsor
GlaxoSmithKline
Phase
Phase 2
Started
2025-02-18
Last updated
2026-05-22

Condition(s) studied

Neoplasms, Colon

Investigational drug(s) / intervention(s)

DostarlimabCAPEOX

Dostarlimab: Dostarlimab will be administered.

CAPEOX: CAPEOX chemotherapy consisting of capecitabine and oxaliplatin will be administered.

Study summary

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
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

Primary outcome measure(s)

Trial sites (33)

FacilityCityRegionStatus
GSK Investigational Site Aalst Belgium Recruiting
GSK Investigational Site Bonheiden Belgium Recruiting
GSK Investigational Site Brussels Belgium Recruiting
GSK Investigational Site Brussels Belgium Recruiting
GSK Investigational Site Ghent Belgium Recruiting
GSK Investigational Site Leuven Belgium Recruiting
GSK Investigational Site Liège Belgium Recruiting
GSK Investigational Site Liège Belgium Recruiting
GSK Investigational Site Ostend Belgium Recruiting
GSK Investigational Site Roeselare Belgium Recruiting
GSK Investigational Site Turnhout Belgium Recruiting
GSK Investigational Site Milan Italy Recruiting
GSK Investigational Site Roma Italy Recruiting
GSK Investigational Site Udine Italy Recruiting
GSK Investigational Site Osaka Japan Recruiting
GSK Investigational Site Osaka Japan Recruiting
GSK Investigational Site Tokyo Japan Withdrawn
GSK Investigational Site Tokyo Japan Recruiting
GSK Investigational Site Barcelona Spain Recruiting
GSK Investigational Site Barcelona Spain Recruiting
GSK Investigational Site Barcelona Spain Recruiting
GSK Investigational Site Madrid Spain Recruiting
GSK Investigational Site Madrid Spain Recruiting
GSK Investigational Site Madrid Spain Recruiting
GSK Investigational Site Madrid Spain Recruiting
GSK Investigational Site Oviedo Spain Recruiting
GSK Investigational Site Valencia Spain Recruiting
GSK Investigational Site Bern Switzerland Recruiting
GSK Investigational Site Geneva Switzerland Recruiting
GSK Investigational Site Glasgow United Kingdom Recruiting
GSK Investigational Site Leeds West Yorkshire United Kingdom Recruiting
GSK Investigational Site London United Kingdom Recruiting
GSK Investigational Site Sutton United Kingdom Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06567782 on ClinicalTrials.gov ↗ ← All trials in the UK