RecruitingPhase 2NCT06567782

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


Sponsor

GlaxoSmithKline

Enrollment

120 participants

Start Date

Feb 17, 2025

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether adding an immunotherapy drug called dostarlimab to standard chemotherapy (CAPEOX) before surgery improves outcomes for people with locally advanced colon cancer. It focuses on a specific type of colon cancer called MMR-proficient (normal DNA repair), which typically does not respond as well to immunotherapy alone. **You may be eligible if:** - You have been diagnosed with colon cancer that has not been treated yet - Your cancer is in an advanced local stage (T4N0 or Stage III) but can still be surgically removed - Your tumor has been confirmed as MMR-proficient (all repair proteins present) or microsatellite stable (MSS) - You are in good general health (ECOG performance status 0 or 1) - Your organ function is adequate - You are willing to use contraception during the study **You may NOT be eligible if:** - Your colon cancer has already spread to distant organs (metastatic) - Your tumor is in the rectum rather than the colon - You have had prior treatment for this cancer - You have significant health conditions that prevent surgery or chemotherapy Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALDostarlimab

Dostarlimab will be administered.

DRUGCAPEOX

CAPEOX chemotherapy consisting of capecitabine and oxaliplatin will be administered.


Locations(33)

GSK Investigational Site

Aalst, Belgium

GSK Investigational Site

Bonheiden, Belgium

GSK Investigational Site

Brussels, Belgium

GSK Investigational Site

Brussels, Belgium

GSK Investigational Site

Ghent, Belgium

GSK Investigational Site

Leuven, Belgium

GSK Investigational Site

Liège, Belgium

GSK Investigational Site

Liège, Belgium

GSK Investigational Site

Ostend, Belgium

GSK Investigational Site

Roeselare, Belgium

GSK Investigational Site

Turnhout, Belgium

GSK Investigational Site

Milan, Italy

GSK Investigational Site

Roma, Italy

GSK Investigational Site

Udine, Italy

GSK Investigational Site

Osaka, Japan

GSK Investigational Site

Osaka, Japan

GSK Investigational Site

Tokyo, Japan

GSK Investigational Site

Tokyo, Japan

GSK Investigational Site

Barcelona, Spain

GSK Investigational Site

Barcelona, Spain

GSK Investigational Site

Barcelona, Spain

GSK Investigational Site

Madrid, Spain

GSK Investigational Site

Madrid, Spain

GSK Investigational Site

Madrid, Spain

GSK Investigational Site

Madrid, Spain

GSK Investigational Site

Oviedo, Spain

GSK Investigational Site

Valencia, Spain

GSK Investigational Site

Bern, Switzerland

GSK Investigational Site

Geneva, Switzerland

GSK Investigational Site

Glasgow, United Kingdom

GSK Investigational Site

Leeds West Yorkshire, United Kingdom

GSK Investigational Site

London, United Kingdom

GSK Investigational Site

Sutton, United Kingdom

View Full Details on ClinicalTrials.gov

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NCT06567782


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