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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
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.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
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
Start Date
February 17, 2025
Primary Completion Date
November 23, 2026
Completion Date
October 26, 2028
Last Updated
March 12, 2026
120
ESTIMATED participants
Dostarlimab
BIOLOGICAL
CAPEOX
DRUG
Lead Sponsor
GlaxoSmithKline
Data Source & Attribution
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Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
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