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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
Sponsor: GlaxoSmithKline
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.
Official title: 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
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
120
Start Date
2025-02-17
Completion Date
2028-10-26
Last Updated
2026-04-02
Healthy Volunteers
No
Conditions
Interventions
Dostarlimab
Dostarlimab will be administered.
CAPEOX
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