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RECRUITING
NCT06567782
PHASE2

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

View on ClinicalTrials.gov

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

Interventions

BIOLOGICAL

Dostarlimab

Dostarlimab will be administered.

DRUG

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