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
Condition(s) studied
Investigational drug(s) / intervention(s)
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
Primary outcome measure(s)
- Major pathological response (mPR) rate — Up to approximately 18 weeks
mPR rate is defined as the proportion of participants with ≤10% residual viable tumor (RVT) value in the surgical resection sample as determined by local assessment. - Number of participants with adverse events (AEs), serious adverse events (SAEs), immune-mediated adverse events (imAEs), and AEs leading to death or discontinuation of study intervention — Up to approximately 105 weeks
Trial sites (33)
| Facility | City | Region | Status |
|---|---|---|---|
| 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 |
More GlaxoSmithKline trials in Italy
Other trials for the same condition
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 Italy