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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
120
Dostarlimab will be administered.
CAPEOX chemotherapy consisting of capecitabine and oxaliplatin will be administered.
GSK Investigational Site
Aalst, Belgium
RECRUITINGGSK Investigational Site
Bonheiden, Belgium
RECRUITINGGSK Investigational Site
Brussels, Belgium
RECRUITINGGSK Investigational Site
Brussels, Belgium
RECRUITINGGSK Investigational Site
Ghent, Belgium
RECRUITINGGSK Investigational Site
Leuven, Belgium
RECRUITINGGSK Investigational Site
Liège, Belgium
RECRUITINGGSK Investigational Site
Liège, Belgium
RECRUITINGGSK Investigational Site
Ostend, Belgium
RECRUITINGGSK Investigational Site
Roeselare, Belgium
RECRUITING...and 11 more locations
Major pathological response (mPR) rate
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.
Time frame: Up to approximately 18 weeks
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
Time frame: Up to approximately 105 weeks
Percentage of participants for whom primary tumour resection is not excluded
Time frame: Up to approximately 18 weeks
Complete pathologic response (cPR) rate
cPR rate is defined as the proportion of participants with 0% RVT value in the surgical resection sample as determined by local assessment.
Time frame: Up to approximately 18 weeks
Major pathological response excluding cPR rate
mPR rate is defined as the proportion of participants with ≤10% RVT value in the surgical resection sample as determined by local assessment. cPR rate is defined as the proportion of participants with 0% RVT value in the surgical resection sample as determined by local assessment.
Time frame: Up to approximately 18 weeks
Partial pathologic response rate
Partial pathologic response rate is defined as the proportion of participants with \>10% and ≤50% RVT value in the surgical resection sample as determined by local assessment.
Time frame: Up to approximately 18 weeks
Negligible pathologic response rate
Negligible pathologic response rate is defined as the proportion of participants with \>50% RVT value in the surgical resection sample as determined by local assessment.
Time frame: Up to approximately 18 weeks
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