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
NCT Number: NCT06567782
Acronym: AZUR-4
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Neoplasms, Colon
Interventions: BIOLOGICAL: Dostarlimab|DRUG: CAPEOX
Sponsor: GlaxoSmithKline
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 120
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-12-05
Completion Date: 2028-09-07
Locations: GSK Investigational Site, Aalst, 9300, Belgium|GSK Investigational Site, Bonheiden, 2820, Belgium|GSK Investigational Site, Bruxelles, 1070, Belgium|GSK Investigational Site, Bruxelles, 1200, Belgium|GSK Investigational Site, Gent, 9000, Belgium|GSK Investigational Site, Leuven, 3000, Belgium|GSK Investigational Site, LiEge, 4000, Belgium|GSK Investigational Site, Liege, 4000, Belgium|GSK Investigational Site, Roeselare, 8800, Belgium|GSK Investigational Site, Barcelona, 8035, Spain|GSK Investigational Site, Madrid, 28222, Spain|GSK Investigational Site, Glasgow, G12 0YN, United Kingdom|GSK Investigational Site, Leeds West Yorkshire, LS9 7TF, United Kingdom|GSK Investigational Site, London, NW1 2PG, United Kingdom|GSK Investigational Site, Sutton, SM2 5PT, United Kingdom

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.

Primary Outcome Measures: 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., 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 and by Severity, Up to approximately 105 weeks
Secondary Outcome Measures: Percentage of participants for whom primary tumour resection is not excluded, 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., 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., Up to approximately 18 weeks|Partial pathologic response rate, Partial pathological 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., Up to approximately 18 weeks|Negligible pathologic response rate, Negligible pathological response rate is defined as the proportion of participants with \>50% RVT value in the surgical resection sample as determined by local assessment., Up to approximately 18 weeks