Last updated: 12/13/2025 12:10:59

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 cancerAZUR-4

GSK study ID
222892
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Trial status
Recruiting
Recruiting
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

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
Trial description: 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 purpose:
Treatment
Trial design:
Parallel
Masking:
None (Open Label)
Allocation:
Randomized
Primary outcomes:

Major pathological response (mPR) rate

Timeframe: 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

Timeframe: Up to approximately 105 weeks

Secondary outcomes:

Percentage of participants for whom primary tumour resection is not excluded

Timeframe: Up to approximately 18 weeks

Complete pathologic response (cPR) rate

Timeframe: Up to approximately 18 weeks

Major pathological response excluding cPR rate

Timeframe: Up to approximately 18 weeks

Partial pathologic response rate

Timeframe: Up to approximately 18 weeks

Negligible pathologic response rate

Timeframe: Up to approximately 18 weeks

Interventions:
  • Biological/vaccine: Dostarlimab
  • Drug: CAPEOX
  • Enrollment:
    120
    Primary completion date:
    2026-13-11
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Not applicable
    Medical condition
    Neoplasms, Colon
    Product
    Dostarlimab
    Collaborators
    Not applicable
    Study date(s)
    February 2025 to October 2028
    Type
    Interventional
    Phase
    2

    Participation criteria

    Sex
    Female & Male
    Age
    18+ years
    Accepts healthy volunteers
    No
    • Has untreated pathologically confirmed colon adenocarcinoma
    • Has resectable colon adenocarcinoma defined as clinically T4N0 or Stage III
    • Has distant metastatic disease
    • Has received prior medical therapy (chemotherapy, immunotherapy, biologic, or targeted therapy), radiation therapy or surgery for management of colon cancer

    Trial location(s)

    Location
    Status
    Contact us
    Contact us
    Location
    GSK Investigational Site
    Leuven, Belgium, 3000
    Status
    Recruiting
    Location
    GSK Investigational Site
    Aalst, Belgium, 9300
    Status
    Recruiting
    Location
    GSK Investigational Site
    Barcelona, Spain, 8035
    Status
    Recruiting
    Location
    GSK Investigational Site
    Bonheiden, Belgium, 2820
    Status
    Recruiting
    Location
    GSK Investigational Site
    Madrid, Spain, 28222
    Status
    Recruiting
    Location
    GSK Investigational Site
    Bruxelles, Belgium, 1070
    Status
    Recruiting
    Showing 1 - 6 of 20 Results

    Study documents

    No study documents available.

    Results overview

    Study Results yet to be posted

    Recruitment status
    Recruiting
    Actual primary completion date
    Not applicable
    Actual study completion date
    Not applicable

    Plain language summaries

    Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.

    Additional information about the trial

    Additional information
    Not applicable
    Participate in clinical trial
    Access to clinical trial data by researchers
    Visit website