Last updated: 05/21/2026 09:50:15

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
Observational study model:
Not applicable
Primary completion date:
2026-23-11
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
Location
GSK Investigational Site
Bruxelles, Belgium, 1200
Status
Recruiting
Location
GSK Investigational Site
Gent, Belgium, 9000
Status
Recruiting
Location
GSK Investigational Site
Liege, Belgium, 4000
Status
Recruiting
Location
GSK Investigational Site
Madrid, Spain, 28034
Status
Recruiting
Location
GSK Investigational Site
Oostende, Belgium, 8400
Status
Recruiting
Location
GSK Investigational Site
Roeselare, Belgium, 8800
Status
Recruiting
Location
GSK Investigational Site
Glasgow, Unmapped, G12 0YN
Status
Recruiting
Location
GSK Investigational Site
Leeds West Yorkshire, Unmapped, LS9 7TF
Status
Recruiting
Location
GSK Investigational Site
London, Unmapped, NW1 2PG
Status
Recruiting
Location
GSK Investigational Site
Madrid, Spain, 28041
Status
Recruiting
Location
GSK Investigational Site
Madrid, Spain, 28007
Status
Recruiting
Location
GSK Investigational Site
Valencia, Spain, 46010
Status
Recruiting
Location
GSK Investigational Site
Udine, Italy, 33100
Status
Recruiting
Location
GSK Investigational Site
Sutton, Unmapped, SM2 5PT
Status
Recruiting
Location
GSK Investigational Site
Osaka, Japan, 5731191
Status
Recruiting
Location
GSK Investigational Site
Turnhout, Belgium, 2300
Status
Recruiting
Location
GSK Investigational Site
Barcelona, Spain, 8025
Status
Recruiting
Location
GSK Investigational Site
Roma, Italy, 00168
Status
Recruiting
Location
GSK Investigational Site
Milano, Italy, 20162
Status
Recruiting
Location
GSK Investigational Site
Tokyo, Japan, 135-8550
Status
Recruiting
Location
GSK Investigational Site
Osaka, Japan, 565-0871
Status
Recruiting
Location
GSK Investigational Site
OVIEDO, Spain, 33011
Status
Recruiting
Location
GSK Investigational Site
Barcelona, Spain, 8036
Status
Recruiting
Location
GSK Investigational Site
Geneve, Switzerland, 1205
Status
Recruiting
Location
GSK Investigational Site
Bern, Switzerland, 3010
Status
Recruiting
Location
GSK Investigational Site
Tokyo, Japan, 104-0045
Status
Terminated/Withdrawn

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
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