AzTrials
AzTrials

Neoplasms, ColonPhase 2AZUR-4NCT06567782

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

A Phase 2 study testing Dostarlimab and CAPEOX in people with Neoplasms, Colon, run by GlaxoSmithKline at 33 sites in 6 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Neoplasms, Colon
What is being tested?
Dostarlimab and CAPEOX
Could I receive a placebo?
No, everyone receives an active treatment
How many people
120 participants
Where
33 sitesin 6 countries
Study dates
18 Feb 2025to 26 Oct 2028
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Has untreated pathologically confirmed colon adenocarcinoma
  • Has resectable colon adenocarcinoma defined as clinically T4N0 or Stage III
  • Has a tumor demonstrating the presence of either-
  • MMR status: MMR status must be assessed by Immunohistochemistry (IHC) for MMR protein expression (MLH1, MSH2, MSH6, PMS2) where all proteins are present indicates MMRp; MMR status may be determined local laboratory; or
  • MSS or Microsatellite Instability-L (MSI-L) phenotype as determined by polymerase chain reaction (PCR) or by tissue next generation sequencing (NGS), determined by local laboratory
  • Provides fresh tumor tissue obtained during either the pre-screening or screening period via colonoscopy performed per procedure manual. Tissue biopsy is required
Show all 9Show fewer
  • Is willing to use adequate contraception male and/or female participants
  • Has an Eastern Cooperative Oncology Group - Performance status (ECOG-PS) of 0 or 1
  • Has adequate organ function

Who cannot join

  • Has distant metastatic disease
  • Has received prior medical therapy (chemotherapy, immunotherapy, biologic, or targeted therapy), radiation therapy or surgery for management of colon cancer
  • Has, in the investigator's opinion, a tumor that is not amenable to surgery or has any other contraindication to surgery
  • Has experienced any of the following with prior immunotherapy: any imAE ≥ Grade 3, immune-mediated severe neurologic events of any-grade (e.g., myasthenic syndrome/myasthenia gravis, encephalitis, Guillain Barré Syndrome, or transverse myelitis), exfoliative dermatitis of any grade [Stevens-Johnson Syndrome (SJS), Toxic Epidermal Necrolysis (TEN), or Drug rash with eosinophilia and systemic symptoms (DRESS) syndrome], or myocarditis of any grade. Non-clinically significant laboratory abnormalities are not exclusionary
  • Has any history of interstitial lung disease or immune-related pneumonitis
  • Has a history or current evidence of any medical condition, therapy, or laboratory abnormality that might confound the study results, interfere with their participation for the full duration of the study intervention, or indicate it is not in the best interest of the participant to participate, in the opinion of the investigator
Show all 10Show fewer
  • Is considered, in investigator's opinion, a poor medical risk due to a serious, uncontrolled medical disorder, non-malignant systemic disease, or active infection requiring systemic therapy
  • Has received treatment with an investigational agent within [4 weeks] of the first dose of study intervention
  • Is pregnant or breastfeeding
  • Has a history of severe allergic and/or anaphylactic reactions to chimeric, human, or humanized antibodies, fusion proteins, or known allergies to dostarlimab, or its excipients, or any components of CAPEOX

Trial locations and contacts

33 sites in 6 countries. Contact the study team or a site near you to ask about taking part.

US GSK Clinical Trials Call Center contact

877-379-3718

GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Center contact

+44 (0) 20 89904466

GSKClinicalSupportHD@gsk.com

33 sites in 6 countries

Belgium11 sites, 11 recruiting
  • GSK Investigational Site

    Aalst, 9300

    US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com

    EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com

    Recruiting
  • GSK Investigational Site

    Bonheiden, 2820

    US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com

    EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com

    Recruiting
  • GSK Investigational Site

    Brussels, 1070

    US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com

    EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com

    Recruiting
  • GSK Investigational Site

    Brussels, 1200

    US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com

    EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com

    Recruiting
  • GSK Investigational Site

    Ghent, 9000

    US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com

    EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com

    Recruiting
  • GSK Investigational Site

    Leuven, 3000

    US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com

    EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com

    Recruiting
  • GSK Investigational Site

    Liège, 4000

    US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com

    EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com

    Recruiting
  • GSK Investigational Site

    Liège, 4000

    US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com

    EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com

    Recruiting
  • GSK Investigational Site

    Ostend, 8400

    US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com

    EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com

    Recruiting
  • GSK Investigational Site

    Roeselare, 8800

    US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com

    EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com

    Recruiting
  • GSK Investigational Site

    Turnhout, 2300

    US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com

    EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com

    Recruiting

Other trials in Belgium

Spain9 sites, 9 recruiting
  • GSK Investigational Site

    Barcelona, 8025

    US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com

    EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com

    Recruiting
  • GSK Investigational Site

    Barcelona, 8035

    US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com

    EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com

    Recruiting
  • GSK Investigational Site

    Barcelona, 8036

    US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com

    EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com

    Recruiting
  • GSK Investigational Site

    Madrid, 28007

    US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com

    EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com

    Recruiting
  • GSK Investigational Site

    Madrid, 28034

    US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com

    EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com

    Recruiting
  • GSK Investigational Site

    Madrid, 28041

    US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com

    EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com

    Recruiting
  • GSK Investigational Site

    Madrid, 28222

    US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com

    EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com

    Recruiting
  • GSK Investigational Site

    Oviedo, 33011

    US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com

    EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com

    Recruiting
  • GSK Investigational Site

    Valencia, 46010

    US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com

    EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com

    Recruiting

Other trials in Spain

Japan4 sites, 3 recruiting
  • GSK Investigational Site

    Osaka, 565-0871

    US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com

    EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com

    Recruiting
  • GSK Investigational Site

    Osaka, 5731191

    US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com

    EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com

    Recruiting
  • GSK Investigational Site

    Tokyo, 104-0045

    Withdrawn
  • GSK Investigational Site

    Tokyo, 135-8550

    US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com

    EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com

    Recruiting

Other trials in Japan

United Kingdom4 sites, 4 recruiting
  • GSK Investigational Site

    Glasgow, G12 0YN

    US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com

    EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com

    Recruiting
  • GSK Investigational Site

    Leeds West Yorkshire, LS9 7TF

    US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com

    EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com

    Recruiting
  • GSK Investigational Site

    London, NW1 2PG

    US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com

    EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com

    Recruiting
  • GSK Investigational Site

    Sutton, SM2 5PT

    US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com

    EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com

    Recruiting

Other trials in United Kingdom

Italy3 sites, 3 recruiting
  • GSK Investigational Site

    Milan, 20162

    US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com

    EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com

    Recruiting
  • GSK Investigational Site

    Roma, 00168

    US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com

    EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com

    Recruiting
  • GSK Investigational Site

    Udine, 33100

    US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com

    EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com

    Recruiting

Other trials in Italy

Switzerland2 sites, 2 recruiting
  • GSK Investigational Site

    Bern, 3010

    US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com

    EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com

    Recruiting
  • GSK Investigational Site

    Geneva, 1205

    US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com

    EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com

    Recruiting

Other trials in Switzerland

About this study

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

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.

Being tested
Dostarlimab, CAPEOX
Keywords
Colon cancer, MMRp, MSS, Dostarlimab, CAPEOX, Neoadjuvant, GSK4057190A, TSR-042, Chemotherapy, Immunotherapy
Medical subject headings
Colonic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DostarlimabBiological

    Also called GSK4057190A, TSR-042

    Dostarlimab will be administered.

  • CAPEOXDrug

    CAPEOX chemotherapy consisting of capecitabine and oxaliplatin will be administered.

Study groups in NCT06567782
Study groupRoleWhat they receive
Dostarlimab plus CAPEOXExperimentalParticipants will receive dostarlimab plus CAPEOX (chemotherapy).
Receives: Biological: Dostarlimab; Drug: CAPEOX
CAPEOXActive comparatorParticipants will receive CAPEOX (chemotherapy).
Receives: Drug: CAPEOX

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Up to approximately 18 weeks

  2. 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

    Measured: Up to approximately 105 weeks

Secondary outcomes (5)
  1. Percentage of participants for whom primary tumour resection is not excluded

    Measured: Up to approximately 18 weeks

  2. 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.

    Measured: Up to approximately 18 weeks

  3. 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.

    Measured: Up to approximately 18 weeks

  4. 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.

    Measured: Up to approximately 18 weeks

  5. 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.

    Measured: Up to approximately 18 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Aug 2024
  2. Study start18 Feb 2025
  3. Primary completion23 Nov 2026 (estimated)
  4. Study completion26 Oct 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
120 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06567782
Sponsor's protocol ID
222892
Other IDs
2024-513441-36
Acronym
AZUR-4
Status last verified
May 2026
First submitted
20 Aug 2024
Last updated
22 May 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: Qualified researchers may request access to anonymized individual patient-level data (IPD) and related study documents of the eligible studies via the Data Sharing Portal. Details on GSK's data sharing criteria can be found at: https://www.gsk.com/en-gb/innovation/trials/data-transparency/

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Dostarlimab and CAPEOX in people with Neoplasms, Colon, run by GlaxoSmithKline at 33 sites in 6 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 22 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 33 sites in Belgium, Spain, Japan, United Kingdom, Italy and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact US GSK Clinical Trials Call Center (877-379-3718, GSKClinicalSupportHD@gsk.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Major pathological response (mPR) rate (time frame: Up to approximately 18 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2026.

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