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 (AZUR-4)

May 21, 2026 updated by: GlaxoSmithKline

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

120

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Belgium
      • Aalst, Belgium, 9300
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Koenraad A.M. Hendrickx
      • Bonheiden, Belgium, 2820
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Pieter-Jan Cuyle
      • Brussels, Belgium, 1200
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Marc Van den Eynde
        • Contact:
        • Contact:
      • Brussels, Belgium, 1070
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Francesco Sclafani
        • Contact:
        • Contact:
      • Ghent, Belgium, 9000
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Vincent Bouderez
      • Leuven, Belgium, 3000
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Sabine Tejpar
        • Contact:
        • Contact:
      • Liège, Belgium, 4000
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Catherine Loly
      • Ostend, Belgium, 8400
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Antoon Billiet
      • Roeselare, Belgium, 8800
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Sofie De Meulder
      • Turnhout, Belgium, 2300
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Leen Mortier
  • Italy
      • Milan, Italy, 20162
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Salvatore Siena
      • Roma, Italy, 00168
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Lisa Salvatore
      • Udine, Italy, 33100
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Giuseppe Aprile
        • Contact:
        • Contact:
  • Japan
      • Osaka, Japan, 565-0871
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Mamoru Uemura
      • Osaka, Japan, 5731191
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Jun Watanabe
      • Tokyo, Japan, 135-8550
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Takashi Akiyoshi
      • Tokyo, Japan, 104-0045
        • Withdrawn
        • GSK Investigational Site
  • Spain
      • Barcelona, Spain, 8025
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • David Paez Lopez-Bravo
      • Barcelona, Spain, 8035
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Elena Elez
      • Barcelona, Spain, 8036
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Joan Maurel Santasusana
      • Madrid, Spain, 28034
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Íñigo Martínez Delfrade
      • Madrid, Spain, 28041
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Maria Del Carmen Riesco Martinez
      • Madrid, Spain, 28007
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Pilar Garcia Alfonso
      • Madrid, Spain, 28222
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Ana Ruiz Casado
      • Oviedo, Spain, 33011
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Paula Jimenez Fonseca
        • Contact:
        • Contact:
      • Valencia, Spain, 46010
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Noelia Tarazona Llavero
  • Switzerland
      • Bern, Switzerland, 3010
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Martin Berger
      • Geneva, Switzerland, 1205
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Thibaud Koessler
  • United Kingdom
      • Glasgow, United Kingdom, G12 0YN
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Janet Graham
        • Contact:
        • Contact:
      • Leeds West Yorkshire, United Kingdom, LS9 7TF
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Jenny Seligmann
      • London, United Kingdom, NW1 2PG
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Kai-Keen Shiu
      • Sutton, United Kingdom, SM2 5PT
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Naureen Starling

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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-

    1. 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
    2. 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
  • 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

Exclusion Criteria:

  • 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
  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Dostarlimab plus CAPEOX
Participants will receive dostarlimab plus CAPEOX (chemotherapy).
Biological: Dostarlimab
Dostarlimab will be administered.
Other Names:
  • TSR-042
  • GSK4057190A
Drug: CAPEOX
CAPEOX chemotherapy consisting of capecitabine and oxaliplatin will be administered.
Active Comparator: CAPEOX
Participants will receive CAPEOX (chemotherapy).
Drug: CAPEOX
CAPEOX chemotherapy consisting of capecitabine and oxaliplatin will be administered.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Major pathological response (mPR) rate
Time Frame: Up to approximately 18 weeks
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
Time Frame: Up to approximately 105 weeks
Up to approximately 105 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of participants for whom primary tumour resection is not excluded
Time Frame: Up to approximately 18 weeks
Up to approximately 18 weeks
Complete pathologic response (cPR) rate
Time Frame: Up to approximately 18 weeks
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
Time Frame: Up to approximately 18 weeks
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
Time Frame: Up to approximately 18 weeks
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.
Up to approximately 18 weeks
Negligible pathologic response rate
Time Frame: Up to approximately 18 weeks
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.
Up to approximately 18 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

GlaxoSmithKline

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 18, 2025

Primary Completion (Estimated)

November 23, 2026

Study Completion (Estimated)

October 26, 2028

Study Registration Dates

First Submitted

August 20, 2024

First Submitted That Met QC Criteria

August 20, 2024

First Posted (Actual)

August 23, 2024

Study Record Updates

Last Update Posted (Actual)

May 22, 2026

Last Update Submitted That Met QC Criteria

May 21, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 222892
  • 2024-513441-36 (Registry Identifier: CTIS)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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/

IPD Sharing Time Frame

Anonymized IPD will be made available within 6 months of publication of primary, key secondary and safety results for studies in product with approved indication(s) or terminated asset(s) across all indications.

IPD Sharing Access Criteria

Anonymized IPD is shared with researchers whose proposals are approved by an Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension may be granted, when justified, for up to 6 months.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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