NCT06567782

Brief 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.

Trial Health

83
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for phase_2

Timeline
30mo left

Started Feb 2025

Typical duration for phase_2

Geographic Reach
6 countries

33 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress33%
Feb 2025Oct 2028

First Submitted

Initial submission to the registry

August 20, 2024

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 23, 2024

Completed
6 months until next milestone

Study Start

First participant enrolled

February 17, 2025

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 23, 2026

Expected
1.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 26, 2028

Last Updated

April 2, 2026

Status Verified

March 1, 2026

Enrollment Period

1.8 years

First QC Date

August 20, 2024

Last Update Submit

April 1, 2026

Conditions

Neoplasms, Colon

Keywords

Colon cancerMMRpMSSDostarlimabCAPEOXNeoadjuvantGSK4057190ATSR-042ChemotherapyImmunotherapy

Outcome Measures

Primary Outcomes (2)

  • 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

    Up to approximately 105 weeks

Secondary Outcomes (5)

  • Percentage of participants for whom primary tumour resection is not excluded

    Up to approximately 18 weeks

  • Complete pathologic response (cPR) rate

    Up to approximately 18 weeks

  • Major pathological response excluding cPR rate

    Up to approximately 18 weeks

  • Partial pathologic response rate

    Up to approximately 18 weeks

  • Negligible pathologic response rate

    Up to approximately 18 weeks

Study Arms (2)

Dostarlimab plus CAPEOX

EXPERIMENTAL

Participants will receive dostarlimab plus CAPEOX (chemotherapy).

Biological: DostarlimabDrug: CAPEOX

CAPEOX

ACTIVE COMPARATOR

Participants will receive CAPEOX (chemotherapy).

Drug: CAPEOX

Interventions

DostarlimabBIOLOGICAL

Dostarlimab will be administered.

Also known as: GSK4057190A, TSR-042
Dostarlimab plus CAPEOX
CAPEOXDRUG

CAPEOX chemotherapy consisting of capecitabine and oxaliplatin will be administered.

CAPEOXDostarlimab plus CAPEOX

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • 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

You may not qualify if:

  • 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 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (33)

GSK Investigational Site

Aalst, 9300, Belgium

RECRUITING

GSK Investigational Site

Bonheiden, 2820, Belgium

RECRUITING

GSK Investigational Site

Brussels, 1070, Belgium

RECRUITING

GSK Investigational Site

Brussels, 1200, Belgium

RECRUITING

GSK Investigational Site

Ghent, 9000, Belgium

RECRUITING

GSK Investigational Site

Leuven, 3000, Belgium

RECRUITING

GSK Investigational Site

Liège, 4000, Belgium

RECRUITING

GSK Investigational Site

Liège, 4000, Belgium

RECRUITING

GSK Investigational Site

Ostend, 8400, Belgium

RECRUITING

GSK Investigational Site

Roeselare, 8800, Belgium

RECRUITING

GSK Investigational Site

Turnhout, 2300, Belgium

RECRUITING

GSK Investigational Site

Milan, 20162, Italy

RECRUITING

GSK Investigational Site

Roma, 00168, Italy

RECRUITING

GSK Investigational Site

Udine, 33100, Italy

RECRUITING

GSK Investigational Site

Osaka, 565-0871, Japan

RECRUITING

GSK Investigational Site

Osaka, 5731191, Japan

RECRUITING

GSK Investigational Site

Tokyo, 104-0045, Japan

RECRUITING

GSK Investigational Site

Tokyo, 135-8550, Japan

RECRUITING

GSK Investigational Site

Barcelona, 8025, Spain

RECRUITING

GSK Investigational Site

Barcelona, 8035, Spain

RECRUITING

GSK Investigational Site

Barcelona, 8036, Spain

RECRUITING

GSK Investigational Site

Madrid, 28007, Spain

RECRUITING

GSK Investigational Site

Madrid, 28034, Spain

RECRUITING

GSK Investigational Site

Madrid, 28041, Spain

RECRUITING

GSK Investigational Site

Madrid, 28222, Spain

RECRUITING

GSK Investigational Site

Oviedo, 33011, Spain

RECRUITING

GSK Investigational Site

Valencia, 46010, Spain

RECRUITING

GSK Investigational Site

Bern, 3010, Switzerland

RECRUITING

GSK Investigational Site

Geneva, 1205, Switzerland

RECRUITING

GSK Investigational Site

Glasgow, G12 0YN, United Kingdom

RECRUITING

GSK Investigational Site

Leeds West Yorkshire, LS9 7TF, United Kingdom

RECRUITING

GSK Investigational Site

London, NW1 2PG, United Kingdom

RECRUITING

GSK Investigational Site

Sutton, SM2 5PT, United Kingdom

RECRUITING

MeSH Terms

Conditions

Colonic Neoplasms

Interventions

dostarlimab

Condition Hierarchy (Ancestors)

Colorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal Diseases

Central Study Contacts

US GSK Clinical Trials Call Center

CONTACT

877-379-3718GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Center

CONTACT

+44 (0) 20 89904466GSKClinicalSupportHD@gsk.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 20, 2024

First Posted

August 23, 2024

Study Start

February 17, 2025

Primary Completion (Estimated)

November 23, 2026

Study Completion (Estimated)

October 26, 2028

Last Updated

April 2, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will share

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/

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR
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.
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.
More information

Locations

IT(3)CH(2)ES(9)BE(11)JP(4)GB(4)