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
NCT ID: NCT06567782
Last Updated: 2025-12-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
PHASE2
120 participants
INTERVENTIONAL
2025-02-17
2028-10-24
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Study of Perioperative Dostarlimab in Participants With Untreated T4N0 or Stage III dMMR/MSI-H Resectable Colon Cancer
NCT05855200
Cetuximab, Capecitabine, Oxaliplatin and Bevacizumab in Advanced Colorectal Cancer
NCT00208546
Prospective Study on the Efficacy and Safety of 2 Week or 3 Week Xelox Regimen for Adjuvant Chemotherapy in CRC
NCT03564912
Serplulimab Combined with CAPEOX + Celecoxib As Neoadjuvant Treatment for Locally Advanced Rectal Cancer
NCT05731726
Phase II Study of Neoadjuvant Dostarlimab in Patients With Untreated T3-4N0-2 or Stage III pMMR/MSS Resectable Colon Cancer
NCT06830239
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Dostarlimab plus CAPEOX
Participants will receive dostarlimab plus CAPEOX (chemotherapy).
Dostarlimab
Dostarlimab will be administered.
CAPEOX
CAPEOX chemotherapy consisting of capecitabine and oxaliplatin will be administered.
CAPEOX
Participants will receive CAPEOX (chemotherapy).
CAPEOX
CAPEOX chemotherapy consisting of capecitabine and oxaliplatin will be administered.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Dostarlimab
Dostarlimab will be administered.
CAPEOX
CAPEOX chemotherapy consisting of capecitabine and oxaliplatin will be administered.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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 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
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
GlaxoSmithKline
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
GSK Investigational Site
Aalst, , Belgium
GSK Investigational Site
Bonheiden, , Belgium
GSK Investigational Site
Brussels, , Belgium
GSK Investigational Site
Brussels, , Belgium
GSK Investigational Site
Ghent, , Belgium
GSK Investigational Site
Leuven, , Belgium
GSK Investigational Site
Liège, , Belgium
GSK Investigational Site
Liège, , Belgium
GSK Investigational Site
Ostend, , Belgium
GSK Investigational Site
Roeselare, , Belgium
GSK Investigational Site
Udine, , Italy
GSK Investigational Site
Barcelona, , Spain
GSK Investigational Site
Madrid, , Spain
GSK Investigational Site
Madrid, , Spain
GSK Investigational Site
Madrid, , Spain
GSK Investigational Site
Madrid, , Spain
GSK Investigational Site
Valencia, , Spain
GSK Investigational Site
Geneva, , Switzerland
GSK Investigational Site
Glasgow, , United Kingdom
GSK Investigational Site
Leeds West Yorkshire, , United Kingdom
GSK Investigational Site
London, , United Kingdom
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2024-513441-36
Identifier Type: REGISTRY
Identifier Source: secondary_id
222892
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.