NCT06567782Recruiting

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

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.

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

Contacts

The trial team's contact details are shown on request.

See the official trial record

Status: Recruiting
Phase: Phase 2
Study type: Interventional
Countries: Switzerland, Italy, Belgium, Japan, Spain, United Kingdom
Sponsor: GlaxoSmithKline(Industry)
Protocol no.: 222892
Conditions: Neoplasms, Colon
Interventions: Biological, Drug

Treatments studied

Dostarlimab
CAPEOX

Locations · 32

Bern, SwitzerlandGSK Investigational SiteRecruiting at this site
Geneva, SwitzerlandGSK Investigational SiteRecruiting at this site
Milan, ItalyGSK Investigational SiteRecruiting at this site
Roma, ItalyGSK Investigational SiteRecruiting at this site
Udine, ItalyGSK Investigational SiteRecruiting at this site
Aalst, BelgiumGSK Investigational SiteRecruiting at this site
Bonheiden, BelgiumGSK Investigational SiteRecruiting at this site
Brussels, BelgiumGSK Investigational SiteRecruiting at this site
Brussels, BelgiumGSK Investigational SiteRecruiting at this site
Ghent, BelgiumGSK Investigational SiteRecruiting at this site
Leuven, BelgiumGSK Investigational SiteRecruiting at this site
Liège, BelgiumGSK Investigational SiteRecruiting at this site
Liège, BelgiumGSK Investigational SiteRecruiting at this site
Ostend, BelgiumGSK Investigational SiteRecruiting at this site
Roeselare, BelgiumGSK Investigational SiteRecruiting at this site
Turnhout, BelgiumGSK Investigational SiteRecruiting at this site
Osaka, JapanGSK Investigational SiteRecruiting at this site
Osaka, JapanGSK Investigational SiteRecruiting at this site
Tokyo, JapanGSK Investigational SiteRecruiting at this site
Barcelona, SpainGSK Investigational SiteRecruiting at this site
Barcelona, SpainGSK Investigational SiteRecruiting at this site
Barcelona, SpainGSK Investigational SiteRecruiting at this site
Madrid, SpainGSK Investigational SiteRecruiting at this site
Madrid, SpainGSK Investigational SiteRecruiting at this site
Madrid, SpainGSK Investigational SiteRecruiting at this site
Madrid, SpainGSK Investigational SiteRecruiting at this site
Oviedo, SpainGSK Investigational SiteRecruiting at this site
Valencia, SpainGSK Investigational SiteRecruiting at this site
Glasgow, United KingdomGSK Investigational SiteRecruiting at this site
Leeds West Yorkshire, United KingdomGSK Investigational SiteRecruiting at this site

In total, worldwide, 32 of the 33 sites listed in the registry are recruiting; the other one is not currently recruiting.

Site status per the ClinicalTrials.gov registry (last update posted: May 22, 2026).

This status may have changed and says nothing about your eligibility: before taking any step, check with your oncologist or the site.

+ 2 more locations

Other identifiers

2024-513441-36 · other registry

Other versions

These results are indicative and do not replace medical advice — discuss them with your doctor.