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

Last updated: March 7, 2025
Sponsor: GlaxoSmithKline
Overall Status: Active - Recruiting

Phase

2

Condition

Colorectal Cancer

Colon Cancer

Treatment

Dostarlimab

CAPEOX

Clinical Study ID

NCT06567782
222892
2024-513441-36
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 MMRprotein expression (MLH1, MSH2, MSH6, PMS2) where all proteins are presentindicates MMRp; MMR status may be determined local laboratory; or

  2. MSS or Microsatellite Instability-L (MSI-L) phenotype as determined bypolymerase 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 screeningperiod 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

Exclusion Criteria:

  • Has distant metastatic disease

  • Has received prior medical therapy (chemotherapy, immunotherapy, biologic, ortargeted 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 hasany 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., myasthenicsyndrome/myasthenia gravis, encephalitis, Guillain Barré Syndrome, or transversemyelitis), exfoliative dermatitis of any grade [Stevens-Johnson Syndrome (SJS),Toxic Epidermal Necrolysis (TEN), or Drug rash with eosinophilia and systemicsymptoms (DRESS) syndrome], or myocarditis of any grade. Non-clinically significantlaboratory 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 laboratoryabnormality that might confound the study results, interfere with theirparticipation for the full duration of the study intervention, or indicate it is notin the best interest of the participant to participate, in the opinion of theinvestigator

  • Is considered, in investigator's opinion, a poor medical risk due to a serious,uncontrolled medical disorder, non-malignant systemic disease, or active infectionrequiring systemic therapy

  • Has received treatment with an investigational agent within [4 weeks] of the firstdose 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 itsexcipients, or any components of CAPEOX

Study Design

Total Participants: 120
Treatment Group(s): 2
Primary Treatment: Dostarlimab
Phase: 2
Study Start date:
February 17, 2025
Estimated Completion Date:
June 15, 2028

Connect with a study center

  • GSK Investigational Site

    Aalst, 9300
    Belgium

    Site Not Available

  • GSK Investigational Site

    Bonheiden, 2820
    Belgium

    Site Not Available

  • GSK Investigational Site

    Bruxelles, 1200
    Belgium

    Site Not Available

  • GSK Investigational Site

    Gent, 9000
    Belgium

    Site Not Available

  • GSK Investigational Site

    Leuven, 3000
    Belgium

    Active - Recruiting

  • GSK Investigational Site

    LiEge, 4000
    Belgium

    Site Not Available

  • GSK Investigational Site

    Roeselare, 8800
    Belgium

    Site Not Available

  • GSK Investigational Site

    Barcelona, 8035
    Spain

    Site Not Available

  • GSK Investigational Site

    Madrid, 28222
    Spain

    Site Not Available

  • GSK Investigational Site

    Glasgow, G12 0YN
    United Kingdom

    Site Not Available

  • GSK Investigational Site

    Leeds West Yorkshire, LS9 7TF
    United Kingdom

    Site Not Available

  • GSK Investigational Site

    London, NW1 2PG
    United Kingdom

    Site Not Available

  • GSK Investigational Site

    Sutton, SM2 5PT
    United Kingdom

    Site Not Available

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