Status:
RECRUITING
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
Lead Sponsor:
GlaxoSmithKline
Conditions:
Neoplasms, Colon
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 +...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
February 17 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 24 2028
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT06567782
Start Date
February 17 2025
End Date
October 24 2028
Last Update
December 15 2025
Active Locations (21)
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1
GSK Investigational Site
Aalst, Belgium, 9300
2
GSK Investigational Site
Bonheiden, Belgium, 2820
3
GSK Investigational Site
Brussels, Belgium, 1070
4
GSK Investigational Site
Brussels, Belgium, 1200