colon adenocarcinoma
Conditions
Interventions
Dostarlimab + CAPEOX
Dostarlimab will be administered as an infusion with dose of 500 mg once in 21 days beginning on Day 1 of each 21-day cycles for 4 cycles.
Oxaliplatin will be administered as a
Sponsors
Ishibashi Hideyasu
Eligibility
Sex/Gender
All
Inclusion criteria
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 pMMR; 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
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 Barre 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Major pathological response (mPR) rate 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 | — |
Secondary
| Measure | Time frame |
|---|---|
| Percentage of participants for whom primary tumour resection is not excluded Complete pathologic response (cPR) rate Major pathological response excluding cPR rate Partial pathologic response rate Negligible pathologic response rate | — |
Countries
Belgium, Italy, Japan, Spein, Sweden, Swizerland, UK
Contacts
Public ContactHideyasu Ishibashi
GlaxoSmithKline K.K.
Outcome results
None listed