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
- Conditions
- Neoplasms, Colon
- Registration Number
- NCT06567782
- Lead Sponsor
- GlaxoSmithKline
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not yet recruiting
- Sex
- All
- Target Recruitment
- 120
Inclusion Criteria:<br><br> - Has untreated pathologically confirmed colon adenocarcinoma<br><br> - Has resectable colon adenocarcinoma defined as clinically T4N0 or Stage III<br><br> - Has a tumor demonstrating the presence of either-<br><br> 1. MMR status: MMR status must be assessed by Immunohistochemistry (IHC) for MMR<br> protein expression (MLH1, MSH2, MSH6, PMS2) where all proteins are present<br> indicates MMRp; MMR status may be determined local laboratory; or<br><br> 2. MSS or MSI-L phenotype as determined by polymerase chain reaction (PCR) or by<br> tissue next generation sequencing (NGS), determined by local laboratory<br><br> - Provides fresh tumor tissue obtained during either the pre-screening or screening<br> period via colonoscopy performed per procedure manual. Tissue biopsy is required<br><br> - Is willing to use adequate contraception male and/or female participants<br><br> - Has an Eastern Cooperative Oncology Group - Performance status (ECOG-PS) of 0 or 1<br><br> - Has adequate organ function<br><br>Exclusion Criteria:<br><br> - Has distant metastatic disease<br><br> - Has received prior medical therapy (chemotherapy, immunotherapy, biologic, or<br> targeted therapy), radiation therapy or surgery for management of colon cancer<br><br> - Has, in the investigator's opinion, a tumor that is not amenable to surgery or has<br> any other contraindication to surgery<br><br> - Has experienced any of the following with prior immunotherapy: any imAE = Grade 3,<br> immune-mediated severe neurologic events of any-grade (e.g., myasthenic<br> syndrome/myasthenia gravis, encephalitis, Guillain Barré Syndrome, or transverse<br> myelitis), exfoliative dermatitis of any grade [Stevens-Johnson Syndrome (SJS),<br> Toxic Epidermal Necrolysis (TEN), or Drug rash with eosinophilia and systemic<br> symptoms (DRESS) syndrome], or myocarditis of any grade. Non-clinically significant<br> laboratory abnormalities are not exclusionary<br><br> - Has any history of interstitial lung disease or immune-related pneumonitis<br><br> - Has a history or current evidence of any medical condition, therapy, or laboratory<br> abnormality that might confound the study results, interfere with their<br> participation for the full duration of the study intervention, or indicate it is not<br> in the best interest of the participant to participate, in the opinion of the<br> investigator<br><br> - Is considered, in investigator's opinion, a poor medical risk due to a serious,<br> uncontrolled medical disorder, non-malignant systemic disease, or active infection<br> requiring systemic therapy<br><br> - Has received treatment with an investigational agent within [4 weeks] of the first<br> dose of study intervention<br><br> - Is pregnant or breastfeeding<br><br> - Has a history of severe allergic and/or anaphylactic reactions to chimeric, human,<br> or humanized antibodies, fusion proteins, or known allergies to dostarlimab, or its<br> excipients, or any components of CAPEOX
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 and by Severity
- Secondary Outcome Measures
Name Time Method 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