Phase 2 Study of Dostarlimab in Untreated dMMR/MSI-H Locally Advanced Rectal Cancer
- Conditions
- eoplasms, RectalTherapeutic area: Diseases [C] - Neoplasms [C04]
- Registration Number
- CTIS2023-509583-22-00
- Lead Sponsor
- Glaxosmithkline Research & Development Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 150
Is at least 18 years of age (or the local legal age of consent) at the time of signing the ICF, Has histologically confirmed Stage II to III (T3-T4, N0, or T any, N+) locally advanced rectal adenocarcinoma, Has radiologically and endoscopically evaluable disease, Has an archival FFPE tissue sample that must be available and submitted to the central reference laboratory for testing at Screening, Has an ECOG performance status of 0 or 1, Has adequate organ function, Has a tumor demonstrating the presence of either dMMR status or MSI-H phenotype
Has distant metastatic disease, Has received prior radiation therapy, systemic therapy, or surgery for management of rectal cancer, Has a tumor that, in the investigator's judgment, is causing symptomatic bowel obstruction or otherwise requires urgent/emergent local intervention, Has a known additional malignancy that progressed or required active treatment within the past 2 years (Exceptions include adequately treated superficial skin cancers, superficial bladder cancers, and other in situ cancers), Is immunocompromised in the opinion of the investigator, Has an active autoimmune disease that has required systemic treatment in the past 2 years, Is receiving immunosuppressive medication ; Has received systemic corticosteroids, Has received or plans to receive an organ or stem cell transplant that uses donor stem cells (allogeneic stem cell transplant).
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
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