A Phase 3, Open-Label, Randomized Study of Perioperative Dostarlimab Monotherapy Versus Standard of Care in Participants With Untreated T4N0 or Stage III dMMR/MSI-H Resectable Colon Cancer
GlaxoSmithKline
Summary
The primary purpose of this study is to evaluate the efficacy of perioperative dostarlimab compared with standard of care (SOC) in participants with untreated T4N0 or Stage III (resectable), defective mismatch repair/ microsatellite instability high (dMMR/MSI-H) colon cancer.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Has untreated pathologically confirmed colon adenocarcinoma * Has resectable colon adenocarcinoma defined as clinically T4N0 or Stage III * Has radiologically evaluable disease * Has a tumor demonstrating the presence of either dMMR status or MSI-H Exclusion Criteria: * Has distant metastatic disease. * Has received prior medical therapy (chemotherapy, immunotherapy, biologic, or targeted therapy), radiation therapy or surgery for management of the current diagnosis of colon cancer * Has a tumor that, in the investigator's judgment is causing symptomatic bowel obstruct…
Interventions
- BiologicalDostarlimab
Dostarlimab will be administered.
- DrugCAPEOX
CAPEOX will be administered.
- DrugFOLFOX
FOLFOX will be administered.
Locations (266)
- GSK Investigational SiteTucson, Arizona
- GSK Investigational SiteLos Angeles, California
- GSK Investigational SiteNew Haven, Connecticut
- GSK Investigational SiteWashington D.C., District of Columbia
- GSK Investigational SiteDeerfield Beach, Florida
- GSK Investigational SiteFort Lauderdale, Florida