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A Study of Dostarlimab in Untreated dMMR/MSI-H Locally Advanced Rectal Cancer
Sponsor: GlaxoSmithKline
Summary
The purpose of this study is to investigate dostarlimab monotherapy in participants with locally advanced Mismatch-repair deficient (dMMR)/Microsatellite instability-high (MSI-H) rectal cancer who have received no prior treatment. Participants who achieve complete clinical response (cCR) following dostarlimab treatment will undergo non-operative management (NOM), including close surveillance for recurrent disease. The goal of the study is to determine if Dostarlimab therapy alone is an effective treatment that can allow participants to avoid chemotherapy, radiation, and surgery.
Official title: A Phase 2, Single-Arm, Open-Label Study With Dostarlimab Monotherapy in Participants With Untreated Stage II/III dMMR/MSI-H Locally Advanced Rectal Cancer
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
154
Start Date
2023-04-03
Completion Date
2029-10-11
Last Updated
2026-01-08
Healthy Volunteers
No
Conditions
Interventions
Dostarlimab
Dostarlimab will be administered.
Locations (42)
GSK Investigational Site
Los Angeles, California, United States
GSK Investigational Site
Albuquerque, New Mexico, United States
GSK Investigational Site
New York, New York, United States
GSK Investigational Site
Pittsburgh, Pennsylvania, United States
GSK Investigational Site
Nashville, Tennessee, United States
GSK Investigational Site
Dallas, Texas, United States
GSK Investigational Site
Richmond, Virginia, United States
GSK Investigational Site
Ottawa, Ontario, Canada
GSK Investigational Site
Toronto, Ontario, Canada
GSK Investigational Site
Montreal, Quebec, Canada
GSK Investigational Site
Sherbrooke, Quebec, Canada
GSK Investigational Site
Besançon, France
GSK Investigational Site
Marseille, France
GSK Investigational Site
Paris, France
GSK Investigational Site
Pessac, France
GSK Investigational Site
Rennes, France
GSK Investigational Site
Berlin, Germany
GSK Investigational Site
Dresden, Germany
GSK Investigational Site
Düsseldorf, Germany
GSK Investigational Site
Frankfurt, Germany
GSK Investigational Site
München, Germany
GSK Investigational Site
Milan, Italy
GSK Investigational Site
Padova, Italy
GSK Investigational Site
Roma, Italy
GSK Investigational Site
Chiba, Japan
GSK Investigational Site
Kanagawa, Japan
GSK Investigational Site
Osaka, Japan
GSK Investigational Site
Osaka, Japan
GSK Investigational Site
Utrecht, Netherlands
GSK Investigational Site
Seoul, South Korea
GSK Investigational Site
Seoul, South Korea
GSK Investigational Site
Seoul, South Korea
GSK Investigational Site
Seoul, South Korea
GSK Investigational Site
Barcelona, Spain
GSK Investigational Site
Granada, Spain
GSK Investigational Site
Madrid, Spain
GSK Investigational Site
Madrid, Spain
GSK Investigational Site
Santander, Spain
GSK Investigational Site
Valencia, Spain
GSK Investigational Site
Leeds West Yorkshire, United Kingdom
GSK Investigational Site
London, United Kingdom
GSK Investigational Site
Sutton, United Kingdom