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ACTIVE NOT RECRUITING
NCT05723562
PHASE2

A Study of Dostarlimab in Untreated dMMR/MSI-H Locally Advanced Rectal Cancer

Sponsor: GlaxoSmithKline

View on ClinicalTrials.gov

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

Interventions

BIOLOGICAL

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