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
Status: Recruiting
Location: See all (260) locations...
Intervention Type: Drug, Biological
Study Type: Interventional
Study Phase: Phase 3
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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
Locations
United States
Arizona
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Tucson
California
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Los Angeles
Connecticut
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New Haven
Washington, D.c.
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Washington D.c.
Florida
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Deerfield Beach
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Fort Lauderdale
Georgia
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Marietta
Illinois
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Chicago
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Chicago
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Chicago
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Naperville
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Naperville
Kansas
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Westwood
Kentucky
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Lexington
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Louisville
Louisiana
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Baton Rouge
Maryland
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Bethesda
Michigan
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Ann Arbor
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Detroit
Minnesota
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Minneapolis
Missouri
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Joplin
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St Louis
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St Louis
North Carolina
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Durham
Nebraska
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Grand Island
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Omaha
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Omaha
New Hampshire
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Lebanon
New York
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New York
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New York
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New York
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New York
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The Bronx
Ohio
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Akron
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Cincinnati
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Cleveland
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Cleveland
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Cleveland
Oklahoma
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Oklahoma City
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Oklahoma City
Pennsylvania
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Pittsburgh
South Dakota
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Sioux Falls
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Sioux Falls
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Sioux Falls
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Sioux Falls
Texas
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Dallas
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Dallas
Virginia
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Richmond
Wisconsin
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Appleton
Other Locations
Argentina
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Buenos Aires
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Buenos Aires
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Buenos Aires
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Capital Federal
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Ciudad Autonoma De Buenos Aire
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Córdoba
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Mar Del Plata
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Rosario
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San Miguel De Tucumán
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Santa Fe
Australia
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Heidelberg
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Melbourne
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Newcastle
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St Leonards
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Woolangabba
Belgium
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Aalst
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Brussels
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Brussels
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Edegem
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Ghent
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Leuven
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Liège
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Roeselare
Brazil
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Barretos
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Belém
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Campo Grande
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Lages
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Natal
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Porto Alegre
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Salvador
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São José Do Rio Preto
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São Paulo
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São Paulo
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Teresina
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Vitória
Canada
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Edmonton
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Halifax
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Montreal
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Ottawa
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Toronto
China
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Beijing
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Beijing
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Beijing
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Changchun
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Changsha
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Chengdu
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Chongqing
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Guangzhou
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Guangzhou
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Hangzhou
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Hangzhou
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Hangzhou
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Hangzhou
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Harbin
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Jinan
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Kunming
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Meizhou
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Nanchang
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Nanchang
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Shanghai
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Shenzhen
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Taiyuan
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Tianjin
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Wuhan
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Xiamen
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Yangzhou
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Zhengzhou
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Tallinn
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Tallinn
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Lyon
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Marseille
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Nantes
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Paris
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Pessac
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Rennes
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Rouen
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Saint-priest-en-jarez
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Suresnes
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Toulouse
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Villejuif
Germany
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Berlin
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Düsseldorf
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Frankfurt
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Halle
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Lübeck
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Mannheim
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München
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München
Greece
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Athens
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Thessaloniki
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Thessaloniki
India
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Belagavi
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Bengaluru
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Pune
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Milan
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Roma
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Chiba
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Fukuoka
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Hokkaido
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Hyōgo
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Kyoto
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Okayama
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Osaka
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Osaka
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Osaka
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Osaka
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Tokyo
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Tokyo
Mexico
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Df
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Utrecht
Norway
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Bergen
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Kristiansand
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Lrenskog
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Oslo
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Stavanger
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Tromsø
Panama
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Poland
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Bydgoszcz
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Warsaw
Portugal
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Almada
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Coimbra
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Lisbon
Republic of Korea
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Daegu
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Gyeonggi-do
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Seoul
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Seoul
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Seoul
Spain
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Badajoz
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Baracaldovizcaya
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Barcelona
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Barcelona
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Barcelona
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Córdoba
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Donostia / San Sebastian
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Elche Alicante
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Granada
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Jaén
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L'hospitalet De Llobrega
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Las Palmas De Gran Canar
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Madrid
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Madrid
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Madrid
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Madrid
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Madrid
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Madrid
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Madrid
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Madrid
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Málaga
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Oviedo
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Pamplona
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Santander
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Seville
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Valencia
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Valencia
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Valencia
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Zaragoza
Sweden
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Eskilstuna
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Gothenburg
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Linköping
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Malmö
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Stockholm
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Stockholm
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Uppsala
Taiwan
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Kaohsiung City
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Tainan
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Taipei
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Taoyuan
Turkey
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Ankara
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Ankara
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Ankara
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Istanbul
United Kingdom
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Birmingham
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Chelmsford
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Cheltenham
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Edinburgh
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Hull
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Leeds West Yorkshire
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London
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London
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Manchester
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Sutton
Contact Information
Primary
US GSK Clinical Trials Call Center
GSKClinicalSupportHD@gsk.com
877-379-3718
Backup
EU GSK Clinical Trials Call Center
GSKClinicalSupportHD@gsk.com
+44 (0) 20 89904466
Time Frame
Start Date: 2023-08-01
Estimated Completion Date: 2031-03-27
Participants
Target number of participants: 892
Treatments
Experimental: Dostarlimab
Participants will receive Dostarlimab pre and post surgery
Active_comparator: Standard of Care (SOC)
Participants will receive SOC (FOLFOX/CAPEOX) or undergo expectant observation post surgery.
Related Therapeutic Areas
Sponsors
Leads: GlaxoSmithKline