RecruitingPhase 3NCT05855200

Study of Perioperative Dostarlimab in Participants With Untreated T4N0 or Stage III dMMR/MSI-H Resectable Colon Cancer

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

Sponsor

GlaxoSmithKline

Enrollment

892 participants

Start Date

Aug 1, 2023

Study Type

INTERVENTIONAL

Conditions

Colonic Neoplasms Neoplasms, Colon

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether adding Dostarlimab — an immunotherapy drug — before and after surgery can improve outcomes for people with a specific type of colon cancer that has certain DNA repair defects (called dMMR or MSI-H), making these tumors more likely to respond to immunotherapy. **You may be eligible if...** - You have been diagnosed with colon cancer (not yet treated) that is stage III or locally advanced (T4N0) - Your tumor has been confirmed as dMMR (mismatch repair deficient) or MSI-H (microsatellite instability-high) — your doctor can check this with a simple test - Your cancer has not spread to distant organs - You have not had any prior treatment for this diagnosis **You may NOT be eligible if...** - Your cancer has spread to other organs (distant metastases) - You have already received surgery, chemotherapy, radiation, or other treatments for this cancer - Your cancer is causing a bowel blockage requiring emergency surgery - You have had a major surgery or serious injury within the past 28 days - You have a history of lung inflammation (pneumonitis) or severe autoimmune disease Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALDostarlimab

Dostarlimab will be administered.

DRUGCAPEOX

CAPEOX will be administered.

DRUGFOLFOX

FOLFOX will be administered.

Locations(266)

GSK Investigational Site

Tucson, Arizona, United States

GSK Investigational Site

Los Angeles, California, United States

GSK Investigational Site

New Haven, Connecticut, United States

GSK Investigational Site

Washington D.C., District of Columbia, United States

GSK Investigational Site

Deerfield Beach, Florida, United States

GSK Investigational Site

Fort Lauderdale, Florida, United States

GSK Investigational Site

Marietta, Georgia, United States

GSK Investigational Site

Chicago, Illinois, United States

GSK Investigational Site

Chicago, Illinois, United States

GSK Investigational Site

Chicago, Illinois, United States

GSK Investigational Site

Naperville, Illinois, United States

GSK Investigational Site

Naperville, Illinois, United States

GSK Investigational Site

Westwood, Kansas, United States

GSK Investigational Site

Lexington, Kentucky, United States

GSK Investigational Site

Louisville, Kentucky, United States

GSK Investigational Site

Baton Rouge, Louisiana, United States

GSK Investigational Site

Bethesda, Maryland, United States

GSK Investigational Site

Ann Arbor, Michigan, United States

GSK Investigational Site

Detroit, Michigan, United States

GSK Investigational Site

Minneapolis, Minnesota, United States

GSK Investigational Site

Joplin, Missouri, United States

GSK Investigational Site

St Louis, Missouri, United States

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St Louis, Missouri, United States

GSK Investigational Site

Grand Island, Nebraska, United States

GSK Investigational Site

Omaha, Nebraska, United States

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Omaha, Nebraska, United States

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Lebanon, New Hampshire, United States

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New York, New York, United States

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New York, New York, United States

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New York, New York, United States

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New York, New York, United States

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The Bronx, New York, United States

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Durham, North Carolina, United States

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Akron, Ohio, United States

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Cincinnati, Ohio, United States

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Cleveland, Ohio, United States

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Cleveland, Ohio, United States

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Cleveland, Ohio, United States

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Oklahoma City, Oklahoma, United States

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Oklahoma City, Oklahoma, United States

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Pittsburgh, Pennsylvania, United States

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Sioux Falls, South Dakota, United States

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Sioux Falls, South Dakota, United States

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Sioux Falls, South Dakota, United States

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Sioux Falls, South Dakota, United States

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Dallas, Texas, United States

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Dallas, Texas, United States

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Richmond, Virginia, United States

GSK Investigational Site

Appleton, Wisconsin, United States

GSK Investigational Site

Buenos Aires, Argentina

GSK Investigational Site

Buenos Aires, Argentina

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Buenos Aires, Argentina

GSK Investigational Site

Capital Federal, Argentina

GSK Investigational Site

Ciudad Autonoma de Buenos Aire, Argentina

GSK Investigational Site

Córdoba, Argentina

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Mar del Plata, Argentina

GSK Investigational Site

Rosario, Argentina

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San Miguel de Tucumán, Argentina

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Santa Fe, Argentina

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Newcastle, New South Wales, Australia

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St Leonards, New South Wales, Australia

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Woolangabba, Queensland, Australia

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Heidelberg, Victoria, Australia

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Melbourne, Victoria, Australia

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Aalst, Belgium

GSK Investigational Site

Brussels, Belgium

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Brussels, Belgium

GSK Investigational Site

Edegem, Belgium

GSK Investigational Site

Ghent, Belgium

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Leuven, Belgium

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Liège, Belgium

GSK Investigational Site

Roeselare, Belgium

GSK Investigational Site

Barretos, Brazil

GSK Investigational Site

Belém, Brazil

GSK Investigational Site

Campo Grande, Brazil

GSK Investigational Site

Lages, Brazil

GSK Investigational Site

Natal, Brazil

GSK Investigational Site

Porto Alegre, Brazil

GSK Investigational Site

Salvador, Brazil

GSK Investigational Site

São José do Rio Preto, Brazil

GSK Investigational Site

São Paulo, Brazil

GSK Investigational Site

São Paulo, Brazil

GSK Investigational Site

Teresina, Brazil

GSK Investigational Site

Vitória, Brazil

GSK Investigational Site

Edmonton, Alberta, Canada

GSK Investigational Site

Halifax, Nova Scotia, Canada

GSK Investigational Site

Ottawa, Ontario, Canada

GSK Investigational Site

Toronto, Ontario, Canada

GSK Investigational Site

Montreal, Quebec, Canada

GSK Investigational Site

Beijing, China

GSK Investigational Site

Beijing, China

GSK Investigational Site

Beijing, China

GSK Investigational Site

Changchun, China

GSK Investigational Site

Changsha, China

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Chengdu, China

GSK Investigational Site

Chongqing, China

GSK Investigational Site

Chongqing, China

GSK Investigational Site

Guangzhou, China

GSK Investigational Site

Guangzhou, China

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Hangzhou, China

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Hangzhou, China

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Hangzhou, China

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Hangzhou, China

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Harbin, China

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Jinan, China

GSK Investigational Site

Kunming, China

GSK Investigational Site

Meizhou, China

GSK Investigational Site

Nanchang, China

GSK Investigational Site

Nanchang, China

GSK Investigational Site

Shanghai, China

GSK Investigational Site

Shanghai, China

GSK Investigational Site

Shenzhen, China

GSK Investigational Site

Taiyuan, China

GSK Investigational Site

Tianjin, China

GSK Investigational Site

Wuhan, China

GSK Investigational Site

Xiamen, China

GSK Investigational Site

Yangzhou, China

GSK Investigational Site

Zhengzhou, China

GSK Investigational Site

Hradec Králové, Czechia

GSK Investigational Site

Nový Jičín, Czechia

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Prague, Czechia

GSK Investigational Site

Tallinn, Estonia

GSK Investigational Site

Tallinn, Estonia

GSK Investigational Site

Tartu, Estonia

GSK Investigational Site

Helsinki, Finland

GSK Investigational Site

Tampere, Finland

GSK Investigational Site

Turku, Finland

GSK Investigational Site

Lyon, France

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Marseille, France

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Nantes, France

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Paris, France

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Pessac, France

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Rennes, France

GSK Investigational Site

Rouen, France

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Saint-Priest-en-Jarez, France

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Suresnes, France

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Toulouse, France

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Villejuif, France

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Berlin, Germany

GSK Investigational Site

Düsseldorf, Germany

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Frankfurt, Germany

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Halle, Germany

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Lübeck, Germany

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Mannheim, Germany

GSK Investigational Site

München, Germany

GSK Investigational Site

München, Germany

GSK Investigational Site

Athens, Greece

GSK Investigational Site

Thessaloniki, Greece

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Thessaloniki, Greece

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Bengaluru, Karnataka, India

GSK Investigational Site

Ludhiana, Punjab, India

GSK Investigational Site

Belagavi, India

GSK Investigational Site

Hyderabad, India

GSK Investigational Site

Nashik, India

GSK Investigational Site

Pune, India

GSK Investigational Site

Cagliari, Italy

GSK Investigational Site

Genova, Italy

GSK Investigational Site

Milan, Italy

GSK Investigational Site

Naples, Italy

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Padova, Italy

GSK Investigational Site

Pisa, Italy

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Reggio Emilia, Italy

GSK Investigational Site

Roma, Italy

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Roma, Italy

GSK Investigational Site

Rozzano MI, Italy

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Aichi, Japan

GSK Investigational Site

Chiba, Japan

GSK Investigational Site

Fukuoka, Japan

GSK Investigational Site

Hokkaido, Japan

GSK Investigational Site

Hyōgo, Japan

GSK Investigational Site

Ibaraki, Japan

GSK Investigational Site

Kanagawa, Japan

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Kanagawa, Japan

GSK Investigational Site

Kyoto, Japan

GSK Investigational Site

Okayama, Japan

GSK Investigational Site

Osaka, Japan

GSK Investigational Site

Osaka, Japan

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Osaka, Japan

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Osaka, Japan

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Osaka, Japan

GSK Investigational Site

Shizuoka, Japan

GSK Investigational Site

Tokyo, Japan

GSK Investigational Site

Tokyo, Japan

GSK Investigational Site

DF, Mexico

GSK Investigational Site

Guadalajara, Mexico

GSK Investigational Site

Guadalajara, Mexico

GSK Investigational Site

Mexico City, Mexico

GSK Investigational Site

Oaxaca City, Mexico

GSK Investigational Site

San Pedro Garza García, Mexico

GSK Investigational Site

Tijuana, Mexico

GSK Investigational Site

Breda, Netherlands

GSK Investigational Site

Maastricht, Netherlands

GSK Investigational Site

Nijmegen, Netherlands

GSK Investigational Site

Utrecht, Netherlands

GSK Investigational Site

Bergen, Norway

GSK Investigational Site

Kristiansand, Norway

GSK Investigational Site

Lrenskog, Norway

GSK Investigational Site

Oslo, Norway

GSK Investigational Site

Stavanger, Norway

GSK Investigational Site

Tromsø, Norway

GSK Investigational Site

Punta Pacifica Panama City Panama, Panama

GSK Investigational Site

Bydgoszcz, Poland

GSK Investigational Site

Warsaw, Poland

GSK Investigational Site

Almada, Portugal

GSK Investigational Site

Coimbra, Portugal

GSK Investigational Site

Lisbon, Portugal

GSK Investigational Site

Daegu, South Korea

GSK Investigational Site

Gyeonggi-do, South Korea

GSK Investigational Site

Seoul, South Korea

GSK Investigational Site

Seoul, South Korea

GSK Investigational Site

Seoul, South Korea

GSK Investigational Site

Badajoz, Spain

GSK Investigational Site

BaracaldoVizcaya, Spain

GSK Investigational Site

Barcelona, Spain

GSK Investigational Site

Barcelona, Spain

GSK Investigational Site

Barcelona, Spain

GSK Investigational Site

Córdoba, Spain

GSK Investigational Site

Donostia / San Sebastian, Spain

GSK Investigational Site

Elche Alicante, Spain

GSK Investigational Site

Granada, Spain

GSK Investigational Site

Jaén, Spain

GSK Investigational Site

L'Hospitalet de Llobrega, Spain

GSK Investigational Site

Las Palmas de Gran Canar, Spain

GSK Investigational Site

Madrid, Spain

GSK Investigational Site

Madrid, Spain

GSK Investigational Site

Madrid, Spain

GSK Investigational Site

Madrid, Spain

GSK Investigational Site

Madrid, Spain

GSK Investigational Site

Madrid, Spain

GSK Investigational Site

Madrid, Spain

GSK Investigational Site

Madrid, Spain

GSK Investigational Site

Madrid, Spain

GSK Investigational Site

Málaga, Spain

GSK Investigational Site

Oviedo, Spain

GSK Investigational Site

Pamplona, Spain

GSK Investigational Site

Santander, Spain

GSK Investigational Site

Seville, Spain

GSK Investigational Site

Valencia, Spain

GSK Investigational Site

Valencia, Spain

GSK Investigational Site

Valencia, Spain

GSK Investigational Site

Zaragoza, Spain

GSK Investigational Site

Eskilstuna, Sweden

GSK Investigational Site

Gothenburg, Sweden

GSK Investigational Site

Linköping, Sweden

GSK Investigational Site

Malmö, Sweden

GSK Investigational Site

Stockholm, Sweden

GSK Investigational Site

Stockholm, Sweden

GSK Investigational Site

Uppsala, Sweden

GSK Investigational Site

Kaohsiung City, Taiwan

GSK Investigational Site

Tainan, Taiwan

GSK Investigational Site

Taipei, Taiwan

GSK Investigational Site

Taoyuan, Taiwan

GSK Investigational Site

Ankara, Turkey (Türkiye)

GSK Investigational Site

Ankara, Turkey (Türkiye)

GSK Investigational Site

Ankara, Turkey (Türkiye)

GSK Investigational Site

Istanbul, Turkey (Türkiye)

GSK Investigational Site

Birmingham, United Kingdom

GSK Investigational Site

Chelmsford, United Kingdom

GSK Investigational Site

Cheltenham, United Kingdom

GSK Investigational Site

Edinburgh, United Kingdom

GSK Investigational Site

Hull, United Kingdom

GSK Investigational Site

Leeds West Yorkshire, United Kingdom

GSK Investigational Site

London, United Kingdom

GSK Investigational Site

London, United Kingdom

GSK Investigational Site

Manchester, United Kingdom

GSK Investigational Site

Sutton, United Kingdom

View Full Details on ClinicalTrials.gov

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NCT05855200

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Conditions

Summary

Eligibility

Plain Language Summary

Interventions

Locations(266)

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