Study of Perioperative Dostarlimab in Participants With Untreated T4N0 or Stage III dMMR/MSI-H Resectable Colon Cancer
Launched by GLAXOSMITHKLINE · May 3, 2023
Trial Information
Current as of June 26, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is studying a medication called dostarlimab for patients with a specific type of colon cancer that has not been treated yet. The trial is focused on patients who have a form of colon cancer known as T4N0 or Stage III, which means the cancer is potentially removable through surgery but has certain characteristics that make it harder to treat. The goal is to see if dostarlimab is more effective than the standard treatment options currently available.
To participate in this trial, individuals must have confirmed colon cancer that hasn’t been treated before and meets specific criteria regarding its stage and characteristics. They should not have any distant spread of the disease or have had previous treatments like chemotherapy or surgery for their colon cancer. If eligible, participants can expect to receive either dostarlimab or standard care and will be closely monitored throughout the study. It's important for potential participants to be aware that certain medical histories or conditions may prevent them from joining the trial, such as severe lung issues or certain liver diseases.
Gender
ALL
Eligibility criteria
- 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 colon cancer
- • Has a tumor that, in the investigator's judgment is causing symptomatic bowel obstruction or otherwise requires urgent/emergent surgery
- • Has undergone any major surgical procedure, open biopsy, or experienced significant traumatic injury within 28 days prior to randomization
- • Has any history of interstitial lung disease or pneumonitis
- • Has cirrhosis or current unstable liver or biliary disease per investigator assessment defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminemia, esophageal/gastric varices, or persistent jaundice
- • Has a history of allogenic stem cell transplantation or organ transplantation
- • Is receiving any other anticancer or experimental therapy. No other experimental therapies (including but not limited to chemotherapy, radiation, hormonal treatment, antibody therapy, immunotherapy, gene therapy, vaccine therapy, or other experimental drugs) of any kind are permitted while the participant is receiving study intervention
- • Is pregnant, breastfeeding, or expecting to conceive children within the projected duration of the study
- • Has a history of severe allergic and/or anaphylactic reactions to chimeric, human or humanized antibodies, fusion proteins, or known allergies to dostarlimab, or its excipients, or any components of FOLFOX or CAPEOX
About Glaxosmithkline
GlaxoSmithKline (GSK) is a global healthcare company dedicated to improving the quality of human life by enabling people to do more, feel better, and live longer. With a strong focus on research and development, GSK specializes in pharmaceuticals, vaccines, and consumer health products. The company is committed to advancing innovative therapies and preventive measures across various therapeutic areas, including respiratory, oncology, immunology, and infectious diseases. GSK's collaborative approach and rigorous clinical trial processes underscore its dedication to delivering safe and effective healthcare solutions that meet the needs of patients worldwide.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Los Angeles, California, United States
Bronx, New York, United States
Dallas, Texas, United States
Richmond, Virginia, United States
Genova, Liguria, Italy
Padova, Veneto, Italy
Lisboa, , Portugal
Sevilla, , Spain
Valencia, , Spain
Minneapolis, Minnesota, United States
Raleigh, North Carolina, United States
Akron, Ohio, United States
Cincinnati, Ohio, United States
Tucson, Arizona, United States
Washington, District Of Columbia, United States
Napoli, Campania, Italy
Coimbra, , Portugal
Las Palmas De Gran Canaria, , Spain
Lexington, Kentucky, United States
Detroit, Michigan, United States
Greenville, North Carolina, United States
Oklahoma City, Oklahoma, United States
Fort Lauderdale, Florida, United States
Leuven, , Belgium
Liege, , Belgium
London, , United Kingdom
Durham, North Carolina, United States
Bruxelles, , Belgium
Edegem, , Belgium
Toronto, Ontario, Canada
Beijing, , China
Tianjin, , China
Helsinki, , Finland
Jaen, , Spain
Taipei, , Taiwan
Marietta, Georgia, United States
Lebanon, New Hampshire, United States
Rochester, New York, United States
Cary, North Carolina, United States
Monroeville, Pennsylvania, United States
Woolloongabba, Queensland, Australia
Aalst, , Belgium
Gent, , Belgium
Lille Cedex, , France
Rouen, , France
Leipzig, Sachsen, Germany
Luebeck, Schleswig Holstein, Germany
Pisa, Toscana, Italy
Mexico, , Mexico
Nijmegen, , Netherlands
Almada, , Portugal
Madrid, , Spain
Malaga, , Spain
Pamplona, , Spain
Leeds, , United Kingdom
Wexford, Pennsylvania, United States
Nashville, Tennessee, United States
Heidelberg, Victoria, Australia
Orange, California, United States
New York, New York, United States
Villejuif Cedex, , France
Manchester, , United Kingdom
Sioux Falls, South Dakota, United States
Ann Arbor, Michigan, United States
Cincinnati, Ohio, United States
Pittsburgh, Pennsylvania, United States
Joplin, Missouri, United States
St Leonards, New South Wales, Australia
Omaha, Nebraska, United States
Nantes Cedex 1, , France
Paris, , France
Edmonton, Alberta, Canada
Capital Federal, Buenos Aires, Argentina
Roeselare, , Belgium
Halle, Sachsen Anhalt, Germany
Berlin, , Germany
Roma, Lazio, Italy
Utrecht, , Netherlands
Baracaldo/Vizcaya, , Spain
Zaragoza, , Spain
Liège, , Belgium
Suresnes, , France
New Hyde Park, New York, United States
Chicago, Illinois, United States
Naperville, Illinois, United States
New York, New York, United States
Bruxelles, , Belgium
Ottawa, Ontario, Canada
Tallinn, , Estonia
Tampere, , Finland
Mannheim, Baden Wuerttemberg, Germany
Marburg, Hessen, Germany
Porto Alegre, Rio Grande Do Sul, Brazil
Lyon, , France
Maastricht, , Netherlands
Tainan, , Taiwan
Taoyuan, , Taiwan
Oslo, , Norway
New Haven, Connecticut, United States
Bethesda, Maryland, United States
Cordoba, , Spain
Jaén, , Spain
Tucson, Arizona, United States
Chelmsford, Essex, United Kingdom
Richmond, Virginia, United States
Nantes, , France
Omaha, Nebraska, United States
Baton Rouge, Louisiana, United States
Waratah, New South Wales, Australia
Pessac Cedex, , France
Jefferson Hills, Pennsylvania, United States
Cordoba, , Argentina
Rozzano (Mi), Lombardia, Italy
Guadalajara, Jalisco, Mexico
Granada, , Spain
Breda, , Netherlands
Duesseldorf, Nordrhein Westfalen, Germany
Panama, , Panama
Hull, , United Kingdom
Athens, , Greece
Linköping, , Sweden
Uppsala, , Sweden
Kaohsiung, , Taiwan
Richmond, Virginia, United States
Debrecen, , Hungary
Toulouse Cedex 9, , France
Saint Louis, Missouri, United States
Frankfurt, Hessen, Germany
Sheffield, , United Kingdom
Tokyo, , Japan
Drammen, , Norway
Osaka, , Japan
Córdoba, , Spain
Deerfield Beach, Florida, United States
Ciudad De Buenos Aires, Buenos Aires, Argentina
Muenchen, Bayern, Germany
Shanghai, , China
London, , United Kingdom
Nice Cedex 2, , France
Milano, Lombardia, Italy
Westwood, Kansas, United States
Bergen, , Norway
Wynnewood, Pennsylvania, United States
Oviedo, , Spain
Sutton, , United Kingdom
Saint Priest En Jarez, , France
Lørenskog, , Norway
Aichi, , Japan
Chiba, , Japan
Shizuoka, , Japan
Barretos, São Paulo, Brazil
Monserrato, Sardegna, Italy
Málaga, , Spain
Birmingham, , United Kingdom
Hokkaido, , Japan
Kyoto, , Japan
Fukuoka, , Japan
Kanagawa, , Japan
Mar Del Plata, Buenos Aires, Argentina
Marseille Cedex 5, , France
Roma, , Italy
Santa Fe, , Argentina
Louisville, Kentucky, United States
Cottingham, , United Kingdom
Sao Jose Do Rio Preto, São Paulo, Brazil
Halle, , Germany
Hyogo, , Japan
Chengdu, , China
Cheltenham, , United Kingdom
Edinburgh, , United Kingdom
Stavanger, , Norway
Chelmsford, , United Kingdom
Goteborg, , Sweden
Linkoping, , Sweden
Oviedo, Asturias, Spain
Genova, , Italy
Chongqing, , China
Nanchang, , China
Changsha, , China
Df, , Mexico
Sungnam, , Korea, Republic Of
Seoul, , Korea, Republic Of
Kristiansand, , Norway
Pisa, , Italy
Ibaraki, , Japan
Cheltenham, Gloucestershire, United Kingdom
Montreal, Quebec, Canada
Mexico City, , Mexico
Dallas, Texas, United States
Elche, , Spain
Elmhurst, Illinois, United States
Rennes Cedex, , France
Buenos Aires, , Argentina
Barcelona, , Spain
Napoli, , Italy
Padova, , Italy
Cleveland, Ohio, United States
Ciudad De México, Estado De México, Mexico
San Sebastian, , Spain
Milano, , Italy
Tartu, , Estonia
Majadahonda, Madrid, Spain
Taiyuan, , China
Vitória, Espírito Santo, Brazil
Harbin, , China
Hospitalet De Llobregat (Barcelona), , Spain
Taoyuan City, , Taiwan
Zhengzhou, , China
Natal, Rio Grande Do Norte, Brazil
Shenyang, , China
Shirley, New York, United States
São Paulo, , Brazil
Xiamen, , China
Salvador, Bahía, Brazil
Spartanburg, South Carolina, United States
Ankara, , Turkey
Turku, , Finland
Rosario, Santa Fe, Argentina
Ciudad Autonoma De Buenos Aires, Buenos Aires, Argentina
Melbourne, , Australia
Anderlecht, , Belgium
Teresina, Piauí, Brazil
Lages, Santa Catarina, Brazil
Halifax, , Canada
Thessaloniki, , Greece
Reggio Emilia, Emilia Romagna, Italy
Okayama, , Japan
Daegu, , Korea, Republic Of
Tijuana, Baja California, Mexico
San Pedro Garza Garcia, Nuevo Leon, Mexico
Oaxaca De Juarez, Oaxaca, Mexico
Ciudad De Mexico, , Mexico
Tromsø, , Norway
Santander, , Spain
Eskilstuna, , Sweden
Götebrog, , Sweden
Malmö, , Sweden
Stockholm, , Sweden
Istanbul, , Turkey
Manchester, Greater Manchester, United Kingdom
Louisville, Kentucky, United States
Cleveland, Ohio, United States
Salvador, Bahia, Brazil
Aberdeen, South Dakota, United States
Pierre, South Dakota, United States
Yankton, South Dakota, United States
Hangzhou, , China
Rosario, , Argentina
Capital Federal, , Argentina
Edmonton, , Canada
Toronto, , Canada
Frankfurt, , Germany
Rozzano Mi, , Italy
Barretos, , Brazil
Porto Alegre, , Brazil
Vitoria, , Brazil
Jinan, , China
Wuhan, , China
Oaxaca, , Mexico
Baracaldovizcaya, , Spain
L'hospitalet De Llobrega, , Spain
Ottawa, , Canada
Montreal, , Canada
Changchun, , China
Tromsoe, , Norway
Elche Alicante, , Spain
Mar Del Plata, , Argentina
Duesseldorf, , Germany
Rouen Cedex, , France
Leeds West Yorkshire, , United Kingdom
Naperville, Illinois, United States
Sioux Falls, South Dakota, United States
Appleton, Wisconsin, United States
Ciudad Autonoma De Buenos Aire, , Argentina
Heidelberg, , Australia
Newcastle, , Australia
St Leonards, , Australia
Woolangabba, , Australia
Lages, , Brazil
Natal, , Brazil
Salvador, , Brazil
Sao Jose Do Rio Preto, , Brazil
Sao Paulo, , Brazil
Teresina, , Brazil
Guangzhou, , China
Kunming, , China
Meizhou, , China
Shenzhen, , China
Yangzhou, , China
Luebeck, , Germany
Mannheim, , Germany
Munchen, , Germany
Cagliari, , Italy
Reggio Emilia, , Italy
Gyeonggi Do, , Korea, Republic Of
Guadalajara, , Mexico
San Pedro Garza Garcia, , Mexico
Tijuana, , Mexico
Lrenskog, , Norway
Punta Pacifica Panama City Panama, , Panama
Las Palmas De Gran Canar, , Spain
Malmo, , Sweden
Umea, , Sweden
Patients applied
Trial Officials
GSK Clinical Trials
Study Director
GlaxoSmithKline
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported