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

NCT05855200 · GlaxoSmithKline
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Official title
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
About this study
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 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 the current diagnosis of colon cancer * Has a tumor that, in the investigator's judgment is causing symptomatic bowel obstruction or otherwise requires urgent/emergent surgery at the time of screening. Participants with a history of colonic obstruction are eligible after obstruction is relieved by a diverting stoma (defunctioning ileostomy or colostomy). Patients with a history of colonic obstruction in the context of current colon cancer diagnosis and treated with colonic stents are not eligible. * 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 and/or history of radiation induced enteritis. * 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
Study design
Enrollment target: 892 participants
Allocation: randomized
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2023-08-01
Estimated completion: 2031-03-27
Last updated: 2026-01-23
Interventions
Biological: DostarlimabDrug: CAPEOXDrug: FOLFOX
Primary outcomes
  • Event-free Survival (EFS) Assessed by Blinded Independent Central Review (BICR) (Up to approximately 5 years)
Sponsor
GlaxoSmithKline · industry
Contacts & investigators
ContactUS GSK Clinical Trials Call Center · contact · GSKClinicalSupportHD@gsk.com · 877-379-3718
ContactEU GSK Clinical Trials Call Center · contact · GSKClinicalSupportHD@gsk.com · +44 (0) 20 89904466
InvestigatorGSK Clinical Trials · study_director, GlaxoSmithKline
All locations (266)
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Tucson, Arizona, United States
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Los Angeles, California, United States
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New Haven, Connecticut, United States
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Washington D.C., District of Columbia, United States
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Deerfield Beach, Florida, United States
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Fort Lauderdale, Florida, United States
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Marietta, Georgia, United States
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Chicago, Illinois, United States
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Chicago, Illinois, United States
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Chicago, Illinois, United States
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Naperville, Illinois, United States
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Naperville, Illinois, United States
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Westwood, Kansas, United States
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Lexington, Kentucky, United States
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Louisville, Kentucky, United States
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Baton Rouge, Louisiana, United States
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Bethesda, Maryland, United States
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Ann Arbor, Michigan, United States
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Detroit, Michigan, United States
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Minneapolis, Minnesota, United States
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Joplin, Missouri, United States
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St Louis, Missouri, United States
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St Louis, Missouri, United States
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Grand Island, Nebraska, United States
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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
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Appleton, Wisconsin, United States
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Buenos Aires, Argentina
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Buenos Aires, Argentina
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Buenos Aires, Argentina
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Capital Federal, Argentina
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Ciudad Autonoma de Buenos Aire, Argentina
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Córdoba, Argentina
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Mar del Plata, Argentina
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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
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Brussels, Belgium
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Brussels, Belgium
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Edegem, Belgium
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Ghent, Belgium
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Leuven, Belgium
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Liège, Belgium
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Roeselare, Belgium
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Barretos, Brazil
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Belém, Brazil
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Campo Grande, Brazil
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Lages, Brazil
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Natal, Brazil
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Porto Alegre, Brazil
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Salvador, Brazil
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São José do Rio Preto, Brazil
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São Paulo, Brazil
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São Paulo, Brazil
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Teresina, Brazil
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Vitória, Brazil
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Edmonton, Alberta, Canada
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Halifax, Nova Scotia, Canada
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Ottawa, Ontario, Canada
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Toronto, Ontario, Canada
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Montreal, Quebec, Canada
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Beijing, China
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Beijing, China
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Beijing, China
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Changchun, China
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Changsha, China
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Chengdu, China
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Chongqing, China
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Chongqing, China
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Guangzhou, China
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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
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Kunming, China
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Meizhou, China
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Nanchang, China
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Nanchang, China
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Shanghai, China
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Shanghai, China
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Shenzhen, China
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Taiyuan, China
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Tianjin, China
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Wuhan, China
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Xiamen, China
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Yangzhou, China
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Zhengzhou, China
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Hradec Králové, Czechia
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Nový Jičín, Czechia
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Prague, Czechia
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Tallinn, Estonia
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Tallinn, Estonia
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Tartu, Estonia
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Helsinki, Finland
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Tampere, Finland
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Turku, Finland
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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
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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
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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
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München, Germany
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München, Germany
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Athens, Greece
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Thessaloniki, Greece
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Thessaloniki, Greece
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Bengaluru, Karnataka, India
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Ludhiana, Punjab, India
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Belagavi, India
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Hyderabad, India
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Nashik, India
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Pune, India
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Cagliari, Italy
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Genova, Italy
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Milan, Italy
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Naples, Italy
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Padova, Italy
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Pisa, Italy
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Reggio Emilia, Italy
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Roma, Italy
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Roma, Italy
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Rozzano MI, Italy
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Aichi, Japan
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Chiba, Japan
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Fukuoka, Japan
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Hokkaido, Japan
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Hyōgo, Japan
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Ibaraki, Japan
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Kanagawa, Japan
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Kanagawa, Japan
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Kyoto, Japan
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Okayama, Japan
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Osaka, Japan
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Osaka, Japan
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Osaka, Japan
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Osaka, Japan
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Osaka, Japan
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Shizuoka, Japan
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Tokyo, Japan
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Tokyo, Japan
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DF, Mexico
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Guadalajara, Mexico
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Guadalajara, Mexico
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Mexico City, Mexico
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Oaxaca City, Mexico
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San Pedro Garza García, Mexico
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Tijuana, Mexico
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Breda, Netherlands
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Maastricht, Netherlands
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Nijmegen, Netherlands
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Utrecht, Netherlands
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Bergen, Norway
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Kristiansand, Norway
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Lrenskog, Norway
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Oslo, Norway
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Stavanger, Norway
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Tromsø, Norway
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Punta Pacifica Panama City Panama, Panama
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Bydgoszcz, Poland
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Warsaw, Poland
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Almada, Portugal
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Coimbra, Portugal
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Lisbon, Portugal
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Daegu, South Korea
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Gyeonggi-do, South Korea
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Seoul, South Korea
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Seoul, South Korea
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Seoul, South Korea
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Badajoz, Spain
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BaracaldoVizcaya, Spain
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Barcelona, Spain
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Barcelona, Spain
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Barcelona, Spain
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Córdoba, Spain
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Donostia / San Sebastian, Spain
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Elche Alicante, Spain
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Granada, Spain
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Jaén, Spain
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L'Hospitalet de Llobrega, Spain
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Las Palmas de Gran Canar, Spain
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Madrid, Spain
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Madrid, Spain
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Madrid, Spain
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Madrid, Spain
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Madrid, Spain
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Madrid, Spain
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Madrid, Spain
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Madrid, Spain
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Madrid, Spain
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Málaga, Spain
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Oviedo, Spain
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Pamplona, Spain
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Santander, Spain
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Seville, Spain
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Valencia, Spain
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Valencia, Spain
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Valencia, Spain
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Zaragoza, Spain
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Eskilstuna, Sweden
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Gothenburg, Sweden
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Linköping, Sweden
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Malmo, Sweden
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Stockholm, Sweden
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Stockholm, Sweden
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Uppsala, Sweden
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Kaohsiung City, Taiwan
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Tainan, Taiwan
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Taipei, Taiwan
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Taoyuan District, Taiwan
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Ankara, Turkey (Türkiye)
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Ankara, Turkey (Türkiye)
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Ankara, Turkey (Türkiye)
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Istanbul, Turkey (Türkiye)
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Birmingham, United Kingdom
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Chelmsford, United Kingdom
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Cheltenham, United Kingdom
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Edinburgh, United Kingdom
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Hull, United Kingdom
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Leeds West Yorkshire, United Kingdom
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London, United Kingdom
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London, United Kingdom
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Manchester, United Kingdom
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Sutton, United Kingdom
Study of Perioperative Dostarlimab in Participants With Untreated T4N0 or Stage III dMMR/MSI-H Resectable Colon Cancer · TrialPath