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RECRUITING

NCT05855200

PHASE3

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

Sponsor: GlaxoSmithKline

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

892

Start Date

2023-08-01

Completion Date

2031-03-27

Last Updated

2026-01-23

Healthy Volunteers

Conditions

Colonic Neoplasms Neoplasms, Colon

Interventions

BIOLOGICAL

Dostarlimab

Dostarlimab will be administered.

DRUG

CAPEOX

CAPEOX will be administered.

DRUG

FOLFOX

FOLFOX will be administered.

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

Locations (266)

GSK Investigational Site

Tucson, Arizona, United States

GSK Investigational Site

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

GSK Investigational Site

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

GSK Investigational Site

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

GSK Investigational Site

Barretos, Brazil

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Belém, Brazil

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Campo Grande, Brazil

GSK Investigational Site

Lages, Brazil

GSK Investigational Site

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

GSK Investigational Site

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

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

GSK Investigational Site

Hangzhou, China

And 166 more locations on ClinicalTrials.gov

Clinical Research Directory

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

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (266)