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Recruiting Phase 3 NCT05855200

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

Phase 3 – large-scale trial before approval
Conditions: Colonic Neoplasms Neoplasms, Colon

Sponsor: GlaxoSmithKline

trial.available_in: БГ
Overview
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.
Who can participate
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 27
Argentina (1)
GSK Investigational Site
Buenos Aires
US GSK Clinical Trials Call Center
Australia (1)
GSK Investigational Site
Newcastle , New South Wales
US GSK Clinical Trials Call Center
Belgium (1)
GSK Investigational Site
Aalst
US GSK Clinical Trials Call Center
Brazil (1)
GSK Investigational Site
Barretos
US GSK Clinical Trials Call Center
Canada (1)
GSK Investigational Site
Edmonton , Alberta
WITHDRAWN
China (1)
GSK Investigational Site
Beijing
US GSK Clinical Trials Call Center
Czech Republic (1)
GSK Investigational Site
Hradec Králové
US GSK Clinical Trials Call Center
Estonia (1)
GSK Investigational Site
Tallinn
US GSK Clinical Trials Call Center
Finland (1)
GSK Investigational Site
Helsinki
US GSK Clinical Trials Call Center
France (1)
GSK Investigational Site
Lyon
US GSK Clinical Trials Call Center
Germany (1)
GSK Investigational Site
Berlin
US GSK Clinical Trials Call Center
Greece (1)
GSK Investigational Site
Athens
COMPLETED
India (1)
GSK Investigational Site
Bengaluru , Karnataka
US GSK Clinical Trials Call Center
Italy (1)
GSK Investigational Site
Cagliari
US GSK Clinical Trials Call Center
Japan (1)
GSK Investigational Site
Aichi
US GSK Clinical Trials Call Center
Mexico (1)
GSK Investigational Site
DF
US GSK Clinical Trials Call Center
Netherlands (1)
GSK Investigational Site
Breda
US GSK Clinical Trials Call Center
Norway (1)
GSK Investigational Site
Bergen
US GSK Clinical Trials Call Center
Panama (1)
GSK Investigational Site
Punta Pacifica Panama City Panama
US GSK Clinical Trials Call Center
Poland (1)
GSK Investigational Site
Bydgoszcz
US GSK Clinical Trials Call Center
South Korea (1)
GSK Investigational Site
Daegu
US GSK Clinical Trials Call Center
Spain (1)
GSK Investigational Site
Badajoz
US GSK Clinical Trials Call Center
Sweden (1)
GSK Investigational Site
Eskilstuna
WITHDRAWN
Taiwan (1)
GSK Investigational Site
Kaohsiung City
US GSK Clinical Trials Call Center
Turkey (1)
GSK Investigational Site
Ankara
US GSK Clinical Trials Call Center
United Kingdom (1)
GSK Investigational Site
Birmingham
US GSK Clinical Trials Call Center
United States (1)
GSK Investigational Site
Tucson , Arizona
US GSK Clinical Trials Call Center
Technical details
Status
Recruiting
Phase
Phase 3
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
18 Years
Healthy volunteers
No
Start date
01.08.2023
Completion date
27.03.2031
Registry ID
NCT05855200
Source
anzctr
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