Last updated 3 months ago
Study of Perioperative Dostarlimab in Participants With Untreated T4N0 or Stage III dMMR/MSI-H Resectable Colon Cancer
711 patients around the world
Available in Panama, Spain, United States, Mexico, Argentina, Brazil
GlaxoSmithKline
8Research sites
711Patients around the world
This study is for people with
Colorectal cancer
Colon cancer
Requirements for the patient
From 18 Years
All Gender
Medical requirements
- Has untreated pathologically confirmed colon adenocarcinomaHas resectable colon adenocarcinoma defined as clinically T4N0 or Stage IIIHas radiologically evaluable diseaseHas a tumor demonstrating the presence of either dMMR status or MSI-H
- Has distant metastatic disease.Has received prior medical therapy (chemotherapy, immunotherapy, biologic, or targeted therapy), radiation therapy or surgery for management of colon cancerHas a tumor that, in the investigator's judgment is causing symptomatic bowel obstruction or otherwise requires urgent/emergent surgeryHas undergone any major surgical procedure, open biopsy, or experienced significant traumatic injury within 28 days prior to enrollmentHas any history of interstitial lung disease or pneumonitisHas 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 jaundiceHas a history of allogenic stem cell transplantation or organ transplantationIs 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 interventionIs pregnant, breastfeeding, or expecting to conceive children within the projected duration of the studyHas 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
Sites
Sanatorio de la Mujer - Rosario
Recruiting
CEMIC - Hospital Universitario Sede Saavedra - CABA, Buenos Aires
Recruiting
Sanatorio Médico de Diagnóstico y Tratamiento SA
Recruiting
Hospital Italiano de Buenos Aires - CABA, Buenos Aires
Recruiting
Hospital Privado de la Comunidad
Recruiting
Instituto Médico Especializado Alexander Fleming - CABA, Buenos Aires
Recruiting
Sanatorio Allende (Nueva Córdoba)
Recruiting
Fundación Favaloro para la Docencia e Investigación Médica - CABA, Buenos Aires
Recruiting
StudyAZUR-2
SponsorGlaxoSmithKline
Study typeInterventional
Conditions
Colon cancer
Requirements
From 18 YearsAll Gender
Unique study IDclinicaltrials.gov
NCT05855200
