Informations générales (source: ClinicalTrials.gov)
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 (AZUR-2)
Interventional
Phase 3
GlaxoSmithKline (Voir sur ClinicalTrials)
août 2023
décembre 2030
28 août 2024
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.
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CLCC INSTITUT GUSTAVE ROUSSY | Michel DUCREUX | 21/06/2024 13:38:04 | Contacter | ||
| HOPITAL FOCH | Asmahane BENMAZIANE TEILLET | 05/05/2025 07:12:14 | Contacter | ||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| GSK Investigational Site - 13385 - Marseille Cedex 5 - France | US GSK Clinical Trials Call Center | Contact (sur clinicalTrials) | |||
| GSK Investigational Site - 31059 - Toulouse Cedex 9 - France | US GSK Clinical Trials Call Center | Contact (sur clinicalTrials) | |||
| GSK Investigational Site - 33604 - Pessac cedex - France | US GSK Clinical Trials Call Center | Contact (sur clinicalTrials) | |||
| GSK Investigational Site - 35042 - Rennes Cedex - France | US GSK Clinical Trials Call Center | Contact (sur clinicalTrials) | |||
| GSK Investigational Site - 42270 - Saint-Priest en Jarez - France | US GSK Clinical Trials Call Center | Contact (sur clinicalTrials) | |||
| GSK Investigational Site - 44093 - Nantes cedex 1 - France | US GSK Clinical Trials Call Center | Contact (sur clinicalTrials) | |||
| GSK Investigational Site - 69008 - Lyon - France | US GSK Clinical Trials Call Center | Contact (sur clinicalTrials) | |||
| GSK Investigational Site - 75015 - Paris - France | US GSK Clinical Trials Call Center | Contact (sur clinicalTrials) | |||
| GSK Investigational Site - 76000 - Rouen Cedex - France | US GSK Clinical Trials Call Center | Contact (sur clinicalTrials) | |||
| GSK Investigational Site - 92150 - Suresnes - France | US GSK Clinical Trials Call Center | Contact (sur clinicalTrials) | |||
| GSK Investigational Site - 94805 - Villejuif Cedex - France | US GSK Clinical Trials Call Center | Contact (sur clinicalTrials) | |||
Critères
Tous
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
- 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
- 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