Titre A Phase 3, Open-label, Randomized Study of Nivolumab Combined With Ipilimumab Versus Standard of Care Chemotherapy in Participants With Previously Untreated Unresectable or Metastatic Urothelial Cancer
Protocole ID CA209-901 (CheckMate901)
ClinicalTrials.gov ID NCT03036098
Type(s) de cancer Vessie/urothélial
Phase Phase III
Stade Maladie avancée ou métastatique
Type étude Traitement
Médicament nivolumab et ipilimumab vs chimiothérapie standard
Institution CHU DE QUEBEC – UNIVERSITE LAVAL
   L'HOTEL-DIEU DE QUEBEC ET CRCEO
      11 Côte du Palais, Québec, QC, G1R 2J6
Ville Québec
Investigateur(trice) principal(e) Dr Louis Lacombe
Coordonnateur(trice) Marilyn Savard
 418-525-4444 poste 20414
Statut Fermé
Critètes d'éligibilité
  • Metastatic or inoperable urothelial cancer
  • Must have at least 1 lesion with measurable disease
  • Must have full activity or, if limited, must be able to walk and carry out activities such as light house work or office work
  • No prior systemic chemotherapy treatment in the metastatic setting
Critètes d'exclusion
  • Patients with disease that is suitable for local therapy administered with curative intent
  • Patients with active brain metastases or leptomeningeal metastases
  • Patients with active, known or suspected autoimmune disease
  • Prior treatment with an anti-PD1, anti-PDL1, anti-PDL2, anti-CD137, or anti-CTLA4 antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways