Titre A Phase III Randomized, Open-Label, Multi-Center, Global Study of Durvalumab and Bacillus Calmette-Guerin (BCG) Administered as Combination Therapy Versus BCG Alone in High-Risk, BCG Naïve Non-Muscle Invasive Bladder Cancer Patients
Protocole ID POTOMAC
ClinicalTrials.gov ID NCT03528694
Type(s) de cancer Vessie/urothélial
Phase Phase III
Type étude Traitement
Médicament Durvalumab et Bacillus Calmette-Guerin
Institution CENTRE HOSPITALIER DE L'UNIVERSITE DE MONTREAL  
Ville Montréal
Investigateur(trice) principal(e) Dr Fred Saad
Coordonnateur(trice) Amal Nadiri
 514-890-8000 poste 26074
Statut Fermé
Critètes d'éligibilité
  • Aged at least 18 years
  • BCG-naïve patients.
  • Documented evidence of high-risk transitional cell bladder carcinoma stages T1 tumor, High grade/G3 tumor, CIS, or multiple and recurrent and large (with diameter of largest evaluable node ≥3 cm) tumors (all conditions must be met in this point)
  • Complete resection of all Ta/T1 papillary disease.
  • No prior radiotherapy to the bladder.
  • No prior exposure to immune-mediated therapy of cancer.
Critètes d'exclusion
  • Evidence of muscle-invasive, locally advanced, metastatic, and/or extra vesical bladder cancer (ie, T2, T3, T4, and / or stage IV).
  • Concurrent extravesical (ie, urethra, ureter, or renal pelvis), non-muscle-invasive transitional cell carcinoma of the urothelium.
  • Previous investigational product (IP) assignment in the present study
  • Any concurrent chemotherapy, IP, biologic, or hormonal therapy for cancer treatment.
  • Active or prior documented autoimmune or inflammatory disorders (eg, colitis, Crohn's disease, Graves' disease, rheumatoid arthritis etc.)
  • History of another primary malignancy
  • Active infection including TB, HBV, HCV and HIVActive infection.
  • Current or prior use of immunosuppressive medication within 14 days before the first dose of durvalumab.