Titre A Phase 3, Multinational, Randomized, Open-Label, Three Parallel-Arm Study of PF-06801591, an Anti-PD-1 Antibody, in Combination With Bacillus Calmette-Guerin (BCG Induction With or Without BCG Maintenance) Versus BCG (Induction and Maintenance) in Participants With High-Risk, BCG-Naïve Non-Muscle Invasive Bladder Cancer
Protocole ID CREST (B8011006)
ClinicalTrials.gov ID NCT04165317
Type(s) de cancer Vessie/urothélial
Phase Phase III
Type étude Clinique
Médicament Sasanlimab avec BCG
Institution CIUSSS DU SAGUENAY – LAC-SAINT-JEAN
   HOPITAL DE CHICOUTIMI
      305, rue Saint-Vallier G7H 5H6 , Chicoutimi, QC
Ville Chicoutimi
Investigateur(trice) principal(e) Dr Jean-Benoit Paradis
Coordonnateur(trice) Veronick Tremblay
 418-541-1234 poste 2708
Statut Actif en recrutement
Critètes d'éligibilité
  • Histological confirmed diagnosis of high risk non-muscle invasive transitional cell carcinoma (TCC) of the urothelium of the urinary bladder (tumors of mixed transitional/non-transitional cell histology are allowed, but TCC must be the predominant histology)
  • Complete resection of all Ta/T1 papillary disease (including participants with concurrent CIS), with most recent TURBT occurring within 12 weeks prior to randomization. A second TURBT must have been performed if indicated according to the current locally applicable guidelines, ie, American Urological Association, European Association of Urology
Critètes d'exclusion
  • Evidence of muscle-invasive, locally advanced or metastatic urothelial cancer or concurrent extravesical, non-muscle invasive TCC of the urothelium
  • Intravesical BCG therapy within 2 years prior to randomization. Prior intravesical chemotherapy for NMIBC is allowed
  • Prior immunotherapy with anti PD-1, anti PD-L1, anti PD-L2, or anti cytotoxic T-lymphocyte-associated antigen-4 (CTLA-4) antibody
  • Prior treatment with immunostimulatory agents including interleukin (IL)-2, IL-15, interferon (INF)
  • Prior radiation therapy to the bladder