Groupe d'Etude en Oncologie du Quebec

Title	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
Cancer Type(s)	Bladder/urothelial
Phase	Phase III
Stage
Study Type	Clinical
Drug	Sasanlimab avec BCG
Institution	CIUSSS DU SAGUENAY – LAC-SAINT-JEAN HOPITAL DE CHICOUTIMI 305, rue Saint-Vallier G7H 5H6 , Chicoutimi, QC
City
Principal Investigator	Dr. Jean-Benoit Paradis
Coordinator	Veronick Tremblay 418-541-1234 poste 2708
Status	Closed
Activation Date
Eligibility Criteria	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
Exclusion Criteria	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

Groupe d'étude en oncologie du Québec