A Study of Adjuvant Cretostimogene Grenadenorepvec for Treatment of Intermediate Risk NMIBC Following TURBT
                                  
                                      
                                          
                                          
                                              
                                              
                                                  Bladder Cancer
Unknown Primary
                                              
                                           
                                          
                                          
                                              
                                              
                                                  18 Years and older, Male and Female
                                              
                                           
                                          
                                       
                                      
                                          
                                          
                                              
                                              
                                                  PIVOT-006 (primary)
NCI-2024-03570
                                              
                                           
                                          
                                          
                                       
                                   
                               
                           
                          
                              
Summary
                              This is a Phase 3, open-label, randomized trial designed to evaluate the RFS of TURBT
followed by cretostimogene grenadenorepvec versus TURBT followed by surveillance for the
treatment of participants with IR-NMIBC.
                          
                          
                              
Objectives
                              Participants will be randomized 1:1 to cretostimogene grenadenorepvec after TURBT (Arm A)
vs surveillance after TURBT (Arm B).
Participants in Arm A will receive an induction course and then quarterly maintenance
courses of cretostimogene through Month 13, if there is no disease recurrence.
Disease status will be assessed using urine cytology, cystoscopy, and directed
TURBT/biopsy (if indicated) every 3 months for the first 2 years after randomization and
then every 6 months for an additional year or until disease recurrence. CT Urogram/MRU
every 12 months.
Participants in Arm B who recur with IR-NMIBC after TURBT and surveillance will be
offered treatment with cretostimogene as per the treatment schedule in Arm A.
                          
                          
                              Eligibility
                              
	- Pathologically confirmed IR-NMIBC, per American Urologic Association/Society of Urologic Oncology/National Comprehensive Cancer Network guidelines, within 90 days of participant randomization:
- Recurrent LG Ta within 12 months of prior LG or HG (HG Ta = 3 cm) tumor
- Solitary LG Ta >3 cm tumor
- Multifocal LG Ta tumors
- Primary and solitary HG Ta =3 cm tumor
- LG T1 tumor
- All visible disease removed by TURBT within 90 days of study randomization
- Acceptable baseline organ function
 
                          
                              Treatment Sites in Georgia
                             
                              
                                  
                                  
                                          
                                              
                                                  
                                              
                                              
                                                  
                                                      
230 East DeRenne Ave
Savannah, GA 31405
(912) 790-4036
                                                  
                                                  
                                                  
                                              
 
                                           
                                      
                                          
                                      
                                          
                                      
                                  
                               
                              
                                  
                           
                           
                              
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