Overview
This is a Phase 3, open-label, randomized trial designed to evaluate the RFS of TURBT followed by cretostimogene grenadenorepvec versus TURBT followed by observation for the treatment of participants with IR-NMIBC.
Description
Participants will be randomized 1:1 to cretostimogene grenadenorepvec after TURBT (Arm A) vs observation 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, complete bladder visualization (e.g., 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.
Participants in Arm B who recur with IR-NMIBC after TURBT and observation will be offered treatment with cretostimogene as per the treatment schedule in Arm A.
Eligibility
Inclusion Criteria:
- 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 12 weeks of study randomization
- Acceptable baseline organ function
Exclusion Criteria:
- High-risk NMIBC (e.g., HG T1, Recurrent or multifocal HG Ta>3cm tumor(s), CIS)
- Low-Risk NMIBC (e.g., solitary LG Ta ≤3 cm tumor)
- Disease in the prostatic urethra at any time or in the upper genitourinary tract within 24 months of randomization
- Muscle-invasive bladder cancer, locally advanced or metastatic bladder cancer
- Prior treatment with any human adenovirus serotype 5 based therapy (e.g., Ad-interferon or Adstiladrin)