A Phase 3, Randomized Study of Adjuvant Cretostimogene Grenadenorepvec versus Observation for the Treatment of Intermediate Risk Non-Muscle Invasive Bladder Cancer (IR-NMIBC) Following Transurethral Resection of Bladder Tumor (TURBT).
Primary:
To evaluate the RFS of TURBT followed by cretostimogene versus TURBT followed by observation in participants with IR-NMIBC.
Secondary:
- Evaluate the RFS at 12 months and 24 months
- Assess progression free survival
- Evaluate the frequency of radical cystectomy
- Evaluate the time to next bladder cancer-related intervention
- Evaluate the high-grade RFS
- Evaluate the safety of cretostimogene treatment
- Rutgers University
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: 1. Recurrent LG Ta within 12 months of prior LG or HG (HG Ta ≤ 3 cm) tumor 2. Solitary LG Ta >3 cm tumor 3. Multifocal LG Ta tumors 4. Primary and solitary HG Ta ≤3 cm tumor 5. 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)
Please note that we have obtained the inclusion and exclusion criteria information from the National Institutes of Health’s clinical trials web site ClinicalTrials.gov. The listed criteria may not necessarily reflect recent amendments to the protocol and the current criteria.
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