A Study of Adjuvant Cretostimogene Grenadenorepvec for Treatment of Intermediate Risk NMIBC Following TURBT
Brief 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 observation for the treatment of participants with IR-NMIBC.
Additional Resources
Eligibility Criteria
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)
Last Updated: 4/15/2025
This website provides general information about the clinical trial for informational purposes only. For complete and up-to-date details, please refer to the official listing on ClinicalTrials.gov.
