Status:
RECRUITING
Trial of Nadofaragene Firadenovec vs. Observation in Participants With Intermediate Risk Non-Muscle Invasive Bladder Cancer
Lead Sponsor:
Ferring Pharmaceuticals
Conditions:
Intermediate Risk Non-Muscle Invasive Bladder Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
A phase 3b, Randomized, Controlled Trial of Nadofaragene Firadenovec vs. Observation in Participants with Intermediate Risk Non-Muscle Invasive Bladder Cancer (IR NMIBC)
Eligibility Criteria
Inclusion
- Diagnosed with intermediate risk non-muscle invasive bladder cancer (IR NMIBC) as defined by American Urological Association (AUA)/Society of Urologic Oncology \[SUO\] Guideline (2020)
- Has undergone adequate transurethral resection of bladder tumor (TURBT; with or without peri-operative chemotherapy) within 60 days prior to randomization:
- Recurrence within 1 year, low-grade Ta
- Solitary low-grade Ta \>3 cm
- Low-grade Ta, multifocal
- Solitary high-grade Ta, ≤3 cm
- Low-grade T1
- Restage TURBT may be done at the discretion of the investigator
Exclusion
- Current or previous evidence of muscle invasive (muscularis propria) or metastatic disease presented at the screening visit
- High risk NMIBC defined as:
- High-grade T1
- Any recurrent, high-grade Ta
- High-grade Ta \>3 cm (or multifocal)
- Any carcinoma in situ (CIS)
- Any Bacillus Calmette-Guérin (BCG) failure in high-grade subject
- Any variant histology
- Any prostatic urethral involvement
- Low risk NMIBC defined as:
- First occurrence of low-grade solitary Ta ≤3 cm
- Recurrence of low-grade solitary Ta ≤3 cm \>12 months from previous occurrence
- Papillary urothelial neoplasm of low malignant potential
Key Trial Info
Start Date :
October 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2031
Estimated Enrollment :
454 Patients enrolled
Trial Details
Trial ID
NCT06510374
Start Date
October 1 2024
End Date
June 30 2031
Last Update
January 7 2026
Active Locations (63)
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1
University of South Alabama (USA) Health System - USACM
Mobile, Alabama, United States, 36606
2
Urology Associates of Mobile
Mobile, Alabama, United States, 56608
3
Mayo Clinic Arizona
Phoenix, Arizona, United States, 85054
4
Urology Associates of Central California
Fresno, California, United States, 93720