Trial of Nadofaragene Firadenovec vs. Observation in Participants With Intermediate Risk Non-Muscle Invasive Bladder Cancer
Purpose
A phase 3b, Randomized, Controlled Trial of Nadofaragene Firadenovec vs. Observation in Participants with Intermediate Risk Non-Muscle Invasive Bladder Cancer (IR NMIBC)
Condition
- Intermediate Risk Non-Muscle Invasive Bladder Cancer
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- 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 Criteria
- 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
Study Design
- Phase
- Phase 3
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Arm 1 Nadofaragene Firadenovec |
Participants in the nadofaragene firadenovec arm will receive quarterly instillations with nadofaragene firadenovec for 24 months. For these subjects, the disease evaluation visits will occur within 2 weeks prior to the investigation medicinal products instillation visits. |
|
|
No Intervention Arm 2 - Observation |
Subjects will be followed based on the surveillance schedule of the AUA/SUO guideline (quarterly) over the 24 months treatment period. . |
|
Recruiting Locations
Medstar Georgetown University Hospital
Washington D.C. 4140963, District of Columbia 4138106 20007
Washington D.C. 4140963, District of Columbia 4138106 20007
More Details
- Status
- Recruiting
- Sponsor
- Ferring Pharmaceuticals