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Trial Title:
Trial of Nadofaragene Firadenovec vs. Observation in Participants With Intermediate Risk Non-Muscle Invasive Bladder Cancer
NCT ID:
NCT06510374
Condition:
Intermediate Risk Non-Muscle Invasive Bladder Cancer
Conditions: Official terms:
Urinary Bladder Neoplasms
Non-Muscle Invasive Bladder Neoplasms
Study type:
Interventional
Study phase:
Phase 3
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Nadofaragene Firadenovec
Description:
Vector-based gene therapy for NMIBC treatment to potentiate durable therapeutic responses
by interferon (IFN) alfa-2b (IFN-α2b) amplification.
Arm group label:
Arm 1 Nadofaragene Firadenovec
Other name:
Adstiladrin
Summary:
A phase 3b, Randomized, Controlled Trial of Nadofaragene Firadenovec vs. Observation in
Participants with Intermediate Risk Non-Muscle Invasive Bladder Cancer (IR NMIBC)
Criteria for eligibility:
Criteria:
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 complete 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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Ferring Investigational Site
Address:
City:
Los Angeles
Zip:
90017
Country:
United States
Status:
Recruiting
Contact:
Last name:
Global Clinical Compliance
Start date:
October 1, 2024
Completion date:
January 1, 2031
Lead sponsor:
Agency:
Ferring Pharmaceuticals
Agency class:
Industry
Source:
Ferring Pharmaceuticals
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06510374
