NCT06510374 · Ferring Pharmaceuticals
Trial of Nadofaragene Firadenovec vs. Observation in Participants With Intermediate Risk Non-Muscle Invasive Bladder Cancer
(ABLE-32)
What this study is about
A phase 3b, randomly assigned, Controlled Trial of Nadofaragene Firadenovec vs. Observation in Participants with Intermediate Risk Non-Muscle Invasive Bladder Cancer (IR NMIBC)
View original scientific description
A phase 3b, Randomized, Controlled Trial of Nadofaragene Firadenovec vs.
Interventions
DRUG
Nadofaragene Firadenovec
Vector-based gene therapy for NMIBC treatment to potentiate durable therapeutic responses by interferon (IFN) alfa-2b (IFN-α2b) amplification.
Primary outcome measures
Recurrence Free survival
Time frame: 24 months
Recurrence-free survival, defined as the time from the date of randomization to the date of first documented recurrence, progression or death (due to any cause), whichever occurs first during the treatment period.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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 ureth
Where
- Mobile, Alabama
- Phoenix, Arizona
- Tucson, Arizona
- Little Rock, Arkansas
- Bakersfield, California
- Fresno, California
- Los Angeles, California
- Murrieta, California
- Orange, California
- Santa Monica, California
- Denver, Colorado
- Washington D.C., District of Columbia
And 36 more locations — see the full list below.
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jul 10, 2026 · Source of record for eligibility and locations