Trial of Nadofaragene Firadenovec vs. Observation in Participants With Intermediate Risk Non-Muscle Invasive Bladder Cancer
Part of paid clinical trials in Mobile, Alabama.
- Sponsor
- Ferring Pharmaceuticals
- Study ID
- NCT06510374
- Phase
- PHASE3
- Status
- Recruiting
Conditions
- Intermediate Risk Non-Muscle Invasive Bladder Cancer
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Nadofaragene Firadenovec — DRUGVector-based gene therapy for NMIBC treatment to potentiate durable therapeutic responses by interferon (IFN) alfa-2b (IFN-α2b) amplification.
Study Details
A phase 3b, Randomized, Controlled Trial of Nadofaragene Firadenovec vs. Observation in Participants with Intermediate Risk Non-Muscle Invasive Bladder Cancer (IR NMIBC)
Key Dates
- Start date
- Oct 1, 2024
- Status verified
- May 2026
- Primary completion
- Jun 30, 2028
- Completion
- Jun 30, 2031
Study Design
- Enrollment
- 454 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Experimental: Arm 1 Nadofaragene FiradenovecParticipants 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 - ObservationSubjects will be followed based on the surveillance schedule of the AUA/SUO guideline (quarterly) over the 24 months treatment period. .
Primary Outcome Measure
Recurrence Free survival [ Time Frame: 24 months ]
Central Contacts
- Ferring Pharmaceuticals833-548-1402