Trial of Nadofaragene Firadenovec vs. Observation in Participants With Intermediate Risk Non-Muscle Invasive Bladder Cancer
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorFerring Pharmaceuticals
About this trial
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
Qualifiers
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)
Recurrence within 1 year, low-grade Ta
Solitary low-grade Ta >3 cm
Low-grade Ta, multifocal
Disqualifiers
Current or previous evidence of muscle invasive (muscularis propria) or metastatic disease presented at the screening visit
High-grade T1
Any recurrent, high-grade Ta
High-grade Ta >3 cm (or multifocal)
Trial design
Treatments tested in this trial
- Nadofaragene Firadenovec
Treatment groups
454 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov