Phase 3b Trial Comparing Nadofaragene Firadenovec Treatment to Observation in Adults with Intermediate Risk Non-Muscle Invasive Bladder Cancer

What this Trial Is About

This trial evaluates nadofaragene firadenovec, a gene therapy using interferon alfa-2b amplification, compared with observation in participants with intermediate risk non-muscle invasive bladder cancer IR NMIBC. The study is a phase 3b, randomized, controlled trial aiming to assess treatment effects on recurrence-free survival over 24 months. Participants in the treatment group receive quarterly bladder instillations of nadofaragene firadenovec for 24 months. Disease evaluations occur within two weeks before each treatment instillation. Participants in both groups are followed according to the American Urological AssociationSociety of Urologic Oncology surveillance guidelines, which involve quarterly monitoring during the 24-month treatment period. During the study, participants undergo regular disease assessments, including monitoring for cancer recurrence and safety evaluations over 24 months. The main outcome measured is recurrence-free survival at 24 months. Adverse events and recurrence-free survival at 12 months are also tracked. Participants are monitored closely throughout the treatment and observation periods to evaluate long-term effects and safety.

Trial of Nadofaragene Firadenovec vs. Observation in Participants With Intermediate Risk Non-Muscle Invasive Bladder Cancer