Evaluation of Nadofaragene Firadenovec Alone or with Chemotherapy for High-Grade BCG-Unresponsive Non-Muscle Invasive Bladder Cancer

What this Trial Is About

Researchers are investigating treatments for participants with high-grade non-muscle invasive bladder cancer NMIBC that is unresponsive to Bacillus Calmette-Guerin BCG therapy. This phase 3 trial evaluates the safety and effects of nadofaragene firadenovec, a gene therapy, used alone or combined with chemotherapy or immunotherapy. The study aims to build on earlier findings where over half of participants achieved a complete response in a previous trial. Participants will be randomly assigned to receive one of the following nadofaragene firadenovec alone via intravesical instillation, nadofaragene firadenovec combined with intravesical gemcitabine and docetaxel chemotherapy, or nadofaragene firadenovec combined with intravenous pembrolizumab immunotherapy. The pembrolizumab arm is now closed to new participants, focusing enrollment on the other two arms. Treatments will be administered according to the study protocol to assess their effects on bladder cancer. During the trial, participants will undergo regular evaluations including tumor assessments, pathology staging, and monitoring for disease progression and adverse events for up to 36 months. The main outcomes measured include complete response rates at 3 and 6 months, durability of response, progression to muscle-invasive disease, need for cystectomy, and overall survival. Safety and tolerability will also be closely observed. Participants will be followed throughout the study duration, which extends up to the end of 2030.

A Trial to Evaluate Intravesical Nadofaragene Firadenovec Alone or in Combination With Chemotherapy or Immunotherapy in Participants With High-grade BCG Unresponsive Non-muscle Invasive Bladder Cancer