This study focuses on patients with non-muscle invasive bladder cancer who have not responded to previous treatment with Bacillus Calmette-Guerin therapy. The study will evaluate a new treatment approach using nadofaragene firadenovec, either alone or in combination with other medications. The combinations will include chemotherapy drugs (gemcitabine and docetaxel) or immunotherapy (pembrolizumab).
The purpose of this research is to determine how safe and effective these treatment combinations are for patients whose bladder cancer has not responded to standard therapy. The treatment involves placing medication directly into the bladder through a process called intravesical instillation. The study will monitor how well the cancer responds to these treatments over time.
During the study, which may last up to 24 months, participants will receive their assigned treatment according to a specific schedule. Some patients will receive only nadofaragene firadenovec, while others will receive it in combination with either chemotherapy or immunotherapy. The study will track whether the cancer disappears completely after treatment, which is called a complete response.
Czechia 
Denmark 
France 
Poland 
Spain 
