This study involves people with high-risk non-muscle-invasive bladder cancer who have specific changes in their genes called FGFR alterations. Non-muscle-invasive bladder cancer means the cancer is in the inner lining of the bladder but has not grown into the deeper muscle layer of the bladder wall. High-risk means the cancer is more likely to come back or get worse. These individuals have already received treatment with Bacillus Calmette-Guérin, which is a type of vaccine used to treat bladder cancer by placing it directly into the bladder, but the cancer has either come back or the treatment could not be completed due to side effects. The study will compare a new treatment method using erdafitinib delivered through a device placed inside the bladder called an intravesical delivery system, known as TAR-210, with standard chemotherapy treatments that are also placed directly into the bladder.
The chemotherapy options that doctors may choose from include gemcitabine or mitomycin, which are medications that work to kill cancer cells. The erdafitinib treatment is given using a special catheter device that places the medication directly into the bladder where it can stay and work over time. The purpose of this study is to find out if the erdafitinib delivery system works better than the standard chemotherapy treatments in preventing the cancer from coming back or getting worse.
People in the study will be randomly assigned to receive either the erdafitinib intravesical delivery system or one of the chemotherapy treatments chosen by their doctor. The study will follow participants over time to see how well each treatment works and to check for any side effects. Before joining the study, all visible tumors must be completely removed, and participants must have testing to confirm they have the specific FGFR changes that the erdafitinib treatment targets. The study is designed for people who cannot have or do not want surgery to remove their bladder.
Belgium 
France 
Germany 
Greece 
Italy 
Spain 
The Netherlands 
