A Study to Evaluate TAR-210 Versus Intravesical Chemotherapy Treatment in Participants With High Risk Non-Muscle-Invasive Bladder Cancer

This study is for adults aged 18 or over. To be considered, you must have a specific type of high-risk bladder cancer that hasn't spread into the bladder muscle, and you must have had all visible tumours removed before starting the study. Your cancer must also show a particular genetic change (called an FGFR mutation or fusion) in your urine or tumour tissue.

Importantly, you must have tried a previous treatment called BCG, but it either hasn't worked, you couldn't complete it due to side effects, or the cancer returned after it. You should also be unable to have or be choosing not to have surgery to remove your bladder. Your general health should be good enough to take part in a clinical study.

Unfortunately, you cannot join this study if you have another type of bladder cancer called Carcinoma in situ (CIS), or if your cancer has spread to the muscle of your bladder or other parts of your body. You also can't participate if you have other active cancers that are growing or need treatment.

If you join this study, you will be randomly assigned to receive either the new treatment, TAR-210, or one of the standard chemotherapy treatments (Mitomycin C or Gemcitabine). This is like tossing a coin – neither you nor your doctor can choose which treatment you get. You will have regular visits to the clinic for assessments, which will include examinations, urine tests, and other checks to see how you are responding to the treatment and to monitor for any side effects.

The duration of the treatment and follow-up will depend on your individual response and the specific part of the study you are in. Throughout the study, the research team will closely monitor your health and bladder cancer status. Your participation will involve ongoing check-ups to track your progress and ensure your safety.