This phase II trial is comparing a type of targeted therapy with the investigator's choice of chemotherapy for the treatment of high-risk non-muscle invasive bladder cancer.
This trial is treating patients with non-muscle invasive bladder cancer.
This is a systemic therapy trial.
You may be able to join this trial if:
- You have had treatment, but your cancer has come back.
You may be excluded from this trial if:
- You have a certain disease or psychological condition.
- You have been diagnosed with a prior or secondary type of cancer.
Clinical trials have complex eligibility criteria - talk to your doctor about your interest in this trial.
Clinical Summary Read More
Trial Identifiers
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Scientific Title
A Randomized Phase 2 Study of Erdafitinib Versus Investigator Choice of Intravesical Chemotherapy in Subjects Who Received Bacillus Calmette-Guérin (BCG) and Recurred With High Risk Non-Muscle-Invasive Bladder Cancer (NMIBC) and FGFR Mutations or Fusions
Commercial Sponsor
Janssen-Cilag Pty Ltd
Summary
This trial consists of a screening period, treatment phase and follow-up phase.
Eligible patients will be randomised to receive treatment with oral erdafitinib for a 2-year period OR the investigator's choice of chemotherapy (either intravesical gemcitabine or intravesical mitomycin C (MMC)/hyperthermic MMC) once weekly for at least 4 doses of induction followed by monthly maintenance for at least 6 months.
Recruiting Hospitals Read More