This study is for people with high-risk, non-muscle invasive bladder cancer that has returned after treatment with BCG. Your cancer either did not fully respond to BCG or came back after initially responding, which is called BCG-exposed NMIBC. The purpose of this study is to find out if adding a chemotherapy drug called gemcitabine, given directly into the bladder through a catheter, to BCG works better than BCG alone. In this study, you will either receive BCG alone for up to 6 weeks or gemcitabine plus BCG for up to 10 weeks, called induction therapy. If the treatment is effective, you may continue with maintenance therapy, which is either BCG alone or gemcitabine plus BCG given over several weeks. After treatment, your doctor will monitor you for 5 years with regular checkups, cystoscopies, and CT scans to watch for side effects or recurrence. The main risks are that the study treatment may not work as well as usual care, and it may cause side effects such as pain with urination, urinary urgency, blood in the urine, bladder inflammation, or urinary tract infection. There may also be risks that study doctors do not yet know about.
There will be a total of 17 patients enrolled locally over the course of 42 months.