Study Comparing TAR-200 and Chemotherapy for Recurrent High-Risk Non-Muscle-Invasive Bladder Cancer After BCG Treatment

Inclusion Criteria

• Have a confirmed diagnosis of recurrent high-risk non-muscle-invasive bladder cancer (HR-NMIBC) with papillary tumors only, classified as high-grade Ta or any T1, without carcinoma in situ (CIS).
• Tumors must mainly be of urothelial (transitional cell) type, but not neuroendocrine or small cell types.
• Must be unable or have chosen not to undergo bladder removal surgery (Radical Cystectomy).
• Have a performance status score of 0, 1, or 2, indicating full activity or some restriction in strenuous activities.

Exclusion Criteria

• Have carcinoma in situ (CIS) at any time from diagnosis of recurrent HR-NMIBC to the start of the study.
• Have or have had muscle-invasive, locally advanced, non-removable, or metastatic bladder cancer.
• Have any bladder or urethral conditions that could make it unsafe to use or remove TAR-200, as judged by the study doctor. Men with tumors in the prostatic urethra are excluded.
• Have a history of excessive urination, with more than 4000 milliliters of urine in 24 hours.
• Cannot have a permanent catheter, but occasional catheter use is allowed.
• Have previously been treated with TAR-200.