A Study of TAR-200 in Participants With Muscle-Invasive Urothelial Carcinoma of the Bladder Who Are Ineligible for or Refuse Cisplatin-based Chemotherapy and Who Are Unfit for Radical Cystectomy

A Multicenter Study Evaluating Safety and Efficacy of TAR-200 in Subjects With Muscle-Invasive Urothelial Carcinoma of the Bladder Who Are Ineligible for or Refuse Cisplatin-based Chemotherapy and Who Are Unfit for Radical Cystectomy

The purpose of this study is to evaluate both the safety and tolerability of up to 4 dosing cycles of TAR-200 for 21 days per dosing cycle in the induction period.

Inclusion Criteria:

• Histological proof of non-metastatic muscle-invasive urothelial cell carcinoma of the bladder
• Participant must have been as fully resected as possible per the physician's judgment
• Participants must be deemed unfit for RC due to comorbid conditions with a risk of mortality
• Participants must refuse or be deemed ineligible for cisplatin-based chemotherapy
• Participant must refuse or not be eligible for radiotherapy

Exclusion Criteria:

• Other active malignancies
• Presence of any bladder or urethral anatomic feature that in the opinion of the Investigator may prevent the safe placement, indwelling use, or removal of TAR-200
• Pyeloureteral tube externalized to the skin (ureteral stent or unilateral nephrostomy tube is allowed)
• Evidence of bladder perforation during diagnostic cystoscopy
• Concurrent clinically significant infections as determined by the treating Investigator