Brief Title: Safety and Tolerability of TAR-200 in Subjects With Muscle-Invasive Bladder Cancer Who Are Unfit for Radical Cystectomy

PRIMARY OUTCOMES

Primary Outcome 1 - Measure:

Primary Outcome 1 - Timeframe: N/A

CONDITION

• Urinary Bladder Neoplasms

ELIGIBILITY

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

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

OFFICIAL INFORMATION

Name: Janssen Research & Development, LLC Clinical Trial

Role: Study Director

Affiliation: Janssen Research & Development, LLC

Overall Contact

Name: N/A

Phone: N/A

Email: N/A

LOCATION