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

• Status: Active, not recruiting
• Trial end date: 2022-07-22
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Janssen Research & Development, LLC; Taris Biomedical LLC
• Treatments: Gemcitabine

Criteria

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