Bladder Cancer Clinical Trial
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
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.
Eligibility 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
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There are 12 Locations for this study
Phoenix Arizona, 85054, United States
Dalton Georgia, 30720, United States
Hanover Maryland, 21076, United States
Troy Michigan, 48084, United States
Rochester New York, 14642, United States
Nashville Tennessee, 37209, United States
Nashville Tennessee, 37232, United States
Austin Texas, 78750, United States
Virginia Beach Virginia, 23462, United States
Barcelona , 08025, Spain
Madrid , 28041, Spain
Valencia , 46009, Spain
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