The purpose of study is to compare bladder intact-event free survival (BI-EFS) in
participants receiving TAR-200 in combination with cetrelimab versus concurrent
TAR-200 is a gemcitabine intravesical delivery system that provides a continuous release of
gemcitabine into the urine. Urothelial carcinoma, specifically transitional cell carcinoma of
the upper and lower genitourinary tract, has demonstrated meaningful responsiveness to
deoxycytidine analogues. Gemcitabine has also demonstrated efficacy and a tolerable safety
profile in NMIBC and metastatic urothelial carcinoma. Study consists of screening phase of 42
days, treatment phase and follow up phase. The total duration of study will be up to 8 years.
Efficacy evaluation includes disease assessment (Cystoscopy/TURBT Biopsy/Pathology) and
Patient Reported Outcomes (Quality of Life Assessments) and safety assessments includes vital
sign measurements, 12-lead electrocardiogram (ECG), physical examinations, clinical
laboratory tests, cystoscopic examination, anti-drug antibody (ADA) assessments, concomitant
treatments/procedures and adverse event monitoring.
If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.
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