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A Phase 2b, Single-Arm, Multicenter Trial to Evaluate the Efficacy and Safety of UGN-102 as Primary Chemoablative Therapy in Patients with Low Grade (LG) Non-Muscle-Invasive Bladder Cancer (NMIBC) at Intermediate Risk of Recurrence
This study is for patients with bladder cancer (low-grade non-muscle-invasive) who are at an intermediate risk of recurrence. The purpose of this study is to evaluate the effectiveness and safety of an experimental gel which will serve as a reservoir for a more prolonged release of a type of chemotherapy locally in the bladder.
18 year(s) or older
Inclusion Criteria:Newly diagnosed or historic LG NMIBC (Ta) histologically confirmed by cold cup biopsy at screening or within 6 weeks of screening
At intermediate risk for progression, defined as having 1 or 2 of the following: a. presence of multiple tumors, b. solitary tumor >3 cm c. recurrence (≥ 1 occurrence of LG NMIBC within 1 year of the current diagnosis).
Negative voiding cytology for HG disease at or within 6 weeks of enrollment.
Exclusion Criteria:History of CIS on preliminary cystoscopy within 5 years of enrollment.
Received BCG treatment for UC within previous 2 years.
History of HG papillary UC in the past  years
History of pelvic radiotherapy.
Past or current muscle invasive (i.e., T2, T3, T4) or metastatic UC or concurrent upper tract urothelial carcinoma (UTUC).
Kidney & Urinary System, Cancer