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1 Study Matches

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.
Kathleen Lehman at klehman3@pennstatehealth.psu.edu or 717-531-5930
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18 year(s) or older
This study is NOT accepting healthy volunteers
NCT03558503
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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 [2] 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
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Location
Hershey, PA