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Site for A Phase 3, Single-Arm, Multicenter Study 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 (IR) of Recurrence
This Phase 3, multinational, single-arm, multicenter study will evaluate the efficacy and safety of UGN-102 as primary chemoablative therapy in patients with LG IR NMIBC.
Administered locally via standard catheters, UGN-102 is designed to fill and conform to the anatomy of the bladder and dwell for a period of several hours before being excreted via normal urine flow.
All
18 year(s) or older
NCT05243550
SITE00001122
Inclusion Criteria:
Low Grade Bladder CancerRequiring treatment with TURBT
Multiple tumors
Tumor >3cm
Tumor recurrence within 1 year
Exclusion Criteria:
Received BCG within previous 1 yearHistory of High Grade bladder Cancer in past 2 years
Sensitivity to mitomycin
Neurogenic bladder
Significant urethral stricture precluding passage of urethral catheter
Cancer
Approved drug(s)