A Phase 3 Single-arm Multicenter Study to Evaluate the Efficacy and Safety of UGN-103 a Novel Formulation of UGN-102 for the Treatment of Patients With Low Grade (LG) Nonmuscle Invasive Bladder Cancer (NMIBC) at Intermediate Risk (IR) of Recurrence (UTOPIA)

Brief description of study

This study will test how well UGN-103, a new form of UGN-102, works and how safe it is for patients with low-grade bladder cancer (LG NMIBC). Patients who meet the study's requirements will first be checked to make sure they have LG NMIBC and not high-grade cancer. Then, they will receive UGN-103 in their bladder once a week for 6 weeks. The main goal is to see how many patients have a complete response (CR), which means no signs of cancer in the bladder. After 3 months, patients will be checked again to see if they still have a CR. If they do, they will return for check-ups every 3 months until their cancer comes back, spreads, they pass away, or they complete 12 months of follow-up. If a patient does not have a CR, they will receive standard care treatment. Safety will be monitored by looking at side effects, lab tests, and physical exams. The study will stop when the last patient completes their final visit after 12 months.


Clinical Study Identifier: s24-01042
ClinicalTrials.gov Identifier: NCT06331299
Principal Investigator: William C Huang.
Other Investigators: Victor Ricardo Adorno Febles, James S Wysock, Minas Platon Economides, Anthony Corcoran, Wei Phin Tan, Mary K O'Keeffe, Michael J. Zelefsky, David R. Wise.


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