Bladder Cancer Study Decision Tree

A Phase 1, Open-Label, Dose-Escalation, Multicenter Study to Investigate the Safety, Tolerability, Immunogenicity, and Pharmacokinetics (PK) of UGN-501 Intravesical Solution in Participants with Recurrent Non–Muscle Invasive Bladder Cancer (NMIBC).

BCG naïve (or no BCG in last 2yrs or 2 or fewer doses of BCG in the last 2yrs) CIS +/- papillary disease. Patients are randomized to TARA-002 (which is similar to BCG but composed of strep pyogenes) vs intravesical chemo – both given via induction and maintenance. Crossover allowed.