Bladder Cancer Study Decision Tree

AUA IR NMIBC (including HG <3cm) will be randomized to Adstiladrin (intravesc 1x q3mo) vs observation. Patients on observation who have an IR recurrence can crossover to treatment.

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.

BCG exposed, unresponsive, or intolerant pure papillary disease. Must test FGFR positive. Patients will randomize to TAR-210 (pretzel device) with Erdafitanib (FGFR inhibitor) exchanged q3mo vs intravesical chemo induction and q1mo maintenance.

Cohort B – HR BCG exposed patients with CIS or papillary disease, all patients will have Cretostimogene

BCG unresponsive (by the FDA definition, must have had at least 5 of 6 induction rounds and 2 of 3 maintenance or 2 of 6 reinduction) CIS. All patients will have TARA-002 which is similar to BCG but composed of strep pyogenes – given via induction and maintenance.

A Phase 2 Open-label Randomized Study of V940 in Combination With BCG Versus BCG Monotherapy in Participants With High-risk Non-muscle Invasive Bladder Cancer (INTerpath-011)