drugset / Trial / NCT06919965

A Study to Evaluate TAR-210 Versus Intravesical Chemotherapy Treatment in Participants With High Risk Non-Muscle-Invasive Bladder Cancer

NCT06919965

Phase 3 Recruiting 220 enrolled Janssen Research & Development, LLC
RandomizedParallel-groupOpen-labelTreatment

Summary

The main purpose of this study is to compare the disease-free survival (the length of time after randomization that a participant survives without any signs or symptoms of the cancer returning, or progressing) between Bacillus Calmette-Guérin (BCG) treated participants receiving treatment with TAR-210 versus investigator's choice of intravesical chemotherapy for treatment of high-risk non-muscle-invasive bladder cancer (HR-NMIBC).

Timeline

Start
2025-09-10
Primary completion
2028-04-06
Completion
2032-03-16

Drugs

EvaluationDrugModalityDoseRoute
Subject Erdafitinib Small molecule Intrathecal
Comparator Gemcitabine Small molecule Intrathecal
Comparator Mitomycin C Other / unclassified Intrathecal