drugset / Trial / NCT06211764

A Study of TAR-200 Versus Intravesical Chemotherapy in Participants With Recurrent High-Risk Non-Muscle-Invasive Bladder Cancer (HR-NMIBC) After Bacillus Calmette-Guérin (BCG)

NCT06211764

Phase 3 Active not recruiting 272 enrolled Janssen Research & Development, LLC
RandomizedParallel-groupOpen-labelTreatment

Summary

The purpose of this study is to compare disease free survival (DFS) in participants with recurrence of papillary-only high-risk non-muscle-invasive bladder cancer (HR-NMIBC) within 1 year of last dose of Bacillus Calmette-Guérin (BCG) therapy and who refused or are unfit for Radical Cystectomy (RC), receiving TAR-200 versus investigator's choice of single agent intravesical chemotherapy.

Timeline

Start
2024-04-09
Primary completion
2030-11-27
Completion
2031-04-14

Drugs

EvaluationDrugModalityDoseRoute
Comparator Gemcitabine Small molecule Other
Comparator Mitomycin C Other / unclassified Other
Subject TAR-200 Other / unclassified Other