A Phase 3, Randomized, Open-label, Multicenter Study Evaluating the Efficacy and Safety of TAR-210 Erdafitinib Intravesical Delivery System Versus Investigator's Choice of Intravesical Chemotherapy in Participants With High-risk Non-muscle-invasive Bladder Cancer With Susceptible FGFR Alterations Who Had Received Intravesical Bacillus Calmette-Guérin (BCG)
Janssen Research & Development, LLC
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).
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion criteria: * Histologically confirmed diagnosis by local pathology of papillary-only HR-NMIBC (defined as high-grade Ta or any T1, no CIS). Mixed histology tumors are allowed if urothelial differentiation is predominant. However, neuroendocrine, and small cell variants will be excluded * Have a susceptible fibroblast growth factor receptor (FGFR) mutation or fusion either by urine testing or tumor tissue testing (from TURBT tissue) as determined by central or local testing * All visible tumor completely resected prior to randomization. Urine cytology must not be positive or suspiciou…
Interventions
- DrugTAR-210
TAR-210 will be administered intravesically.
- DrugMitomycin C
MMC will be administered intravesically.
- DrugGemcitabine
Gemcitabine will be administered intravesically.
Locations (108)
- Colorado Clinical ResearchLakewood, Colorado
- Georgia UrologyAtlanta, Georgia
- Associated Urological SpecialistsChicago Ridge, Illinois
- Urology of IndianaCarmel, Indiana
- Greater Boston UrologyPlymouth, Massachusetts
- Comprehensive UrologyRoyal Oak, Michigan