MoonRISe-3
Bladder cancer
A Phase 3, randomized study investigating the efficacy and safety of an erdafitinib intravesical drug releasing system, erda-iDRS (formerly TAR-210), versus intravesical chemotherapy in participants with BCG-treated HR-NMIBC with susceptible FGFR alterations
Phase
Compound
Erda-iDRS
NCT identifier
NCT06919965
Enrollment
N=~220
For more information, including
contact details, please visit
the J&J Clinical Trial Finder
contact details, please visit
the J&J Clinical Trial Finder
Study overview & design
Key eligibility criteria*:
- Histologically confirmed papillary-only HR-NMIBC
- Susceptible FGFR mutation or fusion by urine or tumor tissue testing determined by central or local testing
- All visible tumor completely resected prior to randomization
- No bladder or urethral anatomic feature that may prevent the safe insertion, indwelling use, removal of erda-iDRS, or passage of urethral catheter
- ECOG PS 0‒2
Study
design
Primary outcome:
- DFS
Secondary outcomes‡:
- RFS
- TTNI
- TTDW
- TTP
- OS
- AEs
- HRQoL
*Not a complete list of inclusion and exclusion criteria. †Investigator’s choice. ‡Not a complete list of secondary outcomes.
AE, adverse event; BCG, Bacillus Calmette-Guérin; DFS, disease-free survival; ECOG PS, Eastern Cooperative Oncology Group performance status; FGFR, fibroblast growth factor receptor; HR, high risk; HRQoL, health-related quality of life; NMIBC, non–muscle-invasive bladder cancer; OS, overall survival; R, randomized; RFS, recurrence-free survival; TTDW, time to disease worsening; TTNI, time to next intervention; TTP, time to progression.