MoonRISe-1
Bladder cancer
A Phase 3, randomized study investigating the efficacy and safety of an erdafitinib intravesical drug releasing system, erda-iDRS (formerly TAR-210), vs intravesical chemotherapy in participants with IR-NMIBC with susceptible FGFR alterations
Phase
Compound
Erda-iDRS
NCT identifier
NCT06319820
Enrollment
N=~641
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 IR-NMIBC (diagnosed within 90 days of randomization)
- Susceptible FGFR mutation or fusion by urine or tumor tissue testing determined by central or local testing
- Visible papillary disease must be fully resected prior to randomization
- Prior or concurrent second malignancy acceptable if natural history or treatment unlikely to interfere with study endpoints or efficacy of study treatment
- 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
Substudy only N=80:
- Participants for whom mitocycin C is the therapy of choice
- No previous diagnosis of histologically confirmed urothelial bladder carcinoma at any time prior to current diagnosis
Study
design
Primary outcome:
- DFS
Secondary outcomes:
- HG RFS
- TTNT
- PFS
- OS
- AEs
- Number of diagnostic and therapeutic invasive urological interventions after study treatment
- EORTC QLQ-C30
- EORTC QLQ-NMIBC24
*Not a complete list of inclusion and exclusion criteria. †Investigator’s choice.
AE, adverse event; DFS, disease-free survival; ECOG, Eastern Cooperative Oncology Group; EORTC QLQ-C30, European Organization for Research and Treatment of Cancer-Quality of Life Questionnaire Core-30 items; EORTC QLQ-NMIBC24, European Organization for Research and Treatment of Cancer-Quality of Life Questionnaire for NMIBC; FGFR, fibroblast growth factor receptor; HG, high-grade; IR, intermediate-risk; NMIBC, non-muscle-invasive bladder cancer; OS, overall survival; PFS, progression-free survival; PS, performance status; R, randomized; RFS, recurrence-free survival; TTNT, time to next treatment.