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MoonRISe-1 Bladder cancer

A Phase 3, randomized, open-label 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

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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:

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:

Secondary outcomes:

HG RFS
TTNT
PFS
OS
AEs
Number of diagnostic and therapeutic invasive urological interventions after study treatment
HRQoL

*Not a complete list of inclusion and exclusion criteria. ^†Investigator’s choice.
AE, adverse event; DFS, disease-free survival; ECOG, Eastern Cooperative Oncology Group performance status; erda-iDRS, erdafitinib intravesical drug releasing system; FGFR, fibroblast growth factor receptor; HG, high-grade; HRQoL, health-related quality of life; IR, intermediate-risk; NMIBC, non-muscle-invasive bladder cancer; OS, overall survival; PFS, progression-free survival; R, randomized; RFS, recurrence-free survival; TTNT, time to next treatment.