MoonRISe-3
Research type
Research Study
Full title
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)
IRAS ID
1012467
Contact name
Sarah Pickford
Contact email
Sponsor organisation
Janssen-Cilag International NV
Eudract number
2024-519493-39
Clinicaltrials.gov Identifier
Research summary
High-risk non-muscle invasive bladder cancer (HR-NMIBC) is an early-stage bladder cancer, limited to the inner lining of bladder but has a considerable high chance of cancer coming back or worsening.
Available treatment options include having treatments administered directly into the bladder such as intravesical chemotherapy* or repeat Bacillus Calmette Guerin (BCG) treatment or removing the bladder to treat the cancer (radical cystectomy [RC]). However, there is a high risk of cancer worsening or coming back and removal of bladder can have potentially serious short and long-term complications. Therefore, there is a need for better treatment options.
*Anticancer drugs put directly into the bladder through a thin, flexible tube inserted in urethra.
TAR-210 is an intravesical drug releasing system in which a thin tube is temporarily placed into the bladder. It continuously releases erdafitinib, a medicine being investigated to treat HR-NMIBC in participants with alteration in a gene for fibroblast growth factor receptor (FGFR) present in cancer cells.
In this study, researchers want to compare the length of time participants are alive and without the recurrence of their bladder cancer (disease-free survival), when treated with TAR-210 or single agent intravesical chemotherapy with either mitomycin C (MMC) or gemcitabine.
REC name
London - Fulham Research Ethics Committee
REC reference
25/LO/0546
Date of REC Opinion
15 Sep 2025
REC opinion
Further Information Favourable Opinion