MoonRISe-1
Research type
Research Study
Full title
A Phase 3, Randomized Study Evaluating the Efficacy and Safety of TAR-210 Erdafitinib Intravesical Delivery System Versus Single Agent Intravesical Chemotherapy in Participants With Intermediate-risk Non-muscle Invasive Bladder Cancer
IRAS ID
1009589
Contact name
David Wright
Contact email
Sponsor organisation
Janssen-Cilag International NV
Eudract number
2023-507684-19
ISRCTN Number
ISRCTN76448481
Research summary
Intermediate-risk non-muscle invasive bladder cancer (IR-NMIBC) is an early stage of bladder cancer that is limited to the inner lining of the bladder.
The standard treatment for this type of bladder cancer is removal of cancer by surgery followed by treatment administered directly into the bladder, such as chemotherapy, Bacillus Calmette-Guerin therapy, or other treatments. Even after surgical removal and additional treatments there is a high risk of the cancer coming back or worsening.
The study treatment, TAR-210, is a drug delivery system that is temporarily placed in the bladder. It continuously delivers erdafitinib, a medicine being investigated to treat the bladder cancer.
In this study, researchers want to compare the length of time participants are alive and free of any signs or symptoms of the cancer (disease-free survival), when treated with TAR-210 or intravesical chemotherapy* with mitomycin C (MMC) or gemcitabine in participants with IR-NMIBC with an alteration in a gene called fibroblast growth factor receptor (FGFR).
*Treatment in which anticancer drugs are put directly into the bladder through a thin, flexible tube inserted into urethra.
REC name
North West - Liverpool Central Research Ethics Committee
REC reference
24/NW/0105
Date of REC Opinion
2 May 2024
REC opinion
Further Information Favourable Opinion