About this trial
The MoonRISe 1 study is a Phase 3 trial comparing a new treatment called TAR 210 with standard bladder chemotherapy (mitomycin C or gemcitabine) for adults with non-muscle-invasive bladder cancer (NMIBC) that has changes in the FGFR2 or FGFR3 gene. TAR 210 is a small device that is placed directly into the bladder through a catheter, where it slowly releases a cancer medicine called erdafitinib over several weeks. The device is replaced every 12 weeks for up to one year. The standard treatment group will receive chemotherapy delivered into the bladder through a catheter on a weekly or monthly schedule. The study is open to people who have had all visible tumours removed and have at least one intermediate-risk feature. The main goal is to find out which treatment helps prevent the cancer from coming back for longer, while also monitoring safety, side effects, and time to further treatment.
Patient Profile
Intermediate risk non-muscle invasive bladder cancer
Where’s this trial being run?
Cork University Hospital, Tallaght University Hospital, Mater Misericordiae University Hospital, and Mater Private Hospital
Can I join this study / trial?
The first step we recommend is to talk to your doctor or the cancer trials team at your hospital. You can find contact details for cancer trials research units in Ireland here.
It’s also a good idea to print this page and bring it with you to your appointment. It can help guide the conversation and remind you of what to ask. You may also want to talk to your family or friends about your options, as they can offer support as you make decisions.
For more detailed information
Click HereQuestions?
Here’s a list of questions you may have for your doctor or local cancer research team.
QuestionsSummary Data
| Name: | MoonRISe-1 |
|---|---|
| Number: | 24-47 |
| 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 |
| Principal Investigator: | Prof. Ray McDermott |
|---|---|
| Type: | Industry Sponsored |
| Sponsor: | Janssen |
| Recruitment Started: |
Global: May 2024 Ireland: Q1 2025 |
| Global Recruitment Target: | 540 |
|---|---|
| Ireland Recruitment Target: | 19 |