The MoonRISe-3 Clinical Research Study
Learn about the MoonRISe-3 research study of an investigational drug delivery system for
adults with high-risk non-muscle invasive bladder cancer (HR-NMIBC)
The MoonRISe-3 Clinical Research Study
Learn about the MoonRISe-3 research study of an investigational drug delivery system for
adults with high-risk non-muscle invasive bladder cancer (HR-NMIBC)
Please take a look at some of the key inclusion and exclusion criteria below.
Additional criteria will apply and the site staff will check if you are a good fit for the MoonRISe-3 study.
All study-required visits, tests, and medication will be provided to you.
You may be reimbursed for transportation to your study visits.
You or your loved one can join the study if:
- You are 18 years of age or older
- You have been diagnosed with high-risk non-muscle invasive bladder cancer after receiving Bacillus Calmette-Guérin (BCG)
- You are ineligible for or refuse radical cystectomy (surgery to remove the bladder)
You or your loved one cannot join the study if:
- You have CIS (a surface-level bladder cancer)
- You have ever had bladder cancer that grew into the muscle or spread beyond the bladder.
Screening: up to 60 days before randomization
- You must meet the requirements to be in this study and sign the informed consent form (ICF) to begin.
- Study screening may occur across multiple visits over an approximately 60-day period.
- You will not receive the investigational study medication during this time.
Screening will also include testing your tumor for specific genetic alterations called fibroblast growth factor receptor (FGFR) alterations. FGFR alterations can be a factor driving tumor growth. Thus, the presence of an FGFR alteration makes the tumor susceptible to the investigational medication delivered through the investigational drug delivery system. To learn whether your tumor has FGFR alterations, FGFR testing needs to be performed on a urine and/or tumor tissue sample collected at screening. If your tumor has the required FGFR alterations, you may be eligible to participate in the MoonRISe-3 study.
Treatment Period: 1-2 years
If you are determined to be eligible, you will be randomly assigned (like the flip of a coin) to 1 of 2 study groups:
Group A: Investigational Drug Delivery System
- Study treatment with the investigational drug delivery system which will be placed and remain in the bladder for 12 weeks.
- Visits for treatment will be every 12 weeks through year 2.
Or
Group B: Intravesical chemotherapy
- Study treatment with intravesical chemotherapy. The study doctor will decide which chemotherapy to treat you with. Chemotherapy will be administered directly into the bladder.
- Visits for treatment will be once weekly for 6 weeks, then once monthly for at least 12 months (up to 10 maintenance doses).
- Additional maintenance therapy may be given for a second year; this will be up to your study doctor.
- Crossover: If you are randomized to Group B and have high-risk recurrence, you may have the opportunity to receive treatment with the investigational drug delivery system. The study doctor will let you know if this is an option for you.
Follow-Up: ~3-4 years
- After you have completed study treatment, you will be asked to return for an End of Treatment visit, a 30-day follow-up visit, and then continue with visits every 12 weeks.
Participation in this study will last up to 5 years.
See if you may qualify
Answer the following questions to see if you or someone you know may be eligible to take part in this study.
Please keep in mind: Even if you believe you meet the eligibility criteria, joining a clinical research study is not guaranteed. Whether you’re referred or able to take part depends on a review by a qualified healthcare professional. This questionnaire is intended for United States participants only.
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About your information:
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