Phase 3 Study of UGN-102 for Treating Low-Grade Intermediate-Risk Non-Muscle Invasive Bladder Cancer
Sponsor: UroGen Pharma Ltd.
ClinicalTrials ID:NCT05243550
This study is testing the effectiveness and safety of UGN-102, a new treatment for patients with low-grade intermediate-risk non-muscle invasive bladder cancer that has come back.
Patient Parameters
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Program Overview
This Phase 3 study is being conducted in multiple countries to see if UGN-102 can effectively treat patients with low-grade intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC) that has returned. The study aims to evaluate how well this treatment works and how safe it is for patients.
Description
Patients in this study receive UGN-102 treatment once a week for six weeks, directly into the bladder. About three months after starting treatment, patients return to the clinic to see how well the treatment worked. Doctors will check the bladder using a camera (cystoscopy) and test any remaining or new growths. If no cancer is found, patients enter a follow-up phase. If some cancer remains, patients receive standard treatment and then enter the follow-up phase.
During the follow-up phase, patients visit the clinic every three months for up to two years to check for cancer. If they remain cancer-free, they will continue to be monitored every six months for up to three years or until the cancer returns, progresses, or the study ends.
If cancer returns or progresses, patients receive standard treatment and have a final study visit about three months later. The study is ongoing, and data is being collected up to April 2024. Patients have been followed for at least 15 months, with some followed for up to 21 months.
Eligibility Criteria
Inclusion Criteria
- Able to give written consent and follow study requirements.
- Diagnosed with low-grade non-muscle invasive bladder cancer confirmed by a biopsy.
- History of needing treatment for bladder tumors, but not for the current episode.
- Intermediate-risk cancer, defined by:
- Multiple tumors
- A single tumor larger than 3 cm
- Early or frequent recurrence within a year of diagnosis
- Negative test for high-grade cancer within eight weeks before the study.
- Good organ and bone marrow function based on lab tests.
- Expected to live at least as long as the study duration.
- Agree to use effective birth control during and for six months after treatment.
Exclusion Criteria
- Received BCG treatment for bladder cancer in the past year.
- History of high-grade bladder cancer in the past two years.
- Allergy to mitomycin that cannot be managed.
- Significant urethral stricture preventing catheter use.
- History of:
- Neurogenic bladder
- Active urinary retention
- Conditions preventing normal urination
- Past or current muscle-invasive or metastatic bladder cancer.
- Current tumor grading of T1.
- Concurrent upper tract bladder cancer.
- Active urinary tract infection that cannot be resolved before treatment.
- Pregnant or breastfeeding.
- Substance abuse or psychiatric disorder affecting study compliance.
- Prior treatment with intravesical chemotherapy in the past two years, except a single dose after surgery.
- Participation in another study within 30 days of enrollment.
- Previous participation in a study with UGN-102.
- Other active cancer requiring systemic treatment, except for certain skin cancers treatable locally.
- Any other significant medical or surgical condition affecting safety or study results.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Arizona Urology Specialists | 85704 | Tucson | Arizona |
| Loma Linda University Medical Center | 92350 | Loma Linda | California |
| Genesis Research | 92123 | San Diego | California |
| Wichita Urology Group | 67226 | Wichita | Kansas |
| John Hopkins University | 21218 | Baltimore | Maryland |
| Chesapeake Urology Research Associates | 21076 | Hanover | Maryland |
| University of Missouri | 65212 | Columbia | Missouri |
| Atlantic Health System | 07960 | Morristown | New Jersey |
| Great Lakes Physician dba WNY Urology Associates | 14225 | Cheektowaga | New York |
| AccuMed Research Associates | 11530 | Garden City | New York |
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