A Phase 3 Single-Arm Study of UGN-102 for Treatment of Low-Grade Intermediate-Risk Non-Muscle Inv… (NCT05243550) | Clinical Trial Compass
Active — Not RecruitingPhase 3
A Phase 3 Single-Arm Study of UGN-102 for Treatment of Low-Grade Intermediate-Risk Non-Muscle Invasive Bladder Cancer
United States240 participantsStarted 2022-03-01
Plain-language summary
This Phase 3, multinational, single-arm study was designed to evaluate the efficacy and safety of UGN-102 as primary chemoablative therapy in patients with recurrent low-grade intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC).
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form and the protocol.
✓. Patient who has LG-NMIBC (Ta) histologically confirmed by cold cup biopsy at Screening or within 8 weeks before Screening.
✓. History of LG-NMIBC requiring treatment with transurethral resection of bladder tumors (TURBT). Note: This refers to a previous episode(s) and not to the current episode for which the patient is being screened.
✓. Has intermediate-risk disease, defined as having 1 or 2 of the following:
✓. Negative voiding cytology for high-grade (HG) disease within 8 weeks before Screening.
✓. Has adequate organ and bone marrow function as determined by routine laboratory tests as below:
✓. Has an anticipated life expectancy of at least the duration of the trial.
✓. Contraceptive use by men and women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. Women of childbearing potential (defined as premenopausal women who have not been sterilized), including female patients and female partners of male patients, must be willing to use 2 acceptable forms of effective contraception from enrollment through 6 months post-treatment.