A Phase 2b Study of UGN-102 for Low Grade Intermediate Risk Non-Muscle-Invasive Bladder Cancer (NCT03558503) | Clinical Trial Compass
CompletedPhase 2
A Phase 2b Study of UGN-102 for Low Grade Intermediate Risk Non-Muscle-Invasive Bladder Cancer
United States63 participantsStarted 2018-10-15
Plain-language summary
This Phase 2b, single-arm, multicenter study evaluated the efficacy and safety of UGN-102 as primary chemoablative therapy in patients with 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
✓. Willing and able to sign an informed consent and comply with the protocol.
✓. Has newly diagnosed or historic LG NMIBC (Ta) histologically confirmed by cold cup biopsy at screening or within 6 weeks of screening.
✓. Is at intermediate risk of recurrence, defined as having 1 or 2 of the following:
✓. Has negative voiding cytology for high grade (HG) disease at or within 6 weeks of enrollment.
✓. Willing to use 2 acceptable forms of effective contraception from enrollment through 6 months post treatment if the participant is female or the female partner of a male participant and is of childbearing potential (defined as premenopausal women who have not been sterilized).
✓. Has adequate organ and bone marrow function as determined by routine laboratory tests as below:
✓. Has no evidence of active urinary tract infection (UTI) at Screening and Baseline visits.
Exclusion criteria
✕. History of carcinoma in situ (CIS) on preliminary cystoscopy within 5 years of enrollment.