At a glance
ClinicalIndex Comparison Record- ✓Histologically confirmed low-grade Ta urothelial carcinoma of bladder documented by cold cup biopsy at Screening or within 8 weeks prior
- ✓History of low-grade NMIBC requiring prior TURBT (previous episode(s), not current)
- ✓Intermediate-risk disease: 1 or 2 of the following — multiple tumors, solitary tumor >3 cm, or early/frequent recurrence (≥1 LG-NMIBC within 1 year)
- ✓Negative voiding cytology for high-grade disease within 8 weeks before Screening
- ✕BCG treatment for urothelial carcinoma within 1 year prior
- ✕History of high-grade bladder cancer (papillary or carcinoma in situ) in past 2 years
- ✕Known allergy or sensitivity to mitomycin that cannot be readily managed
- ✕Clinically significant urethral stricture precluding catheter passage
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase 3, Single-Arm, Multicenter Study to Evaluate the Efficacy and Safety of UGN-102 as Primary Chemoablative Therapy in Patients With Low-Grade (LG) Non-Muscle Invasive Bladder Cancer (NMIBC) at Intermediate Risk (IR) of Recurrence
In Brief
A Phase 3 clinical trial evaluating UGN-102 for Bladder Cancer and 2 related conditions. Active but no longer recruiting, targeting 240 participants across 65 sites in 10 countries.
Detailed 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).
Study Details
Timeline
Interventions
UGN-102 consists of mitomycin and sterile hydrogel (a proprietary thermally responsive gel) that is used to reconstitute mitomycin before instillation. The reverse thermal properties of UGN-102 allow for local administration of mitomycin as a liquid under chilled conditions, with subsequent conversion to a semi-solid gel depot following instillation into the bladder.