A Phase 3 Single-Arm Study of UGN-102 for Treatment of Low-Grade Intermediate-Risk Non-Muscle Invasive Bladder Cancer
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Phase
Phase 3
Status
Active, not recruiting
Study type
Interventional
Design
Na · None · Treatment
Enrollment
240actual
Sites
65
Countries
Austria, Bulgaria, Estonia +7
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2022-03-01 | actual | When the study began enrolling |
| Primary completion | 2023-04-26 | actual | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | Mar 2028 | estimated | The whole study's end, after follow-up |
| First posted | 2022-02-17 | actual | When this record first appeared on the registry |
| Results posted | 2024-11-04 | actual | When the sponsor posted results to the registry |
| Record updated | 2026-05-11 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Conditions
- Bladder Cancer
- Urothelial Carcinoma
- Urothelial Carcinoma Bladder
Intervention
- Drug: UGN-102 — also filed as UGN-102 (mitomycin) for intravesical solution
Primary outcome
what the primary-completion date above is the date OFComplete Response Rate (CRR)
measured 3 months
Posted documents
hosted by the registry — we link, never re-serveStudy Protocolposted 2024-02-28 · 1.3 MB · Prot_000.pdf
Statistical Analysis Planposted 2024-03-07 · 958 KB · SAP_001.pdf
Publications
- PMID 39446087 — reports results
- PMID 41880645 — linked by the registry
- PMID 40048558 — linked by the registry
Linked on the registry record. A “linked by the registry” entry is NLM's own automated PubMed match, not a claim by the sponsor that the paper reports this study.
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