A Phase 3 Single-Arm Study of UGN-102 for Treatment of Low-Grade Intermediate-Risk Non-Muscle Invasive Bladder Cancer
NCT05243550 · ENVISION Phase 3Active, not recruiting
- Lead sponsor
- UroGen Pharma Ltd. (Industry)
- Enrollment
- 240 (actual)
- Start date
- 1 Mar 2022
- Primary completion
- 26 Apr 2023 (actual)
- Study completion
- 1 Mar 2028
- Last update posted
- 11 May 2026
Design
- Study type
- Interventional
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None
- Arms
- 1
Interventions
- UGN-102 Drug
Conditions and primary outcome
- Bladder Cancer
- Urothelial Carcinoma
- Urothelial Carcinoma Bladder
Primary outcome
Complete Response Rate (CRR) (3 months)
Posted results on ClinicalTrials.gov
Source: ClinicalTrials.gov results for NCT05243550 (opens in a new tab)· Licence: public-domain
First posted · Last update posted · Imported from ClinicalTrials.gov download 2026-10-25
Primary outcomes with a statistical analysis
No primary outcome with a statistical analysis is posted for this study.
Serious adverse events
Time frame: Up to 21 months. Study conduct is ongoing and data are summarized through a cutoff date of 04 Apr 2024. As of the data cutoff date, ongoing patients were followed through at least Study Month 15, with the earliest enrolled patients followed through Study Month 21.
| Group | Affected | At risk |
|---|---|---|
| UGN-102 | 29 | 240 |
Posted results as ClinicalTrials.gov prints them: primary outcome analyses and serious adverse event totals only. Registry facts, not reviewed by HealthTrade and not investment advice; filing-derived results are listed separately.
Source: ClinicalTrials.gov, U.S. National Library of Medicine. Listing a study does not mean NLM has evaluated it.
Results from company and journal sources
No editor-confirmed results are on record for this study.
Publications
3 on PubMedUGN-102 for Recurrent Low-Grade Intermediate-Risk Nonmuscle-Invasive Bladder Cancer: 24-Month Duration of Response Results From the Phase 3 ENVISION Trial.
The Journal of urology · 2026 Aug
PubMed 41880645 (opens in a new tab)DOI 10.1097/JU.0000000000005041 (opens in a new tab)
Perceived Impact on Patient Routines/Responsibilities for Surgery and a Nonsurgical Primary Treatment Option in Recurrent Low-Grade Intermediate-Risk Nonmuscle-Invasive Bladder Cancer: Findings From the ENVISION Phase 3 Trial.
The Journal of urology · 2025 Jul
PubMed 40048558 (opens in a new tab)DOI 10.1097/JU.0000000000004511 (opens in a new tab)
Primary Chemoablation of Recurrent Low-Grade Intermediate-Risk Nonmuscle-Invasive Bladder Cancer With UGN-102: A Single-Arm, Open-Label, Phase 3 Trial (ENVISION).
The Journal of urology · 2025 Feb
PubMed 39446087 (opens in a new tab)DOI 10.1097/JU.0000000000004296 (opens in a new tab)
Citations from PubMed, U.S. National Library of Medicine; abstracts are not stored. A publication lists this study’s NCT number and may be a review that cites many studies.
CT-VCA trial quality
About CT-VCALoading CT-VCA scores…
Data integrity
Compare what the registry, company releases, FDA documents and publications say about this study.
Drugs on HealthTrade
Source
- NCT05243550 on ClinicalTrials.gov (opens in a new tab) Licence: public-domain. Read
Source: ClinicalTrials.gov, U.S. National Library of Medicine. Listing a study does not mean NLM has evaluated it.
Nothing on this page is medical or investment advice.