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NCT06331299 · ClinicalTrials.gov registry record · Phase 3
A Phase 3 Study of UGN-103 for Treatment of Patients With Low-grade Intermediate-risk Non-muscle Invasive Bladder Cancer
A Phase 3 study of Bladder Cancer and Urothelial Carcinoma, sponsored by UroGen Pharma.
- Active
- Registry status
- Phase 3
- Development phase
- 99
- Enrollment target
- 20
- Study locations
NCT06331299: Active Phase 3 study of Bladder Cancer and Urothelial Carcinoma, sponsored by UroGen Pharma.
NCT06331299 is a Phase 3 study of Bladder Cancer and Urothelial Carcinoma that is active but no longer recruiting, run by UroGen Pharma. The registered enrollment target is 99 participants, below the 12,753-participant average among 175 other Bladder Cancer trials with a reported enrollment target (99% lower). The trial reports 20 study locations across 14 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06331299, a Phase 3 study of Bladder Cancer and Urothelial Carcinoma, is active but no longer recruiting, sponsored by UroGen Pharma.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 99 participants
- Enrollment target
- 20
- Study locations
Study Summary
This Phase 3, single-arm, multicenter study will evaluate the efficacy and safety of UGN-103, a novel formulation of UGN-102, instilled in the urinary bladder of patients with low-grade non-muscle invasive bladder cancer (LG-NMIBC).
Primary Outcome
CRR is defined as the proportion of patients who achieved CR at the 3-month Visit.
Conditions Studied
Interventions
- DRUG UGN-103
Study Locations (20)
New York
- Great Lakes Physician dba WNYU - Cheektowaga
- AccuMed Research Associates - Garden City
- Crystal Run Healthcare - Middletown
- Laura and Isaac Perlmutter Cancer Center at NYU Langone - New York
- Perlmutter Cancer Center at NYU Langone Hospital - Long Island - New York
California
- Loma Linda University Medical Center - Loma Linda
- Genesis Research, LLC - San Diego
Texas
- Houston Metro Urology (HMU) - Southwest Location - Houston
- Houston Methodist Hospital - Houston
District of Columbia
- The George Washington University Medical Faculty Associates - Washington D.C.
Georgia
- Peachtree Clinical Solutions - Powder Springs
Indiana
- Indiana University Melvin and Bren Simon Cancer Center - Indianapolis
Minnesota
- Minnesota Urology - Metro Urology - Woodbury - Woodbury
New Jersey
- Garden State Urology - Morristown
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 99 participants |
| Start Date | 2024-08-29 |
| Est. Completion | 2026-09 |
| Phase | Phase 3 |
What the registry record for NCT06331299 still lists
NCT06331299 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 99 participants, a relatively small participant target, below the 12,753-participant average among 175 other Bladder Cancer trials with a reported enrollment target (99% lower).
The record links to 3 conditions, with Bladder Cancer appearing as the primary indexed condition, and to 1 intervention - of which UGN-103 is the first listed.
NCT06331299 names 20 study sites across 14 states, led by New York, California, Texas.
Frequently Asked Questions
What is clinical trial NCT06331299 about?
NCT06331299 is a clinical study titled "A Phase 3 Study of UGN-103 for Treatment of Patients With Low-grade Intermediate-risk Non-muscle Invasive Bladder Cancer". This Phase 3, single-arm, multicenter study will evaluate the efficacy and safety of UGN-103, a novel formulation of UGN-102, instilled in the urinary bladder of patients with low-grade non-muscle invasive bladder cancer (LG-NMIBC).
What is the current status of trial NCT06331299?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 99 participants. The study started on 2024-08-29. Estimated completion is 2026-09.
What conditions does trial NCT06331299 study?
This clinical trial studies the following conditions: Bladder Cancer, Urothelial Carcinoma, Urothelial Carcinoma Bladder.
What interventions are being tested in trial NCT06331299?
The interventions under investigation include: UGN-103 (DRUG).
Who is sponsoring clinical trial NCT06331299?
This trial is sponsored by UroGen Pharma, which has 9 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06331299 being conducted?
This trial has 20 study locations across California, District of Columbia, Georgia, Indiana, Minnesota. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Bladder Cancer
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06331299's enrollment target sits among peer trials
99 87th of 175 higher than 89 of 175 other Bladder Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Bladder Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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Outcomes of High-risk Non-muscle Invasive Bladder Cancer Treated With Blue Light Resection
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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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-
A Study of Adjuvant Cretostimogene Grenadenorepvec for Treatment of Intermediate Risk NMIBC Following TURBT
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