A Trial to Evaluate Intravesical Nadofaragene Firadenovec Alone or in Combination With Chemotherapy or Immunotherapy in Participants With High-grade BCG Unresponsive Non-muscle Invasive Bladder Cancer
Public ClinicalTrials.gov record NCT06545955. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase 3, Randomised, Multi-center, Open Label Trial to Evaluate the Safety and Efficacy of Intravesical Nadofaragene Firadenovec Alone or in Combination With Chemotherapy or Immunotherapy in Participants With High-grade Bacillus Calmette-Guerin Therapy (BCG) Unresponsive Non-muscle Invasive Bladder Cancer (NMIBC)
Study identification
- NCT ID
- NCT06545955
- Recruitment status
- Recruiting
- Study type
- Interventional
- Phase
- Phase 3
- Lead sponsor
- Ferring Pharmaceuticals
- Industry
- Enrollment
- 250 participants
Conditions and interventions
Interventions
- Docetaxel Drug
- Gemcitabine Drug
- Nadofaragene Firadenovec Drug
- Pembrolizumab Drug
Drug
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Sep 30, 2024
- Primary completion
- Jun 29, 2028
- Completion
- Dec 30, 2030
- Last update posted
- May 7, 2026
2024 – 2030
United States locations
- U.S. sites
- 37
- U.S. states
- 21
- U.S. cities
- 34
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Center for Neurosciences | Tucson | Arizona | 85718 | Recruiting |
| Arkansas Urology, North Little Rock | Little Rock | Arkansas | 72211 | Recruiting |
| American Institute of Research | Los Angeles | California | 90017 | Recruiting |
| USC Kenneth Norris Jr Cancer Hospital | Los Angeles | California | 90080 | Recruiting |
| University of California, Irvine | Orange | California | 92868 | Recruiting |
| Genesis Research, LLC - San Diego | San Diego | California | 92123 | Recruiting |
| Advent Health | Denver | Colorado | 80210 | Recruiting |
| Colorado Urology - St. Anthony Hospital Campus | Lakewood | Colorado | 80228 | Recruiting |
| Yale School of Medicine | New Haven | Connecticut | 06519 | Recruiting |
| Medstar Georgetown University Hospital | Washington D.C. | District of Columbia | 20007 | Recruiting |
| Sarasota Memorial Healthcare System | Sarasota | Florida | 34239 | Recruiting |
| Emory University | Atlanta | Georgia | 30322 | Recruiting |
| Georgia Urology | Atlanta | Georgia | 30328 | Recruiting |
| Boise VA Medical Center | Boise | Idaho | 83702 | Recruiting |
| NextStage Clinical Research | Lisle | Illinois | 60532 | Recruiting |
| Indiana University | Indianapolis | Indiana | 46202 | Recruiting |
| Wichita Urology Group | Wichita | Kansas | 67226 | Recruiting |
| Anne Arundel Urology, PA | Annapolis | Maryland | 21401 | Recruiting |
| Chesapeake Urology Research Associates | Hanover | Maryland | 21076 | Recruiting |
| Atlantic Health | Morristown | New Jersey | 07960 | Recruiting |
| Roswell Park Cancer Institute | Buffalo | New York | 14263 | Recruiting |
| Great Lakes Physician PC d/b/a Western new York Urology Associates | Cheektowaga | New York | 14225 | Recruiting |
| Northwell Health -The Arthur Smith Institute for Urology | Lake Success | New York | 11042 | Recruiting |
| Veterans Affairs New York Harbor Healthcare System - Manhattan VA Medical Center | New York | New York | 10010 | Recruiting |
| James J. Peters VA Medical Center | The Bronx | New York | 10468 | Recruiting |
| University of Cincinnati | Cincinnati | Ohio | 45267 | Recruiting |
| MidLantic Urology | Bala-Cynwyd | Pennsylvania | 19004 | Recruiting |
| Keystone Urology Specialists | Lancaster | Pennsylvania | 17601 | Recruiting |
| University of Pennsylvania - Perelman Center for Advanced Medicine - Penn Urology | Philadelphia | Pennsylvania | 19104 | Recruiting |
| University of Pittsburgh Medical Center - Shadyside Medical Building | Pittsburgh | Pennsylvania | 15232 | Recruiting |
| Carolina Urologic Research Center | Myrtle Beach | South Carolina | 29572 | Recruiting |
| Urology Associates, P.C. | Nashville | Tennessee | 37209 | Recruiting |
| Urology Austin | Austin | Texas | 78759 | Recruiting |
| Urology Clinics of North Texas PLLC (Dallas) | Dallas | Texas | 75231 | Recruiting |
| University of Texas Southwestern Medical Center - Urology Clinic | Dallas | Texas | 75390 | Recruiting |
| Houston Methodist Hospital (Houston) | Houston | Texas | 77030 | Recruiting |
| Virginia Mason Medical Center | Seattle | Washington | 98101 | Recruiting |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 36 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT06545955, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted May 7, 2026 · Synced May 10, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT06545955 live on ClinicalTrials.gov.