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NCT06545955 · ClinicalTrials.gov registry record · Phase 3
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
A Phase 3 study of Non-muscle Invasive Bladder Cancer With Carcinoma in Situ, sponsored by Ferring Pharmaceuticals.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 250
- Enrollment target
- 20
- Study locations
NCT06545955: Recruiting Phase 3 study of Non-muscle Invasive Bladder Cancer With Carcinoma in Situ, sponsored by Ferring Pharmaceuticals.
NCT06545955 is a Phase 3 study of Non-muscle Invasive Bladder Cancer With Carcinoma in Situ that is actively recruiting participants, run by Ferring Pharmaceuticals. The registered enrollment target is 250 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (68% lower). The trial reports 20 study locations across 13 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06545955, a Phase 3 study of Non-muscle Invasive Bladder Cancer With Carcinoma in Situ, is actively recruiting participants, sponsored by Ferring Pharmaceuticals.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 250 participants
- Enrollment target
- 20
- Study locations
Study Summary
The pivotal phase 3 trial (rAd-IFN-CS 003) evaluating the efficacy of nadofaragene firadenovec showed that 55 (53.4%) of 103 subjects with CIS ± high-grade Ta/T1 achieved a complete response (CR) at 3 months. In this trial, the safety and efficacy of intravesical instillation of nadofaragene firadenovec alone or in combination with chemotherapy or immunotherapy will be evaluated in participants with NMIBC CIS (± high-grade Ta/T1).
Primary Outcome
Complete response (CR) at any time from first treatment (defined as absence of high-grade (HG) recurrence).
Conditions Studied
Interventions
- DRUG Pembrolizumab
- DRUG Docetaxel
- DRUG Gemcitabine
- DRUG Nadofaragene Firadenovec
Study Locations (20)
California
- American Institute of Research - Los Angeles
- USC Kenneth Norris Jr Cancer Hospital - Los Angeles
- University of California, Irvine - Orange
- Genesis Research, LLC - San Diego - San Diego
Colorado
- Advent Health - Denver
- Colorado Urology - St. Anthony Hospital Campus - Lakewood
Georgia
- Emory University - Atlanta
- Georgia Urology - Atlanta
Maryland
- Anne Arundel Urology, PA - Annapolis
- Chesapeake Urology Research Associates - Hanover
New York
- Roswell Park Cancer Institute - Buffalo
- Great Lakes Physician PC d/b/a Western new York Urology Associates - Cheektowaga
Connecticut
- Yale School of Medicine - New Haven
District of Columbia
- Medstar Georgetown University Hospital - Washington D.C.
Florida
- Sarasota Memorial Healthcare System - Sarasota
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 250 participants |
| Start Date | 2024-10-01 |
| Est. Completion | 2030-12-31 |
| Phase | Phase 3 |
What NCT06545955 shows while recruiting
NCT06545955 is an interventional study that assigns participants to a tested intervention. The registered 250 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (68% lower).
The record links to 1 condition, with Non-muscle Invasive Bladder Cancer With Carcinoma in Situ appearing as the primary indexed condition, and to 4 interventions - of which Pembrolizumab is the first listed.
NCT06545955 names 20 study sites across 13 states, led by California, Colorado, Georgia.
Frequently Asked Questions
What is clinical trial NCT06545955 about?
NCT06545955 is a clinical study titled "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". The pivotal phase 3 trial (rAd-IFN-CS 003) evaluating the efficacy of nadofaragene firadenovec showed that 55 (53.4%) of 103 subjects with CIS ± high-grade Ta/T1 achieved a complete response (CR) at 3 months. In this trial, the safety and efficacy of intravesical instillation of nadofaragene firaden...
What is the current status of trial NCT06545955?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 250 participants. The study started on 2024-10-01. Estimated completion is 2030-12-31.
What conditions does trial NCT06545955 study?
This clinical trial studies the following conditions: Non-muscle Invasive Bladder Cancer With Carcinoma in Situ.
What interventions are being tested in trial NCT06545955?
The interventions under investigation include: Pembrolizumab (DRUG), Docetaxel (DRUG), Gemcitabine (DRUG), Nadofaragene Firadenovec (DRUG).
Who is sponsoring clinical trial NCT06545955?
This trial is sponsored by Ferring Pharmaceuticals, which has 83 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06545955 being conducted?
This trial has 20 study locations across California, Colorado, Connecticut, District of Columbia, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT06545955's enrollment target sits among peer trials
250 1250th of 2000 higher than 735 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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