Actively Recruiting
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
Led by Ferring Pharmaceuticals · Updated on 2026-05-08
250
Participants Needed
73
Research Sites
326 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosed with carcinoma in situ (CIS) with or without high-grade Ta/T1 disease
- For T1 disease, biopsies must contain muscle fibers
- Unresponsive to at least 2 courses of Bacillus Calmette-Guerin (BCG) therapy within the last 12 months
- Received at least 2 courses of BCG within a 12 month period, with specific dosing requirements
- At tumor recurrence, CIS alone or high-grade Ta/T1 with CIS must be within 12 months of last BCG exposure
- All visible papillary tumors must be resected
- Participants with persistent T1 disease should have an additional re-TURBT within 14 to 70 days before treatment
- Eastern Cooperative Oncology Group (ECOG) status of 2 or less
- Aged 18 years or older at consent
- Available for the full duration of the trial
- Life expectancy greater than 2 years as judged by investigator
- No upper tract urothelial carcinoma or urothelial carcinoma within prostatic urethra
- No evidence of upper tract tumor by imaging within 6 months prior to enrollment
- No locally advanced disease by CT or MRI
- Participants who choose not to undergo cystectomy
- Participants with low-risk prostate cancer on active surveillance may be included
- Females of reproductive potential must have a negative pregnancy test and use effective contraception during treatment and for 6 months after last dose
- Females must be post-menopausal or surgically sterile if not of reproductive potential
- Male participants must use condoms and effective contraception during treatment and for 3 months after last dose
You will not qualify if you...
- Current or prior muscle-invasive or metastatic bladder cancer at screening
- Presence of lymphovascular invasion or specific aggressive histological features
- Participants with CIS+T1 disease and hydronephrosis due to primary tumor
- Current systemic bladder cancer therapy other than study treatments
- Use of investigational drugs within 1 month prior to screening
- Pelvic external beam radiotherapy within 2 years prior to screening
- Prior treatment with nadofaragene firadenovec
- Prior systemic therapy for bladder cancer at any time
- Prior intravesical chemotherapy for BCG-unresponsive NMIBC
AI-Screening
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Trial Site Locations
Total: 73 locations
1
Center for Neurosciences
Tucson, Arizona, United States, 85718
Actively Recruiting
2
Arkansas Urology, North Little Rock
Little Rock, Arkansas, United States, 72211
Actively Recruiting
3
American Institute of Research
Los Angeles, California, United States, 90017
Actively Recruiting
4
USC Kenneth Norris Jr Cancer Hospital
Los Angeles, California, United States, 90080
Actively Recruiting
5
University of California, Irvine
Orange, California, United States, 92868
Actively Recruiting
6
Genesis Research, LLC - San Diego
San Diego, California, United States, 92123
Actively Recruiting
7
Advent Health
Denver, Colorado, United States, 80210
Actively Recruiting
8
Colorado Urology - St. Anthony Hospital Campus
Lakewood, Colorado, United States, 80228
Actively Recruiting
9
Yale School of Medicine
New Haven, Connecticut, United States, 06519
Actively Recruiting
10
Medstar Georgetown University Hospital
Washington D.C., District of Columbia, United States, 20007
Actively Recruiting
11
Sarasota Memorial Healthcare System
Sarasota, Florida, United States, 34239
Actively Recruiting
12
Emory University
Atlanta, Georgia, United States, 30322
Actively Recruiting
13
Georgia Urology
Atlanta, Georgia, United States, 30328
Actively Recruiting
14
Boise VA Medical Center
Boise, Idaho, United States, 83702
Actively Recruiting
15
NextStage Clinical Research
Lisle, Illinois, United States, 60532
Actively Recruiting
16
Indiana University
Indianapolis, Indiana, United States, 46202
Actively Recruiting
17
Wichita Urology Group
Wichita, Kansas, United States, 67226
Actively Recruiting
18
Anne Arundel Urology, PA
Annapolis, Maryland, United States, 21401
Actively Recruiting
19
Chesapeake Urology Research Associates
Hanover, Maryland, United States, 21076
Actively Recruiting
20
Atlantic Health
Morristown, New Jersey, United States, 07960
Actively Recruiting
21
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263
Actively Recruiting
22
Great Lakes Physician PC d/b/a Western new York Urology Associates
Cheektowaga, New York, United States, 14225
Actively Recruiting
23
Northwell Health -The Arthur Smith Institute for Urology
Lake Success, New York, United States, 11042
Actively Recruiting
24
Veterans Affairs New York Harbor Healthcare System - Manhattan VA Medical Center
New York, New York, United States, 10010
Actively Recruiting
25
James J. Peters VA Medical Center
The Bronx, New York, United States, 10468
Actively Recruiting
26
University of Cincinnati
Cincinnati, Ohio, United States, 45267
Actively Recruiting
27
MidLantic Urology
Bala-Cynwyd, Pennsylvania, United States, 19004
Actively Recruiting
28
Keystone Urology Specialists
Lancaster, Pennsylvania, United States, 17601
Actively Recruiting
29
University of Pennsylvania - Perelman Center for Advanced Medicine - Penn Urology
Philadelphia, Pennsylvania, United States, 19104
Actively Recruiting
30
University of Pittsburgh Medical Center - Shadyside Medical Building
Pittsburgh, Pennsylvania, United States, 15232
Actively Recruiting
31
Carolina Urologic Research Center
Myrtle Beach, South Carolina, United States, 29572
Actively Recruiting
32
Urology Associates, P.C.
Nashville, Tennessee, United States, 37209
Actively Recruiting
33
Urology Austin
Austin, Texas, United States, 78759
Actively Recruiting
34
Urology Clinics of North Texas PLLC (Dallas)
Dallas, Texas, United States, 75231
Actively Recruiting
35
University of Texas Southwestern Medical Center - Urology Clinic
Dallas, Texas, United States, 75390
Actively Recruiting
36
Houston Methodist Hospital (Houston)
Houston, Texas, United States, 77030
Actively Recruiting
37
Virginia Mason Medical Center
Seattle, Washington, United States, 98101
Actively Recruiting
38
Prostate Cancer Centre
Calgary, Alberta, Canada, T2V 1P9
Actively Recruiting
39
University Health Network UHN - Princess Margaret Cancer Centre
Toronto, Ontario, Canada, M5G 1Z5
Actively Recruiting
40
Centre Hospitalier de L'Universite de Montreal
Montreal, Quebec, Canada, H2X 0A9
Actively Recruiting
41
Krajska Nemocnice Liberec
Liberec, Liberec Region, Czechia, 46300
Actively Recruiting
42
Fakultní Thomayerova Nemocnice
Prague, Prague, Czechia, 14059
Actively Recruiting
43
Fakultni nemocnice v Motole
Prague, Prague, Czechia, 15006
Actively Recruiting
44
Androgeos, spol. s r.o.
Prague, Prague, Czechia, 16000
Actively Recruiting
45
Kromerizska Nemocnice A S
Kroměříž, Zlín, Czechia, 76701
Actively Recruiting
46
CHU Clermont Ferrand - Hopital Gabriel Montpied
Clermont-Ferrand, Auvergne-Rhône-Alpes, France, 63000
Actively Recruiting
47
Hospices Civils de Lyon - Edouard Herriot Hosp.
Lyon, Auvergne-Rhône-Alpes, France, 69003
Actively Recruiting
48
CHU Toulouse - Hopital Rangueil
Toulouse, Huate-Garonne, France, 31059
Actively Recruiting
49
CHU Nantes - Hotel Dieu
Nantes, Nantes, France, 44093
Actively Recruiting
50
CHU de Bordeaux - Hôpital Pellegrin
Bordeaux, New Aquitaine, France, 33076
Actively Recruiting
51
Centre Hospitalier Universitaire De Nimes (Nîmes)
Nîmes, Occitanie, France, 30900
Actively Recruiting
52
Centre Hospitaliser Universitaire de Lyon Sud
Lyon, Rhone.Alpe, France, 69310
Actively Recruiting
53
Hopital La Pitie Salpetriere
Paris, France, 75013
Actively Recruiting
54
APHP - Hopital Bichat
Paris, Île-de-France Region, France, 75018
Actively Recruiting
55
IN-VIVO Bydgoszcz
Bydgoszcz, Kuyavian-Pomeranian Voivodeship, Poland, 85-048
Actively Recruiting
56
Clinical Research Center Spółka z ograniczoną odpowiedzialnością Medic-R Sp.k.
Poznan, Wielkopolska, Poland, 61731
Actively Recruiting
57
Medical Concierge Centrum Medyczne
Warsaw, Woj. Mazowieckie, Poland, 02798
Actively Recruiting
58
Pusan National University Yangsan Hospital
Yangsan, Gyeongsangnam-do, South Korea, 50612
Actively Recruiting
59
Korea University Anam Hospital
Seoul, Seoul, South Korea, 02841
Actively Recruiting
60
Samsung Medical Center
Seoul, Seoul, South Korea, 06351
Actively Recruiting
61
Seoul National University Hospital
Seoul, Songpa-gu, South Korea, 03080
Actively Recruiting
62
Instituto de Investigacion Valdecilla (IDIVAL) / Hospital universitario Marques de Valdecilla
Santander, Cantabria, Spain, 39008
Actively Recruiting
63
Hospital del Mar
Barcelona, Catalonia, Spain, 08003
Actively Recruiting
64
Hospital Clinic De Barcelona - University of Barcelona
Barcelona, Catalonia, Spain, 08036
Actively Recruiting
65
Hospital Universitario Reina Sofia
Córdoba, Cordoba, Spain, 14004
Actively Recruiting
66
Hospital Universitario de A Coruna
A Coruña, Galicia, Spain, 15006
Actively Recruiting
67
Hospital Universitario Fundacion Alcorcon
Alcorcón, Madrid, Spain, 28922
Actively Recruiting
68
Clinica Universidad de Navarra - Madrid
Madrid, Madrid, Spain, 28027
Actively Recruiting
69
Hospital Universitario 12 De Octubre (Madrid)
Madrid, Madrid, Spain, 28041
Actively Recruiting
70
Universidad Autonoma de Madrid. Hospital Universitario La Paz
Madrid, Madrid, Spain, 28046
Actively Recruiting
71
Clinica Universidad de Navarra - Pamplona
Pamplona, Navarre, Spain, 31008
Actively Recruiting
72
Hospital Universitario Basurto
Bilbao, Vizcaya, Spain
Actively Recruiting
73
Servicio Andaluz de Salud (SAS) - Hospital Universitario Virgen de la Victoria (HUVV)
Málaga, Spain, 29010
Actively Recruiting
Research Team
F
Ferring Pharmaceuticals
CONTACT
F
Ferring Pharmaceuticals
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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