Actively Recruiting
Trial of Nadofaragene Firadenovec vs. Observation in Participants With Intermediate Risk Non-Muscle Invasive Bladder Cancer
Led by Ferring Pharmaceuticals · Updated on 2026-05-12
454
Participants Needed
97
Research Sites
351 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
A phase 3b, Randomized, Controlled Trial of Nadofaragene Firadenovec vs. Observation in Participants with Intermediate Risk Non-Muscle Invasive Bladder Cancer (IR NMIBC)
CONDITIONS
Official Title
Trial of Nadofaragene Firadenovec vs. Observation in Participants With Intermediate Risk Non-Muscle Invasive Bladder Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
-
Diagnosed with intermediate risk non-muscle invasive bladder cancer (IR NMIBC) as defined by American Urological Association (AUA)/Society of Urologic Oncology [SUO] Guideline (2020)
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Has undergone adequate transurethral resection of bladder tumor (TURBT; with or without peri-operative chemotherapy) within 60 days prior to randomization:
-
Recurrence within 1 year, low-grade Ta
-
Solitary low-grade Ta >3 cm
-
Low-grade Ta, multifocal
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Solitary high-grade Ta, ≤3 cm
-
Low-grade T1
- Patients with T1 disease should undergo resection at the base of the lesion and biopsies should contain muscle fibres.
- Restage TURBT may be done at the discretion of the investigator
-
You will not qualify if you...
- Current or previous evidence of muscle invasive (muscularis propria) or metastatic disease presented at the screening visit
High risk NMIBC defined as:
- High-grade T1
- Any recurrent, high-grade Ta
- High-grade Ta >3 cm (or multifocal)
- Any carcinoma in situ (CIS)
- Any Bacillus Calmette-Guérin (BCG) failure in high-grade subject
- Any variant histology
- Any prostatic urethral involvement
Low risk NMIBC defined as:
- First occurrence of low-grade solitary Ta ≤3 cm
- Recurrence of low-grade solitary Ta ≤3 cm >12 months from previous occurrence
- Papillary urothelial neoplasm of low malignant potential
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 97 locations
1
University of South Alabama (USA) Health System - USACM
Mobile, Alabama, United States, 36606
Actively Recruiting
2
Urology Associates of Mobile
Mobile, Alabama, United States, 56608
Actively Recruiting
3
Mayo Clinic Arizona
Phoenix, Arizona, United States, 85054
Actively Recruiting
4
Center for Neurosciences
Tucson, Arizona, United States, 85718
Actively Recruiting
5
Arkansas Urology, North Little Rock
Little Rock, Arkansas, United States, 72211
Actively Recruiting
6
Michael G Oefelein, MD Clinical Trials
Bakersfield, California, United States, 93301
Actively Recruiting
7
Urology Associates of Central California
Fresno, California, United States, 93720
Actively Recruiting
8
American Institute of Research
Los Angeles, California, United States, 90017
Actively Recruiting
9
Urology Center of Southern California
Murrieta, California, United States, 92563
Actively Recruiting
10
University of California, Irvine
Orange, California, United States, 92868
Actively Recruiting
11
Providence Saint John's Cancer Institute
Santa Monica, California, United States, 90404
Actively Recruiting
12
Advent Health
Denver, Colorado, United States, 80210
Actively Recruiting
13
Medstar Georgetown University Hospital
Washington D.C., District of Columbia, United States, 20007
Actively Recruiting
14
Mayo Clinic
Jacksonville, Florida, United States, 32224
Actively Recruiting
15
Advanced Urology institute - Pinellas
Largo, Florida, United States, 33771
Actively Recruiting
16
Sarasota Memorial Healthcare System
Sarasota, Florida, United States, 34239
Actively Recruiting
17
Emory University
Atlanta, Georgia, United States, 30322
Actively Recruiting
18
NextStage Clinical Research
Lisle, Illinois, United States, 60532
Actively Recruiting
19
Blessing Health System
Quincy, Illinois, United States, 62301
Actively Recruiting
20
Urology Center of Iowa Research
Clive, Iowa, United States, 50325
Actively Recruiting
21
Wichita Urology Group
Wichita, Kansas, United States, 67226
Actively Recruiting
22
University of Kentucky (UK) - Markey Cancer Center
Lexington, Kentucky, United States, 40536
Actively Recruiting
23
Anne Arundel Urology, PA
Annapolis, Maryland, United States, 21401
Actively Recruiting
24
Mayo Clinic - Rochester Minnesota
Rochester, Minnesota, United States, 55905
Actively Recruiting
25
Mercy Clinic Oncology and Hematology - David C. Pratt Cancer Center
Creve Coeur, Missouri, United States, 63141
Terminated
26
Specialty Clinical Research of St. Louis
St Louis, Missouri, United States, 63141
Actively Recruiting
27
Adult and Pediatric Urology P.C.
Omaha, Nebraska, United States, 68114
Actively Recruiting
28
Atlantic Health
Morristown, New Jersey, United States, 07960
Actively Recruiting
29
Albany Medical College
Albany, New York, United States, 10461
Actively Recruiting
30
Great Lakes Physician PC d/b/a Western New York Urology Associates
Cheektowaga, New York, United States, 14225
Actively Recruiting
31
AccuMed Research Associates
Garden City, New York, United States, 11530
Actively Recruiting
32
Northwell Health -The Arthur Smith Institute for Urology
Lake Success, New York, United States, 11042
Actively Recruiting
33
Veterans Affairs New York Harbor Healthcare System - Manhattan VA Medical Center
New York, New York, United States, 10010
Actively Recruiting
34
Integrated Medical Professionals, PLLC
New York, New York, United States, 10016
Actively Recruiting
35
Premier Medical Group of the Hudson Valley
Poughkeepsie, New York, United States, 12603
Terminated
36
James J. Peters VA Medical Center
The Bronx, New York, United States, 10468
Actively Recruiting
37
University of Cincinnati
Cincinnati, Ohio, United States, 45267
Actively Recruiting
38
Oregon Health and Science University (Portland)
Portland, Oregon, United States, 97239
Actively Recruiting
39
MidLantic Urology
Bala-Cynwyd, Pennsylvania, United States, 19004
Actively Recruiting
40
Keystone Urology Specialists
Lancaster, Pennsylvania, United States, 17601
Actively Recruiting
41
University of Pennsylvania - Perelman Center for Advanced Medicine - Penn Urology
Philadelphia, Pennsylvania, United States, 19104
Actively Recruiting
42
University of Pittsburgh Medical Center - Shadyside Medical Building
Pittsburgh, Pennsylvania, United States, 15232
Actively Recruiting
43
Carolina Urologic Research Center
Myrtle Beach, South Carolina, United States, 29572
Actively Recruiting
44
Urology Austin
Austin, Texas, United States, 78759
Actively Recruiting
45
Urology Clinics of North Texas PLLC (Dallas)
Dallas, Texas, United States, 75231
Actively Recruiting
46
Houston Metro Urology - Memorial City
Houston, Texas, United States, 77027
Actively Recruiting
47
Houston Methodist Hospital (Houston)
Houston, Texas, United States, 77030
Actively Recruiting
48
Urology of Virginia
Virginia Beach, Virginia, United States, 23462
Actively Recruiting
49
Prostate Cancer Centre
Calgary, Alberta, Canada, T2V1P9
Actively Recruiting
50
G kenneth Jansz Medicine Professional Corporation
Burlington, Ontario, Canada, L7N 3V2
Actively Recruiting
51
University Health Network UHN - Princess Margaret Cancer Centre
Toronto, Ontario, Canada, M5G 1Z5
Actively Recruiting
52
Fakultní Thomayerova Nemocnice
Prague, Prague, Czechia, 140 59
Actively Recruiting
53
Androgeos, spol. s r.o. Location
Prague, Prague, Czechia, 160 00
Actively Recruiting
54
Krajska Nemocnice Liberec
Liberec, Czechia, 46300
Actively Recruiting
55
Fakultní Thomayerova Nemocnice
Prague, Czechia, 140 59
Actively Recruiting
56
CHU Clermont Ferrand - Hopital Gabriel Montpied
Clermont-Ferrand, Auvergne-Rhône-Alpes, France, 63000
Actively Recruiting
57
CHU Toulouse - Hopital Rangueil
Toulouse, Haute-Garonne, France, 31059
Actively Recruiting
58
CHU Nantes - Hotel Dieu
Nantes, Nantes, France, 44093
Actively Recruiting
59
CHU de Bordeaux - Hôpital Pellegrin
Bordeaux, New Aquitaine, France, 33076
Actively Recruiting
60
CHU de Rouen - Hopital Charles-Nicolle
Rouen, Normandy, France, 76031
Actively Recruiting
61
Centre Hospitalier Universitaire De Nimes (Nîmes)
Nîmes, Occitanie, France, 30229
Actively Recruiting
62
Centre Hospitaliser Universitaire de Lyon Sud
Lyon, Rhone-Alpe, France, 69310
Actively Recruiting
63
Hospices Civils de Lyon - Edouard Herriot Hosp.
Lyon, Rhône-Alps, France, 69003
Actively Recruiting
64
Hopital La Pitie Salpetriere
Paris, France, 75013
Actively Recruiting
65
APHP - Hopital Bichat
Paris, Île-de-France Region, France, 75018
Actively Recruiting
66
Aichi Medical University Hospital
Nagakute, Aichi-ken, Japan, 480-1195
Actively Recruiting
67
Nagoya University Hospital
Nagoya, Aichi-ken, Japan, 466-8560
Actively Recruiting
68
Japanese Red Cross Narita Hospital
Narita, Chiba, Japan, 286-8523
Actively Recruiting
69
National Hospital Organization Shikoku Cancer Center
Matsuyama, Ehime, Japan, 791-0280
Actively Recruiting
70
Kyushu University Hospital
Fukuoka, Fukuoka, Japan, 812-8582
Actively Recruiting
71
Hiroshima University Hospital
Hiroshima, Hiroshima, Japan, 734-8551
Actively Recruiting
72
Hitachi General Hospital
Hitachi, Ibaraki, Japan, 317-0077
Actively Recruiting
73
University of Tsukuba Hospital
Tsukuba, Ibaraki, Japan, 305-8576
Actively Recruiting
74
St. Marianna University Hospital
Kawasaki, Kanagawa, Japan, 216-8511
Actively Recruiting
75
Yokohama City University Hospital
Yokohama, Kanagawa, Japan, 236-0004
Actively Recruiting
76
Kochi Medical School Hospital
Nankoku, Kochi, Japan, 783-8505
Actively Recruiting
77
Mie University Hospital
Tsu, Mie-ken, Japan, 514-8507
Actively Recruiting
78
Nara Medical University Hospital
Kashihara, Nara, Japan, 634-8522
Actively Recruiting
79
Institute of Science Tokyo Hospital
Bunkyō-Ku, Tokyo, Japan, 113-8519
Actively Recruiting
80
Wakayama Medical University Hospital
Wakayama, Wakayama, Japan, 641-8510
Actively Recruiting
81
Clinical Research Center Spółka z ograniczoną odpowiedzialnością Medic-R Sp.k.
Poznan, Wielkopolska, Poland, 61-731
Actively Recruiting
82
Medical Concierge Centrum Medyczne
Warsaw, Woj. Mazowieckie, Poland, 02-798
Actively Recruiting
83
National Cancer Center
Goyang-si, Gyeonggi-do, South Korea, 10408
Actively Recruiting
84
Pusan National University Yangsan Hospital
Yangsan, Gyeongsangnam-do, South Korea, 50612
Actively Recruiting
85
Korea University Anam Hospital
Seoul, Seoul, South Korea, 02841
Actively Recruiting
86
Samsung Medical Center
Seoul, Seoul, South Korea, 06351
Actively Recruiting
87
Seoul National University Hospital
Seoul, Songpa-gu, South Korea, 03080
Actively Recruiting
88
Asan Medical Center
Seoul, Songpa-gu, South Korea, 05505
Actively Recruiting
89
Instituto de Investigacion Valdecilla (IDIVAL) / Hospital universitario Marques de Valdecilla
Santander, Cantabria, Spain, 39008
Actively Recruiting
90
Hospital del Mar
Barcelona, Catalonia, Spain, 08003
Actively Recruiting
91
Hospital Universitario Reina Sofia
Córdoba, Córdoba, Spain, 14004
Actively Recruiting
92
Hospital Universitario de A Coruna
A Coruña, Galicia, Spain, 15006
Actively Recruiting
93
Hospital Universitario Virgen De Las Nieves
Granada, Granada, Spain, 18014
Actively Recruiting
94
Universidad Autonoma de Madrid. Hospital Universitario La Paz
Madrid, Madrid, Spain, 28046
Actively Recruiting
95
Hospital Universitario Basurto
Bilbao, Vizcaya, Spain, 48013
Actively Recruiting
96
Hospital Universitario 12 De Octubre (Madrid)
Madrid, Spain, 28041
Actively Recruiting
97
Servicio Andaluz de Salud (SAS) - Hospital Universitario Virgen de la Victoria (HUVV)
Málaga, Spain, 29010
Actively Recruiting
Research Team
F
Ferring Pharmaceuticals
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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