Actively Recruiting
A Study to Evaluate TAR-210 Versus Intravesical Chemotherapy Treatment in Participants With High Risk Non-Muscle-Invasive Bladder Cancer
Led by Janssen Research & Development, LLC · Updated on 2026-05-08
220
Participants Needed
108
Research Sites
339 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The main purpose of this study is to compare the disease-free survival (the length of time after randomization that a participant survives without any signs or symptoms of the cancer returning, or progressing) between Bacillus Calmette-Guérin (BCG) treated participants receiving treatment with TAR-210 versus investigator's choice of intravesical chemotherapy for treatment of high-risk non-muscle-invasive bladder cancer (HR-NMIBC).
CONDITIONS
Official Title
A Study to Evaluate TAR-210 Versus Intravesical Chemotherapy Treatment in Participants With High Risk Non-Muscle-Invasive Bladder Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically confirmed papillary-only high-risk non-muscle-invasive bladder cancer (high-grade Ta or any T1, no carcinoma in situ) with predominant urothelial differentiation
- Presence of susceptible FGFR mutation or fusion confirmed by urine or tumor tissue testing
- Complete removal of all visible tumors before randomization with negative or non-suspicious urine cytology for high-grade urothelial carcinoma
- Participants must have had adequate Bacillus Calmette-Guérin (BCG) treatment fitting one of these: BCG-unresponsive, BCG-experienced, or BCG-intolerant status
- Eastern Cooperative Oncology Group (ECOG) performance status grade 0, 1, or 2
- Must be ineligible for or refuse radical cystectomy surgery
You will not qualify if you...
- Presence of carcinoma in situ from diagnosis to randomization or history of muscle-invasive, locally advanced, nonresectable, or metastatic urothelial carcinoma
- Active malignancies progressing or requiring treatment changes in the last 24 months except certain low-risk or treated malignancies
- Bladder or urethral anatomical features preventing safe use of TAR-210
- History of significant polyuria with 24-hour urine volume over 4,000 milliliters
- Use of indwelling catheters (intermittent catheterization permitted)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 108 locations
1
Colorado Clinical Research
Lakewood, Colorado, United States, 80228
Actively Recruiting
2
Georgia Urology
Atlanta, Georgia, United States, 30328
Actively Recruiting
3
Associated Urological Specialists
Chicago Ridge, Illinois, United States, 60415
Actively Recruiting
4
Urology of Indiana
Carmel, Indiana, United States, 46032
Actively Recruiting
5
Greater Boston Urology
Plymouth, Massachusetts, United States, 02360
Actively Recruiting
6
Comprehensive Urology
Royal Oak, Michigan, United States, 48073
Actively Recruiting
7
UroHealth Partners
Omaha, Nebraska, United States, 68114
Completed
8
New Jersey Urology LLC
Voorhees Township, New Jersey, United States, 08043
Actively Recruiting
9
Associated Medical Professionals
Syracuse, New York, United States, 13210
Actively Recruiting
10
Dayton Physicians Network Urology
Centerville, Ohio, United States, 45459
Actively Recruiting
11
The Urology Group
Cincinnati, Ohio, United States, 45212
Actively Recruiting
12
Helios Clinical Research, LLC
Middleburg Heights, Ohio, United States, 44130
Actively Recruiting
13
Oregon Urology Institute
Springfield, Oregon, United States, 97477
Actively Recruiting
14
MidLantic Urology
Bala-Cynwyd, Pennsylvania, United States, 19004
Actively Recruiting
15
Keystone Urology Specialists
Lancaster, Pennsylvania, United States, 17604
Actively Recruiting
16
University Of Pittsburgh Medical Center UPMC Hillman Cancer Center
Pittsburgh, Pennsylvania, United States, 15232
Actively Recruiting
17
Carolina Urologic Research Center
Myrtle Beach, South Carolina, United States, 29572
Actively Recruiting
18
The Conrad Pearson Clinic
Germantown, Tennessee, United States, 38138
Actively Recruiting
19
Texas Oncology-Austin
Austin, Texas, United States, 78731
Actively Recruiting
20
Urology Austin
Austin, Texas, United States, 78745
Actively Recruiting
21
Urology San Antonio PA dba USA Clinical Trials
San Antonio, Texas, United States, 78229
Actively Recruiting
22
Hospital Sirio Libanes
Buenos Aires, Argentina, C1419AHN
Actively Recruiting
23
Instituto Alexander Fleming
Buenos Aires, Argentina, C1426ANZ
Actively Recruiting
24
Investigaciones Clinico Moleculares (ICM)
Caba, Argentina, C1425
Actively Recruiting
25
Centro Urologico Profesor Bengio
Córdoba, Argentina, X5000KPH
Actively Recruiting
26
Sanatorio de la Mujer
Rosario, Argentina, 2000
Actively Recruiting
27
Hopital Erasme
Brussels, Belgium, 1070
Actively Recruiting
28
Ziekenhuis Oost-Limburg
Genk, Belgium, 3600
Actively Recruiting
29
AZ Maria Middelares
Ghent, Belgium, 9000
Actively Recruiting
30
Universitair Ziekenhuis Leuven
Leuven, Belgium, 3000
Actively Recruiting
31
Algemeen Ziekenhuis Delta
Roeselare, Belgium, 8800
Actively Recruiting
32
Liga Norte Riograndense Contra O Cancer
Natal, Brazil, 59062 000
Actively Recruiting
33
Hospital Regional do Cancer - Hospital de Esperança
Presidente Prudente, Brazil, 19013-050
Actively Recruiting
34
Fundacao Faculdade Regional De Medicina De Sao Jose Do Rio Preto
São José do Rio Preto, Brazil, 15090 000
Actively Recruiting
35
Fundacao Faculdade de Medicina - Instituto do Cancer do Estado de Sao Paulo
São Paulo, Brazil, 01246 000
Actively Recruiting
36
Real e Benemerita Associacao Portuguesa de Beneficencia
São Paulo, Brazil, 01323 010
Actively Recruiting
37
Peking University First Hospital
Beijing, China, 100034
Actively Recruiting
38
The Third People's Hospital of Chengdu
Chengdu, China, 610014
Actively Recruiting
39
West China Hospital Sichuan University
Chengdu, China, 610093
Actively Recruiting
40
Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University
Guangzhou, China, 510260
Actively Recruiting
41
Nanjing Drum Tower Hospital
Nanjing, China, 210008
Actively Recruiting
42
The First Affiliated Hospital of Ningbo University
Ningbo, China, 315020
Actively Recruiting
43
The Second Hospital Of Tianjin Medical University
Tianjin, China, 300211
Actively Recruiting
44
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, China, 325000
Actively Recruiting
45
TongJi Hospital of TongJi Medical College of Huazhong University of Science & Technology
Wuhan, China, 430030
Actively Recruiting
46
Institut Paoli Calmettes
Marseille, France, 13009
Actively Recruiting
47
Hopital Saint Louis
Paris, France, 75010
Actively Recruiting
48
CHU Pitie Salpetriere
Paris, France, 75013
Actively Recruiting
49
Hopital Saint Joseph
Paris, France, 75014
Actively Recruiting
50
Clinique de la Croix du Sud
Quint-Fonsegrives, France, 31130
Actively Recruiting
51
CHP Saint Gregoire
Saint-Grégoire, France, 35768
Actively Recruiting
52
Gustave Roussy
Villejuif, France, 94800
Actively Recruiting
53
Universitaetsklinikum Koeln
Cologne, Germany, 50937
Actively Recruiting
54
Marien hospital Herne
Herne, Germany, 44625
Actively Recruiting
55
Klinikum Leverkusen gGmbH
Leverkusen, Germany, 51375
Actively Recruiting
56
Universitaetsklinikum Mannheim
Mannheim, Germany, 68167
Actively Recruiting
57
Studienpraxis Urologie Nurtingen
Nürtingen, Germany, 72622
Actively Recruiting
58
Caritas-Krankenhaus St. Josef
Regensburg, Germany, 93053
Actively Recruiting
59
General Hospital of Athens G Gennimatas
Athens, Greece, 115 27
Actively Recruiting
60
Laiko General Hospital of Athens
Athens, Greece, 115 27
Actively Recruiting
61
Sismanogleio General Hospital
Athens, Greece, 15126
Actively Recruiting
62
General Hospital Of Thessaloniki Papageorgiou
Thessaloniki, Greece, 56429
Actively Recruiting
63
Athens Medical Center S A Interbalkan Medical Center of Thessaloniki
Thessaloniki, Greece, 57001
Actively Recruiting
64
Rambam Medical Center
Haifa, Israel, 3109601
Actively Recruiting
65
Carmel Medical Center
Haifa, Israel, 3436212
Actively Recruiting
66
Meir Medical Center
Kfar Saba, Israel, 44281
Actively Recruiting
67
Rabin Medical Center
Petah Tikva, Israel, 4941492
Actively Recruiting
68
Sheba Medical Center
Ramat Gan, Israel, 52621
Actively Recruiting
69
Tel Aviv Sourasky Medical Center
Tel Aviv, Israel, 64239
Actively Recruiting
70
Cliniche Humanitas Gavazzeni
Bergamo, Italy, 24125
Actively Recruiting
71
ASST Spedali Civili Brescia
Brescia, Italy, 25123
Actively Recruiting
72
SPDC Villa Scassi
Genova, Italy, 16149
Actively Recruiting
73
Ospedale San Raffaele
Milan, Italy, 20132
Actively Recruiting
74
Fondazione G Pascale Istituto Nazionale Tumori IRCCS
Naples, Italy, 80131
Actively Recruiting
75
Istituto Nazionale Tumori Regina Elena
Roma, Italy, 00144
Actively Recruiting
76
Aou San Luigi Gonzaga
Sanatorio San Luigi, Italy, 10043
Actively Recruiting
77
Ospedale S. Maria Della Misericordia
Udine, Italy, 33100
Actively Recruiting
78
Juntendo University Hospital
Bunkyō City, Japan, 113 8431
Actively Recruiting
79
Funabashi Municipal Medical Center
Funabashi Shi, Japan, 273 8588
Actively Recruiting
80
Hakodate Goryoukaku Hospital
Hakodate, Japan, 040 8611
Actively Recruiting
81
St Marianna University Hospital
Kawasaki, Japan, 216 8511
Actively Recruiting
82
The Jikei University Hospital
Minatoku, Japan, 105 8471
Actively Recruiting
83
Toho University Sakura Medical Center
Sakura, Japan, 285-8741
Actively Recruiting
84
Yokohama Municipal Citizen's Hospital
Yokohama, Japan, 221 0855
Actively Recruiting
85
Yokohama City University Medical Center
Yokohama, Japan, 232 0024
Actively Recruiting
86
Radboud Umcn
Nijmegen, Netherlands, 6525 GA
Actively Recruiting
87
Canisius-Wilhelmina ZH
Nijmegen, Netherlands, 6532 SZ
Actively Recruiting
88
Erasmus MC
Rotterdam, Netherlands, 3015
Actively Recruiting
89
UMC Utrecht
Utrecht, Netherlands, 3584 CX
Actively Recruiting
90
Chungbuk National University Hospital
Cheongju-si, South Korea, 28644
Actively Recruiting
91
Samsung Medical Center
Gangnam Gu, South Korea, 06351
Actively Recruiting
92
Seoul National University Bundang Hospital
Seongnam-si, South Korea, 13620
Actively Recruiting
93
Seoul National University Hospital
Seoul, South Korea, 03080
Actively Recruiting
94
Severance Hospital Yonsei University Health System
Seoul, South Korea, 03722
Actively Recruiting
95
Hosp Univ A Coruna
A Coruña, Spain, 15006
Actively Recruiting
96
Hosp. Clinic de Barcelona
Barcelona, Spain, 08036
Actively Recruiting
97
Hosp. Puerta Del Mar
Cadiz, Spain, 11009
Actively Recruiting
98
Hosp. Gral. Univ. de Castellon
Castellon, Spain, 12004
Actively Recruiting
99
Hosp. Arquitecto Marcide
Ferrol, Spain, 15405
Actively Recruiting
100
Hosp. de Jerez de La Frontera
Jerez de la Frontera, Spain, 11407
Actively Recruiting
101
Hosp. Univ. 12 de Octubre
Madrid, Spain, 28041
Actively Recruiting
102
Hosp Virgen de La Victoria
Málaga, Spain, 29010
Actively Recruiting
103
Hosp.Univ.Parc Tauli
Sabadell, Spain, 08208
Actively Recruiting
104
Hull University Teaching Hospitals NHS Trust
Cottingham, United Kingdom, HU16 5JQ
Actively Recruiting
105
St Bartholomews Hospital
London, United Kingdom, EC1A 7BE
Actively Recruiting
106
Southampton University Hospital
Southampton, United Kingdom, SO16 6HU
Actively Recruiting
107
Lister Hospital
Stevenage, United Kingdom, SG1 4AB
Actively Recruiting
108
Royal Marsden Hospital
Surrey, United Kingdom, SM2 5PT
Actively Recruiting
Research Team
S
Study Contact
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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