Actively Recruiting
Phase 3 Study of TAR-210 Intravesical Delivery System Versus Investigator's Choice of Intravesical Chemotherapy in High-risk Non-muscle-invasive Bladder Cancer with FGFR Alterations After BCG
Led by Janssen Research & Development, LLC · Updated on 2026-06-05
220
Participants Needed
109
Research Sites
205 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This trial investigates treatments for high-risk non-muscle-invasive bladder cancer in participants who have previously received Bacillus Calmette-Gu e9rin (BCG) treatment. It compares disease-free survival between participants treated with TAR-210, a drug delivered inside the bladder, and those receiving intravesical chemotherapy chosen by their doctor. The study focuses on participants with certain FGFR gene alterations and aims to evaluate the length of time participants remain free of cancer signs or symptoms after treatment. Participants are randomly assigned to one of two groups. Group A receives TAR-210 inserted into the bladder on Day 1 and continues this treatment for about two years. Group B receives intravesical chemotherapy with either mitomycin C or gemcitabine, given once weekly for 4 to 6 doses as induction therapy, followed by monthly maintenance doses for up to one year, with an optional second year of maintenance at the doctor's discretion. Treatments are delivered directly into the bladder through a catheter. During the study, participants will be monitored regularly for up to five years to measure outcomes such as disease-free survival, recurrence-free survival, time to disease worsening, and overall survival. Assessments include safety evaluations using standard criteria, laboratory tests, vital sign checks, and quality-of-life questionnaires at multiple scheduled time points. Researchers will also track adverse events and changes in health status to assess the impact of treatments over time.
CONDITIONS
Brief 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 diagnosis of papillary-only high-risk non-muscle-invasive bladder cancer (high-grade Ta or any T1, no CIS) 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 and negative or non-suspicious urine cytology for high-grade urothelial carcinoma
- Prior BCG treatment meeting one of the following: adequate induction and maintenance doses with disease at first assessment or within 6 months after last BCG (BCG-unresponsive), adequate induction with or without maintenance with disease within 12 months (BCG-experienced), or unable to complete induction due to significant toxicity (BCG-intolerant)
- Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
- Ineligible for or refusing radical cystectomy (bladder removal surgery)
You will not qualify if you...
- Presence of carcinoma in situ (CIS) at any time from diagnosis to randomization or history of muscle-invasive, locally advanced, nonresectable, or metastatic urothelial carcinoma
- Active malignancies requiring recent treatment changes in the last 24 months, except certain low-risk or treated cancers
- Anatomic features of bladder or urethra preventing safe use of TAR-210
- History of clinically significant polyuria with 24-hour urine volume greater than 4,000 milliliters
- Use of indwelling catheters (intermittent catheterization allowed)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 2 years for TAR-210; up to 1 year with optional second year for mitomycin C or gemcitabine
Participants receive intravesical drug treatment with either TAR-210, or mitomycin C or gemcitabine, to manage high-risk non-muscle-invasive bladder cancer.
For TAR-210: 1 insertion visit on Day 1; for mitomycin C or gemcitabine: once weekly visits for 4 to 6 weeks followed by monthly visits for up to 1 year, with optional additional monthly visits in second year
Duration - Up to 5 years
Participants are monitored for disease outcomes and side effects after treatment completion.
Regular assessments scheduled during the follow-up period
Trial Site Locations
Total: 109 locations
1
Academic Urology and Urogynecology of Arizona
Sun City, Arizona, United States, 85351
Actively Recruiting
2
Colorado Clinical Research
Lakewood, Colorado, United States, 80228
Actively Recruiting
3
Georgia Urology
Atlanta, Georgia, United States, 30328
Actively Recruiting
4
Associated Urological Specialists
Chicago Ridge, Illinois, United States, 60415
Actively Recruiting
5
Urology of Indiana
Carmel, Indiana, United States, 46032
Actively Recruiting
6
Greater Boston Urology
Plymouth, Massachusetts, United States, 02360
Actively Recruiting
7
Comprehensive Urology
Royal Oak, Michigan, United States, 48073
Actively Recruiting
8
UroHealth Partners
Omaha, Nebraska, United States, 68114
Completed
9
New Jersey Urology LLC
Voorhees Township, New Jersey, United States, 08043
Actively Recruiting
10
Associated Medical Professionals
Syracuse, New York, United States, 13210
Actively Recruiting
11
Dayton Physicians Network Urology
Centerville, Ohio, United States, 45459
Actively Recruiting
12
The Urology Group
Cincinnati, Ohio, United States, 45212
Actively Recruiting
13
Helios Clinical Research, LLC
Middleburg Heights, Ohio, United States, 44130
Actively Recruiting
14
Oregon Urology Institute
Springfield, Oregon, United States, 97477
Actively Recruiting
15
MidLantic Urology
Bala-Cynwyd, Pennsylvania, United States, 19004
Actively Recruiting
16
Keystone Urology Specialists
Lancaster, Pennsylvania, United States, 17604
Actively Recruiting
17
University Of Pittsburgh Medical Center UPMC Hillman Cancer Center
Pittsburgh, Pennsylvania, United States, 15232
Actively Recruiting
18
Carolina Urologic Research Center
Myrtle Beach, South Carolina, United States, 29572
Actively Recruiting
19
The Conrad Pearson Clinic
Germantown, Tennessee, United States, 38138
Actively Recruiting
20
Texas Oncology-Austin
Austin, Texas, United States, 78731
Actively Recruiting
21
Urology Austin
Austin, Texas, United States, 78745
Actively Recruiting
22
Urology San Antonio PA dba USA Clinical Trials
San Antonio, Texas, United States, 78229
Actively Recruiting
23
Hospital Sirio Libanes
Buenos Aires, Argentina, C1419AHN
Actively Recruiting
24
Instituto Alexander Fleming
Buenos Aires, Argentina, C1426ANZ
Actively Recruiting
25
Investigaciones Clinico Moleculares (ICM)
Caba, Argentina, C1425
Actively Recruiting
26
Centro Urologico Profesor Bengio
Córdoba, Argentina, X5000KPH
Actively Recruiting
27
Sanatorio de la Mujer
Rosario, Argentina, 2000
Actively Recruiting
28
Hopital Erasme
Brussels, Belgium, 1070
Actively Recruiting
29
Ziekenhuis Oost-Limburg
Genk, Belgium, 3600
Actively Recruiting
30
AZ Maria Middelares
Ghent, Belgium, 9000
Actively Recruiting
31
Universitair Ziekenhuis Leuven
Leuven, Belgium, 3000
Actively Recruiting
32
Algemeen Ziekenhuis Delta
Roeselare, Belgium, 8800
Actively Recruiting
33
Liga Norte Riograndense Contra O Cancer
Natal, Brazil, 59062 000
Actively Recruiting
34
Hospital Regional do Cancer - Hospital de Esperança
Presidente Prudente, Brazil, 19013-050
Actively Recruiting
35
Fundacao Faculdade Regional De Medicina De Sao Jose Do Rio Preto
São José do Rio Preto, Brazil, 15090 000
Actively Recruiting
36
Fundacao Faculdade de Medicina - Instituto do Cancer do Estado de Sao Paulo
São Paulo, Brazil, 01246 000
Actively Recruiting
37
Real e Benemerita Associacao Portuguesa de Beneficencia
São Paulo, Brazil, 01323 010
Actively Recruiting
38
Peking University First Hospital
Beijing, China, 100034
Actively Recruiting
39
The Third People's Hospital of Chengdu
Chengdu, China, 610014
Actively Recruiting
40
West China Hospital Sichuan University
Chengdu, China, 610093
Actively Recruiting
41
Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University
Guangzhou, China, 510260
Actively Recruiting
42
Nanjing Drum Tower Hospital
Nanjing, China, 210008
Actively Recruiting
43
The First Affiliated Hospital of Ningbo University
Ningbo, China, 315020
Actively Recruiting
44
The Second Hospital Of Tianjin Medical University
Tianjin, China, 300211
Actively Recruiting
45
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, China, 325000
Actively Recruiting
46
TongJi Hospital of TongJi Medical College of Huazhong University of Science & Technology
Wuhan, China, 430030
Actively Recruiting
47
Institut Paoli Calmettes
Marseille, France, 13009
Actively Recruiting
48
Hopital Saint Louis
Paris, France, 75010
Actively Recruiting
49
CHU Pitie Salpetriere
Paris, France, 75013
Actively Recruiting
50
Hopital Saint Joseph
Paris, France, 75014
Actively Recruiting
51
Clinique de la Croix du Sud
Quint-Fonsegrives, France, 31130
Actively Recruiting
52
CHP Saint Gregoire
Saint-Grégoire, France, 35768
Actively Recruiting
53
Gustave Roussy
Villejuif, France, 94800
Actively Recruiting
54
Universitaetsklinikum Koeln
Cologne, Germany, 50937
Actively Recruiting
55
Marien hospital Herne
Herne, Germany, 44625
Actively Recruiting
56
Klinikum Leverkusen gGmbH
Leverkusen, Germany, 51375
Actively Recruiting
57
Universitaetsklinikum Mannheim
Mannheim, Germany, 68167
Actively Recruiting
58
Studienpraxis Urologie Nurtingen
Nürtingen, Germany, 72622
Actively Recruiting
59
Caritas-Krankenhaus St. Josef
Regensburg, Germany, 93053
Actively Recruiting
60
General Hospital of Athens G Gennimatas
Athens, Greece, 115 27
Actively Recruiting
61
Laiko General Hospital of Athens
Athens, Greece, 115 27
Actively Recruiting
62
Sismanogleio General Hospital
Athens, Greece, 15126
Actively Recruiting
63
General Hospital Of Thessaloniki Papageorgiou
Thessaloniki, Greece, 56429
Actively Recruiting
64
Athens Medical Center S A Interbalkan Medical Center of Thessaloniki
Thessaloniki, Greece, 57001
Actively Recruiting
65
Rambam Medical Center
Haifa, Israel, 3109601
Actively Recruiting
66
Carmel Medical Center
Haifa, Israel, 3436212
Actively Recruiting
67
Meir Medical Center
Kfar Saba, Israel, 44281
Actively Recruiting
68
Rabin Medical Center
Petah Tikva, Israel, 4941492
Actively Recruiting
69
Sheba Medical Center
Ramat Gan, Israel, 52621
Actively Recruiting
70
Tel Aviv Sourasky Medical Center
Tel Aviv, Israel, 64239
Actively Recruiting
71
Cliniche Humanitas Gavazzeni
Bergamo, Italy, 24125
Actively Recruiting
72
ASST Spedali Civili Brescia
Brescia, Italy, 25123
Actively Recruiting
73
SPDC Villa Scassi
Genova, Italy, 16149
Actively Recruiting
74
Ospedale San Raffaele
Milan, Italy, 20132
Actively Recruiting
75
Fondazione G Pascale Istituto Nazionale Tumori IRCCS
Naples, Italy, 80131
Actively Recruiting
76
Istituto Nazionale Tumori Regina Elena
Roma, Italy, 00144
Actively Recruiting
77
Aou San Luigi Gonzaga
Sanatorio San Luigi, Italy, 10043
Actively Recruiting
78
Ospedale S. Maria Della Misericordia
Udine, Italy, 33100
Actively Recruiting
79
Juntendo University Hospital
Bunkyō City, Japan, 113 8431
Actively Recruiting
80
Funabashi Municipal Medical Center
Funabashi Shi, Japan, 273 8588
Actively Recruiting
81
Hakodate Goryoukaku Hospital
Hakodate, Japan, 040 8611
Actively Recruiting
82
St Marianna University Hospital
Kawasaki, Japan, 216 8511
Actively Recruiting
83
The Jikei University Hospital
Minatoku, Japan, 105 8471
Actively Recruiting
84
Toho University Sakura Medical Center
Sakura, Japan, 285-8741
Actively Recruiting
85
Yokohama Municipal Citizen's Hospital
Yokohama, Japan, 221 0855
Actively Recruiting
86
Yokohama City University Medical Center
Yokohama, Japan, 232 0024
Actively Recruiting
87
Radboud Umcn
Nijmegen, Netherlands, 6525 GA
Actively Recruiting
88
Canisius-Wilhelmina ZH
Nijmegen, Netherlands, 6532 SZ
Actively Recruiting
89
Erasmus MC
Rotterdam, Netherlands, 3015
Actively Recruiting
90
UMC Utrecht
Utrecht, Netherlands, 3584 CX
Actively Recruiting
91
Chungbuk National University Hospital
Cheongju-si, South Korea, 28644
Actively Recruiting
92
Samsung Medical Center
Gangnam Gu, South Korea, 06351
Actively Recruiting
93
Seoul National University Bundang Hospital
Seongnam-si, South Korea, 13620
Actively Recruiting
94
Seoul National University Hospital
Seoul, South Korea, 03080
Actively Recruiting
95
Severance Hospital Yonsei University Health System
Seoul, South Korea, 03722
Actively Recruiting
96
Hosp Univ A Coruna
A Coruña, Spain, 15006
Actively Recruiting
97
Hosp. Clinic de Barcelona
Barcelona, Spain, 08036
Actively Recruiting
98
Hosp. Puerta Del Mar
Cadiz, Spain, 11009
Actively Recruiting
99
Hosp. Gral. Univ. de Castellon
Castellon, Spain, 12004
Actively Recruiting
100
Hosp. Arquitecto Marcide
Ferrol, Spain, 15405
Actively Recruiting
101
Hosp. de Jerez de La Frontera
Jerez de la Frontera, Spain, 11407
Actively Recruiting
102
Hosp. Univ. 12 de Octubre
Madrid, Spain, 28041
Actively Recruiting
103
Hosp Virgen de La Victoria
Málaga, Spain, 29010
Actively Recruiting
104
Hosp.Univ.Parc Tauli
Sabadell, Spain, 08208
Actively Recruiting
105
Hull University Teaching Hospitals NHS Trust
Cottingham, United Kingdom, HU16 5JQ
Actively Recruiting
106
St Bartholomews Hospital
London, United Kingdom, EC1A 7BE
Actively Recruiting
107
Southampton University Hospital
Southampton, United Kingdom, SO16 6HU
Actively Recruiting
108
Lister Hospital
Stevenage, United Kingdom, SG1 4AB
Actively Recruiting
109
Royal Marsden Hospital
Surrey, United Kingdom, SM2 5PT
Actively Recruiting
Research Team
S
Study 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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