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JOURNAL ONKOLOGIE – STUDIE

A Study of TAR-200 in Combination With Cetrelimab Versus Concurrent Chemoradiotherapy in Participants With Muscle-invasive Bladder Cancer (MIBC) of the Bladder

Rekrutierend

NCT-Nummer:
NCT04658862

Studienbeginn:
Dezember 2020

Letztes Update:
08.01.2021

Wirkstoff:
Cetrelimab, TAR-200, Cisplatin, Gemcitabine

Indikation (Clinical Trials):
Urinary Bladder Neoplasms

Geschlecht:
Alle

Altersgruppe:
Erwachsene (18+)

Phase:
Phase 3

Sponsor:
Janssen Research & Development, LLC

Collaborator:
-

Studienleiter

Janssen Research & Development, LLC Clinical Trials
Study Director
Janssen Research & Development, LLC

Kontakt

Studienlocations (3 von 209)

Urologicum Duisburg
47179 Duisburg
(Nordrhein-Westfalen)
GermanyNoch nicht rekrutierend» Google-Maps
Darmkrebszentrum Universitätsklinikum Düsseldorf
Moorenstraße 5
40225 Düsseldorf
DeutschlandNoch nicht rekrutierend» Google-Maps
Agaplesion Frankfurter Diakonie Kliniken GmbH, Markus Krankenhaus
60431 Frankfurt Am Main
(Hessen)
GermanyNoch nicht rekrutierend» Google-Maps
Universitatsklinikum Frankfurt
60590 Frankfurt am Main
(Hessen)
GermanyNoch nicht rekrutierend» Google-Maps
Klinikum Herne - Urologie
44625 Herne
(Nordrhein-Westfalen)
GermanyNoch nicht rekrutierend» Google-Maps
Matthias Schulze - Germany
04416 Markkleeberg
(Sachsen)
GermanyNoch nicht rekrutierend» Google-Maps
Kinderonkologisches Zentrum am Universitätsklinikum Münster
Albert-Schweitzer-Campus 1
48149 Münster
DeutschlandNoch nicht rekrutierend» Google-Maps
Klinikum Nürnberg Nord - Hautklinik
90419 Nürnberg
(Bayern)
GermanyNoch nicht rekrutierend» Google-Maps
Kliniken Nordoberpfalz AG/Klinikum Weiden
92637 Weiden
(Bayern)
GermanyZurückgezogen» Google-Maps
Bladder Cancer Genitourinary Oncology
85032 Phoenix
United StatesZurückgezogen» Google-Maps
University of Southern California
90033 Los Angeles
United StatesNoch nicht rekrutierend» Google-Maps
The Urology Center of Colorado
80211 Denver
United StatesNoch nicht rekrutierend» Google-Maps
Foothills Urology - Golden Off
80401 Golden
United StatesNoch nicht rekrutierend» Google-Maps
UF Health Jacksonville
32209 Jacksonville
United StatesNoch nicht rekrutierend» Google-Maps
The University Of Chicago Medicine
60637 Chicago
United StatesNoch nicht rekrutierend» Google-Maps
DuPage Medical Group
60532 Lisle
United StatesNoch nicht rekrutierend» Google-Maps
Johns Hopkins Medical Institutions
21287 Baltimore
United StatesZurückgezogen» Google-Maps
Adult Pediatric Urology & Urogynecology, P.C
68114 Omaha
United StatesZurückgezogen» Google-Maps
NYU Langone Health
10017 New York
United StatesNoch nicht rekrutierend» Google-Maps
Icahn School of Medicine at Mount Sinai
10029 New York
United StatesNoch nicht rekrutierend» Google-Maps
Columbia University Medical Center, Herbert Irving Pavilliion
10032 New York
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Associated Medical Professionals
13210 Syracuse
United StatesNoch nicht rekrutierend» Google-Maps
Ohio State University
43210 Columbus
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Oklahoma City VAMC
73104 Oklahoma City
United StatesNoch nicht rekrutierend» Google-Maps
Oregon Urology Institute
97477 Springfield
United StatesNoch nicht rekrutierend» Google-Maps
Urologic Consultants of Southeastern PA
19004 Bala-Cynwyd
United StatesRekrutierend» Google-Maps
Thomas Jefferson University
19107 Philadelphia
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Carolina Urologic Research Center
29572 Myrtle Beach
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Urology Associates, PC
37209 Nashville
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University of Texas Medical Branch
77573 League City
United StatesNoch nicht rekrutierend» Google-Maps
Virginia Oncology Associates
23502 Norfolk
United StatesNoch nicht rekrutierend» Google-Maps
Spokane Urology
99202 Spokane
United StatesNoch nicht rekrutierend» Google-Maps
Centro Urologico Profesor Bengio
X5000KPH Córdoba
ArgentinaNoch nicht rekrutierend» Google-Maps
Centro Oncologico Riojano Integral (Cori)
F5300COE La Rioja
ArgentinaNoch nicht rekrutierend» Google-Maps
Flinders Medical Centre
5042 Bedford Park
AustraliaNoch nicht rekrutierend» Google-Maps
Royal North Shore Hospital
2065 St Leonards
AustraliaNoch nicht rekrutierend» Google-Maps
AZ Sint-Jan Brugge-Oostende AV
8000 Brugge
BelgiumNoch nicht rekrutierend» Google-Maps
Fundacao Pio Xii - Hospital De Cancer De Barretos
14784 Barretos
BrazilNoch nicht rekrutierend» Google-Maps
Fundação Hospitalar São Francisco de Assis
31110-580 Belo Horizonte
BrazilNoch nicht rekrutierend» Google-Maps
Centro de Pesquisa Urologica e Oncologia de Campinas
13073-400 Campinas
BrazilSchwebend» Google-Maps
Hospital Erasto Gaertner
81520-060 Curitiba
BrazilNoch nicht rekrutierend» Google-Maps
Centro de Pesquisas Oncológicas - CEPON
88034-000 Florianópolis
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Centro Regional Integrado de Oncologia - Crio
60336-045 Fortaleza
BrazilNoch nicht rekrutierend» Google-Maps
Hospital de Caridade de Ijui
98700-000 Ijuí
BrazilNoch nicht rekrutierend» Google-Maps
Clinica de Oncologia Reichow
89010-340 Jardim Blumenau
BrazilNoch nicht rekrutierend» Google-Maps
Hospital Amaral Carvalho
17210-180 Jaú
BrazilNoch nicht rekrutierend» Google-Maps
Liga Norte Riograndense Contra O Cancer
59062-000 Natal
BrazilNoch nicht rekrutierend» Google-Maps
Hospital das Clinicas de Porto Alegre
90035-903 Porto Alegre
BrazilSchwebend» Google-Maps
Hospital São Lucas - PUCRS
90610-000 Porto Alegre
BrazilNoch nicht rekrutierend» Google-Maps
Hospital Sao Rafael
41253-190 Salvador
BrazilNoch nicht rekrutierend» Google-Maps
CEPHO - Centro de Estudos e Pesquisa de Hematologia e Oncologia
09060-650 Santo André
BrazilNoch nicht rekrutierend» Google-Maps
ICESP - Instituto do Câncer do Estado de São Paulo
01246 Sao Paolo
BrazilNoch nicht rekrutierend» Google-Maps
Hospital Sirio Libanes
04784180 Sao Paulo
BrazilNoch nicht rekrutierend» Google-Maps
Fundação Faculdade de Medicina de São José Do Rio Preto
15090000 São José Do Rio Preto
BrazilNoch nicht rekrutierend» Google-Maps
Instituto de Assistência Médica ao Servidor Público Estadual - HSPE-FMO
04039-004 São Paulo
BrazilNoch nicht rekrutierend» Google-Maps
Centro Oncológico do Triângulo
38408-150 Uberlândia
BrazilNoch nicht rekrutierend» Google-Maps
Exdeo Clinical Research Inc
V2T1X8 Abbotsford
CanadaNoch nicht rekrutierend» Google-Maps
Vancouver General Hospital
V6H 3Z6 Vancouver
CanadaZurückgezogen» Google-Maps
The Male/Female Health and Research Centre
L4M 7G1 Barrie
CanadaNoch nicht rekrutierend» Google-Maps
University of Toronto
M5G 2M9 Toronto
CanadaNoch nicht rekrutierend» Google-Maps
McGill University Health Centre
H4A 3J1 Montreal
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CHU de Québec -L'Hôtel-Dieu de Québec
G1R 2J6 Québec
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Centre Hospitalier Universitaire de Sherbrooke
J1H 5H3 Sherbrooke
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Kromerizska nemocnice a.s.
767 01 Kromeriz
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746 01 Opava
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Urocentrum Praha
120 00 Praha 2
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140 59 Praha 4
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Fakultni nemocnice v Motole
150 06 Praha 5
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180 81 Praha 8
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Fakultni nemocnice Kralovske Vinohrady
100 34 Praha
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Krajska Nemocnice Tomase Bati
76275 Zlin
CzechiaNoch nicht rekrutierend» Google-Maps
Clinique Sainte Marguerite
83400 Hyeres
FranceNoch nicht rekrutierend» Google-Maps
Polyclinique de Limoges - Francois Chenieux
87000 Limoges
FranceNoch nicht rekrutierend» Google-Maps
Hôpital Edouard Herriot
69437 Lyon Cedex 03
FranceNoch nicht rekrutierend» Google-Maps
Institut Paoli-Calmettes
13009 Marseille
FranceNoch nicht rekrutierend» Google-Maps
Institut Regional du Cancer de Montpellier
34298 Montpellier
FranceNoch nicht rekrutierend» Google-Maps
Hopital Europeen Georges-Pompidou
75015 Paris
FranceNoch nicht rekrutierend» Google-Maps
Hôpital Bichat - Claude Bernard
75018 Paris
FranceNoch nicht rekrutierend» Google-Maps
Centre Hospitalier Prive
35760 Saint-Grégoire
FranceNoch nicht rekrutierend» Google-Maps
Institut Universitaire du Cancer Toulouse Oncopole
31059 Toulouse Cedex 9
FranceNoch nicht rekrutierend» Google-Maps
Jahn Ferenc Del-pesti Korhaz es Rendelointezet
1204 Budapest
HungaryNoch nicht rekrutierend» Google-Maps
Debreceni Egyetem Klinikai Kozpont
4032 Debrecen
HungaryNoch nicht rekrutierend» Google-Maps
Szabolcs-Szatmar-Bereg Megyei Korhazak es Egyetemi Oktatokorhaz
4400 Nyíregyháza
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Jasz-Nagykun-Szolnok Megyei Hetenyi Geza Korhaz-Rendelointezet
5004 Szolnok
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Hillel Yaffe Medical Center
3810101 Hadera
IsraelNoch nicht rekrutierend» Google-Maps
Rambam Health Care Campus
3109601 Haifa
IsraelNoch nicht rekrutierend» Google-Maps
Hadassah University Hospita - Ein Kerem
9112001 Jerusalem
IsraelNoch nicht rekrutierend» Google-Maps
Tel Aviv Sourasky Medical Center
64239 Tel Aviv
IsraelNoch nicht rekrutierend» Google-Maps
Azienda Ospedaliero Universitaria Consorziale Policlinico di Bari
70120 Bari
ItalyNoch nicht rekrutierend» Google-Maps
Azienda Ospedaliero Universitaria Consorziale Policlinico di Bari
70124 Bari
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Ospedale San Martino
16132 Genova
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Ospedale S. Maria della Scaletta
40026 Imola
ItalyNoch nicht rekrutierend» Google-Maps
Istituto Europeo di Oncologia
20141 Milano
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Ospedale San Raffaele
20132 Milan
ItalyNoch nicht rekrutierend» Google-Maps
Azienda Sanitaria Locale Salerno - Po Andrea Tortora Di Pagani
84016 Pagani
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Azienda Ospedaliero Universitaria Pisana
56126 Pisa
ItalyNoch nicht rekrutierend» Google-Maps
ASL Napoli 2 Nord-SM delle Grazie Hospital
80078 Pozzuoli
ItalyNoch nicht rekrutierend» Google-Maps
Policlinico Universitario Agostino Gemelli
00168 Roma
ItalyNoch nicht rekrutierend» Google-Maps
Azienda Ospedaliera Sant Andrea
00189 Roma
ItalyNoch nicht rekrutierend» Google-Maps
Istituto Nazionale Tumori Regina Elena
00144 Rome
ItalyNoch nicht rekrutierend» Google-Maps
Azienda Ospedaliera Universitaria Città della Salute e della Scienza di Torino
10126 Torino
ItalyNoch nicht rekrutierend» Google-Maps
Ospedale di Circolo e Fondazione Macchi
21100 Varese
ItalyNoch nicht rekrutierend» Google-Maps
Ospedale San Bortolo
36100 Vicenza
ItalyNoch nicht rekrutierend» Google-Maps
St.Marianna University School of Medicine
216-8511 Kanagawa
JapanNoch nicht rekrutierend» Google-Maps
Nara Medical University Hospital
634-8522 Kashihara
JapanNoch nicht rekrutierend» Google-Maps
Saitama Medical University Hospital
350-8550 Kawagoe-Shi
JapanNoch nicht rekrutierend» Google-Maps
National Hospital Organization Kumamoto Medical Center
860-0008 Kumamoto
JapanSchwebend» Google-Maps
Nagasaki University Hospital
852-8501 Nagasaki
JapanNoch nicht rekrutierend» Google-Maps
JOHAS Osaka Rosai Hospital
591-8025 Osaka
JapanNoch nicht rekrutierend» Google-Maps
Sagamihara Kyodo Hospital
252-0253 Sagamihara-Shi
JapanNoch nicht rekrutierend» Google-Maps
Tokuyama Central Hospital
745-8522 Shunan
JapanNoch nicht rekrutierend» Google-Maps
Toranomon Hospital
105-8470 Tokyo
JapanNoch nicht rekrutierend» Google-Maps
Fujita Health University Hospital
470-1192 Toyoake
JapanNoch nicht rekrutierend» Google-Maps
Yamaguchi University Hospital
755-8505 Ube
JapanNoch nicht rekrutierend» Google-Maps
Yokohama City University Medical Center
232-0024 Yokohama
JapanNoch nicht rekrutierend» Google-Maps
Inje University Haeundae Paik Hospital
612-896 Busan
Korea, Republic ofNoch nicht rekrutierend» Google-Maps
Kyungpook National University Chilgok Hospital
41404 Daegu
Korea, Republic ofNoch nicht rekrutierend» Google-Maps
Keimyung University Dongsan Hospital
42601 Daegu
Korea, Republic ofNoch nicht rekrutierend» Google-Maps
National Cancer Center
10408 Goyang-si
Korea, Republic ofNoch nicht rekrutierend» Google-Maps
Gachon University Gil Medical Center
405 760 Namdong
Korea, Republic ofNoch nicht rekrutierend» Google-Maps
Seoul National University Hospital
03080 Seoul
Korea, Republic ofNoch nicht rekrutierend» Google-Maps
Severance Hospital
03722 Seoul
Korea, Republic ofNoch nicht rekrutierend» Google-Maps
Gangnam Severance Hospital
06273 Seoul
Korea, Republic ofNoch nicht rekrutierend» Google-Maps
The Catholic University of Korea, Seoul St. Mary's Hospital
06591 Seoul
Korea, Republic ofNoch nicht rekrutierend» Google-Maps
Pusan National University Yangsan Hospital
50612 Yangsan-si
Korea, Republic ofNoch nicht rekrutierend» Google-Maps
CRYPTEX Investigacion clinica S.A De C.V
06100 Ciudad de México
MexicoNoch nicht rekrutierend» Google-Maps
Oncología Integral Satelite
06720 Ciudad de México
MexicoNoch nicht rekrutierend» Google-Maps
Consultorio Privado Dr Jose Arturo Rodriguez Rivera
45050 Guadalajara
MexicoNoch nicht rekrutierend» Google-Maps
Centro De Estudio Y Prevencion Del Cancer
70000 Juchitan De Zaragoza
MexicoNoch nicht rekrutierend» Google-Maps
Dr. Marco Antonio Badillo Santoyo
37000 Leon
MexicoNoch nicht rekrutierend» Google-Maps
i Can Oncology Center
64710 Monterrey
MexicoNoch nicht rekrutierend» Google-Maps
Oncológico Potosino
78250 San Luis Potosi
MexicoNoch nicht rekrutierend» Google-Maps
Investigación Biomedica para el desarrollo de Farmacos, S.A. de C.V.
45070 Zapopan
MexicoNoch nicht rekrutierend» Google-Maps
Hospital Garcia de Orta
2805-267 Almada
PortugalNoch nicht rekrutierend» Google-Maps
Centro Hospitalar de Lisboa Central
1150-199 Lisboa
PortugalNoch nicht rekrutierend» Google-Maps
H. Santa Maria - Centro Hospitalar de Lisboa Norte
1649-035 Lisboa
PortugalNoch nicht rekrutierend» Google-Maps
Fundação Champalimaud
1400-038 Lisbon
PortugalNoch nicht rekrutierend» Google-Maps
Centro Hospitalar de Trás os Montes e Alto-Douro
5000508 Vila Real
PortugalNoch nicht rekrutierend» Google-Maps
Altlay Regional Oncology Dispensary
656045 Barnaul
Russian FederationNoch nicht rekrutierend» Google-Maps
Chelyabinsk Regional Clinical Center Of Oncology And Nuclear Medicine
454087 Chelyabinsk
Russian FederationNoch nicht rekrutierend» Google-Maps
Ivanovo Regional Oncology Dispensary
153040 Ivanovo
Russian FederationNoch nicht rekrutierend» Google-Maps
N. N. Blokhin Russian Academy of Medical Sciences
115478 Moscow
Russian FederationNoch nicht rekrutierend» Google-Maps
Hertzen Oncology Research Institute
125284 Moscow
Russian FederationNoch nicht rekrutierend» Google-Maps
A. Tsyb Medical Radiological Research Center
249031 Obninsk
Russian FederationNoch nicht rekrutierend» Google-Maps
BHI of Omsk region Clinical Oncology Dispensary
644013 Omsk
Russian FederationNoch nicht rekrutierend» Google-Maps
Hospital for War Veterans
344037 Rostov
Russian FederationNoch nicht rekrutierend» Google-Maps
Ryazan State Medical University named after I.P.Pavlov
390011 Ryazan
Russian FederationNoch nicht rekrutierend» Google-Maps
City Multiple-Discipline Hospital # 2
192174 Saint Petersburg
Russian FederationNoch nicht rekrutierend» Google-Maps
FSBHI RSCRST n.a. Ac. Granov A.M. of MoH
197758 Saint Petersburg
Russian FederationNoch nicht rekrutierend» Google-Maps
N.N. Petrov Research Institute Of Oncology
197758 Saint Petersburg
Russian FederationNoch nicht rekrutierend» Google-Maps
Leningrad Regional Oncology Dispensary
191104 Saint-Petersburg
Russian FederationNoch nicht rekrutierend» Google-Maps
Severo-Zapadnyy Gosudarstvennyy Meditsinskiy Universitet Im. I. I. Mechnikova
195067 Sankt-Peterburg
Russian FederationNoch nicht rekrutierend» Google-Maps
Ogarev Mordovian State University
430005 Saransk
Russian FederationNoch nicht rekrutierend» Google-Maps
State Medical Institution Oncological Center #2 of Healthcare Department at Krasnodar Regio
354057 Sochi
Russian FederationNoch nicht rekrutierend» Google-Maps
Multifunctional clinical medical center 'Medical city'
625041 Tyumen
Russian FederationNoch nicht rekrutierend» Google-Maps
Bashkir State Medical University
450008 Ufa
Russian FederationNoch nicht rekrutierend» Google-Maps
Hosp. Univ. A Coruña
15006 A Coruña
SpainNoch nicht rekrutierend» Google-Maps
Hosp. Univ. Germans Trias I Pujol
08916 Badalona
SpainNoch nicht rekrutierend» Google-Maps
Fundacion Puigvert
08025 Barcelona
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Hosp. Univ. Virgen de Las Nieves
18014 Granada
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Hosp. de Jerez de La Frontera
11407 Jerez de la Frontera
SpainNoch nicht rekrutierend» Google-Maps
Clinica Univ. de Navarra
28027 Madrid
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Hosp. Univ. 12 de Octubre
28041 Madrid
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Hosp. Univ. de La Paz
28046 Madrid
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Hosp. Univ. Hm Monteprincipe
28660 Madrid
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Hosp. Virgen de La Victoria
29010 Málaga
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Instituto Valenciano de Oncologia
46009 Valencia
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Kaohsiung Medical University Chung-Ho Memorial Hospital
807 Kaohsiung
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China Medical University Hospital
40447 Taichung
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Taichung Veterans General Hospital
407 Taichung
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National Cheng Kung University Hospital
70403 Tainan
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National Taiwan University Hospital
10048 Taipei City
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Tri-Service General Hospital
11490 Taipei
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Chang Gung Memorial Hospital Linkou Branch
333 Taoyuan
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Adana Baskent Yuregir Hospital
Adana
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Yildirim Beyazit University Medical Faculty Ankara Atatürk Research and Training Hospital
06050 Ankara
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Ankara Universitesi Tip Fakultesi Cebeci Hastanesi
06100 Ankara
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Dokuz Eylul Universitesi Tip Fakultesi
35330 Balcova
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Bezmialem University Medical Faculty
34093 Fatih
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Medical Park Gaziantep Hastanesi
27584 Gaziantep
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Istanbul University Cerrahpasa Medical Faculty
34096 Istanbul
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Istanbul Medeniyet University Goztepe Training and Research Hospital
34732 Istanbul
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Office Of Ahmet Cag Cal, MD
35110 Izmir
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Izmir Medical Park Hospital
35530 Izmir
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Inonu University Medical Faculty
44280 Malatya
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Erciyes Univ MKD Hospital
38039 Melikgazi
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T.C. Saglik Bakanligi Ankara Numune Egitim ve Arastirma Hastanesi
01330 Seyhan
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Chernivtsi Regional Clinical Hospital
58000 Chernivtsi
UkraineNoch nicht rekrutierend» Google-Maps
SE Dnipropetrovsk Medical Academy
49005 Dnipro
UkraineNoch nicht rekrutierend» Google-Maps
MIH V.I. Shapoval Regional Clinical Centre of Urology and Nephrology
61037 Kharkiv
UkraineNoch nicht rekrutierend» Google-Maps
Kharkiv Regional Clinical Hospital
61070 Kharkiv
UkraineNoch nicht rekrutierend» Google-Maps
Main Military Clinical Hospital of MDU
01133 Kiev
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Krivorizhskiy Oncology Dispensary
50048 Kriviy Rih
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Oleksandrivska Clinical Hospital of Kyiv City, Infectional Department #2
01601 Kyiv
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Kyiv City Clinical Hospital #3
02660 Kyiv
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State Institution Academy Of Medical Sciences Of Ukraine
04053 Kyiv
UkraineNoch nicht rekrutierend» Google-Maps
Odes'ka mis'ka klinichna likarnya №10
65000 Odessa
UkraineNoch nicht rekrutierend» Google-Maps
Sumy Regional Clinical Oncology Centre
40022 Sumy
UkraineNoch nicht rekrutierend» Google-Maps
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Studien-Informationen

Detailed Description:

TAR-200 is a gemcitabine intravesical delivery system that provides a continuous release of

gemcitabine into the urine. Urothelial carcinoma, specifically transitional cell carcinoma of

the upper and lower genitourinary tract, has demonstrated meaningful responsiveness to

deoxycytidine analogues. Gemcitabine has also demonstrated efficacy and a tolerable safety

profile in NMIBC and metastatic urothelial carcinoma. Study consists of screening phase of 42

days, treatment phase and follow up phase. The total duration of study will be up to 8 years.

Efficacy evaluation includes disease assessment (Cystoscopy/TURBT Biopsy/Pathology) and

Patient Reported Outcomes (Quality of Life Assessments) and safety assessments includes vital

sign measurements, 12-lead electrocardiogram (ECG), physical examinations, clinical

laboratory tests, cystoscopic examination, anti-drug antibody (ADA) assessments, concomitant

treatments/procedures and adverse event monitoring.

Ein-/Ausschlusskriterien

Inclusion Criteria:

- Ineligible for or have elected not to undergo radical cystectomy

- All adverse events associated with any prior surgery and/or intravesical therapy must

have resolved to Common Terminology Criteria for Adverse Events (CTCAE) version 5.0

Grade less than (<) 2 prior to randomization

- Eastern Cooperative Oncology Group (ECOG) performance status Grade 0, 1, or 2

- Thyroid function tests within normal range or stable on hormone supplementation per

investigator assessment.

- Adequate bone marrow, liver, and renal function: Bone marrow function (without the

support of cytokines or erythropoiesis-stimulating agent in preceding two weeks):

Absolute neutrophil count (ANC) greater than or equal to (>=) 1,000/cubic millimeters

(mm^3); Platelet count >=75,000/mm^3; Hemoglobin >=8.0 grams per deciliter (g/dL);

Liver function: (Total bilirubin less than or equal to (<=) 1.5 * upper limit of

normal (ULN) or direct bilirubin <= ULN for participants with total bilirubin levels

greater than (>)1.5*ULN (except participants with Gilbert's Syndrome, who must have a

total bilirubin < 3.0 mg/dL), and Alanine aminotransferase (ALT) and aspartate

aminotransferase (AST) less than or equal to (<=) 2.5* institutional ULN); Renal

function: Creatinine clearance >40 mL/min either directly measured via 24-hour urine

collection, calculation using the Cockcroft-Gault formula, or calculation for the

modification of diet in renal disease for adult participants

Exclusion Criteria:

- Must not have had urothelial carcinoma or histological variant at any site outside of

the urinary bladder. Ta/T1/Carcinoma in situ (CIS) of the upper urinary tract

(including renal pelvis and ureter) is allowable if treated with complete

nephrouretrectomy within 24 months

- Must not have diffuse CIS based on cystoscopy and biopsy. Diffuse, or multi-focal, CIS

is defined as the presence of at least 4 distinct CIS lesions in the bladder at the

time of the Screening re-TURBT

- Participants must not have evidence of cT4b, or N1-3, or M1 disease based on local

radiology staging (chest, abdomen, and pelvis must be performed using Computed

tomography [CT] or Magnetic resonance imaging [MRI]) within 42 days prior to

randomization

- Presence of any bladder or urethral anatomic feature that, in the opinion of the

investigator, may prevent the safe placement, indwelling use, or removal of TAR 200

- Evidence of bladder perforation during diagnostic cystoscopy

Studien-Rationale

Primary outcome:

1. Time from Randomization to the First Bladder Intact Event-free Survival (BI-EFS) event (Time Frame - Up to 8 years):
Time from randomization to the first BI-EFS event includes histologically proven presence of muscle-invasive bladder cancer (MIBC), clinical evidence of nodal or metastatic disease (as assessed by RECIST 1.1 criteria), radical cystectomy (RC), or death due to any cause.



Secondary outcome:

1. Metastasis-free survival (MFS) (Time Frame - Up to 8 years):
MFS is measured from time from randomization to first radiologic (as assessed by RECIST 1.1 criteria) or histologic evidence of metastatic disease or death due to any cause.

2. Overall Survival (OS) (Time Frame - Up to 8 years):
OS is defined as time from randomization to death.

3. Overall Response Rate (ORR) (Time Frame - Up to 8 years):
ORR is defined as proportion of participants who have complete response (CR) (defined as Negative biopsy, and Computed tomography/Magnetic resonance imaging [CT/MRI] of chest, abdomen, and pelvis showing no evidence of local recurrence, progression, or metastatic disease) or partial response (PR): (defined as down staging: biopsy proven non-invasive disease less than [<] T1 and CT/MRI of chest, abdomen, and pelvis showing no evidence of metastatic disease) or non-response (those not achieving a complete response or down-staging, or those who do not undergo a biopsy will be considered non-responders).

4. Number of Participants with Adverse Events (AEs) According to Common Terminology Criteria for Adverse Events (CTCAE) (Time Frame - Up to 8 years):
Number of Participants with AEs by Severity as assessed by CTCAE version 5 will be reported. Grade refers to the severity of the AE as follows: Grade 1- Mild, asymptomatic or mild symptoms, clinical or diagnostic observations only, intervention not indicated; Grade 2- Moderate, minimal, local or noninvasive intervention indicated, limiting age-appropriate instrumental Activities of Daily Living (ADL); Grade 3- Severe or medically significant but not immediately life-threatening, hospitalization or prolongation of hospitalization indicated, disabling, limiting self-care ADL; Grade 4- Life-threatening consequences, urgent intervention indicated; Grade 5- Death related to AE.

5. Number of Participants with AEs by Severity according to Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (NCI PRO-CTCAE) (Time Frame - Up to 8 years):
NCI PRO-CTCAE is a patient-reported outcome measure used to evaluate symptomatic toxicity in participants on cancer clinical trials. The NCI PRO-CTCAE is an item bank. The items selected for this study include all NCI PRO-CTCAE gastrointestinal items and urinary items. These items include taste changes, decreased appetite, nausea, vomiting, heartburn, gas, bloating, hiccups, constipation, diarrhea, abdominal pain, fecal incontinence, painful, urination, urinary urgency, urinary frequency, change in usual urine color, and urinary incontinence.

6. Number of Participants with Clinical Laboratory Abnormalities (Time Frame - Up to 8 years):
Number of participants with clinical laboratory abnormalities will be reported. Severity will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0. Severity scale ranges from Grade 1 (Mild) to Grade 5 (Death). Grade 1= Mild, Grade 2= Moderate, Grade 3= Severe, Grade 4= Life-threatening, and Grade 5= Death related to adverse event.

7. Change from Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) (Time Frame - From Baseline up to 8 years):
Change from baseline in systolic and diastolic blood pressure over time will be assessed.

8. Change From Baseline in Heart Rate (Time Frame - From Baseline up to 8 years):
Change from baseline in heart rate over time will be assessed.

9. Change from Baseline in Temperature (Time Frame - From Baseline up to 8 years):
Change from baseline in temperature over time will be assessed.

10. Safety Assessment by Changes From Baseline in Physical Examinations (Time Frame - From Baseline up to 8 years):
Physical examination which will be comprised of an examination of head, ears, eyes, nose, throat and neck, cardiovascular, respiratory, abdomen, musculoskeletal, skin, and genitourinary systems as assessed as normal or abnormal. A change from normal to abnormal or abnormal to normal, will be registered as a change from baseline.

11. Change from Baseline in Performance Status as assessed by Eastern Cooperative Oncology Group (ECOG) Scale (Time Frame - From baseline up to 8 years):
Change from baseline in performance status will be assessed by ECOG scale, where Grade 0 (fully active), Grade 1 (restricted in physically strenuous activity), Grade 2 (ambulatory and capable of all self-care), Grade 3 (capable of only limited self-care), Grade 4 (completely disabled), and Grade 5 (dead).

Studien-Arme

  • Experimental: TAR-200 + Cetrelimab
    Participants will receive intravesical TAR-200 every 3 weeks (21 days indwelling) for first 18 weeks and thereafter from Week 24 every 12 weeks through study Year 3 in combination with Cetrelimab.
  • Active Comparator: Chemotherapy (cisplatin or gemcitabine) + Radiation Therapy
    Participants will receive chemotherapy based on investigator's choice from either cisplatin intravenously once weekly for 6 weeks or gemcitabine intravenously twice weekly for 6 weeks as Standard of Care (SOC) along with radiation therapy from either conventional radiotherapy (64 Gray [Gy], bladder only) for up to 6.5 weeks or hypo-fractionated radiotherapy (55 Gy, bladder only) for up to 4 weeks.

Geprüfte Regime

  • Cetrelimab (JNJ-63723283):
    Participants will receive Cetrelimab.
  • TAR-200 (JNJ-17000139):
    Participants will receive intravesical TAR-200.
  • Cisplatin:
    Participants will receive cisplatin intravenously.
  • Gemcitabine:
    Participants will receive gemcitabine intravenously.
  • Conventional radiation therapy:
    Participants will receive conventional radiation therapy for bladder (64 gy).
  • Hypo-fractioned radiation therapy:
    Participants will receive hypo-fractioned radiation therapy for bladder (55 gy).

Quelle: ClinicalTrials.gov


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