Spots Global Cancer Trial Database for A Study of TAR-200 in Combination With Cetrelimab Versus Concurrent Chemoradiotherapy in Participants With Muscle-invasive Bladder Cancer (MIBC) of the Bladder
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Trial Identification
Brief Title: A Study of TAR-200 in Combination With Cetrelimab Versus Concurrent Chemoradiotherapy in Participants With Muscle-invasive Bladder Cancer (MIBC) of the Bladder
Official Title: A Phase 3, Multi-center, Randomized Study Evaluating Efficacy of TAR-200 in Combination With Cetrelimab Versus Concurrent Chemoradiotherapy in Participants With Muscle-Invasive Urothelial Carcinoma (MIBC) of the Bladder Who Are Not Receiving Radical Cystectomy
Study ID: NCT04658862
Conditions
Study Description
Brief Summary: The purpose of study is to compare bladder intact-event free survival (BI-EFS) in participants receiving TAR-200 in combination with intravenous (IV) cetrelimab versus concurrent chemoradiotherapy.
Detailed Description:
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Loma Linda Univ Faculty Medic, Loma Linda, California, United States
University of Southern California, Los Angeles, California, United States
Providence Saint John s Health Center, Santa Monica, California, United States
Stanford University Medical Center, Stanford, California, United States
The Urology Center of Colorado, Denver, Colorado, United States
Foothills Urology - Golden Off, Golden, Colorado, United States
Boca Raton Regional Hospital, Boca Raton, Florida, United States
Urological Research Network, Hialeah, Florida, United States
Memorial Healthcare System, Pembroke Pines, Florida, United States
Winship Cancer Institute of Emory University, Atlanta, Georgia, United States
DuPage Medical Group, Lisle, Illinois, United States
University Hospitals Seidman Cancer Center, Ann Arbor, Michigan, United States
Adult Pediatric Urology & Urogynecology, P.C, Omaha, Nebraska, United States
New Jersey Urology LLC, Voorhees, New Jersey, United States
Cardiology Clinic at Montefiore Hutchinson Complex, Bronx, New York, United States
Duke University Medical Center, Durham, North Carolina, United States
Vidant Urology - Greenville, Greenville, North Carolina, United States
Wake Forest University Baptist Medical Center (WFUBMC) - Comprehensive Cancer Center, Winston-Salem, North Carolina, United States
Wexner Medical Center at the Ohio State University, Columbus, Ohio, United States
Stephenson Cancer Center, Oklahoma City, Oklahoma, United States
MidLantic Urology, Bala-Cynwyd, Pennsylvania, United States
Carolina Urologic Research Center, Myrtle Beach, South Carolina, United States
University of Tennessee Medical Center, Knoxville, Tennessee, United States
Houston Metro Urology, Houston, Texas, United States
University of Texas Medical Branch, League City, Texas, United States
Virginia Oncology Associates, Norfolk, Virginia, United States
Fundacion Intecnus, Bariloche, , Argentina
Sociedade Beneficente de Senhoras - Hospital Sírio Libanês, Buenos Aires, , Argentina
Instituto Medico Especializado Alexander Fleming, Buenos Aires, , Argentina
Centro de Urologia (CDU), Ciudad Automoma Buenos Aires, , Argentina
Hospital Italiano de Buenos Aires, Ciudad Autónoma De Buenos Aires, , Argentina
Cemaic - Centro Privado de Especialidades Medicas Ambulatorias e Investigacion Clinica, Córdoba, , Argentina
Centro Urologico Profesor Bengio, Córdoba, , Argentina
Sanatorio Allende Cerro, Córdoba, , Argentina
Centro Oncologico Riojano Integral (Cori), La Rioja, , Argentina
Centro de Investigacion Pergamino SA, Pergamino, , Argentina
CEDIC Centro de Investigaciones Clinicas, Viedma, , Argentina
Flinders Medical Centre, Bedford Park, , Australia
Krankenhaus der barmherzigen Schwestern, Linz, , Austria
Universitaetsklinikum Salzburg - Landeskrankenhaus, Salzburg, , Austria
Medizinische Universitat Wien, Wien, , Austria
Hopital Erasme, Anderlecht, , Belgium
ZNA Middelheim, Antwerpen, , Belgium
AZ Sint-Lucas, Assebroek, , Belgium
AZ Sint-Jan Brugge-Oostende AV, Brugge, , Belgium
Az Groeninge, Kortrijk, , Belgium
Algemeen Ziekenhuis Delta, Roeselare, , Belgium
Fundacao Pio XII, Barretos, , Brazil
Fundação Hospitalar São Francisco de Assis, Belo Horizonte, , Brazil
Liga Paranaense de Combate ao Cancer, Curitiba, , Brazil
Centro Regional Integrado de Oncologia - CRIO, Fortaleza, , Brazil
Clinica de Oncologia Reichow, Jardim Blumenau, , Brazil
Fundacao Doutor Amaral Carvalho, Jau, , Brazil
Liga Norte Riograndense Contra O Cancer, Natal, , Brazil
Hospital Moinhos de Vento, Porto Alegre, , Brazil
Hospital das Clinicas de Porto Alegre, Porto Alegre, , Brazil
Uniao Brasileira de Educaçao e Assistencia-Hospital Sao Lucas da PUCRS, Porto Alegre, , Brazil
Hospital Regional do Cancer - Hospital de Esperança, Presidente Prudente, , Brazil
Hospital Sao Rafael, Salvador, , Brazil
CEPHO - Centro de Estudos e Pesquisa de Hematologia e Oncologia, Santo André, , Brazil
Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto - Hospital de Base, Sao Jose do Rio Preto, , Brazil
Fundacao Faculdade de Medicina - Instituto do Cancer do Estado de Sao Paulo, Sao Paulo, , Brazil
Hospital Alemao Oswaldo Cruz, Sao Paulo, , Brazil
Ac Camargo Cancer Center, Sao Paulo, , Brazil
Instituto de Assistencia Medica ao Servidor Publico Estadual IAMSPE, Sao Paulo, , Brazil
Sociedade Beneficente de Senhoras - Hospital Sirio Libanes, Sao Paulo, , Brazil
Sociedade Beneficente Israelita Brasileira Hospital Albert Einstein, São Paulo, , Brazil
Centro Oncológico do Triângulo, Uberlândia, , Brazil
McGill University Health Centre, Montreal, Quebec, Canada
CHU de Quebec L Hotel Dieu de Quebec, Québec, Quebec, Canada
Centre Hospitalier Universitaire de Sherbrooke, Sherbrooke, Quebec, Canada
Chinese Academy of Medical Sciences(CAMS) & Peking Union Medical College(PUMC), Beijing, , China
Peking University First Hospital, Beijing, , China
Peking University Third Hospital, Beijing, , China
Beijing Hospital, Beijing, , China
The First Hospital of Jilin University, Changchun, , China
Hunan Cancer hospital, Changsha Shi, , China
The Third Xiangya Hospital of Central Sourth University, Changsha, , China
West China Hospital of Sichuan University, Chengdu, , China
Chongqing University Cancer Hospital, Chongqing, , China
Guangzhou First Municipal People's Hospital, Guang Zhou Shi, , China
Sun Yat-Sen University Cancer Center, Guangzhou, , China
Zhejiang Provincial People's Hospital, Hangzhou, , China
The First Hospital of Jiaxing, Jiaxing, , China
Nanjing Drum Tower Hospital, Nanjing, , China
Qingdao Municipal Hospital, Qingdao, , China
Ruijin Hospital, Shanghai, , China
Renji Hospital, Shanghai, , China
Shengjing Hospital of China Medical University, Shenyang, , China
Tianjin Medical University Cancer Institute and Hospital, Tianjin, , China
The First Affiliated Hospital of Wenzhou Medical University, Wenzhou Shi, , China
Wuhan Union Hospital, Wuhan, , China
Wuhan Tongji Hospital Tongji Medical College, Wuhan, , China
Yantai Yuhuangding Hospital, Yantai, , China
Henan Cancer Hospital, Zhengzhou, , China
Slezska nemocnice v Opave, Opava, , Czechia
Fakultni nemocnice Plze, Plzen-Bory, , Czechia
Urocentrum Praha, Praha 2, , Czechia
Vseobecna fakultni nemocnice v Praze, Praha 2, , Czechia
Thomayerova nemocnice, Praha 4, , Czechia
Fakultni nemocnice v Motole, Praha 5, , Czechia
Nemocnice Na Bulovce, Praha 8, , Czechia
Fakultni nemocnice Kralovske Vinohrady, Praha, , Czechia
Hopital Pellegrin CHU Bordeaux, Bordeaux, , France
ICH Hopital A. Morvan, Brest, , France
Hôpital Côte de Nacre, Caen Cedex 9, , France
Pole Sante Leonard de Vinci, Chambray-lès-Tours, , France
Clinique Sainte Marguerite, Hyeres, , France
CHRU Lille, Lille, , France
Polyclinique de Limoges - Francois Chenieux, Limoges, , France
Hôpital Edouard Herriot, Lyon Cedex 03, , France
Institut Paoli-Calmettes, Marseille, , France
Hôpital Européen, Marseille, , France
Institut Regional du Cancer de Montpellier, Montpellier, , France
CHU Nîmes, Nimes, , France
Institut Mutualiste Montsouris, Paris, , France
Hopital Europeen Georges-Pompidou, Paris, , France
Hôpital Bichat - Claude Bernard, Paris, , France
Hopital Tenon, Paris, , France
Clinical La Croix Du Sud - Ramsay Santé, Quint-Fonsegrives, , France
Centre hospitalier universitaire de St Etienne, Saint-Etienne Cedex 2, , France
Centre Hospitalier Prive, Saint-Grégoire, , France
Hopital Foch, Suresnes, , France
Institut de Cancérologie de Lorraine, Vandoeuvre-les-Nancy, , France
Gustave Roussy, Villejuif Cedex, , France
Staedtisches Klinikum Braunschweig, Braunschweig, , Germany
Universitatsklinikum Carl Gustav Carus Dresden, Dresden, , Germany
Urologicum Duisburg, Duisburg, , Germany
Universitätsklinikum Düsseldorf, Düesseldorf, , Germany
Klinik und Poliklinik für Urologie, Essen, , Germany
Agaplesion Frankfurter Diakonie Kliniken GmbH, Markus Krankenhaus, Frankfurt Am Main, , Germany
Universitatsklinikum Frankfurt, Frankfurt am Main, , Germany
Klinikum Herne - Urologie, Herne, , Germany
Matthias Schulze - Germany, Markkleeberg, , Germany
Universitatsklinikum Munster, Münster, , Germany
Klinikum Nürnberg Nord - Hautklinik, Nürnberg, , Germany
Krankenhaus der Barmherzigen Bruder Trier, Trier, , Germany
Alexandra General Hospital of Athens, Athens, , Greece
Metropolitan General A.E., Holargos, , Greece
Athens Medical Center, Maroussi, , Greece
Metropolitan Hospital, Neo Faliro, , Greece
Bioclinic - Thessaloniki, Thessaloniki, , Greece
Euromedica General Clinic, Thessaloniki, , Greece
Clinic Agios Loukas, Thessaloniki, , Greece
'Papageorgiou' General Hospital of Thessaloniki, Thessaloniki, , Greece
Anassa General Clinic, Volos, , Greece
Orszagos Onkologiai Intezet, Budapest N/a, , Hungary
Eszak Pesti Centrumkorhaz Honvedkorhaz, Budapest, , Hungary
Bajcsy-Zsilinszky Kórház és Rendelőintézet, Budapest, , Hungary
Debreceni Egyetem Klinikai Kozpont, Debrecen, , Hungary
Szabolcs-Szatmar-Bereg Megyei Korhazak es Egyetemi Oktatokorhaz, Nyíregyháza, , Hungary
Sujan Surgical Cancer Hospital & Amravati Cancer Foundation, Amravati, , India
Bangalore Medical College and Research Institute, Bangalore, , India
Acharya Tulsi Regional Cancer Treatment Research Institute, Bikaner, , India
Shatabdi Super Speciality Hospital, Nashik, , India
BLK Super Specialty Hospital, New Delhi, , India
Aakash Healthcare Super Speciality Hospital, New Delhi, , India
Rajiv Gandhi Cancer Institute & Research Centre, New Delhi, , India
Indira Gandhi Institute of Medical Sciences, Patna, , India
Jehangir Clinical Development Center Pvt Ltd, Pune, , India
Ospedale San Donato, Arezzo, , Italy
Fondazione del Piemonte per I'Oncologia IRCC Candiolo, Candiolo, , Italy
Ospedale Civile Ramazzini, Carpi, , Italy
Ospedale Cannizzaro, Catania, , Italy
Azienda Ospedaliero Universitaria Ospedali Riuniti di Foggia, Foggia, , Italy
SPDC Villa Scassi, Genova, , Italy
Ospedale San Martino, Genova, , Italy
Ospedale Umberto I di Lugo, Lugo, , Italy
Istituto Europeo di Oncologia, Milano, , Italy
Ospedale San Raffaele, Milan, , Italy
Azienda Ospedaliera Universitaria Federico II, Napoli, , Italy
Istituto Oncologico Veneto - IRCCS, Padova, , Italy
Azienda Sanitaria Locale Salerno - Po Andrea Tortora Di Pagani, Pagani, , Italy
Azienda Ospedaliero Universitaria Pisana, Pisa, , Italy
ASL Napoli 2 Nord-SM delle Grazie Hospital, Pozzuoli, , Italy
Policlinico Universitario Agostino Gemelli, Roma, , Italy
Azienda Ospedaliera Sant Andrea, Roma, , Italy
Universita Campus Bio-Medico di Roma, Rome, , Italy
Istituto Nazionale Tumori Regina Elena, Rome, , Italy
Istituto Clinico Humanitas Rozzano, IRCCS, Rozzano, , Italy
Azienda Ospedaliera Universitaria Senese Policlinico Santa Maria alle Scotte, Siena, , Italy
Azienda Ospedaliera Universitaria Citta della Salute e della Scienza di Torino, Torino, , Italy
Ospedale di Circolo e Fondazione Macchi, Varese, , Italy
Ospedale San Bortolo, Vicenza, , Italy
Aso Co.,Ltd Iizuka Hospital, Iizuka, , Japan
St Marianna University Hospital, Kanagawa, , Japan
Nara Medical University Hospital, Kashihara, , Japan
Saitama Medical University Hospital, Kawagoe-Shi, , Japan
Kimitsu Chuo Hospital, Kisarazu-shi, , Japan
Nagasaki University Hospital, Nagasaki-shi, , Japan
JOHAS Osaka Rosai Hospital, Osaka, , Japan
Tokuyama Central Hospital, Shunan, , Japan
Toranomon Hospital, Tokyo, , Japan
Nippon Medical School Hospital, Tokyo, , Japan
Fujita Health University Hospital, Toyoake, , Japan
Yamaguchi University Hospital, Ube, , Japan
Yokohama City University Medical Center, Yokohama, , Japan
Inje University Haeundae Paik Hospital, Busan, , Korea, Republic of
Kyungpook National University Chilgok Hospital, Daegu, , Korea, Republic of
Keimyung University Dongsan Hospital, Daegu, , Korea, Republic of
Samsung Medical Center, Gangnam Gu, , Korea, Republic of
National Cancer Center, Goyang-si, , Korea, Republic of
Chonnam National University Hwasun Hospital, Hwasun-gun, , Korea, Republic of
Gachon University Gil Medical Center, Namdong, , Korea, Republic of
Seoul National University Hospital, Seoul, , Korea, Republic of
Severance Hospital, Seoul, , Korea, Republic of
Gangnam Severance Hospital, Seoul, , Korea, Republic of
The Catholic University of Korea Seoul St. Mary's Hospital, Seoul, , Korea, Republic of
Hanyang University Hospital, Seoul, , Korea, Republic of
Pusan National University Yangsan Hospital, Yangsan Si, , Korea, Republic of
Oncologia Integral Satelite, Ciudad de México, , Mexico
Hospital Civil de Guadalajara Fray Antonio Alcalde, Guadalajara, , Mexico
Consultorio Privado Dr Jose Arturo Rodriguez Rivera, Guadalajara, , Mexico
Centro De Estudio Y Prevencion Del Cancer, Juchitan De Zaragoza, , Mexico
Dr. Marco Antonio Badillo Santoyo, Leon, , Mexico
i Can Oncology Center, Monterrey, , Mexico
Centro de Investigacion Clinica Chapultepec, Morelia, , Mexico
Centro de Investigacion Clinica de Oaxaca, Oaxaca, , Mexico
Oncologico Potosino, San Luis Potosi, , Mexico
Investigación Biomedica para el desarrollo de Farmacos, S.A. de C.V., Zapopan, , Mexico
Samodzielny Publiczny Szpital Wojewodzki im. Papieza Jana Pawla II, Siedlce, , Poland
Centrum Medyczne Pratia Poznan, Skorzewo, , Poland
Centralny Szpital Kliniczny MSWiA w Warszawie, Warszawa, , Poland
Uniwersytecki Szpital Kliniczny, Wroclaw, , Poland
Hospital Garcia de Orta, Almada, , Portugal
Centro Hospitalar e Universitario de Coimbra, Coimbra, , Portugal
Centro Hospitalar de Lisboa Central, Lisboa, , Portugal
H. Santa Maria - Centro Hospitalar de Lisboa Norte, Lisboa, , Portugal
Fund. Champalimaud, Lisbon, , Portugal
Hospital de Sao Joao, Porto, , Portugal
Altlay Regional Oncology Dispensary, Barnaul, , Russian Federation
Ivanovo Regional Oncology Dispensary, Ivanovo, , Russian Federation
Krasnoyarsk Regional Oncology Dispensary, Krasnoyarsk, , Russian Federation
Hertzen Oncology Research Institute, Moscow, , Russian Federation
A. Tsyb Medical Radiological Research Center, Obninsk, , Russian Federation
BHI of Omsk region Clinical Oncology Dispensary, Omsk, , Russian Federation
Ryazan State Medical University named after I.P.Pavlov, Ryazan, , Russian Federation
N.N. Petrov Research Institute Of Oncology, Saint Petersburg, , Russian Federation
Ogarev Mordovian State University, Saransk, , Russian Federation
State Medical Institution Oncological Center #2 of Healthcare Department at Krasnodar Regio, Sochi, , Russian Federation
Multifunctional clinical medical center 'Medical city', Tyumen, , Russian Federation
Bashkir State Medical University, Ufa, , Russian Federation
Hosp. Univ. A Coruna, A Coruña, , Spain
Hosp. Univ. Germans Trias I Pujol, Badalona, , Spain
Fund. Puigvert, Barcelona, , Spain
Hosp. Univ. Vall D Hebron, Barcelona, , Spain
Hosp. Univ. Virgen de Las Nieves, Granada, , Spain
Hosp. de Jerez de La Frontera, Jerez de la Frontera, , Spain
Clinica Univ. de Navarra, Madrid, , Spain
Hosp. Univ. 12 de Octubre, Madrid, , Spain
Hosp. Univ. de La Paz, Madrid, , Spain
Hosp. Univ. Hm Sanchinarro, Madrid, , Spain
Corporacio Sanitari Parc Tauli, Sabadell, , Spain
Hosp. Univ. Marques de Valdecilla, Santander, , Spain
Instituto Valenciano de Oncologia, Valencia, , Spain
Hosp. Clinico Univ. de Valencia, Valencia, , Spain
Kaohsiung Medical University Chung-Ho Memorial Hospital, Kaohsiung, , Taiwan
China Medical University Hospital, Taichung, , Taiwan
Taichung Veterans General Hospital, Taichung, , Taiwan
National Cheng Kung University Hospital, Tainan, , Taiwan
National Taiwan University Hospital, Taipei, , Taiwan
Tri-Service General Hospital, Taipei, , Taiwan
Chang Gung Memorial Hospital Linkou Branch, Taoyuan, , Taiwan
Adana Baskent Yuregir Hospital, Adana, , Turkey
Yildirim Beyazit University Medical Faculty Ankara Atatürk Research and Training Hospital, Ankara, , Turkey
Ankara Universitesi Tip Fakultesi Cebeci Hastanesi, Ankara, , Turkey
Dokuz Eylul Universitesi Tip Fakultesi, Balcova, , Turkey
Bezmialem University Medical Faculty, Fatih, , Turkey
Medical Park Gaziantep Hastanesi, Gaziantep, , Turkey
Istanbul Medeniyet University Goztepe Training and Research Hospital, Istanbul, , Turkey
Izmir Medical Park Hospital, Izmir, , Turkey
Inonu University Medical Faculty, Malatya, , Turkey
Erciyes Univ MKD Hospital, Melikgazi, , Turkey
T.C. Saglik Bakanligi Ankara Numune Egitim ve Arastirma Hastanesi, Seyhan, , Turkey
Chernihivskyi oblasnyi onkolohichnyi dyspanser, Chernihiv, , Ukraine
SE Dnipropetrovsk Medical Academy, Dnipro, , Ukraine
Kharkiv Regional Clinical Hospital, Kharkiv, , Ukraine
Khersonsky Regional Oncology Center, Kherson, , Ukraine
Asklepion LLC, Kiev, , Ukraine
Kyiv City Clinical Hospital #3, Kyiv, , Ukraine
State Institution Academy Of Medical Sciences Of Ukraine, Kyiv, , Ukraine
P.L. Shupyk National Medical Academy of Post-Graduate Education, Kyiv, , Ukraine
Lviv Regional Clinical Hospital, Lviv, , Ukraine
Contact Details
Name: Janssen Research & Development, LLC Clinical Trials
Affiliation: Janssen Research & Development, LLC
Role: STUDY_DIRECTOR
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