A Study of TAR-200 in Combination With Cetrelimab Versus Concurrent Chemoradiotherapy in Participants With Muscle-invasive Bladder Cancer (MIBC) of the Bladder
研究单位:[1]Janssen Research & Development, LLC[2]University of Southern California,Los Angeles,California,United States,90033[3]Providence Saint John's Health Center,Santa Monica,California,United States,90404[4]The Urology Center of Colorado,Denver,Colorado,United States,80211[5]Foothills Urology - Golden Off,Golden,Colorado,United States,80401[6]Winship Cancer Institute of Emory University,Atlanta,Georgia,United States,30322[7]DuPage Medical Group,Lisle,Illinois,United States,60532[8]University Hospitals Seidman Cancer Center,Ann Arbor,Michigan,United States,48109[9]New Jersey Urology LLC,Voorhees,New Jersey,United States,08043[10]Duke University Medical Center,Durham,North Carolina,United States,27710[11]Vidant Urology - Greenville,Greenville,North Carolina,United States,27834[12]Wake Forest University Baptist Medical Center (WFUBMC) - Comprehensive Cancer Center,Winston-Salem,North Carolina,United States,27103[13]Stephenson Cancer Center,Oklahoma City,Oklahoma,United States,73104[14]MidLantic Urology,Bala-Cynwyd,Pennsylvania,United States,19004[15]Carolina Urologic Research Center,Myrtle Beach,South Carolina,United States,29572[16]University of Tennessee Medical Center,Knoxville,Tennessee,United States,37920[17]University of Texas Medical Branch,League City,Texas,United States,77573[18]Virginia Oncology Associates,Norfolk,Virginia,United States,23502[19]Fundacion Intecnus,Bariloche,Argentina,8400[20]Sociedade Beneficente de Senhoras - Hospital Sírio Libanês,Buenos Aires,Argentina,C1419AHN[21]Instituto Medico Especializado Alexander Fleming,Buenos Aires,Argentina,C1426ANZ[22]Hospital Italiano de Buenos Aires,Ciudad Autónoma De Buenos Aires,Argentina,C1199ABB[23]Cemaic - Centro Privado de Especialidades Medicas Ambulatorias e Investigacion Clinica,Córdoba,Argentina,5000[24]Centro Urologico Profesor Bengio,Córdoba,Argentina,X5000KPH[25][2Sanatorio Allende Cerro,Córdoba,Argentina,X5004FHP[26]Centro Oncologico Riojano Integral (Cori),La Rioja,Argentina,F5300COE[27]Centro de Investigacion Pergamino SA,Pergamino,Argentina,B2700CPM[28]CEDIC Centro de Investigaciones Clinicas,Viedma,Argentina,R8500EYO[29]Flinders Medical Centre,Bedford Park,Australia,5042[30]Krankenhaus der barmherzigen Schwestern,Linz,Austria,4010[31]Universitätsklinikum Salzburg - Landeskrankenhaus,Salzburg,Austria,5020[32]Hopital Erasme,Anderlecht,Belgium,1070[33]ZNA Middelheim,Antwerpen,Belgium,2020[34]AZ Sint-Lucas,Assebroek,Belgium,8310[35]AZ Sint-Jan Brugge-Oostende AV,Brugge,Belgium,8000[36]Az Groeninge,Kortrijk,Belgium,8500[37]Fundacao Pio XII,Barretos,Brazil,14784-400[38]Fundação Hospitalar São Francisco de Assis,Belo Horizonte,Brazil,31110-580[39]Liga Paranaense de Combate ao Cancer,Curitiba,Brazil,81520-060[40]Centro Regional Integrado de Oncologia - CRIO,Fortaleza,Brazil,60336-232[41]Clinica de Oncologia Reichow,Jardim Blumenau,Brazil,89010-340[42]Fundacao Doutor Amaral Carvalho,Jau,Brazil,17210-080[43]Liga Norte Riograndense Contra O Cancer,Natal,Brazil,59062-000[44]Hospital das Clinicas de Porto Alegre,Porto Alegre,Brazil,90035-903[45]União Brasileira de Educação e Assistência-Hospital São Lucas da PUCRS,Porto Alegre,Brazil,90610-000[46]Hospital Sao Rafael,Salvador,Brazil,41253-190[47]CEPHO - Centro de Estudos e Pesquisa de Hematologia e Oncologia,Santo André,Brazil,09060-650[48]Fundação Faculdade Regional de Medicina de São José do Rio Preto - Hospital de Base,Sao Jose do Rio Preto,Brazil,15090-000[49]Fundacao Faculdade de Medicina - Instituto do Cancer do Estado de Sao Paulo,Sao Paulo,Brazil,01246-000[50]Instituto de Assistencia Medica ao Servidor Publico Estadual - IAMSPE,Sao Paulo,Brazil,04039-004[51]Sociedade Beneficente de Senhoras - Hospital Sirio Libanes,Sao Paulo,Brazil,04784180[52]Centro Oncológico do Triângulo,Uberlândia,Brazil,38408-150[53]Wuhan Tongji Hospital, Tongji Medical College,Wuhan,China,430030[54]Yantai Yuhuangding Hospital,Yantai,China,264000[55]Henan Cancer Hospital,Zhengzhou,China,450008[56]Slezska nemocnice v Opave,Opava,Czechia,746 01[57]Fakultni nemocnice Plze,Plzen-Bory,Czechia,305 99[58]Urocentrum Praha,Praha 2,Czechia,120 00[59]Thomayerova nemocnice,Praha 4,Czechia,140 59[60]Fakultni nemocnice v Motole,Praha 5,Czechia,150 06[61]Nemocnice Na Bulovce,Praha 8,Czechia,180 81[62]Fakultni nemocnice Kralovske Vinohrady,Praha,Czechia,100 34[63]Clinique Sainte Marguerite,Hyeres,France,83400[64]Polyclinique de Limoges - Francois Chenieux,Limoges,France,87000[65]Hôpital Edouard Herriot,Lyon Cedex 03,France,69437[66]Institut Paoli-Calmettes,Marseille,France,13009[67]Institut Regional du Cancer de Montpellier,Montpellier,France,34298[68]CHU Nîmes,Nimes,France,30029[69]Hopital Europeen Georges-Pompidou,Paris,France,75015[70]Hôpital Bichat - Claude Bernard,Paris,France,75018[71]Centre Hospitalier Prive,Saint-Grégoire,France,35760[72]Hopital Foch,Suresnes,France,92150[73]Urologicum Duisburg,Duisburg,Germany,47179[74]Universitätsklinikum Düsseldorf,Düesseldorf,Germany,40225[75]Agaplesion Frankfurter Diakonie Kliniken GmbH, Markus Krankenhaus,Frankfurt Am Main,Germany,60431[76]Universitatsklinikum Frankfurt,Frankfurt am Main,Germany,60590[77]Klinikum Herne - Urologie,Herne,Germany,44625[78]Matthias Schulze - Germany,Markkleeberg,Germany,04416[79]Universitätsklinikum Münster,Münster,Germany,48149[80]Klinikum Nürnberg Nord - Hautklinik,Nürnberg,Germany,90419[81]Alexandra General Hospital of Athens,Athens,Greece,11528[82]Metropolitan General A.E.,Holargos,Greece,155 62[83]Athens Medical Center,Maroussi,Greece,151 25[84]Metropolitan Hospital,Neo Faliro,Greece,18547[85]Bioclinic - Thessaloniki,Thessaloniki,Greece,546 22[86]Euromedica General Clinic,Thessaloniki,Greece,54645[87]'Papageorgiou' General Hospital of Thessaloniki,Thessaloniki,Greece,TK 56403[88]Anassa General Clinic,Volos,Greece,38333[89]Orszagos Onkologiai Intezet,Budapest N/a,Hungary,1122[90]Eszak-Pesti Centrumkorhaz - Honvedkorhaz,Budapest,Hungary,1062[91]Bajcsy-Zsilinszky Kórház és Rendelőintézet,Budapest,Hungary,1106[92]Debreceni Egyetem Klinikai Kozpont,Debrecen,Hungary,4032[93]Szabolcs-Szatmar-Bereg Megyei Korhazak es Egyetemi Oktatokorhaz,Nyíregyháza,Hungary,4400[94]Sujan Surgical Cancer Hospital & Amravati Cancer Foundation,Amravati,India,400601[95]Acharya Tulsi Regional Cancer Treatment Research Institute,Bikaner,India,334 003[96]Shatabdi Super Speciality Hospital,Nashik,India,422005[97]BLK Super Specialty Hospital,New Delhi,India,110005[98]Rajiv Gandhi Cancer Institute & Research Centre,New Delhi,India,110085[99]Indira Gandhi Institute of Medical Sciences,Patna,India,800014[100]Jehangir Clinical Development Center Pvt Ltd,Pune,India,411001[101]Fondazione del Piemonte per I'Oncologia IRCC Candiolo,Candiolo,Italy,10060[102]SPDC Villa Scassi,Genova,Italy,16100[103]Ospedale San Martino,Genova,Italy,16132[104]Istituto Europeo di Oncologia,Milano,Italy,20141[105]Ospedale San Raffaele,Milan,Italy,20132[106]Azienda Sanitaria Locale Salerno - Po Andrea Tortora Di Pagani,Pagani,Italy,84016[107]Azienda Ospedaliero Universitaria Pisana,Pisa,Italy,56126[108]ASL Napoli 2 Nord-SM delle Grazie Hospital,Pozzuoli,Italy,80078[109]Policlinico Universitario Agostino Gemelli,Roma,Italy,00168[110]Azienda Ospedaliera Sant Andrea,Roma,Italy,00189[111]Istituto Nazionale Tumori Regina Elena,Rome,Italy,00144[112]Azienda Ospedaliera Universitaria Città della Salute e della Scienza di Torino,Torino,Italy,10126[113]Ospedale di Circolo e Fondazione Macchi,Varese,Italy,21100[114]Ospedale San Bortolo,Vicenza,Italy,36100[115]Aso Co.,Ltd Iizuka Hospital,Iizuka,Japan,820-8501[116]St.Marianna University Hospital,Kanagawa,Japan,216-8511[117]Nara Medical University Hospital,Kashihara,Japan,634-8522[118]Saitama Medical University Hospital,Kawagoe-Shi,Japan,350-8550[119]Kimitsu Chuo Hospital,Kisarazu-shi,Japan,292-8535[120]Nagasaki University Hospital,Nagasaki-shi,Japan,852-8501[121]JOHAS Osaka Rosai Hospital,Osaka,Japan,591-8025[122]Tokuyama Central Hospital,Shunan,Japan,745-8522[123]Toranomon Hospital,Tokyo,Japan,105-8470[124]Fujita Health University Hospital,Toyoake,Japan,470-1192[125]Yamaguchi University Hospital,Ube,Japan,755-8505[126]Yokohama City University Medical Center,Yokohama,Japan,232-0024[127]Inje University Haeundae Paik Hospital,Busan,Korea, Republic of,612-896[128]Kyungpook National University Chilgok Hospital,Daegu,Korea, Republic of,41404[129]Keimyung University Dongsan Hospital,Daegu,Korea, Republic of,42601[130]National Cancer Center,Goyang-si,Korea, Republic of,10408[131]Gachon University Gil Medical Center,Namdong,Korea, Republic of,405 760[132]Seoul National University Hospital,Seoul,Korea, Republic of,03080[133]Severance Hospital,Seoul,Korea, Republic of,03722[134]Gangnam Severance Hospital,Seoul,Korea, Republic of,06273[135]The Catholic University of Korea, Seoul St. Mary's Hospital,Seoul,Korea, Republic of,06591[136]Pusan National University Yangsan Hospital,Yangsan-si,Korea, Republic of,50612[137]Oncologia Integral Satelite,Ciudad de México,Mexico,06720[138]Consultorio Privado Dr Jose Arturo Rodriguez Rivera,Guadalajara,Mexico,45050[139]Centro De Estudio Y Prevencion Del Cancer,Juchitan De Zaragoza,Mexico,70000[140]Dr. Marco Antonio Badillo Santoyo,Leon,Mexico,37000[141]I Can Oncology Center,Monterrey,Mexico,64710[142]Centro de Investigacion Clinica Chapultepec,Morelia,Mexico,58260[143]Oncológico Potosino,San Luis Potosi,Mexico,78250[144]Investigación Biomedica para el desarrollo de Farmacos, S.A. de C.V.,Zapopan,Mexico,45070[145]Samodzielny Publiczny Szpital Wojewodzki im. Papieza Jana Pawla II,Siedlce,Poland,08-110[146]Centrum Medyczne Pratia Poznan,Skorzewo,Poland,60-185[147]Centralny Szpital Kliniczny MSWiA w Warszawie,Warszawa,Poland,02-507[148]Uniwersytecki Szpital Kliniczny,Wroclaw,Poland,50556[149]Centro Hospitalar e Universitario de Coimbra,Coimbra,Portugal,3000075[150]H. Santa Maria - Centro Hospitalar de Lisboa Norte,Lisboa,Portugal,1649-035[151]Fundação Champalimaud,Lisbon,Portugal,1400-038[152]Hospital de Sao Joao,Porto,Portugal,4200-319[153]Altlay Regional Oncology Dispensary,Barnaul,Russian Federation,656045[154]Ivanovo Regional Oncology Dispensary,Ivanovo,Russian Federation,153040[155]Krasnoyarsk Regional Oncology Dispensary,Krasnoyarsk,Russian Federation,660133[156]Hertzen Oncology Research Institute,Moscow,Russian Federation,125284[157]A. Tsyb Medical Radiological Research Center,Obninsk,Russian Federation,249031[158]BHI of Omsk region Clinical Oncology Dispensary,Omsk,Russian Federation,644013[159]Ryazan State Medical University named after I.P.Pavlov,Ryazan,Russian Federation,390011[160]N.N. Petrov Research Institute Of Oncology,Saint Petersburg,Russian Federation,197758[161]Ogarev Mordovian State University,Saransk,Russian Federation,430005[162]State Medical Institution Oncological Center #2 of Healthcare Department at Krasnodar Regio,Sochi,Russian Federation,354057[163]Multifunctional clinical medical center 'Medical city',Tyumen,Russian Federation,625041[164]Bashkir State Medical University,Ufa,Russian Federation,450008[165]Kaohsiung Medical University Chung-Ho Memorial Hospital,Kaohsiung,Taiwan,807[166]China Medical University Hospital,Taichung,Taiwan,40447[167]Taichung Veterans General Hospital,Taichung,Taiwan,407[168]National Cheng Kung University Hospital,Tainan,Taiwan,70403[169]National Taiwan University Hospital,Taipei,Taiwan,10048[170]Tri-Service General Hospital,Taipei,Taiwan,11490[171]Chang Gung Memorial Hospital Linkou Branch,Taoyuan,Taiwan,333[172]Chernihivskyi oblasnyi onkolohichnyi dyspanser,Chernihiv,Ukraine,14029[173]SE Dnipropetrovsk Medical Academy,Dnipro,Ukraine,49005[174]Kharkiv Regional Clinical Hospital,Kharkiv,Ukraine,61070[175]Khersonsky Regional Oncology Center,Kherson,Ukraine,73000[176]Asklepion LLC,Kiev,Ukraine,08173[177]Kyiv City Clinical Hospital #3,Kyiv,Ukraine,02660[178]State Institution Academy Of Medical Sciences Of Ukraine,Kyiv,Ukraine,04053[179]P.L. Shupyk National Medical Academy of Post-Graduate Education,Kyiv,Ukraine,04112[180]Lviv Regional Clinical Hospital,Lviv,Ukraine,79000
研究目的:
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.