研究单位:[1]北京大学第一医院[2]北京大学第三医院[3]北京友谊医院[4]北京大学肿瘤医院[5]北京协和医院[6]上海市第十人民医院[7]天津医科大学第二医院[8]山东大学齐鲁医院[9]浙江省肿瘤医院[10]南昌大学第一附属医院[11]南京鼓楼医院[12]华西医院[13]湖南省肿瘤医院[14]江苏省人民医院[15]广州中山大学附属第一医院[16]北京医科院肿瘤医院[17]宁波市第一医院[18]四川省肿瘤医院[19]上海交通大学医学院附属瑞金医院[20]广州中山肿瘤医院[21]厦门大学附属第一医院[22]Instituto Alexander Fleming[23]Centro De Diagnostico Urologico S.R.L.[24]Hospital Sirio Libanes[25]Hospital Privado De Comunidad[26]Cemic[27]Clinica Viedma S.A.[28]Instituto Oncologico De Cordoba[29]Southern Highlands Private Hospital[30]Princess Alexandra Hospital[31]Chris O'Brien Lifehouse Hospital[32]Universitatsklinikun Salzburg-Salzburger Landeskliniken[33]Medizinische Universitaet Wien[34]Krankenhaus der Elisabethinen Linz GmbH[35]Klinikum Wels-Grieskirchen Gmbh[36]Centro De Novos Tratamentos Itajai[37]Hospital Moinhos De Vento[38]Centro Oncologico do Triangulo[39]COI Clinicas Oncologicas Integradas SA[40]University Health Network - Princess Margaret Cancer Centre[41]Jewish General Hospital[42]Centre Hospitalier De L'Universite De Montreal[43]CISSS du Bas-Saint-Laurent Hopital Regional de Rimouski[44]Oncocentro Apys[45]IC La Serena Research[46]Bradfordhill[47]Hopital Cochin[48]ICANS-Institut de cancerologie Strasbourg Europe[49]Chu Angers[50]Hopital De La Conception[51]Centre Hospitalier Universitaire Dijon Bocage[52]Institut Gustave Roussy[53]Hopital Pellegrin[54]Hopital Claude Huriez[55]Hopital Bichat Claude Bernard[56]Universitaetsklinikum Jena[57]Urologie Bayenthal[58]Krankenhaus der Barmherzigen Brueder[59]Marien Hospital Herne[60]Interbalkan European Medical Center[61]University General Hospital of Athens Attikon[62]Sheba Medical Center PPDS[63]Tel Aviv Sourasky Medical Center PPDS[64]Shaare Zedek Scientific LTD[65]Azienda Ospedaliera Citta della Salute e della Scienza[66]IRCCS Istituto Nazionale Tumori Milano[67]Arcispedale S. Maria Nuova - A.O. Reggio Emilia[68]Azienda Ospedaliera dei Colli - Monaldi Cotugno CTO[69]Azienda Ospedaliera Universitaria Di Modena[70]Fondazione Policlinico Universitario Agostino Gemelli[71]Osaka Medical and Pharmaceutical University Hospital[72]Nara Medical University Hospital[73]Kindai University Hospital[74]Wakayama Medical University Hospital[75]Yokohama Rosai Hospital[76]Kurashiki Central Hospital[77]University of Tsukuba Hospital[78]Kobe City Medical Center General Hospital[79]St. Marianna University Hospital[80]Nippon Medical School Hospital[81]Sapporo Medical University Hospital[82]Keio University Hospital[83]Hamamatsu University Hospital[84]Nagasaki University Hospital[85]Hirosaki University Hospital[86]Aichi Medical University Hospital[87]Kansai Medical University Hospital[88]Niigata University Medical & Dental Hospital[89]Ziekenhuis Rijnstate[90]Amphia Ziekenhuis[91]Amphia Ziekenhuis,locatie Breda Langendijk[92]AV Medical Group LLC[93]VitaMed LLC[94]Hospital Infanta Cristina[95]Hospital Universitari Germans Trias I Pujol[96]Hospital Parc Tauli[97]Hosp Univer 12 De Octubre[98]H. U. Marques de Valdecilla[99]Hospital Clinico Universitario De Valencia[100]Clinica Universidad de Navarra[101]Vrinnevisjukhuset Norrkoping[102]Norrlands Universitetssjukhus[103]Montefiore Medical Center - Bronx
研究目的:
PRC 评估所有受试者的EFS 所有受试者中比较纳武利尤单抗+BCG vs BCG的WFS和OS 评估纳武利尤单抗+BCG和BCG单药CIS受试者首次疾病评估(第13周时)的CRR和DoR 描述所有受试者中纳武利尤单抗+BCG和BCG单药的安全性和耐受性