1,397
Participants
Start Date
December 24, 2018
Primary Completion Date
December 31, 2025
Study Completion Date
November 20, 2034
Pembrolizumab
Pembrolizumab IV infusion of 200 mg Q3W for BCG Post-Induction Cohort (Cohort A), or IV infusion of 400 mg Q6W for BCG Naïve Cohort (Cohort B), according to randomization
BCG
BCG (intravesical instillation): powder for instillation fluid for intravesical use, administered during Induction and Maintenance therapy
Semmelweis University-Urológiai Klinika ( Site 1301), Budapest
Medizinische Universität Wien ( Site 0054), Vienna
Hopitaux Universitaires de Geneve HUG ( Site 1204), Geneva
Akershus University Hospital ( Site 0553), Lorenskog
GenesisCare North Shore ( Site 0010), St Leonards
Northern Cancer Institute. ( Site 0003), St Leonards
Sydney Adventist Hospital ( Site 0001), Wahroonga
UZA University Hospital Antwerp ( Site 0105), Edegem
Epworth Hospital ( Site 0009), Richmond
Stavanger universitetssykehus ( Site 0555), Stavanger
Ordensklinikum Linz GmbH Elisabethinen ( Site 0052), Linz
Universitaetsspital Basel ( Site 1201), Basel
Debreceni Egyetem Klinikai Kozpont ( Site 1302), Debrecen
Universitaetsklinik Salzburg ( Site 0053), Salzburg
CHU UCL Namur Site de Godinne ( Site 0103), Yvoir
Univ. Klinik f. Urologie Innsbruck ( Site 0051), Innsbruck
Szegedi Tudományegyetem Szent-Györgyi Albert Klinikai Központ-Urológiai Klinika ( Site 1303), Szeged
Pécsi Tudományegyetem Klinikai Központ-Urológiai Klinika ( Site 1304), Pécs
Universitaetsspital Zurich ( Site 1203), Zurich
AZ Maria Middelares Gent ( Site 0102), Ghent
UZ Gent ( Site 0101), Ghent
O.L.V. Ziekenhuis Aalst ( Site 0106), Aalst
Veterans Affairs New York Harbor Healthcare System-PCF COE ( Site 1112), New York
Laura and Isaac Perlmutter Cancer Center at NYU Langone Health ( Site 1074), New York
CIMCA ( Site 1550), San José
Policlinico San Bosco ( Site 0600), San José
Ospedale Mauriziano-SCDU ONCOLOGIA MEDICA ( Site 0366), Turin
R.J. Zuckerberg Cancer Center ( Site 1080), Lake Success
St. Peter's Hospital Cancer Care Center ( Site 1087), Albany
Associated Medical Professionals of NY ( Site 1078), Syracuse
Hospital Nacional Guillermo Almenara Irigoyen ( Site 0601), La Victoria
Oncosalud ( Site 0603), Lima
Hospital Militar Central [Lima, Peru] ( Site 0604), Lima
Ospedale San Martino ( Site 0351), Genova
Lancaster Urology ( Site 1079), Lancaster
MidLantic Urology ( Site 1071), Bala-Cynwyd
University of Pennsylvania ( Site 1088), Philadelphia
IRCCS Ospedale San Raffaele ( Site 0362), Milan
Fondazione IRCCS Istituto Nazionale dei Tumori di Milano ( Site 0353), Milan
Centre Hospitalier Universitaire Dijon Bourgogne - Hôpital François Mitterrand-Urology ( Site 1355), Dijon
Urology of Virginia ( Site 1070), Virginia Beach
Eskisehir Osmangazi Universitesi Hastanesi ( Site 0953), Eskişehir
Hospital Universitario Lucus Augusti ( Site 0852), Lugo
Hospital Universitario Gregorio Maranon ( Site 0854), Madrid
Clinica Universitaria Navarra - Madrid ( Site 0860), Madrid
MD Anderson Cancer Center Madrid ( Site 0859), Madrid
Hospital Universitario Ramon y Cajal ( Site 0857), Madrid
Hospital Universitario La Paz ( Site 0866), Madrid
Hospital Universitario Quiron Madrid ( Site 0862), Pozuelo de Alarcón
Carolina Urologic Research Center ( Site 1085), Myrtle Beach
Advanced Urology ( Site 1092), Roswell
Emory School of Medicine ( Site 1076), Atlanta
Clinica Universitaria de Navarra ( Site 0863), Pamplona
Mayo Clinic in Florida-Urology ( Site 1097), Jacksonville
Woodlands Medical Specialists, PA ( Site 8002), Pensacola
Urological Research Network ( Site 1106), Hialeah
University of Miami Hospital and Clinics, Sylvester Cancer Center ( Site 1056), Miami
Tampere University Hospital [Tampere Finland] ( Site 0201), Tampere
Memorial Sisli Hastanesi-Medical Oncology ( Site 0965), Istanbul
TC Saglik Bakanligi Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi-oncology ( Site 0963), Istanbul
Centre Hospitalier Universitaire de Rennes - Hôpital Pontchaillou ( Site 1353), Rennes
Dokuz Eylul Universitesi ( Site 0959), Izmir
A.O.U. di Verona - Ospedale Civile Maggiore Borgo Trento ( Site 0356), Verona
Urology Associates [Nashville, TN] ( Site 1072), Nashville
Osp Generale Reg di Bolzano ( Site 0355), Bolzano
Necmettin Erbakan Universitesi Meram Tip Fakultesi Hastanesi ( Site 0961), Konya
Ohio State University Arthur G James Cancer Hospital & Richard J Solove Research Institute ( Site 10, Columbus
University Hospitals Cleveland Medical Center ( Site 1066), Cleveland
TriState Urologic Services PSC Inc. dba The Urology Group ( Site 1091), Cincinnati
Hospital La Fe de Valencia ( Site 0855), Valencia
Michigan Institute of Urology ( Site 1077), Troy
Henry Ford Health System ( Site 1062), Detroit
Azienda Ospedaliero Universitaria Careggi ( Site 0360), Florence
Azienda USL 8 di Arezzo-Medical Oncology ( Site 0363), Arezzo
Antikarkiniko Nosokomeio Thessalonikis THEAGENIO ( Site 0303), Thessaloniki
Krankenhaus der Barmherzigen Brüder Trier-Abteilung für Urologie und Kinderurologie ( Site 0262), Trier
Hopital Claude Huriez - CHU de Lille ( Site 1360), Lille
University Malaya Medical Centre ( Site 1180), Kuala Lumpur
Northwestern Memorial Hospital ( Site 1101), Chicago
Ospedale Clinicizzato Santissima Annunziata ( Site 0361), Chieti
Wichita Urology Group ( Site 1086), Wichita
Istituto Tumori Giovanni Paolo II ( Site 0357), Bari
Ochsner LSU Health Shreveport - Regional Urology ( Site 1099), Shreveport
Texas Oncology-Plano West ( Site 8001), Plano
Urology Clinics of North Texas, PLLC ( Site 1064), Dallas
University Of Texas Southwestern Medical Center ( Site 1053), Dallas
Hemato Oncologos SA-Oncology ( Site 1601), Santiago de Cali
Texas Oncology-Fort Worth Cancer Center ( Site 8003), Fort Worth
Houston Metro Urology ( Site 1111), Houston
Urology San Antonio Research ( Site 1108), San Antonio
Colorado Clinical Research ( Site 1100), Lakewood
Klinikum Rechts der Isar. Technischen Universitaet Muenchen ( Site 0266), Munich
Mayo Clinic in Arizona - Phoenix ( Site 1094), Phoenix
Arizona Urology Specialists (AUS)-Professional Park ( Site 1096), Tucson
UCLA Hematology/Oncology - Westwood (Building 200 Suite 140)-Department of Urology/Institute of Uro, Los Angeles
Ospedale Buccheri La Ferla Fatebenefratelli ( Site 0352), Palermo
Genesis Research LLC ( Site 1065), Torrance
Hôpital Foch-Urology department ( Site 1351), Suresnes
Klinikum Weiden ( Site 0259), Weiden in Der Oberpfalz
University of California Irvine Medical Center ( Site 1061), Orange
HENRI MONDOR HOSPITAL ( Site 1357), Créteil
Universitaetsklinikum Wuerzburg ( Site 0265), Würzburg
OHSU Knight Cancer Institute ( Site 1075), Portland
Oregon Urology Institute ( Site 1098), Springfield
Alaska Urological Institute dba Alaska Clinical Research Center ( Site 1083), Anchorage
Cancer Hospital Chinese Academy of Medical Science-Urinary Surgery ( Site 1766), Beijing
Peking University First Hospital ( Site 1759), Beijing
Beijing Cancer hospital-Urinary Surgery ( Site 1755), Beijing
Administradora Country S.A. - Clinica del Country ( Site 1607), Bogotá
Clinica Colsanitas S.A, Sede Clínica Universitaria Colombia-Center Investigator ( Site 1605), Bogotá
Harbin Medical University Cancer Hospital-urology ( Site 1772), Harbin
Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School-Urology ( S, Nanjing
The Second Affiliated Hospital of Soochow University-Urology ( Site 1773), Suzhou
Oncomedica S.A.-Oncomedica S.A ( Site 1604), Montería
The Second Hospital of Tianjin Medical University ( Site 1769), Tianjin
Zhejiang Provincial People's Hospital-Urology ( Site 1762), Hangzhou
The First Affiliated Hospital of Wenzhou Medical University-Urology Surgery ( Site 1774), Wenzhou
The First Affiliated hospital of Xiamen University-Urology ( Site 1776), Xiamen
Chongqing University Cancer Hospital ( Site 1784), Chongqing
Hunan Cancer Hospital ( Site 1763), Changsha
Tongji Hospital Tongji Medical,Science & Technology ( Site 1768), Wuhan
Wuhan Union Hospital ( Site 1771), Wuhan
Henan Cancer Hospital-Urology ( Site 1770), Zhengzhou
SUN YAT-SEN UNIVERSITY CANCER CENTRE ( Site 1752), Guangzhou
The First Affiliated Hospital of Guangzhou Medical University-Urology ( Site 1777), Guangzhou
Sun Yat-sen Memorial Hospital, Sun Yat-sen University-Urology Surgery ( Site 1751), Guangzhou
ShenZhen People's Hospital ( Site 1778), Shenzhen
West China Hospital Sichuan University ( Site 1767), Chengdu
Oncologos del Occidente ( Site 1608), Pereira
The First Affiliated Hospital of Xi'an Jiaotong University ( Site 1764), Xi'an
Clínica Imbanaco S.A.S ( Site 1611), Santiago de Cali
Hospital Erasto Gaertner-CEPEP - Pesquisa Clínica ( Site 1551), Curitiba
Coastal Urology Associates ( Site 1055), Brick
Morristown Medical Center ( Site 1090), Morristown
Rutgers Cancer Institute of New Jersey ( Site 1059), New Brunswick
University of Vermont Medical Center ( Site 1057), Burlington
Hospital São Carlos-Oncocentro Ce ( Site 1558), Fortaleza
Fundação Pio XII - Hospital de Câncer de Barretos-Unidade de Pesquisa Clínica ( Site 1553), Barretos
ICESP - INSTITUTO DO CÂNCER DO ESTADO DE SÃO PAULO ( Site 1560), São Paulo
BP - A Beneficencia Portuguesa de São Paulo ( Site 1559), São Paulo
Núcleo de Pesquisa Clínica da Rede São Camilo ( Site 1554), São Paulo
Exdeo Clinical Research Inc. ( Site 0165), Abbotsford
Silverado Resarch Inc. ( Site 0155), Victoria
Horizon Health Network ( Site 0160), Moncton
Princess Margaret Cancer Centre ( Site 0153), Toronto
CIUSSS du Saguenay-Lac-St-Jean ( Site 0164), Chicoutimi
CIUSSS de l Est de L Ile de Montreal - Hopital Maisonneuve-Rosemont ( Site 0157), Montreal
Centre intégré de cancérologie du CHU de Québec Université Laval, Hôpital de l'Enfant-Jésus ( Site 0, Québec
CHUS - Hopital Fleurimont ( Site 0152), Sherbrooke
Instituto de Cancerología-Oncology ( Site 1609), Medellín
Fundación Hospital San Vicente de Paúl - Rionegro - Centros Especializados o de Centros Especializad, Rionegro
Universitaetsklinikum Jena ( Site 0252), Jena
Olympion General Clinic ( Site 0306), Pátrai
General University Hospital of Patras ( Site 0302), Pátrai
ATTIKON GENERAL UNIVERSITY HOSPITAL ( Site 0304), Chaïdári
University Hospital of Larissa ( Site 0301), Larissa
INTEGRA Cancer Institute ( Site 1451), Guatemala City
Onco Go, S.A ( Site 1454), Guatemala City
Grupo Medico Angeles ( Site 1453), Guatemala City
Policlinico Universitario A. Gemelli ( Site 0358), Roma
Hirosaki University Hospital ( Site 0407), Hirosaki
Ehime University Hospital ( Site 0414), Tōon
University of Tsukuba Hospital ( Site 0412), Tsukuba
St. Marianna University Hospital ( Site 0415), Kawasaki
Kitasato University Hospital ( Site 0403), Sagamihara
Yokosuka Kyosai Hospital ( Site 0406), Yokosuka
Nara Medical University Hospital ( Site 0411), Kashihara
Hamamatsu University Hospital ( Site 0416), Hamamatsu
Chiba Cancer Center ( Site 0401), Chiba
Harasanshin Hospital ( Site 0410), Fukuoka
Osaka International Cancer Institute ( Site 0413), Osaka
Osaka Metropolitan University Hospital ( Site 0404), Osaka
Institute of Science Tokyo Hospital ( Site 0409), Tokyo
Keio University Hospital ( Site 0405), Tokyo
Maastricht University Medical Centre ( Site 0453), Maastricht
Erasmus MC ( Site 0451), Rotterdam
Universitair Medisch Centrum Utrecht-Medical Oncology ( Site 0455), Utrecht
Clinical Research Center Sp. z o.o. ( Site 0674), Poznan
MICS Centrum Medyczne Torun ( Site 0679), Torun
Pratia MCM Krakow ( Site 0668), Krakow
Szpital Wojewódzki im. Świętego Lukasza SP ZOZ w Tarnowie ( Site 0681), Tarnów
Uniwesytecki Szpital Kliniczny we Wroclawiu ( Site 0669), Wroclaw
Urologica Praktyka Lekarska Adam Marcheluk ( Site 0654), Siedlce
Luxmed Onkologia sp. z o. o. ( Site 0653), Warsaw
Medical Concierge Centrum Medyczne ( Site 0676), Warsaw
Wojewodzki Szpital im. Sw. Ojca Pio w Przemyslu ( Site 0678), Przemyśl
Szpital Specjalistyczny w Koscierzynie Sp. z o.o. ( Site 0671), Kościerzyna
Wojewodzki Szpital Specjalistyczny im. Janusza Korczaka w Slupsku ( Site 0655), Słupsk
LIFTMED ( Site 0652), Rybnik
Unidade Local de Saude de Santa Maria - Hospital de Santa Maria ( Site 0702), Lisbon
Unidade Local de Saude de Braga - Hospital de Braga ( Site 0705), Braga
Inst. Portugues de Oncologia de Coimbra Francisco Gentil EPE ( Site 0704), Coimbra
Inst. Portugues de Oncologia de Lisboa Francisco Gentil EPE ( Site 0708), Lisbon
Hospital CUF Descobertas ( Site 0706), Lisbon
Inst. Portugues de Oncologia de Porto Francisco Gentil EPE ( Site 0701), Porto
Advance Urology and Laparoscopic Center ( Site 0757), Ponce
Ad-Vance Medical Research ( Site 0756), Ponce
Asan Medical Center ( Site 0804), Songpagu
Korea University Anam Hospital ( Site 0801), Seoul
Seoul National University Hospital ( Site 0802), Seoul
Samsung Medical Center ( Site 0803), Seoul
Fundacio Puigvert ( Site 0864), Barcelona
Ankara Universitesi Tip Fakultesi Hastanesi ( Site 0966), Ankara
Raigmore Hospital ( Site 1006), Inverness
St Bartholomew s Hospital ( Site 1008), London
St Georges University Hospitals NHS Foundation Trust. ( Site 1005), London
Merck Sharp & Dohme LLC
INDUSTRY