520
Participants
Start Date
May 19, 2020
Primary Completion Date
January 31, 2027
Study Completion Date
November 1, 2031
Pembrolizumab
400 mg of IV (intravenous) pembrolizumab once every 6 weeks.
Conventional Radiotherapy (Bladder only)
64 Gy of radiation administered to participant's bladder only. Thirty-two fractions will be administered over 6.5 weeks.
Conventional Radiotherapy (Bladder and pelvic nodes)
64 Gy of radiation administered to participant's bladder and pelvic nodes. Thirty-two fractions will be administered over 6.5 weeks.
Hypofractionated Radiotherapy (Bladder only)
55 Gy of radiation administered to participant's bladder only. Twenty fractions will be administered over 4 weeks.
Cisplatin
35 mg of cisplatin per cubic meter of body volume, administered once weekly via IV infusion.
Fluorouracil (5-FU)
5-FU administered via IV infusion at a dose of 500 mg per cubic meter of body volume on Days 1-5 and 22-26.
Mitomycin C (MMC)
MMC administered via IV infusion at a dose of 12 mg per cubic meter of body volume on Day 1.
Gemcitabine
Gemcitabine administered via IV infusion at a dose of 27 mg per cubic meter of body volume twice weekly.
Placebo to Pembrolizumab
Placebo to intravenous (IV) pembrolizumab administered once every 6 weeks.
Egeszsegugyi Tudomanyos Tanacs Klinikai Farmakologiai Etikai Bizottsaga ( Site 0095), Budapest
GenesisCare North Shore ( Site 0217), St Leonards
Liverpool Hospital ( Site 0220), Liverpool
Herlev og Gentofte Hospital. ( Site 0401), Herlev
Austin Health ( Site 0218), Heidelberg
Monash Medical Centre ( Site 0216), Clayton
BAZ Megyei Korhaz. Klinikai Onkologia es Sugarterapias Centrum ( Site 0092), Miskolc
Debreceni Egyetem Klinikai Kozpont ( Site 0097), Debrecen
Odense Universitetshospital ( Site 0403), Odense
Sir Charles Gairdner Hospital ( Site 0223), Nedlands
Somogy Megyei Kaposi Mor Oktato Korhaz ( Site 0091), Kaposvár
Petz Aladar Megyei Oktato Korhaz ( Site 0099), Győr
New York University Perlmutter Cancer Center ( Site 0001), New York
National Cancer Center ( Site 0202), Gyeonggi-do
Hospital Pulau Pinang ( Site 0239), George Town
Winthrop University Hospital ( Site 0069), Mineola
New York Oncology Hematology P.C ( Site 0024), Albany
North Estonia Medical Centre Foundation ( Site 0081), Tallinn
Seoul National University Bundang Hospital ( Site 0204), Seongnam-si
Roswell Park Cancer Institute ( Site 6009), Buffalo
Hospital Universiti Sains Malaysia ( Site 0237), Kubang Kerian
MidLantic urology ( Site 0070), Bala-Cynwyd
Washington Cancer Institute at MedStar Washington Hospital Center ( Site 0041), Washington D.C.
Ospedale San Raffaele ( Site 0194), Milan
Fondazione IRCCS Istituto Nazionale dei Tumori di Milano ( Site 0186), Milan
Baltimore VA Medical Center ( Site 0054), Baltimore
Inova Schar Cancer Institute ( Site 6006), Fairfax
Ukranian Center of TomoTherapy ( Site 0140), Kropyvnytskiy
West Virginia University - Charleston Area Medical Center ( Site 6003), Charleston
Carolina Urologic Research Center ( Site 0002), Myrtle Beach
Saint Francis Cancer Center ( Site 0026), Greenville
AdventHealth Orlando-AdventHealth Medical Group Hematology & Oncology at Orlandoc ( Site 0004), Orlando
Bay Pines VA Medical Center ( Site 0055), Bay Pines
Istanbul Uni. Cerrahpasa Tip Fakultesi ( Site 0501), Istanbul
T.C. Saglik Bakanligi Turkiye Kamu Hastaneleri Kurumu - Baki-Istanbul Bakirkoy Sadi Konuk Training (, Istanbul
Göztepe Prof. Dr. Süleyman Yalçın Şehir Hastanesi-oncology ( Site 0504), Istanbul
Chungnam National University Hospital ( Site 0203), Daejeon
Ege University Medical Faculty ( Site 0508), Izmir
Norton Cancer Institute ( Site 0044), Louisville
HOSPITAL UNIVERSITARIO VIRGEN DEL ROCIO-Medical Oncology ( Site 0106), Seville
Azienda Ospedaliero - Universitaria Policlinico di Modena ( Site 0188), Modena
Pikeville Medical Center ( Site 0009), Pikeville
Fairview Hospital-Moll Cancer Center ( Site 6013), Cleveland
Cleveland Clinic - Hillcrest Hospital-Hillcrest Hospital Cancer Center ( Site 6012), Mayfield Heights
Cleveland Clinic Main ( Site 0062), Cleveland
Hospital La Fe de Valencia ( Site 0105), Valencia
Clinical oncology dispensary of Dnipro ( Site 0133), Dnipro
AOU Careggi ( Site 0191), Florence
Hospital Kuala Lumpur ( Site 0238), Kuala Lumpur
Tartu University Hospital ( Site 0079), Tartu
Froedtert and Medical College of Wisconsin ( Site 0022), Milwaukee
University Malaya Medical Centre ( Site 0236), Kuala Lumpur
Grigoriev Institute for medical Radiology NAMS of Ukraine ( Site 0139), Kharkiv
MNPE Regional Center of Oncology ( Site 0134), Kharkiv
Karadeniz Teknik Universitesi Tip Fakultesi ( Site 0503), Trabzon
Ospedale Civile di Macerata ( Site 0190), Macerata
Washington University ( Site 0003), St Louis
IRCCS Giovanni Paolo II. Ospedale Oncologico ( Site 0193), Bari
Institut Curie ( Site 0112), Paris
A.P.H. Paris. Hopital Bichat Claude Bernard ( Site 0115), Paris
Fakultni nemocnice Olomouc ( Site 0559), Olomouc
Urology San Antonio Research ( Site 6010), San Antonio
CHU Amiens Picardie Site Sud Amiens ( Site 0123), Amiens
Istituto Nazionale Tumori IRCCS Fondazione Pascale ( Site 0192), Napoli
Institut Sainte Catherine ( Site 0121), Avignon
S.C. Centrul de Oncologie Sf. Nectarie SRL ( Site 0248), Craiova
Policlinica Oncomed SRL ( Site 0254), Timișoara
Institutul Oncologic Prof.Dr. Ion Chiricuta Cluj-Napoca ( Site 0249), Cluj-Napoca
Institutul Oncologic-Oncologie Medicala ( Site 0256), Cluj-Napoca
S.C. Radiotherapy Center Cluj S.R.L ( Site 0252), Cluj-Napoca
Institutul Regional de Oncologie Iasi ( Site 0255), Iași
Bradford Hill Norte ( Site 7052), Antofagasta
ONCOCENTRO APYS-ACEREY ( Site 7054), Viña del Mar
Rambam Health Care Campus-Oncology Division ( Site 0088), Haifa
Oncocentro Valdivia ( Site 7055), Valdivia
Chaim Sheba Medical Center ( Site 0087), Ramat Gan
Osaka Medical and Pharmaceutical University Hospital ( Site 0604), Takatsuki
Sourasky Medical Center ( Site 0089), Tel Aviv
FALP ( Site 7056), Santiago
Soroka Medical Center-Oncology ( Site 7031), Beersheba
Bradfordhill-Clinical Area ( Site 7051), Santiago
Hadassah Medical Center. Ein Kerem ( Site 0086), Jerusalem
Summit Medical Group Cancer Center ( Site 6008), Florham Park
John Theurer Cancer Center at Hackensack University Medical Center ( Site 0005), Hackensack
2. LF UK a FN Motol ( Site 0555), Prague
Nemocnice Na Bulovce ( Site 0556), Prague
Centro de Investigaciones Clinicas de Latinoamerica S.A. - CELAN ( Site 0146), Guatemala City
Oncomedica ( Site 0145), Guatemala City
Grupo Medico Angeles ( Site 0143), Guatemala City
Medi-K Cayala ( Site 0142), Guatemala City
Centro Medico Integral De Cancerología (CEMIC) ( Site 0144), Quetzaltenango
Rabin Medical Center ( Site 7032), Petah Tikva
Fondazione Policlinico Universitario Campus Bio-Medico-Radiation Oncology ( Site 7041), Rome
Hirosaki University Hospital ( Site 0602), Hirosaki
University of Tsukuba Hospital ( Site 0605), Tsukuba
Nagasaki University Hospital ( Site 0600), Nagasaki
Institute of Science Tokyo Hospital ( Site 0601), Tokyo
Tokyo Metropolitan Komagome Hospital ( Site 0606), Tokyo
Pauls Stradins Clinical University Hospital ( Site 0073), Riga
Netherlands Cancer Institute (NKI) ( Site 0183), Amsterdam
Erasmus MC ( Site 0182), Rotterdam
Szpital Specjalistyczny im. Ludwika Rydygiera w Krakowie ( Site 0153), Krakow
Mazowiecki Szpital Wojewódzki w Siedlcach ( Site 0154), Siedlce
Szpital Wojewodzki im. Mikolaja Kopernika ( Site 0152), Koszalin
Unidade Local de Saude Loures-Odivelas - Hospital Beatriz Angelo ( Site 0303), Loures
Centro Hospitalar e Universitario de Coimbra ( Site 0306), Coimbra
Unidade Local de Saude Lisboa Ocidental - Hospital de São Francisco Xavier ( Site 0302), Lisbon
Unidade Local de Saude de Santa Maria - Hospital de Santa Maria ( Site 0305), Lisbon
Advance Urology and Laparoscopic Center ( Site 0281), Ponce
PAN American Center Oncologic ( Site 0280), San Juan, Rio Piedras
MEMORIAL HEALTHCARE INTERNATIONAL S.R.L. ( Site 0253), Bucharest
Asan Medical Center ( Site 0200), Songpagu
Korea University Anam Hospital ( Site 0205), Seoul
Severance Hospital Yonsei University Health System ( Site 0201), Seoul
Instituto Catalan de Oncologia - ICO ( Site 0103), L'Hospitalet de Llobregat
University of Health Sciences,Gulhane School of Medicine-Oncology ( Site 0509), Ankara
Ankara Universitesi Tip Fakultesi. ( Site 0502), Ankara
SNPE National Cancer Institute ( Site 0136), Kyiv
Kyiv City Clinical Oncology Center ( Site 0135), Kyiv
Betsi Cadwaladr University Health Board ( Site 0447), Rhyl
South Devon Healthcare Foundation Trust. Torbay Hospital ( Site 0444), Torquay
Royal Preston Hospital ( Site 0449), Preston
University College London Hospitals NHS Foundation Trust ( Site 0445), London
The Royal Marsden NHS Foundation Trust. ( Site 0442), London
Nottingham University Hospital NHS Trust ( Site 0250), Nottingham
Darlington Memorial Hospital NHS Trust ( Site 0446), Darlington
Merck Sharp & Dohme LLC
INDUSTRY