595
Participants
Start Date
July 24, 2019
Primary Completion Date
June 6, 2025
Study Completion Date
December 15, 2027
Pembrolizumab
Pembrolizumab 200 mg by intravenous (IV) infusion, given on Day 1 of each 21-day cycle.
Surgery (radical cystectomy (RC) plus Pelvic Lymph Node Dissection [PLND])
Surgical RC+PLND will be done in accordance with the American Urological Association (AUA)/American Society of Clinical Oncology (ASCO)/American Society for Radiation Oncology (ASTRO)/Society of Urologic Oncology (SUO) guidelines.
Enfortumab Vedotin
Enfortumab vedotin 1.25 mg/kg by intravenous (IV) infusion, given on Days 1 and 8 of each 21-day cycle.
Bajcsy Zsilinszki Korhaz es Rendelointezet ( Site 1001), Budapest
St. Luke s Medical Center ( Site 1751), Quezon City
UCL Saint-Luc - Oncologie Medicale ( Site 0357), Brussels
The Medical City ( Site 1752), Pasig
Rigshospitalet University Hospital ( Site 0411), Copenhagen
Macquarie University ( Site 1251), Macquarie Park
Western Sydney Local Health District ( Site 1259), Blacktown
Herlev og Gentofte Hospital. ( Site 0412), Herlev
UZ Leuven ( Site 0361), Leuven
Eastern Health ( Site 1255), Box Hill
Monash Health ( Site 1260), Clayton
Debreceni Egyetem Klinikai Kozpont ( Site 1006), Debrecen
Mater Misericordiae Ltd ( Site 1258), South Brisbane
Cairns Base Hospital ( Site 1257), Cairns
Odense Universitetshospital ( Site 0413), Odense
THE MEDICAL CITY ILOILO ( Site 1756), Iloilo City
CHU UCL Namur Site de Godinne ( Site 0354), Yvoir
SZTE Szent-Gyorgyi Albert Klinikai Kozpont ( Site 1010), Szeged
Somogy Megyei Kaposi Mor Oktato Korhaz ( Site 1007), Kaposvár
Groote Schuur Hospital ( Site 1602), Cape Town
AZ Sint-Jan Brugge ( Site 0352), Bruges
Aarhus University Hospital Skejby ( Site 0418), Aarhus
AZ Delta vzw-Oncology ( Site 0362), Roeselare
AZ Maria Middelares Gent ( Site 0353), Ghent
Petz Aladar Megyei Oktato Korhaz ( Site 1012), Győr
Zhytomyr Regional Oncology Center ( Site 0971), Zhytomyr
Hospital San Pedro de Alcantara ( Site 0697), Cáceres
New York University Perlmutter Cancer Center ( Site 0008), New York
Icahn School of Medicine at Mount Sinai ( Site 0031), New York
Azienda Sanitaria Ospedaliera S Luigi Gonzaga-SCDU Oncologia Medica ( Site 0563), Orbassano
Ramathibodi Hospital. ( Site 1451), Bangkok
National Cancer Center ( Site 1354), Goyang-si
Faculty of Medicine Siriraj Hospital ( Site 1452), Bangkok
Vivantes Klinikum am Urban ( Site 0529), Berlin
Hospital Pulau Pinang ( Site 1703), George Town
Northwell Health - Monter Cancer Center ( Site 0083), Lake Success
Hopital de la Timone ( Site 0489), Marseille
Seoul National University Bundang Hospital ( Site 1356), Seongnam-si
Centre Francois Baclesse ( Site 0459), Caen
Instituto Nacional de Cancerologia. ( Site 0256), Mexico City
Allegheny General Hospital ( Site 0048), Pittsburgh
Institut Català d'Oncologia (ICO) - Girona ( Site 0700), Girona
Cherkasy Regional Oncology Dispensary ( Site 0959), Cherkasy
MidLantic Urology ( Site 0089), Bala-Cynwyd
Abramson Cancer Center of the University of Pennsylvania ( Site 0074), Philadelphia
Thomas Jefferson University ( Site 1579), Philadelphia
Fox Chase Cancer Center ( Site 0055), Philadelphia
Georgetown University Medical Center ( Site 0022), Washington D.C.
Investigacion Biomedica para el Desarrollo de Farmacos S.A. de C.V. ( Site 0300), Aguascalientes
Ospedale San Raffaele-Oncologia Medica ( Site 0561), Milan
Istituto Nazionale Studio e Cura dei Tumori ( Site 0551), Milan
Universitaetsklinikum Hamburg-Eppendorf-Onkologisches Zentrum ( Site 0528), Hamburg
Centre Georges Francois Leclerc ( Site 0488), Dijon
Greater Baltimore Medical Center ( Site 0014), Baltimore
Inova Schar Cancer Institute ( Site 0007), Fairfax
CHU Jean Minjoz ( Site 0455), Besançon
Charleston Area Medical Center ( Site 0023), Charleston
Fondazione Salvatore Maugeri IRCCS ( Site 0554), Pavia
Hospital Universitario Ramon y Cajal ( Site 0691), Madrid
Hospital Universitario San Carlos ( Site 0678), Madrid
Hospital Universitario la Paz ( Site 0690), Madrid
Hospital Universitario Quiron Madrid ( Site 0694), Pozuelo de Alarcón
Carolina Urologic Research Center ( Site 0062), Myrtle Beach
Bon Secours St. Francis Health System ( Site 1572), Greenville
Institut de Cancerologie du Gard - CHU Caremeau ( Site 0490), Nîmes
Emory School of Medicine ( Site 0006), Atlanta
Centro Estatal de Cancerologia de Chihuahua ( Site 0254), Chihuahua City
Institut Claudius Regaud IUCT Oncopole ( Site 0486), Toulouse
CHU de Bordeaux- Hopital Saint Andre ( Site 0456), Bordeaux
Istanbul Universitesi Cerrahpasa Tip Fakultesi ( Site 0930), Istanbul
CHU de Montpellier - Hopital Saint-Eloi ( Site 0469), Montpellier
TC Saglik Bakanligi Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi-oncology ( Site 0926), Istanbul
Marmara Universitesi Pendik Egitim ve Arastirma Hastanesi ( Site 0921), Istanbul
C.H.R.U. de Rennes. Hopital de Pontchaillou ( Site 0492), Rennes
AULSS8 Berica-Ospedale S.Bortolo-ONCOLOGIA CLINICA ( Site 0562), Vicenza
University of South Alabama, Mitchell Cancer Institute ( Site 1582), Mobile
Urology Associates [Nashville, TN] ( Site 0053), Nashville
Vanderbilt University Medical Center ( Site 0017), Nashville
Universitaetsklinikum Magdeburg A.o.R. ( Site 0535), Magdeburg
Srinagarind Hospital ( Site 1454), Khon Kaen
Hospital de Nuestra Senora de Valme ( Site 0693), Seville
Kyungpook National University Chilgok Hospital-Urology ( Site 1357), Deagu
Necmettin Erbakan Universitesi Meram Tip Fakultesi Hastanesi ( Site 0929), Konya
CHU Hotel Dieu Nantes ( Site 0458), Nantes
Cleveland Clinic Main ( Site 1576), Cleveland
Instituto Valenciano de Oncologia - IVO ( Site 0679), Valencia
Indiana University Melvin and Bren Simon Comprehensive Cancer Center ( Site 0004), Indianapolis
Parkview Cancer Institute ( Site 0077), Fort Wayne
ME І.І. Mechnykov Dnipro Regional Clinical Hospital ( Site 0963), Dnipropetrovsk
MNPE City Clinical Hospital #4 of Dnipro Regional Council ( Site 0951), Dnipro
Maharaj Nakorn Chiangmai Hospital ( Site 1453), Chiang Mai
Azienda USL 8 di Arezzo-Medical Oncology ( Site 0565), Arezzo
Centro de Tratamiento de Cancer ( Site 0266), Metepec
Universitaetsklinikum Bonn ( Site 0550), Bonn
Sakarya Universitesi Tip Fakultesi ( Site 0933), Sakarya
M Health Fairview Ridges Hospital ( Site 1555), Burnsville
Hopital Belle Isle ( Site 0452), Vantoux
University Malaya Medical Centre ( Site 1702), Lembah Pantai
John H. Stroger Jr. Hospital of Cook County ( Site 1551), Chicago
University of Chicago ( Site 0068), Chicago
Regional Oncology Center of Kharkiv ( Site 0958), Kharkiv
MNPE V.I. Shapoval Regional Medical Clinical Urology and Nephrology Center of KharkivRegCouncil ( Site 0969), Kharkiv
Karadeniz Teknik Universitesi Tip Fakultesi Farabi Hastanesi ( Site 0924), Trabzon
Municipal Non-profit Enterprise of Kharkiv Regional Council RCSDRPP ( Site 0973), Kharkiv
Centro de Urologia Avanzada del Noreste S.A. de C.V. ( Site 0253), Monterrey
Wichita Urology Group ( Site 0059), Wichita
C.H.U. Lyon Sud ( Site 0466), Pierre-Bénite
Tulane University School of Medicine ( Site 0088), New Orleans
Klinikum Stuttgart - Katharinenhospital ( Site 0520), Stuttgart
Yitzhak Shamir Medical Center. ( Site 0848), Ẕerifin
Klinikum der Eberhard-Karls-Universitaet Tuebingen ( Site 0549), Tübingen
CARTI Cancer Center ( Site 1577), Little Rock
"Communal nonprofit enterprise Kherson Regional Oncology Dispensary of Kherson Regional Council ( Site 0976)", Antonivka Village
Oklahoma Cancer Specialists and Research Institute, LLC ( Site 0021), Tulsa
CHU Cochin ( Site 0475), Paris
Hopital Europeen Georges Pompidou ( Site 0476), Paris
Hopital Bichat du Paris ( Site 0462), Paris
Texas Oncology-Baylor Sammons Cancer Center ( Site 1552), Dallas
MNPE Lviv Regional Clinical Hospital of Lviv Regional Council ( Site 0955), Lviv
Lviv State Regional Oncological Center ( Site 0967), Lviv
University of Colorado Hospital ( Site 0098), Aurora
Istituto Nazionale Per Lo Studio E La Cura Dei Tumori ( Site 0552), Napoli
Klinikum der Universitaet Muenchen - Grosshadern ( Site 0548), Munich
UNM Comprehensive Cancer Center-Clinical Research Office ( Site 0045), Albuquerque
John Wayne Cancer Institute ( Site 0075), Santa Monica
Universitaetsklinikum Erlangen ( Site 0546), Erlangen
Scripps MD Anderson ( Site 0010), La Jolla
Hoag Memorial Hospital Presbyterian ( Site 1595), Newport Beach
St. Joseph Heritage Healthcare ( Site 0046), Fullerton
Sarawak General Hospital ( Site 1701), Kuching
Institut Gustave Roussy ( Site 0487), Villejuif
A.O.U. Policlinico Vittorio Emanuele - Presidio Gaspare Rodolico ( Site 0559), Catania
Universitaetsklinikum Wuerzburg ( Site 0547), Würzburg
Providence Portland Medical Center [Portland, OR] ( Site 0095), Portland
Clinica Colsanitas S.A, Sede Clínica Universitaria Colombia-Center Investigator ( Site 2002), Bogotá
Russian Oncological Research Center n.a. N.N.Blokhin of MoH ( Site 0878), Moscow
National University Hospital ( Site 1802), Singapore
First Moscow State Medical University n.a. I.M.Sechenov ( Site 0884), Moscow
Central Clinical Hospital with outpatient Clinic ( Site 0856), Moscow
Ivanovo Regional Oncology Dispensary ( Site 0852), Ivanovo
Bayandin Murmansk Regional Clinical Hospital ( Site 0859), Murmansk
Leningrad Regional Oncology Center ( Site 0868), Saint Petersburg
Clinical Hospital Saint Luka ( Site 0867), Saint Petersburg
First St. Petersburg State Medical University n.a. acad. I.P. Pavlov ( Site 0872), Saint Petersburg
National Medical Research Center of Oncology N.A. N.N. Petrov ( Site 0860), Saint Petersburg
IMAT S.A.S ( Site 2001), Montería
Kursk Regional Clinical Oncology Dispensary ( Site 0854), Kursk
Tan Tock Seng Hospital ( Site 1804), Singapore
Saratov State Medical University n.a. V.I.Razumovskiy ( Site 0866), Saratov
Clinic of Bashkortostan State Medical University ( Site 0873), Ufa
Volga District Medical Center Federal Medical and Biological Agency ( Site 0857), Nizhny Novgorod
Sverdlovsk Regional Oncology Hospital ( Site 0874), Yekaterinburg
Medical Sanitary Unit Neftyannik ( Site 0888), Tyumen
Omsk Clinical Oncology Dispensary ( Site 0865), Omsk
Krasnoyarsk Regional Clinical Oncological Dispensary ( Site 0861), Krasnoyarsk
Fundación Cardiovascular de Colombia ( Site 2004), Piedecuesta
Fundacion Valle del Lili- CIC-Fundacion Valle del Lili ( Site 2005), Santiago de Cali
Ha Emek Medical Center ( Site 0843), Afula
Rambam Health Care Campus-Oncology Division ( Site 0845), Haifa
Dokkyo Medical University Saitama Medical Center ( Site 2304), Koshigaya
Meir Medical Center ( Site 0846), Kfar Saba
Rabin Medical Center ( Site 0847), Petah Tikva
Sheba Medical Center ( Site 0844), Ramat Gan
Sourasky Medical Center ( Site 0850), Tel Aviv
Soroka Medical Center ( Site 0849), Beersheba
Shaare Zedek Medical Center ( Site 0842), Jerusalem
Hadassah Ein Kerem Medical Center ( Site 0841), Jerusalem
New England Cancer Specialists ( Site 0070), Westbrook
Dana-Farber Cancer Institute ( Site 1596), Boston
Morristown Medical Center ( Site 0015), Morristown
Asociación de Beneficencia Hospital Sirio Libanés ( Site 2102), Buenos Aires
Arthur J.E. Child Comprehensive Cancer Centre ( Site 0100), Calgary
BC Cancer Vancouver-Clinical Trials Unit ( Site 0121), Vancouver
Silverado Resarch Inc. ( Site 0111), Victoria
Moncton Hospital - Horizon Health Network ( Site 0112), Moncton
Sunnybrook Research Institute ( Site 0110), Toronto
Princess Margaret Cancer Centre ( Site 0107), Toronto
CIUSSS du Saguenay-Lac-St-Jean ( Site 0116), Chicoutimi
CIUSSS de l Est de L Ile de Montreal - Hopital Maisonneuve-Rosemont ( Site 0105), Montreal
Jewish General Hospital ( Site 0120), Montreal
McGill University Health Centre ( Site 0123), Montreal
CIUSSS de l'Estrie-CHUS ( Site 0106), Sherbrooke
Fundacion Colombiana de Cancerología Clinica Vida ( Site 2003), Medellín
Universitaetsklinikum Carl Gustav Carus ( Site 0532), Dresden
SRH Wald-Klinikum Gera-Zentrum für klinische Studien ( Site 0533), Gera
Tallaght University Hospital ( Site 0734), Dublin
University Hospital Waterford ( Site 0747), Waterford
Policlinico Gemelli di Roma ( Site 0558), Roma
Azienda Ospedaliera Santa Maria Terni-S.C. Oncologia Medica e Traslazionale ( Site 0564), Terni
National Cancer Center Hospital East ( Site 2305), Kashiwa
University of Tsukuba Hospital ( Site 2302), Tsukuba
St. Marianna University Hospital ( Site 2321), Kawasaki
Kitasato University Hospital ( Site 2306), Sagamihara
Yokosuka Kyosai Hospital ( Site 2307), Yokosuka
Tohoku University Hospital ( Site 2301), Sendai
Nagano Municipal Hospital ( Site 2309), Tomitake
Nara Medical University Hospital ( Site 2312), Kashihara
Osaka Rosai Hospital ( Site 2320), Sakai
Saitama Prefectural Cancer Center ( Site 2319), Ina-machi
Hamamatsu University Hospital ( Site 2311), Hamamatsu
Institute of Science Tokyo Hospital ( Site 2303), Bunkyō
Toranomon Hospital ( Site 2322), Minato-ku
Toyama University Hospital ( Site 2308), Toyoma
Gifu University Hospital ( Site 2310), Gifu
Kagoshima University Hospital ( Site 2317), Kagoshima
Nagasaki University Hospital ( Site 2315), Nagasaki
Hospital Angeles Roma ( Site 0262), Mexico City
Clinical Research Center Medic-R ( Site 1073), Poznan
Centrum Onkologii im.prof. F. Lukaszczyka w Bydgoszczy ( Site 1068), Bydgoszcz
Szpital Wojewodzki ( Site 1062), Tarnów
Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego ( Site 1063), Wroclaw
Europejskie Centrum Zdrowia Otwock ( Site 1058), Otwock
Luxmed Onkologia sp. z o. o. ( Site 1051), Warsaw
Bialostockie Centrum Onkologii ( Site 1072), Bialystok
Wojewodzki Szpital Specjalistyczny im. Janusza Korczaka w Slupsku ( Site 1057), Słupsk
Beskidzkie Centrum Onkologii im. Jana Pawla II ( Site 1061), Bielsko-Biala
Steve Biko Academic Hospital-Medical Oncology ( Site 1601), Pretoria
Asan Medical Center ( Site 1355), Songpagu
Korea University Anam Hospital ( Site 1351), Seoul
Seoul National University Hospital ( Site 1352), Seoul
Samsung Medical Center ( Site 1353), Seoul
Hosp. Gral. Universitari Germans Trias i Pujol ( Site 0675), Badalona
Hospital Clinic i Provincial ( Site 0674), Barcelona
Hospital del Mar ( Site 0698), Barcelona
Laenssjukhuset Ryhov ( Site 1215), Jönköping
Karolinska Universitetssjukhuset Solna ( Site 1212), Stockholm
Akademiska Sjukhuset ( Site 1211), Uppsala
Cancercentrum ( Site 1214), Umeå
Onkologiska kliniken ( Site 1217), Gothenburg
Hacettepe Universitesi Tıp Fakultesi ( Site 0931), Ankara
SNPE National Cancer Institute ( Site 0962), Kyiv
Kyiv City Clinical Oncology Center ( Site 0960), Kyiv
Walsall Manor Hospital-Oncology ( Site 0743), Walsall
Kent and Canterbury Hospital ( Site 0733), Canterbury
The James Cook University Hospital ( Site 0730), Middlesbrough
Imperial College Healthcare NHS Trust ( Site 0745), London
Lister Hospital ( Site 0739), Stevenage
Barts Health NHS Trust - St Bartholomew s Hospital ( Site 0725), London
The Royal Marsden Foundation Trust ( Site 0726), London
Western General Hospital ( Site 0749), Edinburgh
Clatterbridge Oncology Centre ( Site 0731), Metropolitan Borough of Wirral
Royal Cornwall Hospital ( Site 0727), Truro
Seagen Inc.
INDUSTRY
Astellas Pharma Global Development, Inc.
INDUSTRY
Merck Sharp & Dohme LLC
INDUSTRY