808
Participants
Start Date
April 21, 2021
Primary Completion Date
December 23, 2026
Study Completion Date
December 23, 2026
Pembrolizumab
200 mg of Pembrolizumab IV infusion, on Day 1 Q3W for 4 cycles (each cycle length = 21 days) in preoperative phase (up to approximately 3 months) and on Day 1 Q3W for 13 cycles in postoperative phase (up to approximately 9 months). The total duration of treatment is up to approximately 1 year.
Enfortumab vedotin (EV)
1.25 mg/kg of EV IV infusion, on Day 1 and Day 8 Q3W for 4 cycles (each cycle length = 21 days) in preoperative phase (up to approximately 3 months) and on Day 1 and Day 8 Q3W for 5 cycles (each cycle length = 21 days) in postoperative phase (up to approximately 4 months). The total duration of treatment is up to approximately 7 months.
RC + PLND
Curative intent RC + PLND surgery will be administered to all participants randomized to Arm A and B after completion of preoperative systemic treatment (RC + PLND to be done approximately at 15 weeks from randomization).
Gemcitabine
1000 mg/m\^2 of Gemcitabine IV infusion, Day 1 and Day 8 Q3W for 4 cycles in preoperative phase (up to approximately 3 months)
Cisplatin
70 mg/m\^2 of Cisplatin IV infusion, Day 1, Q3W for 4 cycles in preoperative phase (up to approximately 3 months)
Taipei Veterans General Hospital ( Site 1201), Taipei
Centro de Urología (CDU) ( Site 1552), Buenos Aires
MHAT Serdika ( Site 1152), Sofia
Macquarie University-MQ Health Clinical Trials Unit ( Site 1259), Macquarie University
Wits Clinical Research ( Site 0603), Johannesburg
Frankston Hospital-Oncology and Haematology ( Site 1258), Frankston
Complex Oncology Center Plovdiv ( Site 1151), Plovdiv
MHAT Central Onco Hospital OOD ( Site 1158), Plovdiv
Debreceni Egyetem Klinikai Kozpont ( Site 1006), Debrecen
Mater Hospital Brisbane ( Site 1257), South Brisbane
"MHAT Uni Hospital OOD ( Site 1154)", Panagyurishte
THE MEDICAL CITY ILOILO-The Medical City Iloilo - Clinical and Translational Research Institute-Ilo ( Site 0801), Iloilo City
Jász-Nagykun-Szolnok Vármegyei Hetényi Géza Kórház ( Site 1002), Szolnok
Lyell McEwin Hospital ( Site 1252), Elizabeth Vale
Szegedi Tudományegyetem Szent-Györgyi Albert Klinikai Központ ( Site 1010), Szeged
Groote Schuur Hospital ( Site 0602), Cape Town
Klinički bolnički centar Sestre milosrdnice ( Site 1703), Zagreb
Klinički bolnički centar Zagreb-Klinika za onkologiju ( Site 1701), Zagreb
Zhytomyr Regional Oncology Center ( Site 0961), Zhytomyr
Icahn School of Medicine at Mount Sinai ( Site 0011), New York
AOU San Luigi Gonzaga di Orbassano ( Site 0595), Orbassano
Hospital Pulau Pinang ( Site 0355), George Town
White Plains Hospital ( Site 0039), White Plains
Vivantes Klinikum Am Urban ( Site 0519), Berlin
CHU La Timone ( Site 0456), Marseille
Seoul National University Bundang Hospital ( Site 1355), Gyeonggi-do
CHUS - Hospital Clinico Universitario-Servicio de Oncologia ( Site 0660), Santiago de Compostela
Institut Català d'Oncologia (ICO) - Girona ( Site 0653), Girona
MidLantic Urology ( Site 0002), Bala-Cynwyd
IRCCS Ospedale San Raffaele ( Site 0596), Milan
Fondazione IRCCS Istituto Nazionale dei Tumori-Struttura Complessa Oncologia Medica 1 ( Site 0588), Milan
Klinički Bolnički Centar Split-Oncology and Radiotherapy ( Site 1702), Split
Gachon University Gil Medical Center ( Site 1356), Incheon
CHU Jean Minjoz ( Site 0453), Besançon
UNIVERSITY HOSPITAL OF PATRAS-DIVISION OF ONCOLOGY ( Site 0305), Pátrai
Wake Forest Baptist Health ( Site 0014), Winston-Salem
Duke University Medical Center ( Site 0017), Durham
Hospital Clinico Universitario San Carlos de Madrid ( Site 0651), Madrid
C.H. regional Unv. de Brest - Hopital La Cavale Blanche - Institut de Cancerologie et d Imagerie ( Site 0461), Brest
Saint Francis Cancer Center ( Site 0008), Greenville
Klinički bolnički centar Osijek ( Site 1705), Osijek
Institut Universitaire du Cancer Toulouse - Oncopole ( Site 0455), Toulouse
UF Health ( Site 0031), Gainesville
Hospital Universitario Central de Asturias ( Site 0654), Oviedo
Hospital Universitario Insular de Gran Canaria ( Site 0657), Las Palmas de Gran Canaria
Istituto Oncologico Veneto IRCCS-Oncologia Medica 1 ( Site 0600), Padua
Azienda Ospedaliera Universitaria Integrata Verona - Ospedale Borgo Trento ( Site 0598), Verona
The University of Tennessee Medical Center ( Site 0034), Knoxville
CHU GRENOBLE ALPES ( Site 0468), La Tronche
University of Louisville, James Graham Brown Cancer Center ( Site 0022), Louisville
Hospital Virgen del Rocio ( Site 0659), Seville
Kyungpook National University Chilgok Hospital ( Site 1354), Daegu
Kath. Krankenhaus Marienhospital. Universitaetsklinik ( Site 0511), Herne
Centre Hospitalier Regional du Orleans ( Site 0463), Orléans
Fundación Instituto Valenciano de Oncología-Oncologico ( Site 0662), Valencia
Indiana University Melvin and Bren Simon Cancer Center ( Site 0050), Indianapolis
Sunway Medical Centre ( Site 0353), Petaling Jaya
Universitaetsklinikum Muenster ( Site 0516), Münster
I.I. Mechnykov Dnipropetrovsk Regional Clinical Hospital ( Site 0959), Dnipro
MI Clinical oncology dispensary of Dnipropetrovsk regional council ( Site 0954), Dnipro
Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wrocławiu ( Site 1058), Wrocław
University of Iowa Hospital and Clinics ( Site 0029), Iowa City
University of Wisconsin Hospital and Clinics ( Site 0037), Madison
Chonnam National University Hwasun Hospital ( Site 1353), Jeollanam-do
Polyclinique du Bois ( Site 0458), Lille
University Malaya Medical Centre ( Site 0352), Lembah Pantai
Azienda Ospedaliero Universitaria delle Marche-Clinica Oncologica ( Site 0593), Ancona
Regional Clinical Center of Urology and Nephrology n.a. V.I. Shapoval ( Site 0952), Kharkiv
MNPE Regional Center of Oncology ( Site 0955), Kharkiv
Municipal Non-profit Enterprise of Kharkiv Regional Council RCSDRPP ( Site 0965), Kharkiv
Yitzhak Shamir Medical Center-Oncology ( Site 0756), Ẕerifin
Universitaetsklinik fuer Urologie ( Site 0501), Tübingen
UT Southwestern Medical Center ( Site 0003), Dallas
Hopital Diaconesses Croix Saint Simon ( Site 0465), Paris
Houston Methodist Urology Associates ( Site 0033), Houston
Fakultni Nemocnice Olomouc ( Site 0251), Olomouc
Urology of San Antonio ( Site 0020), San Antonio
Lviv Oncology Regional Treatment and Diagnostic Center ( Site 0960), Lviv
Universitaetsklinikum Freiburg ( Site 0512), Freiburg im Breisgau
University of Colorado, Anschutz Cancer Pavilion ( Site 0009), Aurora
Presidio Ospedaliero Santa Maria delle Grazie ( Site 0599), Pozzuoli
Chang Gung Memorial Hospital at Kaohsiung ( Site 1203), Kaohsiung City
Mayo Clinic in Arizona - Phoenix ( Site 0043), Phoenix
CHU Limoges Hopital Dupuytren ( Site 0459), Limoges
UCLA Hematology/Oncology - Westwood (Building 200 Suite 140)-Department of Urology/Institute of Uro ( Site 0005), Los Angeles
St Joseph Heritage Healthcare-Oncology ( Site 0035), Fullerton
Caritas Krankenhaus St. Josef ( Site 0502), Regensburg
Sarawak General Hospital ( Site 0351), Kuching
University of California San Francisco ( Site 0010), San Francisco
Stanford University ( Site 0023), Stanford
Gustave Roussy ( Site 0467), Villejuif
Ospedale Cannizzaro ( Site 0590), Catania
Universitaetsklinikum Wuerzburg ( Site 0520), Würzburg
Clinica Colsanitas S.A, Sede Clínica Universitaria Colombia-Center Investigator ( Site 1654), Bogotá
National Medical Research Centre of Oncology named after N.N. Blokhin ( Site 0865), Moscow
First Moscow State Medical University n.a. I.M.Sechenov ( Site 0871), Moscow
St.Petersburg Clinical Hospital RAS ( Site 0864), Saint Petersburg
St.Petersburg State Medical Univ. n.a. acad. I.P.Pavlov ( Site 0856), Saint Petersburg
Scientific Research Oncology Institute n.a. N.N.Petrov ( Site 0852), Saint Petersburg
Fudan University Shanghai Cancer Center-Urology department ( Site 1401), Shanghai
Renji Hospital Shanghai Jiao Tong University School of Medicine ( Site 1402), Shanghai
S.C. Centrul de Oncologie Sf. Nectarie SRL ( Site 1107), Craiova
Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School-Urology ( Site 1404), Nanjing
Nantong Tumor Hospital-Urology ( Site 1405), Nantong
IMAT S.A.S ( Site 1652), Montería
National Medical Research Radiology Centre ( Site 0869), Obninsk
Policlinica Oncomed SRL ( Site 1106), Timișoara
Tan Tock Seng Hospital ( Site 0704), Singapore
Cardiomed SRL Cluj-Napoca ( Site 1101), Cluj-Napoca
Institutul Oncologic Prof.Dr. Ion Chiricuta Cluj-Napoca ( Site 1102), Cluj-Napoca
Institutul Oncologic Prof.Dr. Ion Chiricuta Cluj-Napoca ( Site 1103), Cluj-Napoca
Institutul Oncologic Cluj-Oncologie Medicala ( Site 1109), Cluj-Napoca
Volgograd Regional Uronephrological Center ( Site 0870), Volzhsky
China Medical University Hospital ( Site 1202), Taichung
SC Radiotherapy Center Cluj SRL ( Site 1108), Comuna Floresti
Hunan Cancer Hospital ( Site 1403), Changsha
SUN YAT-SEN UNIVERSITY CANCER CENTRE ( Site 1406), Guangzhou
Sun Yat-sen Memorial Hospital, Sun Yat-sen University ( Site 1413), Guangzhou
Volga District Medical Center ( Site 0876), Nizhny Novgorod
Sverdlovsk Regional Oncology Hospital ( Site 0867), Yekaterinburg
Sverdlovsky Regional Clinical hospital #1 ( Site 0868), Yekaterinburg
Altay Regional Oncology Dispensary ( Site 0851), Barnaul
Fundación Cardiovascular de Colombia-Santander ( Site 1657), Piedecuesta
Fundación Valle del Lili ( Site 1656), Santiago de Cali
Rambam Health Care Campus-Oncology ( Site 0751), Haifa
Meir Medical Center-oncology ( Site 0754), Kfar Saba
Rabin Medical Center-Oncology ( Site 0752), Petah Tikva
Sheba Medical Center-ONCOLOGY ( Site 0753), Ramat Gan
Sourasky Medical Center-Oncology ( Site 0755), Tel Aviv
Hadassah Medical Center-Oncology ( Site 0757), Jerusalem
Oregon Health and Science University ( Site 0028), Portland
Hospital Británico de Buenos Aires-Oncology ( Site 1551), Ciudad Autónoma de Buenos Aires
Hospital Italiano de Buenos Aires ( Site 1554), ABB
Asociación de Beneficencia Hospital Sirio Libanés ( Site 1553), Buenos Aires
Centro de Educación Médica e Investigaciones Clínicas (CEMIC) ( Site 1558), Buenos Aires
Fundacion Estudios Clinicos-Oncology ( Site 1557), Rosario
BC Cancer - Vancouver Center ( Site 0110), Vancouver
CancerCare Manitoba ( Site 0108), Winnipeg
Moncton Hospital ( Site 0107), Moncton
Ottawa Hospital Research Institute ( Site 0109), Ottawa
Jewish General Hospital ( Site 0106), Montreal
Fundacion Colombiana de Cancerología Clinica Vida ( Site 1653), Medellín
Fakultni nemocnice u sv. Anny v Brne ( Site 0253), Brno
Fakultni nemocnice Hradec Kralove-Klinika onkologie a radioterapie ( Site 0254), Hradec Králové
Fakultni Thomayerova nemocnice ( Site 0252), Prague
Universitaetsklinikum Carl Gustav Carus ( Site 0509), Dresden
Krankenhaus Martha Maria Halle-Doelau ( Site 0507), Halle
"General Hospital of Athens Alexandra ( Site 0303)", Athens
Athens Medical Center ( Site 0304), Athens
ATTIKON GENERAL UNIVERSITY HOSPITAL ( Site 0301), Chaïdári
University General Hospital of Larissa ( Site 0302), Larissa
Nagoya University Hospital ( Site 1512), Nagoya
Hirosaki University Hospital ( Site 1501), Hirosaki
University of Tsukuba Hospital ( Site 1502), Tsukuba
Kanazawa University Hospital ( Site 1509), Kanazawa
Kitasato University Hospital ( Site 1506), Sagamihara
Yokohama City University Medical Center ( Site 1508), Yokohama
Kanagawa Cancer Center ( Site 1507), Yokohama
Tohoku University Hospital ( Site 1503), Sendai
Hamamatsu University Hospital ( Site 1511), Hamamatsu
Gifu University Hospital ( Site 1513), Gifu
Nagasaki University Hospital ( Site 1517), Nagasaki
Okayama University Hospital ( Site 1516), Okayama
Osaka International Cancer Institute ( Site 1514), Osaka
Osaka Metropolitan University Hospital ( Site 1515), Osaka
Institute of Science Tokyo Hospital ( Site 1505), Tokyo
Keio University Hospital ( Site 1504), Tokyo
Toyama University Hospital ( Site 1510), Toyama
Clinical Research Center Medic-R ( Site 1061), Poznan
Mazowiecki Szpital Wojewódzki w Siedlcach-Siedleckie Centrum Onkologii ( Site 1057), Siedlce
Narodowy Instytut Onkologii ( Site 1051), Warsaw
Wojewodzki Szpital im. Sw. Ojca Pio w Przemyslu ( Site 1053), Przemyśl
Szpital Wojewodzki im. Mikolaja Kopernika ( Site 1055), Koszalin
Unidade Local de Saude de Coimbra - Hospitais da Universidade de Coimbra ( Site 0406), Coimbra
Inst. Portugues de Oncologia de Lisboa Francisco Gentil EPE ( Site 0409), Lisbon
Unidade Local de Saude Lisboa Ocidental - Hospital de São Francisco Xavier ( Site 0401), Lisbon
Unidade Local de Saude de Santo António - Hospital Santo António ( Site 0408), Porto
MEMORIAL HEALTHCARE INTERNATIONAL S.R.L. ( Site 1104), Bucharest
Steve Biko Academic Hospital ( Site 0601), Pretoria
Asan Medical Center ( Site 1352), Songpagu
Korea University Anam Hospital ( Site 1357), Seoul
Seoul National University Hospital ( Site 1351), Seoul
Hospital Germans Trias i Pujol. ICO de Badalona ( Site 0658), Badalona
Xarxa Assistencial Universitaria Manresa ( Site 0655), Manresa
Hospital Universitari Vall d'Hebron-Departamento de Oncologia- VHIO ( Site 0661), Barcelona
Torbay Hospital ( Site 1804), Torquay
Charing Cross Hospital-Oncology Research ( Site 1802), London
St Bartholomew's Hospital-Centre for Experimental Cancer Medicine ( Site 1801), London
Collaborators (1)
Seagen Inc.
INDUSTRY
Astellas Pharma Inc
INDUSTRY
Merck Sharp & Dohme LLC
INDUSTRY