907
Participants
Start Date
June 13, 2019
Primary Completion Date
January 26, 2026
Study Completion Date
September 1, 2026
Pembrolizumab
Pembrolizumab 200 mg by intravenous (IV) infusion, given on Day 1 of each 21-day cycle
Gemcitabine
Gemcitabine 1000 mg/m\^2, IV infusion on Days 1 and 8 of each 21-day cycle
Cisplatin
Cisplatin 70 mg/m\^2, IV infusion 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.
Placebo
Placebo to pembrolizumab by IV infusion, given on Day 1 of each 21-day cycle
UZ Brussel ( Site 0358), Brussels
Bajcsy Zsilinszki Korhaz es Rendelointezet ( Site 1001), Budapest
Rigshospitalet University Hospital ( Site 0401), Copenhagen
Southside Cancer Care Centre ( Site 1252), Sydney
Mid North Coast Cancer Institute ( Site 1256), Port Macquarie
Herlev og Gentofte Hospital. ( Site 0402), Herlev
Eastern Health ( Site 1255), Box Hill
Peninsula Health Frankston Hospital ( Site 1258), Frankston
Jessa Ziekenhuis ( Site 0360), Hasselt
Debreceni Egyetem Klinikai Kozpont ( Site 1006), Debrecen
Cairns Base Hospital ( Site 1257), Cairns
Odense Universitetshospital ( Site 0403), Odense
Jasz Nagykun Szolnok Megyei Hetenyi Geza Korhaz Rendelointezet ( Site 1002), Szolnok
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
Pecsi Tudomanyegyetem AOK ( Site 1009), Pécs
AZ Maria Middelares Gent ( Site 0353), Ghent
Petz Aladar Megyei Oktato Korhaz ( Site 1012), Győr
O.L.V. Ziekenhuis Aalst ( Site 0356), Aalst
Hospital San Pedro de Alcantara ( Site 0654), Cáceres
New York University Perlmutter Cancer Center ( Site 0008), New York
Charite Universitaetsmedizin Berlin ( Site 0515), Berlin
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 0522), Berlin
Seoul National University Bundang Hospital ( Site 1356), Seongnam-si
Centre Francois Baclesse ( Site 0459), Caen
Instituto Nacional de Cancerologia ( Site 0256), Tlalpan
Allegheny General Hospital ( Site 0048), Pittsburgh
H. de Gerona Dr. Josep Trueta ( Site 0651), Girona
Cherkasy Regional Oncology Dispensary ( Site 0959), Cherkasy
Georgetown University Medical Center ( Site 0022), Washington D.C.
Investigacion Biomedica para el Desarrollo de Farmacos S.A. de C.V. ( Site 0300), Aguascalientes
Istituto Nazionale Studio e Cura dei Tumori ( Site 0551), Milan
Inova Schar Cancer Institute ( Site 0007), Fairfax
Centre Armoricain de Radiotherapie Imagerie medicale et Oncologie ( Site 0457), Plérin
Universitaetsklinikum Schleswig-Holstein-Campus Lubeck ( Site 0512), Lübeck
Charleston Area Medical Center ( Site 0023), Charles Town
Fondazione Salvatore Maugeri IRCCS. ( Site 0554), Pavia
Hospital Universitario Ramon y Cajal ( Site 0660), Madrid
Hospital Universitario San Carlos ( Site 0663), Madrid
Hospital Universitario La Paz ( Site 0661), Madrid
Hospital Universitario Quiron Madrid ( Site 0657), Pozuelo de Alarcón
Centro Estatal de Cancerologia de Chihuahua ( Site 0253), Chihuahua City
AdventHealth Orlando-AdventHealth Medical Group Hematology & Oncology at Orlando ( Site 0005), Orlando
CHU de Bordeaux- Hopital Saint Andre ( Site 0456), Bordeaux
Istanbul Universitesi Cerrahpasa Tip Fakultesi ( Site 0910), Istanbul
CHU de Montpellier - Hopital Saint-Eloi ( Site 0469), Montpellier
TC Saglik Bakanligi Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi-oncology ( Site 0906), Istanbul
Universitesi Pendik Egitim ve Arastirma Hastanesi ( Site 0901), Istanbul
Universitaetsklinikum Magdeburg A.o.R. ( Site 0516), Magdeburg
Srinagarind Hospital ( Site 1454), Khon Kaen
Hospital Nuestra Sra. de Valme ( Site 0658), Seville
Policlinico di Modena ( Site 0553), Modena
Necmettin Erbakan Universitesi Meram Tip Fakultesi Hastanesi ( Site 0909), Konya
University Hospitals Cleveland Medical Center ( Site 0038), Cleveland
Instituto Valenciano de Oncologia - IVO ( Site 0662), Valencia
Indiana University Melvin and Bren Simon Cancer Center ( Site 0004), Indianapolis
Parkview Cancer Institute ( Site 0077), Fort Wayne
Henry Ford Hospital ( Site 0039), Detroit
Institut de Cancerologie de l Ouest Site Paul Papin ( Site 0453), Angers
MI Dnipr Regional Clinical Hospital named after I.I. Mechnikov ( Site 0963), Dnipropetrovsk
Regional Oncological Hospital ( Site 0956), Dnipro
Dnipropetrovsk City Multidiscipline Clinical Hosp. 4 of DRC ( Site 0951), Dnipro
Maharaj Nakorn Chiangmai Hospital ( Site 1453), Chiang Mai
Sakarya Universitesi Tip Fakultesi ( Site 0913), Sakarya
Hopital Robert Schuman ( Site 0452), Metz
Reg. Clinical Center of Urology and Nephrology n.a. V. I. Shapoval ( Site 0969), Kharkiv
"CNPE Regional Center of Oncology ( Site 0958)", Kharkiv
Karadeniz Teknik Universitesi Tip Fakultesi Farabi Hastanesi ( Site 0904), Trabzon
Centre Jean Perrin ( Site 0460), Clermont-Ferrand
Mercy Hospital Saint Louis ( Site 0064), St Louis
Centro de Urologia Avanzada del Noreste S.A. de C.V. ( Site 0254), Monterrey
Centre Leon Berard ( Site 0465), Lyon
Ochsner Medical Center ( Site 0049), New Orleans
Clinique Victor Hugo ( Site 0463), Le Mans
Klinikum der Eberhard-Karls-Universitaet Tuebingen ( Site 0502), Tübingen
Oklahoma Cancer Specialists and Research Institute, LLC ( Site 0021), Tulsa
CHU de Rouen ( Site 0493), Rouen
Central Texas Veterans Healthcare System ( Site 0057), Temple
MD Anderson Cancer Center ( Site 0063), Houston
Lviv Regional Clinical Hospital ( Site 0955), Lviv
Lviv State Oncology Regional Treatment and Diagnostic Center ( Site 0967), Lviv
Istituto Nazionale Per Lo Studio E La Cura Dei Tumori ( Site 0552), Napoli
Institut Sainte Catherine ( Site 0454), Avignon
UNM Comprehensive Cancer Center-Clinical Research Office ( Site 0045), Albuquerque
Providence Saint John's Health Center ( Site 0075), Santa Monica
Universitaetsklinikum Erlangen ( Site 0505), Erlangen
Scripps MD Anderson ( Site 0010), La Jolla
Hopital Foch ( Site 0483), Suresnes
A.O.U. Policlinico Vittorio Emanuele - Presidio Gaspare Rodolico ( Site 0559), Catania
Portland VA Medical Center ( Site 0084), Portland
Seattle Cancer Care Alliance/Univ of Washington Medical Center ( Site 0033), Seattle
Northwest Medical Specialties, PLLC ( Site 0061), Puyallup
"FSBI United Hospital with Polyclinic of the Administrative Department of the President of the Ru", 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
Kursk Regional Clinical Oncology Dispensary ( Site 0854), Kursk
Saratov State Medical University n.a. V.I.Razumovskiy ( Site 0866), Saratov
Clinic of Bashkortostan State Medical University ( Site 0869), Ufa
Volga District Medical Center Federal Medical and Biological Agency ( Site 0857), Nizhny Novgorod
Omsk Clinical Oncology Dispensary ( Site 0865), Omsk
Krasnoyarsk Regional Clinical Oncological Dispensary ( Site 0861), Krasnoyarsk
Ha Emek Medical Center ( Site 0808), Afula
National Cancer Center Hospital East ( Site 1504), Kashiwa
Rambam Health Care Campus-Oncology Division ( Site 0802), Haifa
Meir Medical Center ( Site 0803), Kfar Saba
Rabin Medical Center ( Site 0804), Petah Tikva
Sheba Medical Center ( Site 0801), Ramat Gan
Sourasky Medical Center ( Site 0807), Tel Aviv
Yitzhak Shamir Medical Center ( Site 0805), Ẕerifin
Soroka Medical Center ( Site 0806), Beersheba
Shaare Zedek Medical Center ( Site 0809), Jerusalem
Hadassah Ein Kerem Medical Center ( Site 0810), Jerusalem
New England Cancer Specialists ( Site 0070), Scarborough
UMass Memorial Medical Center ( Site 0051), Worcester
Morristown Medical Center ( Site 0015), Morristown
Tom Baker Cancer Centre ( Site 0100), Calgary
Nova Scotia Health Authority ( Site 0109), Halifax
Kingston Health Sciences Centre ( Site 0103), Kingston
Lakeridge Health ( Site 0104), Oshawa
Sunnybrook Research Institute ( Site 0110), Toronto
Princess Margaret Cancer Centre ( Site 0107), Toronto
CIUSSS de l Est de L Ile de Montreal - Hopital Maisonneuve-Rosemont ( Site 0105), Montreal
Centre intégré de cancérologie du CHU de Québec Université Laval, Hôpital de l'Enfant-Jésus ( Site 0, Québec
Universitaetsklinikum Carl Gustav Carus ( Site 0519), Dresden
Cork University Hospital ( Site 0722), Cork
Tallaght University Hospital ( Site 0710), Dublin
University Hospital Waterford ( Site 0723), Waterford
Policlinico Gemelli di Roma ( Site 0558), Roma
Azienda Ospedaliera San Camillo Forlanini ( Site 0560), Roma
Azienda Ospedaliera Santa Maria Terni ( Site 0557), Terni
Hirosaki University Hospital ( Site 1502), Hirosaki
Ehime University Hospital ( Site 1508), Tōon
Sapporo Medical University Hospital ( Site 1501), Sapporo
University of Tsukuba Hospital ( Site 1503), Tsukuba
Yokosuka Kyosai Hospital ( Site 1509), Yokosuka
Nara Medical University Hospital ( Site 1510), Kashihara
Saitama Medical University International Medical Center ( Site 1505), Hidaka
Chiba Cancer Center ( Site 1506), Chiba
Harasanshin Hospital ( Site 1515), Fukuoka
Hiroshima City Hiroshima Citizens Hospital ( Site 1513), Hiroshima
Nagano Municipal Hospital ( Site 1516), Nagano
Osaka Metropolitan University Hospital ( Site 1512), Osaka
Tokushima University Hospital ( Site 1514), Tokushima
Tokyo Medical and Dental University Hospital ( Site 1517), Tokyo
Centrum Onkologii im.prof. F. Lukaszczyka w Bydgoszczy ( Site 1068), Bydgoszcz
Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego ( Site 1062), Wroclaw
Europejskie Centrum Zdrowia Otwock ( Site 1057), Otwock
Luxmed Onkologia sp. z o. o. ( Site 1051), Warsaw
Beskidzkie Centrum Onkologii im. Jana Pawla II ( Site 1060), Bielsko-Biala
Korea University Anam Hospital ( Site 1351), Seoul
Seoul National University Hospital ( Site 1352), Seoul
Asan Medical Center ( Site 1355), Seoul
Samsung Medical Center ( Site 1353), Seoul
Hospital del Mar ( Site 0653), Barcelona
Laenssjukhuset Ryhov ( Site 1205), Jönköping
Akademiska Sjukhuset ( Site 1201), Uppsala
Cancercentrum ( Site 1204), Umeå
Hacettepe Universitesi Tıp Fakultesi ( Site 0911), Ankara
National Cancer Institute of the MoH of Ukraine ( Site 0962), Kyiv
Kyiv City Clinical Oncology Center ( Site 0960), Kyiv
Aberdeen Royal Infirmary ( Site 0708), Aberdeen
Torbay Hospital ( Site 0704), Torquay
Kent and Canterbury Hospital ( Site 0709), Canterbury
Lister Hospital ( Site 0715), Stevenage
The Royal Marsden Foundation Trust ( Site 0702), London
Imperial College Healthcare NHS Trust ( Site 0721), London
Norfolk & Norwich University Hospital NHS Foundation Trust ( Site 0725), Norwich
Royal Cornwall Hospital ( Site 0703), Truro
Merck Sharp & Dohme LLC
INDUSTRY