Perioperative Enfortumab Vedotin (EV) Plus Pembrolizumab (MK-3475) Versus Neoadjuvant Chemotherapy for Cisplatin-eligible Muscle Invasive Bladder Cancer (MIBC) (MK-3475-B15/ KEYNOTE-B15 / EV-304) (KEYNOTE-B15)

January 25, 2024 updated by: Merck Sharp & Dohme LLC

A Phase 3, Randomized, Open-label Study to Evaluate Perioperative Enfortumab Vedotin Plus Pembrolizumab (MK-3475) Versus Neoadjuvant Gemcitabine and Cisplatin in Cisplatin-eligible Participants With Muscle-invasive Bladder Cancer (KEYNOTE-B15 / EV-304)

The purpose of this study is to assess the antitumor efficacy and safety of perioperative enfortumab vedotin (EV) plus pembrolizumab and radical cystectomy (RC) + pelvic lymph node dissection (PLND) compared with the current standard of care (neoadjuvant chemotherapy [gemcitabine plus cisplatin] and RC + PLND) for participants with MIBC who are cisplatin-eligible. The primary hypothesis is perioperative EV and pembrolizumab and RC + PLND (Arm A) will achieve superior event free survival (EFS) compared with neoadjuvant gemcitabine + cisplatin and RC + PLND (Arm B).

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

784

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Argentina
      • Buenos Aires, Argentina, 1120
        • Centro de Urología (CDU) ( Site 1552)
      • Buenos Aires, Argentina, C1419AHN
        • Asociación de Beneficencia Hospital Sirio Libanés ( Site 1553)
    • Buenos Aires
      • Ciudad autónoma de Buenos Aires, Buenos Aires, Argentina, 1280
        • Hospital Británico de Buenos Aires-Oncology ( Site 1551)
    • Caba
      • ABB, Caba, Argentina, C1199ABB
        • Hospital Italiano de Buenos Aires ( Site 1554)
      • Buenos Aires, Caba, Argentina, C1431FWO
        • Centro de Educación Médica e Investigaciones Clínicas (CEMIC) ( Site 1558)
    • Santa Fe
      • Rosario, Santa Fe, Argentina, 2000
        • Fundacion Estudios Clinicos-Oncology ( Site 1557)
  • Australia
    • New South Wales
      • Macquarie University, New South Wales, Australia, 2109
        • Macquarie University-MQ Health Clinical Trials Unit ( Site 1259)
    • Queensland
      • South Brisbane, Queensland, Australia, 4101
        • Mater Hospital Brisbane ( Site 1257)
    • South Australia
      • Elizabeth Vale, South Australia, Australia, 5112
        • Lyell McEwin Hospital ( Site 1252)
    • Victoria
      • Frankston, Victoria, Australia, 3199
        • Frankston Hospital-Oncology and Haematology ( Site 1258)
  • Bulgaria
      • Plovdiv, Bulgaria, 4000
        • Complex Oncology Center Plovdiv ( Site 1151)
      • Plovdiv, Bulgaria, 4000
        • MHAT Central Onco Hospital OOD ( Site 1158)
      • Sofia, Bulgaria, 1632
        • MHAT Serdika ( Site 1152)
    • Pazardzhik
      • Panagyurishte, Pazardzhik, Bulgaria, 4500
        • MHAT "Uni Hospital" OOD ( Site 1154)
  • Canada
    • British Columbia
      • Vancouver, British Columbia, Canada, V5Z 4E6
        • BC Cancer - Vancouver Center ( Site 0110)
    • Manitoba
      • Winnipeg, Manitoba, Canada, R3E 0V9
        • CancerCare Manitoba ( Site 0108)
    • New Brunswick
      • Moncton, New Brunswick, Canada, E1C 6Z8
        • Moncton Hospital ( Site 0107)
    • Ontario
      • Ottawa, Ontario, Canada, K1H 8L6
        • Ottawa Hospital Research Institute ( Site 0109)
    • Quebec
      • Montreal, Quebec, Canada, H3T 1E2
        • Jewish General Hospital ( Site 0106)
  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510060
        • SUN YAT-SEN UNIVERSITY CANCER CENTRE ( Site 1406)
      • Guangzhou, Guangdong, China, 510120
        • Sun Yat-sen Memorial Hospital, Sun Yat-sen University ( Site 1413)
    • Hunan
      • Changsha, Hunan, China, 410013
        • Hunan Cancer Hospital ( Site 1403)
    • Jiangsu
      • Nanjing, Jiangsu, China, 210000
        • Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School-Urology ( S
      • Nantong, Jiangsu, China, 226361
        • Nantong Tumor Hospital-Urology ( Site 1405)
    • Shanghai
      • Shanghai, Shanghai, China, 200032
        • Fudan University Shanghai Cancer Center-Urology department ( Site 1401)
      • Shanghai, Shanghai, China, 200127
        • Renji Hospital Shanghai Jiao Tong University School of Medicine ( Site 1402)
  • Colombia
    • Antioquia
      • Medellin, Antioquia, Colombia, 050030
        • Fundación Colombiana de Cancerología Clínica Vida ( Site 1653)
    • Cordoba
      • Montería, Cordoba, Colombia, 230002
        • Oncomédica S.A.S ( Site 1652)
    • Distrito Capital De Bogota
      • Bogota, Distrito Capital De Bogota, Colombia, 111321
        • Clinica Colsanitas S.A, Sede Clínica Universitaria Colombia-Center Investigator ( Site 1654)
    • Santander
      • Piedecuesta, Santander, Colombia, 681017
        • Fundación Cardiovascular de Colombia-Santander ( Site 1657)
    • Valle Del Cauca
      • Cali, Valle Del Cauca, Colombia, 760032
        • Fundacion Valle del Lili- CIC ( Site 1656)
  • Croatia
    • Grad Zagreb
      • Zagreb, Grad Zagreb, Croatia, 10000
        • Klinički bolnički centar Sestre milosrdnice ( Site 1703)
      • Zagreb, Grad Zagreb, Croatia, 10000
        • Klinički bolnički centar Zagreb-Klinika za onkologiju ( Site 1701)
    • Osjecko-baranjska Zupanija
      • Osijek, Osjecko-baranjska Zupanija, Croatia, 31000
        • Klinički bolnički centar Osijek ( Site 1705)
    • Splitsko-dalmatinska Zupanija
      • Split, Splitsko-dalmatinska Zupanija, Croatia, 21000
        • Klinički Bolnički Centar Split-Oncology and Radiotherapy ( Site 1702)
  • Czechia
      • Hradec Kralove, Czechia, 500 05
        • Fakultni nemocnice Hradec Kralove-Klinika onkologie a radioterapie ( Site 0254)
      • Olomouc, Czechia, 779 00
        • Fakultni Nemocnice Olomouc ( Site 0251)
      • Praha 4, Czechia, 140 59
        • Fakultni Thomayerova nemocnice ( Site 0252)
    • Jihomoravsky Kraj
      • Brno, Jihomoravsky Kraj, Czechia, 656 91
        • Fakultni nemocnice u sv. Anny v Brne ( Site 0253)
  • France
      • Paris, France, 75020
        • Hopital Diaconesses Croix Saint Simon ( Site 0465)
    • Bouches-du-Rhone
      • Marseille, Bouches-du-Rhone, France, 13005
        • CHU La Timone ( Site 0456)
    • Doubs
      • Besancon, Doubs, France, 25000
        • CHU Jean Minjoz ( Site 0453)
    • Finistere
      • Brest, Finistere, France, 29200
        • CHU de Brest -Site Hopital Morvan ( Site 0461)
    • Haute-Garonne
      • Toulouse, Haute-Garonne, France, 31059
        • Institut Universitaire du Cancer Toulouse - Oncopole ( Site 0455)
    • Haute-Vienne
      • Limoges, Haute-Vienne, France, 87042
        • CHU Limoges Hopital Dupuytren ( Site 0459)
    • Ile-de-France
      • Villejuif, Ile-de-France, France, 94800
        • Gustave Roussy ( Site 0467)
    • Isere
      • La Tronche, Isere, France, 38700
        • CHU GRENOBLE ALPES ( Site 0468)
    • Loiret
      • Orleans, Loiret, France, 45067
        • Centre Hospitalier Regional du Orleans ( Site 0463)
    • Nord
      • Lille, Nord, France, 59000
        • Polyclinique du Bois ( Site 0458)
  • Germany
      • Berlin, Germany, 10967
        • Vivantes Klinikum Am Urban ( Site 0519)
    • Baden-Wurttemberg
      • Freiburg, Baden-Wurttemberg, Germany, 79106
        • Universitaetsklinikum Freiburg ( Site 0512)
      • Tuebingen, Baden-Wurttemberg, Germany, 72076
        • Universitaetsklinik fuer Urologie ( Site 0501)
    • Bayern
      • Regensburg, Bayern, Germany, 93053
        • Caritas Krankenhaus St. Josef ( Site 0502)
      • Wuerzburg, Bayern, Germany, 97080
        • Universitaetsklinikum Wuerzburg ( Site 0520)
    • Nordrhein-Westfalen
      • Herne, Nordrhein-Westfalen, Germany, 44625
        • Kath. Krankenhaus Marienhospital. Universitaetsklinik ( Site 0511)
      • Muenster, Nordrhein-Westfalen, Germany, 48149
        • Universitaetsklinikum Muenster ( Site 0516)
    • Sachsen
      • Dresden, Sachsen, Germany, 01307
        • Universitaetsklinikum Carl Gustav Carus ( Site 0509)
    • Sachsen-Anhalt
      • Halle, Sachsen-Anhalt, Germany, 06120
        • Krankenhaus Martha Maria Halle-Doelau ( Site 0507)
  • Greece
    • Achaia
      • Patras, Achaia, Greece, 26504
        • UNIVERSITY HOSPITAL OF PATRAS-DIVISION OF ONCOLOGY ( Site 0305)
    • Attiki
      • Athens, Attiki, Greece, 115 28
        • General Hospital of Athens "Alexandra" ( Site 0303)
      • Athens, Attiki, Greece, 151 25
        • Athens Medical Center ( Site 0304)
      • Chaidari, Attiki, Greece, 124 62
        • ATTIKON GENERAL UNIVERSITY HOSPITAL ( Site 0301)
    • Thessalia
      • Larissa, Thessalia, Greece, 411 10
        • University General Hospital of Larissa ( Site 0302)
  • Hungary
      • Debrecen, Hungary, 4032
        • Debreceni Egyetem Klinikai Kozpont ( Site 1006)
    • Csongrad
      • Szeged, Csongrad, Hungary, 6720
        • Szegedi Tudományegyetem Szent-Györgyi Albert Klinikai Központ ( Site 1010)
    • Jasz-Nagykun-Szolnok
      • Szolnok, Jasz-Nagykun-Szolnok, Hungary, 5000
        • Jász-Nagykun-Szolnok Vármegyei Hetényi Géza Kórház ( Site 1002)
  • Israel
      • Haifa, Israel, 3109601
        • Rambam Health Care Campus-Oncology ( Site 0751)
      • Jerusalem, Israel, 9112001
        • Hadassah Medical Center-Oncology ( Site 0757)
      • Kfar Saba, Israel, 4428164
        • Meir Medical Center-oncology ( Site 0754)
      • Petah-Tikva, Israel, 4941492
        • Rabin Medical Center-Oncology ( Site 0752)
      • Ramat Gan, Israel, 5262100
        • Sheba Medical Center-ONCOLOGY ( Site 0753)
      • Tel Aviv, Israel, 6423906
        • Sourasky Medical Center-Oncology ( Site 0755)
      • Zerifin, Israel, 70300
        • Yitzhak Shamir Medical Center-Oncology ( Site 0756)
  • Italy
      • Ancona, Italy, 60126
        • Azienda Ospedaliero Universitaria delle Marche-Clinica Oncologica ( Site 0593)
      • Catania, Italy, 95126
        • Ospedale Cannizzaro ( Site 0590)
      • Milano, Italy, 20132
        • IRCCS Ospedale San Raffaele ( Site 0596)
      • Padova, Italy, 35128
        • Istituto Oncologico Veneto IRCCS-Oncologia Medica 1 ( Site 0600)
    • Lombardia
      • Milan, Lombardia, Italy, 20133
        • Fondazione IRCCS Istituto Nazionale dei Tumori-Struttura Complessa Oncologia Medica 1 ( Site 0588)
    • Napoli
      • Pozzuoli, Napoli, Italy, 80078
        • Presidio Ospedaliero Santa Maria delle Grazie ( Site 0599)
    • Torino
      • Orbassano, Torino, Italy, 10043
        • AOU San Luigi Gonzaga di Orbassano ( Site 0595)
    • Veneto
      • Verona, Veneto, Italy, 37126
        • Azienda Ospedaliera Universitaria Integrata Verona - Ospedale Borgo Trento ( Site 0598)
  • Japan
      • Gifu, Japan, 501-1194
        • Gifu University Hospital ( Site 1513)
      • Nagasaki, Japan, 852-8510
        • Nagasaki University Hospital ( Site 1517)
      • Okayama, Japan, 700-8558
        • Okayama University Hospital ( Site 1516)
      • Osaka, Japan, 541-8567
        • Osaka International Cancer Institute ( Site 1514)
      • Osaka, Japan, 545-8586
        • Osaka Metropolitan University Hospital ( Site 1515)
      • Tokyo, Japan, 113-8519
        • Tokyo Medical and Dental University Hospital ( Site 1505)
      • Tokyo, Japan, 160-8582
        • Keio University Hospital ( Site 1504)
      • Toyama, Japan, 930-0194
        • Toyama University Hospital ( Site 1510)
    • Aichi
      • Nagoya, Aichi, Japan, 466-8560
        • Nagoya University Hospital ( Site 1512)
    • Aomori
      • Hirosaki, Aomori, Japan, 036-8563
        • Hirosaki University Hospital ( Site 1501)
    • Ibaraki
      • Tsukuba, Ibaraki, Japan, 305-8576
        • University of Tsukuba Hospital ( Site 1502)
    • Ishikawa
      • Kanazawa, Ishikawa, Japan, 920-8641
        • Kanazawa University Hospital ( Site 1509)
    • Kanagawa
      • Sagamihara, Kanagawa, Japan, 252-0375
        • Kitasato University Hospital ( Site 1506)
      • Yokohama, Kanagawa, Japan, 232-0024
        • Yokohama City University Medical Center ( Site 1508)
      • Yokohama, Kanagawa, Japan, 241-8515
        • Kanagawa Cancer Center ( Site 1507)
    • Miyagi
      • Sendai, Miyagi, Japan, 980-8574
        • Tohoku University Hospital ( Site 1503)
    • Shizuoka
      • Hamamatsu, Shizuoka, Japan, 431-3192
        • Hamamatsu University Hospital ( Site 1511)
  • Korea, Republic of
      • Incheon, Korea, Republic of, 21565
        • Gachon University Gil Medical Center ( Site 1356)
      • Seoul, Korea, Republic of, 02841
        • Korea University Anam Hospital ( Site 1357)
      • Seoul, Korea, Republic of, 03080
        • Seoul National University Hospital ( Site 1351)
    • Jeonranamdo
      • Jeollanam-do, Jeonranamdo, Korea, Republic of, 58128
        • Chonnam National University Hwasun Hospital ( Site 1353)
    • Kyonggi-do
      • Gyeonggi-do, Kyonggi-do, Korea, Republic of, 13620
        • Seoul National University Bundang Hospital ( Site 1355)
    • Seoul
      • Songpagu, Seoul, Korea, Republic of, 05505
        • Asan Medical Center ( Site 1352)
    • Taegu-Kwangyokshi
      • Daegu, Taegu-Kwangyokshi, Korea, Republic of, 41404
        • Kyungpook National University Chilgok Hospital ( Site 1354)
  • Malaysia
    • Kuala Lumpur
      • Lembah Pantai, Kuala Lumpur, Malaysia, 59100
        • University Malaya Medical Centre ( Site 0352)
    • Pulau Pinang
      • George Town, Pulau Pinang, Malaysia, 10990
        • Hospital Pulau Pinang ( Site 0355)
    • Sarawak
      • Kuching, Sarawak, Malaysia, 93586
        • Sarawak General Hospital ( Site 0351)
    • Selangor
      • Petaling Jaya, Selangor, Malaysia, 47500
        • Sunway Medical Centre ( Site 0353)
  • Philippines
    • Iloilo
      • Iloilo City, Iloilo, Philippines, 5000
        • THE MEDICAL CITY ILOILO-The Medical City Iloilo - Clinical and Translational Research Institute-Ilo
  • Poland
    • Dolnoslaskie
      • Wrocław, Dolnoslaskie, Poland, 50-556
        • Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wrocławiu ( Site 1058)
    • Mazowieckie
      • Siedlce, Mazowieckie, Poland, 08-110
        • Mazowiecki Szpital Wojewódzki w Siedlcach-Siedleckie Centrum Onkologii ( Site 1057)
      • Warszawa, Mazowieckie, Poland, 02-781
        • Narodowy Instytut Onkologii ( Site 1051)
    • Podkarpackie
      • Przemysl, Podkarpackie, Poland, 37-700
        • Wojewodzki Szpital im. Sw. Ojca Pio w Przemyslu ( Site 1053)
    • Wielkopolskie
      • Poznan, Wielkopolskie, Poland, 61-731
        • Clinical Research Center Medic-R ( Site 1061)
    • Zachodniopomorskie
      • Koszalin, Zachodniopomorskie, Poland, 75-581
        • Szpital Wojewodzki im. Mikolaja Kopernika ( Site 1055)
  • Portugal
      • Coimbra, Portugal, 3000-075
        • Centro Hospitalar e Universitario de Coimbra ( Site 0406)
      • Lisboa, Portugal, 1099-023
        • Inst. Portugues de Oncologia de Lisboa Francisco Gentil EPE ( Site 0409)
      • Lisboa, Portugal, 1449-005
        • CHLO, EPE - Hospital de Sao Francisco Xavier ( Site 0401)
      • Porto, Portugal, 4099-001
        • Hospital Geral de Santo Antonio ( Site 0408)
  • Romania
      • Bucuresti, Romania, 022548
        • SC Focus Lab Plus SRL ( Site 1104)
      • Cluj, Romania, 400015
        • Institutul Oncologic Cluj-Oncologie Medicala ( Site 1109)
    • Cluj
      • Cluj Napoca, Cluj, Romania, 400015
        • Institutul Oncologic Prof.Dr. Ion Chiricuta Cluj-Napoca ( Site 1102)
      • Cluj-Napoca, Cluj, Romania, 400015
        • Cardiomed SRL Cluj-Napoca ( Site 1101)
      • Cluj-Napoca, Cluj, Romania, 400015
        • Institutul Oncologic Prof.Dr. Ion Chiricuta Cluj-Napoca ( Site 1103)
      • Comuna Floresti, Cluj, Romania, 407280
        • SC Radiotherapy Center Cluj SRL ( Site 1108)
    • Dolj
      • Craiova, Dolj, Romania, 200542
        • S.C. Centrul de Oncologie Sf. Nectarie SRL ( Site 1107)
    • Timis
      • Timisoara, Timis, Romania, 300239
        • Policlinica Oncomed SRL ( Site 1106)
  • Russian Federation
    • Altayskiy Kray
      • Barnaul, Altayskiy Kray, Russian Federation, 656040
        • Altay Regional Oncology Dispensary ( Site 0851)
    • Kaluzskaja Oblast
      • Obninsk, Kaluzskaja Oblast, Russian Federation, 249036
        • National Medical Research Radiology Centre ( Site 0869)
    • Moskva
      • Moscow, Moskva, Russian Federation, 115230
        • National Medical Research Centre of Oncology named after N.N. Blokhin ( Site 0865)
      • Moscow, Moskva, Russian Federation, 119991
        • First Moscow State Medical University n.a. I.M.Sechenov ( Site 0871)
    • Nizhegorodskaya Oblast
      • Nizhny Novgorod, Nizhegorodskaya Oblast, Russian Federation, 603074
        • Volga District Medical Center ( Site 0876)
    • Sankt-Peterburg
      • Saint Petersburg, Sankt-Peterburg, Russian Federation, 194017
        • St.Petersburg Clinical Hospital RAS ( Site 0864)
      • Saint Petersburg, Sankt-Peterburg, Russian Federation, 197101
        • St.Petersburg State Medical Univ. n.a. acad. I.P.Pavlov ( Site 0856)
      • Saint Petersburg, Sankt-Peterburg, Russian Federation, 197758
        • Scientific Research Oncology Institute n.a. N.N.Petrov ( Site 0852)
    • Sverdlovskaya Oblast
      • Ekaterinburg, Sverdlovskaya Oblast, Russian Federation, 620036
        • Sverdlovsk Regional Oncology Hospital ( Site 0867)
      • Ekaterinburg, Sverdlovskaya Oblast, Russian Federation, 620102
        • Sverdlovsky Regional Clinical hospital #1 ( Site 0868)
    • Volgogradskaya Oblast
      • Volzhsky, Volgogradskaya Oblast, Russian Federation, 404120
        • Volgograd Regional Uronephrological Center ( Site 0870)
  • Singapore
    • Central Singapore
      • Singapore, Central Singapore, Singapore, 308442
        • Tan Tock Seng Hospital ( Site 0704)
  • South Africa
    • Gauteng
      • Johannesburg, Gauteng, South Africa, 2193
        • Wits Clinical Research ( Site 0603)
      • Pretoria, Gauteng, South Africa, 0002
        • Steve Biko Academic Hospital ( Site 0601)
    • Western Cape
      • Cape Town, Western Cape, South Africa, 7925
        • Groote Schuur Hospital ( Site 0602)
  • Spain
      • Barcelona, Spain, 08035
        • Hospital Universitari Vall d'Hebron-Departamento de Oncologia- VHIO ( Site 0661)
      • Madrid, Spain, 28040
        • Hospital Clinico Universitario San Carlos de Madrid ( Site 0651)
      • Sevilla, Spain, 41013
        • Hospital Virgen del Rocio ( Site 0659)
    • Asturias
      • Oviedo, Asturias, Spain, 33011
        • Hospital Universitario Central de Asturias ( Site 0654)
    • Barcelona
      • Badalona, Barcelona, Spain, 08916
        • Hospital Germans Trias i Pujol. ICO de Badalona ( Site 0658)
      • Manresa, Barcelona, Spain, 08243
        • Xarxa Assistencial Universitaria Manresa ( Site 0655)
    • Gerona
      • Girona, Gerona, Spain, 17007
        • Institut Català d'Oncologia (ICO) - Girona ( Site 0653)
    • La Coruna
      • Santiago de Compostela, La Coruna, Spain, 15706
        • CHUS - Hospital Clinico Universitario-Servicio de Oncologia ( Site 0660)
    • Las Palmas
      • Las Palmas de Gran Canaria, Las Palmas, Spain, 35001
        • Hospital Universitario Insular de Gran Canaria ( Site 0657)
    • Valenciana, Comunitat
      • Valencia, Valenciana, Comunitat, Spain, 46009
        • Fundación Instituto Valenciano de Oncología-Oncologico ( Site 0662)
  • Taiwan
      • Taichung, Taiwan, 404332
        • China Medical University Hospital ( Site 1202)
      • Taipei, Taiwan, 11217
        • Taipei Veterans General Hospital ( Site 1201)
    • Kaohsiung
      • Kaohsiung Niao Sung Dist, Kaohsiung, Taiwan, 83301
        • Chang Gung Memorial Hospital at Kaohsiung ( Site 1203)
  • Ukraine
    • Dnipropetrovska Oblast
      • Dnipro, Dnipropetrovska Oblast, Ukraine, 49005
        • I.I. Mechnykov Dnipropetrovsk Regional Clinical Hospital ( Site 0959)
      • Dnipro, Dnipropetrovska Oblast, Ukraine, 49055
        • MI Clinical oncology dispensary of Dnipropetrovsk regional council ( Site 0954)
    • Kharkivska Oblast
      • Kharkiv, Kharkivska Oblast, Ukraine, 61037
        • Regional Clinical Center of Urology and Nephrology n.a. V.I. Shapoval ( Site 0952)
      • Kharkiv, Kharkivska Oblast, Ukraine, 61070
        • MNPE Regional Center of Oncology ( Site 0955)
      • Kharkiv, Kharkivska Oblast, Ukraine, 61166
        • Municipal Non-profit Enterprise of Kharkiv Regional Council RCSDRPP ( Site 0965)
    • Lvivska Oblast
      • Lviv, Lvivska Oblast, Ukraine, 79031
        • Lviv Oncology Regional Treatment and Diagnostic Center ( Site 0960)
    • Zhytomyrska Oblast
      • Zhytomyr, Zhytomyrska Oblast, Ukraine, 10002
        • Zhytomyr Regional Oncology Center ( Site 0961)
  • United Kingdom
    • Devon
      • Torquay, Devon, United Kingdom, TQ2 7AA
        • Torbay Hospital ( Site 1804)
    • London, City Of
      • London, London, City Of, United Kingdom, EC1A 7BE
        • St Bartholomew's Hospital-Centre for Experimental Cancer Medicine ( Site 1801)
      • London, London, City Of, United Kingdom, W2 1NY
        • Imperial College Healthcare NHS Foundation Trust - St Mary's Hospital ( Site 1802)
  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85054
        • Mayo Clinic in Arizona - Phoenix ( Site 0043)
    • California
      • Fullerton, California, United States, 92835
        • St Joseph Heritage Healthcare-Oncology ( Site 0035)
      • Los Angeles, California, United States, 90095
        • UCLA Hematology/Oncology - Westwood (Building 200 Suite 140)-Department of Urology/Institute of Uro
      • San Francisco, California, United States, 94158
        • University of California San Francisco ( Site 0010)
      • Stanford, California, United States, 94305-5826
        • Stanford University ( Site 0023)
    • Colorado
      • Aurora, Colorado, United States, 80045
        • University of Colorado, Anschutz Cancer Pavilion ( Site 0009)
    • Florida
      • Gainesville, Florida, United States, 32608
        • UF Health ( Site 0031)
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Indiana University Melvin and Bren Simon Cancer Center ( Site 0050)
    • Iowa
      • Iowa City, Iowa, United States, 52242
        • University of Iowa Hospital and Clinics ( Site 0029)
    • Kentucky
      • Louisville, Kentucky, United States, 40202
        • University of Louisville, James Graham Brown Cancer Center ( Site 0022)
    • New York
      • New York, New York, United States, 10029
        • Icahn School of Medicine at Mount Sinai ( Site 0011)
      • White Plains, New York, United States, 10601
        • White Plains Hospital ( Site 0039)
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Duke University Medical Center ( Site 0017)
      • Winston-Salem, North Carolina, United States, 27157
        • Wake Forest Baptist Health ( Site 0014)
    • Oregon
      • Portland, Oregon, United States, 97239-3011
        • Oregon Health and Science University ( Site 0028)
    • Pennsylvania
      • Bala-Cynwyd, Pennsylvania, United States, 19004
        • MidLantic Urology ( Site 0002)
    • South Carolina
      • Greenville, South Carolina, United States, 29607
        • Saint Francis Cancer Center ( Site 0008)
    • Tennessee
      • Knoxville, Tennessee, United States, 37920
        • The University of Tennessee Medical Center ( Site 0034)
    • Texas
      • Dallas, Texas, United States, 75390
        • UT Southwestern Medical Center ( Site 0003)
      • Houston, Texas, United States, 77030
        • Houston Methodist Urology Associates ( Site 0033)
      • San Antonio, Texas, United States, 78229
        • Urology of San Antonio ( Site 0020)
    • Wisconsin
      • Madison, Wisconsin, United States, 53792
        • University of Wisconsin Hospital and Clinics ( Site 0037)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Have a histologically confirmed diagnosis of urothelial carcinoma (UC) / muscle invasive bladder cancer (MIBC) (T2-T4aN0M0 or T1-T4aN1M0) with predominant (≥50%) urothelial histology.
  • Have clinically non-metastatic bladder cancer (N≤1 M0) determined by imaging (computed tomography (CT) or magnetic resonance imaging (MRI) of the chest/abdomen/pelvis
  • Be deemed eligible for Radical Cystectomy (RC) + Pelvic Lymph Node Dissection (PLND)
  • Have Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  • Have adequate organ function.

Exclusion Criteria:

  • Has a known additional malignancy that is progressing or has required active anti-cancer treatment ≤3 years of study randomization with certain exceptions
  • Has received any prior systemic treatment for MIBC or non-invasive muscle bladder cancer (NMIBC - prior treatment for NMIBC with intravesical BCG/chemotherapy is permitted) or prior therapy with an anti- programmed cell death 1 (PD-1), anti-programmed cell death ligand 1/ ligand 2 (PD-L1/L2), or anti-cytotoxic T-lymphocyte-associated protein 4 (CTLA-4)
  • Has ≥N2 disease or metastatic disease (M1) as identified by imaging
  • Is cisplatin-ineligible, as defined by meeting any one of the cisplatin ineligibility criteria as per protocol
  • Has received prior systemic anticancer therapy including investigational agents within 3 years of randomization or any radiotherapy to the bladder
  • Has undergone partial cystectomy of the bladder to remove any NMIBC or MIBC
  • Has received a live or live attenuated vaccine within 30 days before the first dose of study intervention
  • Has a diagnosis of immunodeficiency or has a known history of human immunodeficiency virus (HIV) infection. Hepatitis B infection or known active Hepatitis C infection
  • Has a known psychiatric or substance abuse disorder
  • Has had an allogenic tissue/solid organ transplant
  • Has ongoing sensory or motor neuropathy Grade 2 or higher
  • Has active keratitis (superficial punctate keratitis) or corneal ulcerations
  • Has a history of uncontrolled diabetes defined as hemoglobin A1c (HbA1c) ≥8% or HbA1c 7% to <8% with associated diabetes symptoms

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Arm A: Perioperative EV+ Pembrolizumab and RC + PLND
Participants receive 4 cycles (each cycle length = 21 days) of EV intravenous (IV) infusion plus pembrolizumab IV infusion preoperatively, followed by RC + PLND, followed by 5 cycles of adjuvant EV IV infusion plus 13 cycles of adjuvant pembrolizumab IV infusion postoperatively. The total treatment duration is up to approximately 1 year.
Biological: 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.
Other Names:
  • MK-3475
  • KEYTRUDA®
Biological: 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.
Other Names:
  • Padcev
Procedure: 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).
Other Names:
  • Surgery
Active Comparator: Arm B: Standard of Care (SOC)-Neoadjuvant chemotherapy (gemcitabine + cisplatin) and RC + PLND
Participants receive 4 cycles (each cycle length = 21 days) of standard of care (SOC) chemotherapy (gemcitabine IV infusion plus cisplatin IV infusion) preoperatively, followed by RC + PLND. The total treatment duration is up to approximately 3 months.
Procedure: 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).
Other Names:
  • Surgery
Drug: 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)
Other Names:
  • Gemzar
Drug: Cisplatin
70 mg/m^2 of Cisplatin IV infusion, Day 1, Q3W for 4 cycles in preoperative phase (up to approximately 3 months)
Other Names:
  • Platinol®
  • Platinol®-AQ

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Event-Free Survival (EFS)
Time Frame: Up to ~68 months
EFS is defined as the time from randomization to the first occurrence of following events: radiographic disease progression precluding RC + PLND, failure to undergo surgery in participants with residual disease, gross residual disease left behind at time of surgery, local or distant recurrence based on blinded independent central review (BICR) or death due to any cause.
Up to ~68 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pathologic Complete Response (pCR) Rate
Time Frame: Up to ~47 months
pCR rate is defined as defined as the proportion of participants having pCR. pCR is defined as absence of viable tumor (pT0N0) in examined tissue from radical cystectomy (RC) + pelvic lymph node dissection (PLND), as assessed by blinded central pathologic review.
Up to ~47 months
Overall Survival (OS)
Time Frame: Up to ~68 months
OS is defined as the time from randomization to death due to any cause.
Up to ~68 months
Pathologic Downstaging (pDS) Rate
Time Frame: Up to ~47 months
pDS is defined as participants with <pT2 (includes pT0, pTis, pTa, and pT1) and N0 in examined tissue from RC plus PLND, based on central pathologic review.
Up to ~47 months
Number of Participants Who Experienced An Adverse Event (AE) (Arm A only)
Time Frame: Up to ~68 months
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants who experience an AE will be presented.
Up to ~68 months
Disease Free Survival (DFS)
Time Frame: From ~12 months to up to ~68 months
DFS is defined as the time from postsurgery baseline scan until the first occurrence of either local/distant recurrence as assessed by BICR imaging and/or biopsy or death from any cause.
From ~12 months to up to ~68 months
Number of Participants Who Discontinued Study Treatment Due to An AE (Arm A only)
Time Frame: Up to ~68 months
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants who discontinue study treatment due to an AE will be presented.
Up to ~68 months
Change from Baseline in the European Organization for Research and Treatment of Cancer (EORTC)-Quality of Life Questionnaire-Core 30 (QLQ-C30) Global Health Status/Quality of Life (Items 29 and 30) Combined Score
Time Frame: Baseline, Up to ~68 months
The EORTC QLQ-C30 is a 30-item questionnaire to assess the overall quality of life in cancer participants. Participant responses to questions 29 ("How would you rate your overall health during the past week?") and 30 ("How would you rate your overall quality of life during the past week?") are scored on a 7-point scale (1= Very poor to 7=Excellent). A higher score indicates a better overall health/quality of life status. The change from baseline in EORTC QLQ-C30 Items 29 and 30 combined scores will be presented.
Baseline, Up to ~68 months
Change from Baseline in EORTC QLQ-C30 Physical Functioning Scale
Time Frame: Baseline, Up to ~68 months
The EORTC QLQ-C30 is a 30-item questionnaire to assess the overall quality of life of cancer patients. Participant responses to 5 questions about their physical functioning are scored on a 4-point scale (1=not at all to 4=very much). A higher score indicates a better quality of life. The change from baseline in physical function (EORTC QLQ-C30 Items 1-5) score will be presented.
Baseline, Up to ~68 months
Change From Baseline in Urinary, Bowel and Sexual Domains per Bladder Cancer Index (BCI)
Time Frame: Baseline, Up to ~68 months
The BCI is a 36-item validated, condition-specific health questionnaire to assess the quality of life among participants with bladder cancer. The BCI contains 3 domains: urinary (14 items), bowel (10 items), and sexual (12 items) with function (Likert response scale: 0 [Never] - 4 [Always]) and bother (Likert response scale: 0 [No problem] - 4 [Big problem]) subdomains. The domain and subdomain scores are standardized to a 0 to 100 point scale where higher scores correspond better functioning and health-related qualify of life. The change from baseline in the combined scores of the urinary, bowel, and sexual domains of the BCI will be presented.
Baseline, Up to ~68 months
Change from Baseline in EuroQoL-5 Dimensions, 5-level Questionnaire (EQ-5D-5L) Visual Analogue Score (VAS)
Time Frame: Baseline, Up to ~68 months
The EQ-5D-5L VAS records the respondent's self-rated health on a 10 centimeter (cm) vertical, visual analogue scale. It is rated by the respondent on a scale 0 to 100, with 0 being "the worst health you can imagine" and 100 being "the best health you can imagine". The change from baseline in EQ-5D-5L VAS will be presented.
Baseline, Up to ~68 months
Change from Baseline in EORTC QLQ-C30 Role Functioning Combined Score (Items 6-7)
Time Frame: Baseline, Up to ~68 months
The EORTC QLQ-C30 is a 30-item questionnaire to assess the overall quality of life of cancer patients. Participant responses to the questions "Were you limited in doing either your work or other daily activities during the past week?" and " Were you limited in pursuing your hobbies or other leisure time activities during the past week?" will be scored on a 4-point scale (1=Not at All to 4=Very Much). Higher scores indicate a better level of role functioning. Change from baseline in the role functioning (EORTC QLQ-C30 Items 6-7) combined score will be presented.
Baseline, Up to ~68 months
Number of Participants Experiencing Perioperative Complications
Time Frame: Up to ~68 months
Perioperative complications are defined as both intraoperative and postoperative complications, potentially contributing to increased length of inpatient care and/or delay of adjuvant therapy. The number of participants experiencing perioperative complications will be presented.
Up to ~68 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Merck Sharp & Dohme LLC

Collaborators

Astellas Pharma Inc
Seagen Inc.

Investigators

  • Study Director: Medical Director, Merck Sharp & Dohme LLC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 21, 2021

Primary Completion (Estimated)

December 23, 2026

Study Completion (Estimated)

December 23, 2026

Study Registration Dates

First Submitted

January 5, 2021

First Submitted That Met QC Criteria

January 5, 2021

First Posted (Actual)

January 7, 2021

Study Record Updates

Last Update Posted (Actual)

January 26, 2024

Last Update Submitted That Met QC Criteria

January 25, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 3475-B15
  • MK-3475-B15 (Other Identifier: Merck)
  • KEYNOTE-B15 (Other Identifier: Merck)
  • EV-304 (Other Identifier: Merck)
  • jRCT2041210011 (Registry Identifier: jRCT)
  • PHRR221021-005086 (Registry Identifier: Philippine Health Research Registry (PHRR))
  • 2020-003106-31 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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