Perioperative Pembrolizumab (MK-3475) Plus Cystectomy or Perioperative Pembrolizumab Plus Enfortumab Vedotin Plus Cystectomy Versus Cystectomy Alone in Participants Who Are Cisplatin-ineligible or Decline Cisplatin With Muscle-invasive Bladder Cancer (MK-3475-905/KEYNOTE-905/EV-303)

April 4, 2024 updated by: Merck Sharp & Dohme LLC

A Randomized Phase 3 Study Evaluating Cystectomy With Perioperative Pembrolizumab and Cystectomy With Perioperative Enfortumab Vedotin and Pembrolizumab Versus Cystectomy Alone in Participants Who Are Cisplatin-Ineligible or Decline Cisplatin With Muscle-Invasive Bladder Cancer (KEYNOTE-905/EV-303)

This is a study of perioperative pembrolizumab or enfortumab vedotin in combination with pembrolizumab in participants who are cisplatin-ineligible or decline cisplatin with muscle-invasive bladder cancer (MIBC).

The primary hypothesis is that perioperative pembrolizumab plus radical cystectomy (RC) plus pelvic lymph node dissection (PLND) and perioperative enfortumab vedotin in combination with pembrolizumab plus RC+PLND will achieve superior event-free survival (EFS) compared with RC+PLND alone.

With Amendment 5, outcome measures for programmed cell death ligand 1 (PD-L1) combined positive score (CPS) were removed.

With Amendment 8, the primary outcome measure of pathologic complete response (pCR) rates was changed to a secondary outcome measure.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

857

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
    • Caba
      • Buenos Aires, Caba, Argentina, C1419AHN
        • Recruiting
        • Asociación de Beneficencia Hospital Sirio Libanés ( Site 2102)
        • Contact:
          • Study Coordinator
          • Phone Number: +5491157654803
  • Australia
    • New South Wales
      • Blacktown, New South Wales, Australia, 2148
        • Completed
        • Western Sydney Local Health District ( Site 1259)
      • Macquarie Park, New South Wales, Australia, 2109
        • Completed
        • Macquarie University ( Site 1251)
    • Queensland
      • Cairns, Queensland, Australia, 4870
        • Completed
        • Cairns Base Hospital ( Site 1257)
      • South Brisbane, Queensland, Australia, 4101
        • Completed
        • Mater Misericordiae Ltd ( Site 1258)
    • Victoria
      • Box Hill, Victoria, Australia, 3128
        • Completed
        • Eastern Health ( Site 1255)
      • Clayton, Victoria, Australia, 3168
        • Completed
        • Monash Health ( Site 1260)
  • Belgium
    • Bruxelles-Capitale, Region De
      • Bruxelles, Bruxelles-Capitale, Region De, Belgium, 1200
        • Recruiting
        • UCL Saint-Luc - Oncologie Medicale ( Site 0357)
        • Contact:
          • Study Coordinator
          • Phone Number: +3227649457
    • Namur
      • Yvoir, Namur, Belgium, 5530
        • Completed
        • CHU UCL Namur Site de Godinne ( Site 0354)
    • Oost-Vlaanderen
      • Gent, Oost-Vlaanderen, Belgium, 9000
        • Recruiting
        • AZ Maria Middelares Gent ( Site 0353)
        • Contact:
          • Study Coordinator
          • Phone Number: +3292469522
    • Vlaams-Brabant
      • Leuven, Vlaams-Brabant, Belgium, 3000
        • Completed
        • UZ Leuven ( Site 0361)
    • West-Vlaanderen
      • Brugge, West-Vlaanderen, Belgium, 8000
        • Recruiting
        • AZ Sint-Jan Brugge ( Site 0352)
        • Contact:
          • Study Coordinator
          • Phone Number: +3250452806
      • Roeselare, West-Vlaanderen, Belgium, 8800
        • Recruiting
        • AZ Delta vzw-Oncology ( Site 0362)
        • Contact:
          • Study Coordinator
          • Phone Number: +3251237511
  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2N 4N2
        • Recruiting
        • Tom Baker Cancer Centre ( Site 0100)
        • Contact:
          • Study Coordinator
          • Phone Number: 4034762543
    • British Columbia
      • Vancouver, British Columbia, Canada, V5Z 4E6
        • Recruiting
        • BC Cancer Vancouver-Clinical Trials Unit ( Site 0121)
        • Contact:
          • Study Coordinator
          • Phone Number: 6048776000
      • Victoria, British Columbia, Canada, V8T 2C1
        • Completed
        • Silverado Resarch Inc. ( Site 0111)
    • New Brunswick
      • Moncton, New Brunswick, Canada, E1C 6Z8
        • Recruiting
        • Moncton Hospital - Horizon Health Network ( Site 0112)
        • Contact:
          • Study Coordinator
          • Phone Number: 5068575669
    • Ontario
      • Toronto, Ontario, Canada, M4N 3M5
        • Recruiting
        • Sunnybrook Research Institute ( Site 0110)
        • Contact:
          • Study Coordinator
          • Phone Number: 4164804928
      • Toronto, Ontario, Canada, M5G 2M9
        • Active, not recruiting
        • Princess Margaret Cancer Centre ( Site 0107)
    • Quebec
      • Chicoutimi, Quebec, Canada, G7H 5H6
        • Recruiting
        • CIUSSS du Saguenay-Lac-St-Jean ( Site 0116)
        • Contact:
          • Study Coordinator
          • Phone Number: 4185411000
      • Montreal, Quebec, Canada, H3T 1E2
        • Recruiting
        • Jewish General Hospital ( Site 0120)
        • Contact:
          • Study Coordinator
          • Phone Number: 5143408222
      • Montreal, Quebec, Canada, H1T 2M4
        • Completed
        • CIUSSS de l Est de L Ile de Montreal - Hopital Maisonneuve-Rosemont ( Site 0105)
      • Montréal, Quebec, Canada, H4A 3J1
        • Recruiting
        • McGill University Health Centre ( Site 0123)
        • Contact:
          • Study Coordinator
          • Phone Number: 5149341934 x35800
      • Sherbrooke, Quebec, Canada, J1H 5N4
        • Recruiting
        • CIUSSS de l'Estrie-CHUS ( Site 0106)
        • Contact:
          • Study Coordinator
          • Phone Number: 819346111012827
  • Colombia
    • Antioquia
      • Medellin, Antioquia, Colombia, 050030
        • Recruiting
        • Fundación Colombiana de Cancerología Clínica Vida ( Site 2003)
        • Contact:
          • Study Coordinator
          • Phone Number: 573147362301
    • Cordoba
      • Montería, Cordoba, Colombia, 230002
        • Recruiting
        • Oncomédica S.A.S ( Site 2001)
        • Contact:
          • Study Coordinator
          • Phone Number: 3105394868
    • Distrito Capital De Bogota
      • Bogota, Distrito Capital De Bogota, Colombia, 111321
        • Recruiting
        • Clinica Colsanitas S.A, Sede Clínica Universitaria Colombia-Center Investigator ( Site 2002)
        • Contact:
          • Study Coordinator
          • Phone Number: 573103469453
    • Santander
      • Piedecuesta, Santander, Colombia, 681017
        • Recruiting
        • Fundación Cardiovascular de Colombia ( Site 2004)
        • Contact:
          • Study Coordinator
          • Phone Number: 3107814776
    • Valle Del Cauca
      • Cali, Valle Del Cauca, Colombia, 760032
        • Recruiting
        • Fundacion Valle del Lili- CIC-Fundacion Valle del Lili ( Site 2005)
        • Contact:
          • Study Coordinator
          • Phone Number: 57 3162801914
  • Denmark
    • Hovedstaden
      • Herlev, Hovedstaden, Denmark, 2730
        • Recruiting
        • Herlev og Gentofte Hospital. ( Site 0412)
        • Contact:
          • Study Coordinator
          • Phone Number: +45 38683868
      • Kobenhavn, Hovedstaden, Denmark, 2100
        • Recruiting
        • Rigshospitalet University Hospital ( Site 0411)
        • Contact:
          • Study Coordinator
          • Phone Number: +45 35453545
    • Midtjylland
      • Aarhus, Midtjylland, Denmark, 8200
        • Recruiting
        • Aarhus University Hospital Skejby ( Site 0418)
        • Contact:
          • Study Coordinator
          • Phone Number: 78450000
    • Syddanmark
      • Odense, Syddanmark, Denmark, 5000
        • Recruiting
        • Odense Universitetshospital ( Site 0413)
        • Contact:
          • Study Coordinator
          • Phone Number: +4524998173
  • France
      • Paris, France, 75018
        • Recruiting
        • Hopital Bichat du Paris ( Site 0462)
        • Contact:
          • Study Coordinator
          • Phone Number: 33158412754
      • Paris, France, 75014
        • Active, not recruiting
        • CHU Cochin ( Site 0475)
      • Paris, France, 75015
        • Active, not recruiting
        • Hopital Europeen Georges Pompidou ( Site 0476)
    • Bouches-du-Rhone
      • Marseille, Bouches-du-Rhone, France, 13005
        • Recruiting
        • Hopital de la Timone ( Site 0489)
        • Contact:
          • Study Coordinator
          • Phone Number: +3391387658
    • Calvados
      • Caen, Calvados, France, 14075
        • Recruiting
        • Centre Francois Baclesse ( Site 0459)
        • Contact:
          • Study Coordinator
          • Phone Number: +33231455002
    • Cote-d Or
      • Dijon, Cote-d Or, France, 21000
        • Active, not recruiting
        • Centre Georges Francois Leclerc ( Site 0488)
    • Doubs
      • Besancon, Doubs, France, 25000
        • Active, not recruiting
        • CHU Jean Minjoz ( Site 0455)
    • Gard
      • Nimes, Gard, France, 30029
        • Recruiting
        • Institut de Cancerologie du Gard - CHU Caremeau ( Site 0490)
        • Contact:
          • Study Coordinator
          • Phone Number: +33466683301
    • Gironde
      • Bordeaux, Gironde, France, 33075
        • Active, not recruiting
        • CHU de Bordeaux- Hopital Saint Andre ( Site 0456)
    • Haute-Garonne
      • Toulouse, Haute-Garonne, France, 31059
        • Recruiting
        • Institut Claudius Regaud IUCT Oncopole ( Site 0486)
        • Contact:
          • Study Coordinator
          • Phone Number: +33531155993
    • Ille-et-Vilaine
      • Rennes, Ille-et-Vilaine, France, 35033
        • Active, not recruiting
        • C.H.R.U. de Rennes. Hopital de Pontchaillou ( Site 0492)
    • Languedoc-Roussillon
      • Montpellier, Languedoc-Roussillon, France, 34295
        • Recruiting
        • CHU de Montpellier - Hopital Saint-Eloi ( Site 0469)
        • Contact:
          • Study Coordinator
          • Phone Number: +33467332309
    • Loire-Atlantique
      • Nantes, Loire-Atlantique, France, 44093
        • Recruiting
        • CHU Hotel Dieu Nantes ( Site 0458)
        • Contact:
          • Study Coordinator
          • Phone Number: 33244765930
    • Moselle
      • Vantoux, Moselle, France, 57070
        • Recruiting
        • Hopital Belle Isle ( Site 0452)
        • Contact:
          • Study Coordinator
          • Phone Number: +0357841650
    • Rhone
      • Pierre Benite, Rhone, France, 69310
        • Active, not recruiting
        • C.H.U. Lyon Sud ( Site 0466)
    • Val-de-Marne
      • Villejuif, Val-de-Marne, France, 94805
        • Active, not recruiting
        • Institut Gustave Roussy ( Site 0487)
  • Germany
      • Berlin, Germany, 10967
        • Recruiting
        • Vivantes Klinikum am Urban ( Site 0529)
        • Contact:
          • Study Coordinator
          • Phone Number: +4930130226301
      • Hamburg, Germany, 20246
        • Recruiting
        • Universitaetsklinikum Hamburg-Eppendorf-Onkologisches Zentrum ( Site 0528)
        • Contact:
          • Study Coordinator
          • Phone Number: +49 15222815585
    • Baden-Wurttemberg
      • Stuttgart, Baden-Wurttemberg, Germany, 70174
        • Recruiting
        • Klinikum Stuttgart - Katharinenhospital ( Site 0520)
        • Contact:
          • Study Coordinator
          • Phone Number: 49711 278-33801
      • Tuebingen, Baden-Wurttemberg, Germany, 72076
        • Recruiting
        • Klinikum der Eberhard-Karls-Universitaet Tuebingen ( Site 0549)
        • Contact:
          • Study Coordinator
          • Phone Number: +4970712987235
    • Bayern
      • Erlangen, Bayern, Germany, 91058
        • Recruiting
        • Universitaetsklinikum Erlangen ( Site 0546)
        • Contact:
          • Study Coordinator
          • Phone Number: 4991318223122
      • Muenchen, Bayern, Germany, 81377
        • Recruiting
        • Klinikum der Universitaet Muenchen - Grosshadern ( Site 0548)
        • Contact:
          • Study Coordinator
          • Phone Number: +498944000
      • Wuerzburg, Bayern, Germany, 97080
        • Recruiting
        • Universitaetsklinikum Wuerzburg ( Site 0547)
        • Contact:
          • Study Coordinator
          • Phone Number: +4993120132091
    • Nordrhein-Westfalen
      • Bonn, Nordrhein-Westfalen, Germany, 53127
        • Recruiting
        • Universitaetsklinikum Bonn ( Site 0550)
        • Contact:
          • Study Coordinator
          • Phone Number: +4922828714184
    • Sachsen
      • Dresden, Sachsen, Germany, 01307
        • Completed
        • Universitaetsklinikum Carl Gustav Carus ( Site 0532)
    • Sachsen-Anhalt
      • Magdeburg, Sachsen-Anhalt, Germany, 39120
        • Recruiting
        • Universitaetsklinikum Magdeburg A.o.R. ( Site 0535)
        • Contact:
          • Study Coordinator
          • Phone Number: +493916715034
    • Thuringen
      • Gera, Thuringen, Germany, 07548
        • Recruiting
        • SRH Wald-Klinikum Gera-Zentrum für klinische Studien ( Site 0533)
        • Contact:
          • Study Coordinator
          • Phone Number: +493658287758
  • Hungary
      • Budapest, Hungary, 1106
        • Recruiting
        • Bajcsy Zsilinszki Korhaz es Rendelointezet ( Site 1001)
        • Contact:
          • Study Coordinator
          • Phone Number: +36703815172
      • Debrecen, Hungary, 4032
        • Recruiting
        • Debreceni Egyetem Klinikai Kozpont ( Site 1006)
        • Contact:
          • Study Coordinator
          • Phone Number: +3652255585
      • Gyor, Hungary, 9023
        • Completed
        • Petz Aladar Megyei Oktato Korhaz ( Site 1012)
      • Kaposvar, Hungary, 7400
        • Completed
        • Somogy Megyei Kaposi Mor Oktato Korhaz ( Site 1007)
    • Csongrad
      • Szeged, Csongrad, Hungary, 6720
        • Recruiting
        • SZTE Szent-Gyorgyi Albert Klinikai Kozpont ( Site 1010)
        • Contact:
          • Study Coordinator
          • Phone Number: +3662545405
  • Ireland
      • Dublin, Ireland, D24 NR0A
        • Recruiting
        • Tallaght University Hospital ( Site 0734)
        • Contact:
          • Study Coordinator
          • Phone Number: +35314144259
      • Waterford, Ireland, X91ER8E
        • Recruiting
        • University Hospital Waterford ( Site 0747)
        • Contact:
          • Study Coordinator
          • Phone Number: +35351848934
  • Israel
      • Afula, Israel, 1834111
        • Completed
        • Ha Emek Medical Center ( Site 0843)
      • Beer Sheva, Israel, 8410101
        • Recruiting
        • Soroka Medical Center ( Site 0849)
        • Contact:
          • Study Coordinator
          • Phone Number: +972523514527
      • Haifa, Israel, 3109601
        • Recruiting
        • Rambam Health Care Campus-Oncology Division ( Site 0845)
        • Contact:
          • Study Coordinator
          • Phone Number: +97247776750
      • Jerusalem, Israel, 9103102
        • Recruiting
        • Shaare Zedek Medical Center ( Site 0842)
        • Contact:
          • Study Coordinator
          • Phone Number: +97226666331
      • Jerusalem, Israel, 9112001
        • Recruiting
        • Hadassah Ein Kerem Medical Center ( Site 0841)
        • Contact:
          • Study Coordinator
          • Phone Number: +972505172315
      • Kfar Saba, Israel, 4428164
        • Recruiting
        • Meir Medical Center ( Site 0846)
        • Contact:
          • Study Coordinator
          • Phone Number: +97297471606
      • Petach Tikva, Israel, 4941492
        • Recruiting
        • Rabin Medical Center ( Site 0847)
        • Contact:
          • Study Coordinator
          • Phone Number: +97239378074
      • Ramat Gan, Israel, 5265601
        • Recruiting
        • Sheba Medical Center ( Site 0844)
        • Contact:
          • Study Coordinator
          • Phone Number: +97235302191
      • Tel Aviv, Israel, 6423906
        • Recruiting
        • Sourasky Medical Center ( Site 0850)
        • Contact:
          • Study Coordinator
          • Phone Number: +97236973413
      • Zerifin, Israel, 70300
        • Recruiting
        • Yitzhak Shamir Medical Center ( Site 0848)
        • Contact:
          • Study Coordinator
          • Phone Number: +97289779715
  • Italy
      • Arezzo, Italy, 52100
        • Recruiting
        • Azienda USL 8 di Arezzo-Medical Oncology ( Site 0565)
        • Contact:
          • Study Coordinator
          • Phone Number: 390575255446
      • Catania, Italy, 95123
        • Recruiting
        • A.O.U. Policlinico Vittorio Emanuele - Presidio Gaspare Rodolico ( Site 0559)
        • Contact:
          • Study Coordinator
          • Phone Number: +390953781518
      • Milano, Italy, 20133
        • Recruiting
        • Istituto Nazionale Studio e Cura dei Tumori ( Site 0551)
        • Contact:
          • Study Coordinator
          • Phone Number: +390223902402
      • Napoli, Italy, 80131
        • Recruiting
        • Istituto Nazionale Per Lo Studio E La Cura Dei Tumori ( Site 0552)
        • Contact:
          • Study Coordinator
          • Phone Number: +39815903637
      • Pavia, Italy, 27100
        • Completed
        • Fondazione Salvatore Maugeri IRCCS ( Site 0554)
      • Terni, Italy, 05100
        • Recruiting
        • Azienda Ospedaliera Santa Maria Terni-S.C. Oncologia Medica e Traslazionale ( Site 0564)
        • Contact:
          • Study Coordinator
          • Phone Number: 390744205410
    • Abruzzo
      • Roma, Abruzzo, Italy, 00168
        • Recruiting
        • Policlinico Gemelli di Roma ( Site 0558)
        • Contact:
          • Study Coordinator
          • Phone Number: +390630154953
    • Lombardia
      • Milano, Lombardia, Italy, 20132
        • Recruiting
        • Ospedale San Raffaele-Oncologia Medica ( Site 0561)
        • Contact:
          • Study Coordinator
          • Phone Number: +390226435668
    • Piemonte
      • Orbassano, Piemonte, Italy, 10043
        • Recruiting
        • Azienda Sanitaria Ospedaliera S Luigi Gonzaga-SCDU Oncologia Medica ( Site 0563)
        • Contact:
          • Study Coordinator
          • Phone Number: +390119026993
    • Veneto
      • Vicenza, Veneto, Italy, 36100
        • Completed
        • AULSS8 Berica-Ospedale S.Bortolo-ONCOLOGIA CLINICA ( Site 0562)
  • Japan
      • Gifu, Japan, 501-1112
        • Recruiting
        • Gifu University Hospital ( Site 2310)
        • Contact:
          • Study Coordinator
          • Phone Number: +81 582306000
      • Kagoshima, Japan, 890-8520
        • Recruiting
        • Kagoshima University Hospital ( Site 2317)
        • Contact:
          • Study Coordinator
          • Phone Number: +81 992755111
      • Nagasaki, Japan, 852-8501
        • Recruiting
        • Nagasaki University Hospital ( Site 2315)
        • Contact:
          • Study Coordinator
          • Phone Number: +81 958197200
    • Chiba
      • Kashiwa, Chiba, Japan, 277-8577
        • Recruiting
        • National Cancer Center Hospital East ( Site 2305)
        • Contact:
          • Study Coordinator
          • Phone Number: +81471331111
    • Ibaraki
      • Tsukuba, Ibaraki, Japan, 305-8576
        • Recruiting
        • Tsukuba University Hospital ( Site 2302)
        • Contact:
          • Study Coordinator
          • Phone Number: +81298533900
    • Kanagawa
      • Kawasaki, Kanagawa, Japan, 216-8511
        • Recruiting
        • St. Marianna University Hospital ( Site 2321)
        • Contact:
          • Study Coordinator
          • Phone Number: 81449778111
      • Sagamihara, Kanagawa, Japan, 252-0375
        • Recruiting
        • Kitasato University Hospital ( Site 2306)
        • Contact:
          • Study Coordinator
          • Phone Number: +81427788111
      • Yokosuka, Kanagawa, Japan, 238-8558
        • Recruiting
        • Yokosukakyosai ( Site 2307)
        • Contact:
          • Study Coordinator
          • Phone Number: +81 468222710
    • Miyagi
      • Sendai-shi, Miyagi, Japan, 980-8574
        • Recruiting
        • Tohoku University Hospital ( Site 2301)
        • Contact:
          • Study Coordinator
          • Phone Number: +81227177000
    • Nagano
      • Tomitake, Nagano, Japan, 381-8551
        • Recruiting
        • Nagano Municipal Hospital ( Site 2309)
        • Contact:
          • Study Coordinator
          • Phone Number: +81 262951199
    • Nara
      • Kashihara, Nara, Japan, 634-0813
        • Recruiting
        • Nara Medical University Hospital ( Site 2312)
        • Contact:
          • Study Coordinator
          • Phone Number: +81 744223051
    • Osaka
      • Sakai, Osaka, Japan, 591-8025
        • Recruiting
        • Osaka Rosai Hospital ( Site 2320)
        • Contact:
          • Study Coordinator
          • Phone Number: +81 722523561
    • Saitama
      • Ina-machi, Saitama, Japan, 362-0806
        • Recruiting
        • Saitama Prefectural Cancer Center ( Site 2319)
        • Contact:
          • Study Coordinator
          • Phone Number: +81 487221111
      • Koshigaya, Saitama, Japan, 3438555
        • Recruiting
        • Dokkyo Medical University Saitama Medical Center ( Site 2304)
        • Contact:
          • Study Coordinator
          • Phone Number: +81282861111
    • Shizuoka
      • Hamamatsu, Shizuoka, Japan, 431-3192
        • Recruiting
        • Hamamatsu University Hospital ( Site 2311)
        • Contact:
          • Study Coordinator
          • Phone Number: +81534352111
    • Tokyo
      • Bunkyō, Tokyo, Japan, 113-8519
        • Recruiting
        • Tokyo Medical and Dental University Hospital ( Site 2303)
        • Contact:
          • Study Coordinator
          • Phone Number: +81338136111
      • Minato-ku, Tokyo, Japan, 105-8470
        • Recruiting
        • Toranomon Hospital ( Site 2322)
        • Contact:
          • Study Coordinator
          • Phone Number: +81 335881111
    • Toyama
      • Toyoma, Toyama, Japan, 930-0194
        • Recruiting
        • Toyama University Hospital ( Site 2308)
        • Contact:
          • Study Coordinator
          • Phone Number: +81 764342315
  • Korea, Republic of
      • Seoul, Korea, Republic of, 02841
        • Recruiting
        • Korea University Anam Hospital ( Site 1351)
        • Contact:
          • Study Coordinator
          • Phone Number: +8229206610
      • Seoul, Korea, Republic of, 03080
        • Recruiting
        • Seoul National University Hospital ( Site 1352)
        • Contact:
          • Study Coordinator
          • Phone Number: +82220720361
      • Seoul, Korea, Republic of, 06351
        • Recruiting
        • Samsung Medical Center ( Site 1353)
        • Contact:
          • Study Coordinator
          • Phone Number: +82234103557
    • Kyonggi-do
      • Goyang-si, Kyonggi-do, Korea, Republic of, 10408
        • Recruiting
        • National Cancer Center ( Site 1354)
        • Contact:
          • Study Coordinator
          • Phone Number: +82319201678
      • Seongnam-si, Kyonggi-do, Korea, Republic of, 13620
        • Recruiting
        • Seoul National University Bundang Hospital ( Site 1356)
        • Contact:
          • Study Coordinator
          • Phone Number: +82317877351
    • Seoul
      • Songpagu, Seoul, Korea, Republic of, 05505
        • Completed
        • Asan Medical Center ( Site 1355)
    • Taegu-Kwangyokshi
      • Deagu, Taegu-Kwangyokshi, Korea, Republic of, 41404
        • Recruiting
        • Kyungpook National University Chilgok Hospital-Urology ( Site 1357)
        • Contact:
          • Study Coordinator
          • Phone Number: +82-53-200-3027
  • Malaysia
    • Kuala Lumpur
      • Lembah Pantai, Kuala Lumpur, Malaysia, 59100
        • Completed
        • University Malaya Medical Centre ( Site 1702)
    • Pulau Pinang
      • Georgetown, Pulau Pinang, Malaysia, 10990
        • Completed
        • Hospital Pulau Pinang ( Site 1703)
    • Sarawak
      • Kuching, Sarawak, Malaysia, 93586
        • Recruiting
        • Sarawak General Hospital ( Site 1701)
        • Contact:
          • Study Coordinator
          • Phone Number: +6082-276666
  • Mexico
      • Aguascalientes, Mexico, 20010
        • Completed
        • Investigacion Biomedica para el Desarrollo de Farmacos S.A. de C.V. ( Site 0300)
      • Chihuahua, Mexico, 31000
        • Completed
        • Centro Estatal de Cancerologia de Chihuahua ( Site 0254)
      • Ciudad de Mexico, Mexico, 14080
        • Completed
        • Instituto Nacional de Cancerologia. ( Site 0256)
      • Metepec, Mexico, 52140
        • Completed
        • Centro de Tratamiento de Cancer ( Site 0266)
      • Mexico City, Mexico, 06700
        • Completed
        • Hospital Angeles Roma ( Site 0262)
    • Nuevo Leon
      • Monterrey, Nuevo Leon, Mexico, 66269
        • Completed
        • Centro de Urologia Avanzada del Noreste S.A. de C.V. ( Site 0253)
  • Philippines
    • Iloilo
      • Iloilo City, Iloilo, Philippines, 5000
        • Recruiting
        • THE MEDICAL CITY ILOILO ( Site 1756)
        • Contact:
          • Study Coordinator
          • Phone Number: 09274761729
    • National Capital Region
      • Pasig City, National Capital Region, Philippines, 1605
        • Completed
        • The Medical City ( Site 1752)
      • Quezon City, National Capital Region, Philippines, 1112
        • Completed
        • St. Luke s Medical Center ( Site 1751)
  • Poland
    • Dolnoslaskie
      • Wroclaw, Dolnoslaskie, Poland, 50-556
        • Recruiting
        • Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego ( Site 1063)
        • Contact:
          • Study Coordinator
          • Phone Number: +48601143281
    • Kujawsko-pomorskie
      • Bydgoszcz, Kujawsko-pomorskie, Poland, 85-796
        • Recruiting
        • Centrum Onkologii im.prof. F. Lukaszczyka w Bydgoszczy ( Site 1068)
        • Contact:
          • Study Coordinator
          • Phone Number: +48605680944
    • Malopolskie
      • Tarnow, Malopolskie, Poland, 33-100
        • Recruiting
        • Szpital Wojewodzki ( Site 1062)
        • Contact:
          • Study Coordinator
          • Phone Number: +48728355694
    • Mazowieckie
      • Otwock, Mazowieckie, Poland, 05-400
        • Completed
        • Europejskie Centrum Zdrowia Otwock ( Site 1058)
      • Warszawa, Mazowieckie, Poland, 01-748
        • Recruiting
        • Luxmed Onkologia sp. z o. o. ( Site 1051)
        • Contact:
          • Study Coordinator
          • Phone Number: +48224308700
    • Podlaskie
      • Bialystok, Podlaskie, Poland, 15-027
        • Completed
        • Bialostockie Centrum Onkologii ( Site 1072)
    • Pomorskie
      • Slupsk, Pomorskie, Poland, 76-200
        • Recruiting
        • Wojewodzki Szpital Specjalistyczny im. Janusza Korczaka w Slupsku ( Site 1057)
        • Contact:
          • Study Coordinator
          • Phone Number: +48598460705
    • Slaskie
      • Bielsko-Biala, Slaskie, Poland, 43-300
        • Active, not recruiting
        • Beskidzkie Centrum Onkologii im. Jana Pawla II ( Site 1061)
    • Wielkopolskie
      • Poznań, Wielkopolskie, Poland, 60-848
        • Recruiting
        • Clinical Research Center Medic-R ( Site 1073)
        • Contact:
          • Study Coordinator
          • Phone Number: 48 508 109 295
  • Russian Federation
    • Baskortostan, Respublika
      • Ufa, Baskortostan, Respublika, Russian Federation, 450081
        • Suspended
        • Clinic of Bashkortostan State Medical University ( Site 0873)
    • Ivanovskaya Oblast
      • Ivanovo, Ivanovskaya Oblast, Russian Federation, 153040
        • Completed
        • Ivanovo Regional Oncology Dispensary ( Site 0852)
    • Krasnoyarskiy Kray
      • Krasnoyarsk, Krasnoyarskiy Kray, Russian Federation, 660133
        • Suspended
        • Krasnoyarsk Regional Clinical Oncological Dispensary ( Site 0861)
    • Kurskaya Oblast
      • Kursk, Kurskaya Oblast, Russian Federation, 305524
        • Completed
        • Kursk Regional Clinical Oncology Dispensary ( Site 0854)
    • Moskva
      • Moscow, Moskva, Russian Federation, 115478
        • Suspended
        • Russian Oncological Research Center n.a. N.N.Blokhin of MoH ( Site 0878)
      • Moscow, Moskva, Russian Federation, 119991
        • Suspended
        • First Moscow State Medical University n.a. I.M.Sechenov ( Site 0884)
      • Moscow, Moskva, Russian Federation, 121359
        • Completed
        • Central Clinical Hospital with outpatient Clinic ( Site 0856)
    • Murmanskaya Oblast
      • Murmansk, Murmanskaya Oblast, Russian Federation, 183057
        • Completed
        • Bayandin Murmansk Regional Clinical Hospital ( Site 0859)
    • Nizhegorodskaya Oblast
      • Nizhny Novgorod, Nizhegorodskaya Oblast, Russian Federation, 603074
        • Suspended
        • Volga District Medical Center Federal Medical and Biological Agency ( Site 0857)
    • Omskaya Oblast
      • Omsk, Omskaya Oblast, Russian Federation, 644013
        • Suspended
        • Omsk Clinical Oncology Dispensary ( Site 0865)
    • Sankt-Peterburg
      • Saint Petersburg, Sankt-Peterburg, Russian Federation, 188663
        • Completed
        • Leningrad Regional Oncology Center ( Site 0868)
      • Saint-Petersburg, Sankt-Peterburg, Russian Federation, 197758
        • Suspended
        • National Medical Research Center of Oncology N.A. N.N. Petrov ( Site 0860)
      • Saint-Petersburg, Sankt-Peterburg, Russian Federation, 197022
        • Completed
        • First St. Petersburg State Medical University n.a. acad. I.P. Pavlov ( Site 0872)
      • St. Petersburg, Sankt-Peterburg, Russian Federation, 194044
        • Completed
        • Clinical Hospital Saint Luka ( Site 0867)
    • Saratovskaya Oblast
      • Saratov, Saratovskaya Oblast, Russian Federation, 410012
        • Completed
        • Saratov State Medical University n.a. V.I.Razumovskiy ( Site 0866)
    • Sverdlovskaya Oblast
      • Ekaterinburg, Sverdlovskaya Oblast, Russian Federation, 620036
        • Suspended
        • Sverdlovsk Regional Oncology Hospital ( Site 0874)
    • Tyumenskaya Oblast
      • Tyumen, Tyumenskaya Oblast, Russian Federation, 625000
        • Completed
        • Medical Sanitary Unit Neftyannik ( Site 0888)
  • Singapore
    • Central Singapore
      • Singapore, Central Singapore, Singapore, 398442
        • Recruiting
        • Tan Tock Seng Hospital ( Site 1804)
        • Contact:
          • Study Coordinator
          • Phone Number: +6563596554
      • Singapore, Central Singapore, Singapore, 119074
        • Completed
        • National University Hospital ( Site 1802)
  • South Africa
    • Gauteng
      • Pretoria, Gauteng, South Africa, 0001
        • Recruiting
        • Steve Biko Academic Hospital-Medical Oncology ( Site 1601)
        • Contact:
          • Study Coordinator
          • Phone Number: +27123541771
    • Western Cape
      • Cape Town, Western Cape, South Africa, 7925
        • Recruiting
        • Groote Schuur Hospital ( Site 1602)
        • Contact:
          • Study Coordinator
          • Phone Number: +27 214485707
  • Spain
      • Barcelona, Spain, 08003
        • Recruiting
        • Hospital del Mar ( Site 0698)
        • Contact:
          • Study Coordinator
          • Phone Number: +34932483139
      • Madrid, Spain, 28034
        • Recruiting
        • Hospital Universitario Ramon y Cajal ( Site 0691)
        • Contact:
          • Study Coordinator
          • Phone Number: +34913368263
      • Madrid, Spain, 28040
        • Recruiting
        • Hospital Universitario San Carlos ( Site 0678)
        • Contact:
          • Study Coordinator
          • Phone Number: +34913303000ext7554
      • Madrid, Spain, 28046
        • Recruiting
        • Hospital Universitario la Paz ( Site 0690)
        • Contact:
          • Study Coordinator
          • Phone Number: +34912071138
      • Sevilla, Spain, 41014
        • Recruiting
        • Hospital de Nuestra Senora de Valme ( Site 0693)
        • Contact:
          • Study Coordinator
          • Phone Number: +34955015000
    • Barcelona
      • Badalona, Barcelona, Spain, 08916
        • Recruiting
        • Hosp. Gral. Universitari Germans Trias i Pujol ( Site 0675)
        • Contact:
          • Study Coordinator
          • Phone Number: +349334978925
    • Cataluna
      • Barcelona, Cataluna, Spain, 08036
        • Recruiting
        • Hospital Clinic i Provincial ( Site 0674)
        • Contact:
          • Study Coordinator
          • Phone Number: +34932275400
    • Extremadura
      • Caceres, Extremadura, Spain, 10003
        • Recruiting
        • Hospital San Pedro de Alcantara ( Site 0697)
        • Contact:
          • Study Coordinator
          • Phone Number: +34927256200
    • Gerona
      • Girona, Gerona, Spain, 17007
        • Recruiting
        • Institut Català d'Oncologia (ICO) - Girona ( Site 0700)
        • Contact:
          • Study Coordinator
          • Phone Number: +349722258284028
    • Madrid, Comunidad De
      • Pozuelo de Alarcon, Madrid, Comunidad De, Spain, 28223
        • Completed
        • Hospital Universitario Quiron Madrid ( Site 0694)
    • Valenciana, Comunitat
      • Valencia, Valenciana, Comunitat, Spain, 46009
        • Recruiting
        • Instituto Valenciano de Oncologia - IVO ( Site 0679)
        • Contact:
          • Study Coordinator
          • Phone Number: +34961114605
  • Sweden
    • Jonkopings Lan
      • Jonkoping, Jonkopings Lan, Sweden, 551 85
        • Completed
        • Laenssjukhuset Ryhov ( Site 1215)
    • Stockholms Lan
      • Stockholm, Stockholms Lan, Sweden, 171 76
        • Recruiting
        • Karolinska Universitetssjukhuset Solna ( Site 1212)
        • Contact:
          • Study Coordinator
          • Phone Number: +46851770000
    • Uppsala Lan
      • Uppsala, Uppsala Lan, Sweden, 751 85
        • Recruiting
        • Akademiska Sjukhuset ( Site 1211)
        • Contact:
          • Study Coordinator
          • Phone Number: +46186110000
    • Vasterbottens Lan
      • Umea, Vasterbottens Lan, Sweden, 901 85
        • Completed
        • Cancercentrum ( Site 1214)
    • Vastra Gotalands Lan
      • Goteborg, Vastra Gotalands Lan, Sweden, 413 45
        • Completed
        • Onkologiska kliniken ( Site 1217)
  • Thailand
      • Chiang Mai, Thailand, 50200
        • Active, not recruiting
        • Maharaj Nakorn Chiangmai Hospital ( Site 1453)
      • Khon Kaen, Thailand, 40002
        • Recruiting
        • Srinagarind Hospital ( Site 1454)
        • Contact:
          • Study Coordinator
          • Phone Number: +6643363225
    • Krung Thep Maha Nakhon
      • Bangkok, Krung Thep Maha Nakhon, Thailand, 10700
        • Recruiting
        • Faculty of Medicine Siriraj Hospital ( Site 1452)
        • Contact:
          • Study Coordinator
          • Phone Number: +6624194488
      • Bangkok, Krung Thep Maha Nakhon, Thailand, 10400
        • Active, not recruiting
        • Ramathibodi Hospital. ( Site 1451)
  • Turkey
      • Ankara, Turkey, 06100
        • Recruiting
        • Hacettepe Universitesi Tıp Fakultesi ( Site 0931)
        • Contact:
          • Study Coordinator
          • Phone Number: +903123055000
      • Istanbul, Turkey, 34096
        • Recruiting
        • Istanbul Universitesi Cerrahpasa Tip Fakultesi ( Site 0930)
        • Contact:
          • Study Coordinator
          • Phone Number: +905324167355
      • Istanbul, Turkey, 34722
        • Recruiting
        • TC Saglik Bakanligi Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi-oncology ( Site 0926)
        • Contact:
          • Study Coordinator
          • Phone Number: +905323430723
      • Istanbul, Turkey, 34899
        • Recruiting
        • Marmara Universitesi Pendik Egitim ve Arastirma Hastanesi ( Site 0921)
        • Contact:
          • Study Coordinator
          • Phone Number: +905333832234
      • Konya, Turkey, 42080
        • Recruiting
        • Necmettin Erbakan Universitesi Meram Tip Fakultesi Hastanesi ( Site 0929)
        • Contact:
          • Study Coordinator
          • Phone Number: +903322236000
      • Sakarya, Turkey, 54290
        • Recruiting
        • Sakarya Universitesi Tip Fakultesi ( Site 0933)
        • Contact:
          • Study Coordinator
          • Phone Number: +905054785576
      • Trabzon, Turkey, 61080
        • Recruiting
        • Karadeniz Teknik Universitesi Tip Fakultesi Farabi Hastanesi ( Site 0924)
        • Contact:
          • Study Coordinator
          • Phone Number: +905052292035
  • Ukraine
      • Kyiv, Ukraine, 03115
        • Suspended
        • Kyiv City Clinical Oncology Center ( Site 0960)
    • Cherkaska Oblast
      • Cherkasy, Cherkaska Oblast, Ukraine, 18009
        • Suspended
        • Cherkasy Regional Oncology Dispensary ( Site 0959)
    • Dnipropetrovska Oblast
      • Dnipro, Dnipropetrovska Oblast, Ukraine, 49102
        • Suspended
        • MNPE City Clinical Hospital #4 of Dnipro Regional Council ( Site 0951)
      • Dnipropetrovsk, Dnipropetrovska Oblast, Ukraine, 49005
        • Suspended
        • ME І.І. Mechnykov Dnipro Regional Clinical Hospital ( Site 0963)
    • Kharkivska Oblast
      • Kharkiv, Kharkivska Oblast, Ukraine, 61000
        • Recruiting
        • Regional Oncology Center of Kharkiv ( Site 0958)
        • Contact:
          • Study Coordinator
          • Phone Number: +380508266088
      • Kharkiv, Kharkivska Oblast, Ukraine, 61166
        • Completed
        • Municipal Non-profit Enterprise of Kharkiv Regional Council RCSDRPP ( Site 0973)
      • Kharkiv, Kharkivska Oblast, Ukraine, 61037
        • Suspended
        • MNPE V.I. Shapoval Regional Medical Clinical Urology and Nephrology Center of KharkivRegCouncil ( Si
    • Khersonska Oblast
      • Antonivka Village, Khersonska Oblast, Ukraine, 73000
        • Suspended
        • Communal nonprofit enterprise "Kherson Regional Oncology Dispensary" of Kherson Regional Council (
    • Kyivska Oblast
      • Kyiv, Kyivska Oblast, Ukraine, 03022
        • Suspended
        • SNPE National Cancer Institute ( Site 0962)
    • Lvivska Oblast
      • Lviv, Lvivska Oblast, Ukraine, 79031
        • Suspended
        • Lviv State Regional Oncological Center ( Site 0967)
      • Lviv, Lvivska Oblast, Ukraine, 79010
        • Suspended
        • MNPE Lviv Regional Clinical Hospital of Lviv Regional Council ( Site 0955)
    • Zhytomyrska Oblast
      • Zhytomyr, Zhytomyrska Oblast, Ukraine, 10002
        • Completed
        • Zhytomyr Regional Oncology Center ( Site 0971)
  • United Kingdom
      • Truro, United Kingdom, TR1 3LJ
        • Completed
        • Royal Cornwall Hospital ( Site 0727)
      • Walsall, United Kingdom, WS2 9PS
        • Completed
        • Walsall Manor Hospital-Oncology ( Site 0743)
      • Wirral, United Kingdom, CH63 4JY
        • Recruiting
        • Clatterbridge Oncology Centre ( Site 0731)
        • Contact:
          • Study Coordinator
          • Phone Number: +441513341155
    • England
      • Canterbury, England, United Kingdom, CT1 3NG
        • Completed
        • Kent and Canterbury Hospital ( Site 0733)
      • Middlesbrough, England, United Kingdom, TS4 3BW
        • Recruiting
        • The James Cook University Hospital ( Site 0730)
        • Contact:
          • Study Coordinator
          • Phone Number: +441642 850850
    • Hertfordshire
      • Stevenage, Hertfordshire, United Kingdom, SG1 4AB
        • Completed
        • Lister Hospital ( Site 0739)
    • London, City Of
      • London, London, City Of, United Kingdom, EC1A 7BE
        • Recruiting
        • Barts Health NHS Trust - St Bartholomew s Hospital ( Site 0725)
        • Contact:
          • Study Coordinator
          • Phone Number: +442078828505
      • London, London, City Of, United Kingdom, SW3 6JJ
        • Recruiting
        • The Royal Marsden Foundation Trust ( Site 0726)
        • Contact:
          • Study Coordinator
          • Phone Number: +4402078082911
      • London, London, City Of, United Kingdom, W6 8RF
        • Recruiting
        • Imperial College Healthcare NHS Trust ( Site 0745)
        • Contact:
          • Study Coordinator
          • Phone Number: +442033117627
    • Midlothian
      • Edinburgh, Midlothian, United Kingdom, EH4 2XU
        • Recruiting
        • Western General Hospital ( Site 0749)
        • Contact:
          • Study Coordinator
          • Phone Number: +441315372211
  • United States
    • Alabama
      • Mobile, Alabama, United States, 36604
        • Completed
        • University of South Alabama, Mitchell Cancer Institute ( Site 1582)
    • Arkansas
      • Little Rock, Arkansas, United States, 72205
        • Active, not recruiting
        • CARTI Cancer Center ( Site 1577)
    • California
      • Fullerton, California, United States, 92835
        • Completed
        • St. Joseph Heritage Healthcare ( Site 0046)
      • La Jolla, California, United States, 92037
        • Completed
        • Scripps MD Anderson ( Site 0010)
      • Newport Beach, California, United States, 92663
        • Recruiting
        • Hoag Memorial Hospital Presbyterian ( Site 1595)
        • Contact:
          • Study Coordinator
          • Phone Number: 949-764-4060
      • Santa Monica, California, United States, 90404
        • Completed
        • John Wayne Cancer Institute ( Site 0075)
    • Colorado
      • Aurora, Colorado, United States, 80045
        • Completed
        • University of Colorado Hospital ( Site 0098)
    • District of Columbia
      • Washington, District of Columbia, United States, 20007
        • Completed
        • Georgetown University Medical Center ( Site 0022)
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Completed
        • Emory School of Medicine ( Site 0006)
    • Illinois
      • Chicago, Illinois, United States, 60637
        • Active, not recruiting
        • University of Chicago ( Site 0068)
      • Chicago, Illinois, United States, 60612
        • Completed
        • John H. Stroger Jr. Hospital of Cook County ( Site 1551)
    • Indiana
      • Fort Wayne, Indiana, United States, 46845
        • Recruiting
        • Parkview Cancer Institute ( Site 0077)
        • Contact:
          • Study Coordinator
          • Phone Number: 833-724-8326
      • Indianapolis, Indiana, United States, 46202
        • Recruiting
        • Indiana University Melvin and Bren Simon Comprehensive Cancer Center ( Site 0004)
        • Contact:
          • Study Coordinator
          • Phone Number: 317-274-7477
    • Kansas
      • Wichita, Kansas, United States, 67226
        • Completed
        • Wichita Urology Group ( Site 0059)
    • Louisiana
      • New Orleans, Louisiana, United States, 70112
        • Active, not recruiting
        • Tulane University School of Medicine ( Site 0088)
    • Maine
      • Scarborough, Maine, United States, 04074
        • Active, not recruiting
        • New England Cancer Specialists ( Site 0070)
    • Maryland
      • Baltimore, Maryland, United States, 21204
        • Active, not recruiting
        • Greater Baltimore Medical Center ( Site 0014)
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Recruiting
        • Dana-Farber Cancer Institute ( Site 1596)
        • Contact:
          • Study Coordinator
          • Phone Number: 111-111-1111
    • Minnesota
      • Burnsville, Minnesota, United States, 55337
        • Completed
        • M Health Fairview Ridges Hospital ( Site 1555)
    • New Jersey
      • Morristown, New Jersey, United States, 07960
        • Active, not recruiting
        • Morristown Medical Center ( Site 0015)
    • New Mexico
      • Albuquerque, New Mexico, United States, 87106
        • Active, not recruiting
        • UNM Comprehensive Cancer Center-Clinical Research Office ( Site 0045)
    • New York
      • Lake Success, New York, United States, 11042
        • Completed
        • Northwell Health - Monter Cancer Center ( Site 0083)
      • New York, New York, United States, 10016
        • Active, not recruiting
        • New York University Perlmutter Cancer Center ( Site 0008)
      • New York, New York, United States, 10029
        • Recruiting
        • Icahn School of Medicine at Mount Sinai ( Site 0031)
        • Contact:
          • Study Coordinator
          • Phone Number: 212-659-5452
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Recruiting
        • Cleveland Clinic ( Site 1576)
        • Contact:
          • Study Coordinator
          • Phone Number: 866-223-8100
    • Oklahoma
      • Tulsa, Oklahoma, United States, 74146
        • Completed
        • Oklahoma Cancer Specialists and Research Institute, LLC ( Site 0021)
    • Oregon
      • Portland, Oregon, United States, 97213
        • Completed
        • Providence Portland Medical Center [Portland, OR] ( Site 0095)
    • Pennsylvania
      • Bala-Cynwyd, Pennsylvania, United States, 19004
        • Completed
        • MidLantic Urology ( Site 0089)
      • Philadelphia, Pennsylvania, United States, 19104
        • Completed
        • Abramson Cancer Center of the University of Pennsylvania ( Site 0074)
      • Philadelphia, Pennsylvania, United States, 19107
        • Active, not recruiting
        • Thomas Jefferson University ( Site 1579)
      • Philadelphia, Pennsylvania, United States, 19111
        • Completed
        • Fox Chase Cancer Center ( Site 0055)
      • Pittsburgh, Pennsylvania, United States, 15212
        • Completed
        • Allegheny General Hospital ( Site 0048)
    • South Carolina
      • Greenville, South Carolina, United States, 29607
        • Active, not recruiting
        • Bon Secours St. Francis Health System ( Site 1572)
      • Myrtle Beach, South Carolina, United States, 29572
        • Recruiting
        • Carolina Urologic Research Center ( Site 0062)
        • Contact:
          • Study Coordinator
          • Phone Number: 8434491010257
    • Tennessee
      • Nashville, Tennessee, United States, 37209
        • Recruiting
        • Urology Associates [Nashville, TN] ( Site 0053)
        • Contact:
          • Study Coordinator
          • Phone Number: 615-250-9268
      • Nashville, Tennessee, United States, 37232
        • Active, not recruiting
        • Vanderbilt University Medical Center ( Site 0017)
    • Texas
      • Dallas, Texas, United States, 75246
        • Completed
        • Texas Oncology-Baylor Sammons Cancer Center ( Site 1552)
    • Virginia
      • Fairfax, Virginia, United States, 22031
        • Recruiting
        • Inova Schar Cancer Institute ( Site 0007)
        • Contact:
          • Study Coordinator
          • Phone Number: 571-472-0623
    • West Virginia
      • Charleston, West Virginia, United States, 25304
        • Active, not recruiting
        • Charleston Area Medical Center ( Site 0023)

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/muscle-invasive bladder cancer [MIBC] (cT2-T4aN0M0 or T1-T4aN1M0) with predominant (≥50%) urothelial histology to be confirmed by Blinded Independent Central Review (BICR) (central pathology and/or imaging).
  • Clinically nonmetastatic bladder cancer determined by imaging
  • Eligible for radical cystectomy (RC) + pelvic lymph node dissection (PLND), and agreement to undergo curative intent standard RC + PLND (including prostatectomy if applicable)

  • Ineligible for treatment with cisplatin, as defined by meeting at least one of the following criteria OR be eligible for treatment with cisplatin but decline treatment with cisplatin-based chemotherapy:

    • Impaired renal function with measured or calculated creatinine clearance (CrCl) 30 to 59 mL/min (calculated by Cockcroft-Gault method, Modification of Diet of Renal Disease [MDRD] equations, or measured by 24-hour urine collection)
    • Eastern Cooperative Oncology Group (ECOG) Performance Status 2
    • Common Terminology Criteria for Adverse Events (CTCAE) v.4 Grade ≥2 audiometric hearing loss
    • New York Heart Association (NYHA) Class III heart failure
  • Transurethral resection (TUR) of a bladder tumor that is submitted for central pathology assessment and adequate to determine urothelial histology and PD-L1 expression assessment
  • ECOG performance status of 0, 1, or 2
  • Adequate organ function
  • A male participant is eligible to participate if he agrees to use contraception and refrain from donating sperm during the intervention period and for at least 180 days after the last dose of enfortumab vedotin. If the male participants are receiving pembrolizumab only or undergoing surgery only, there are no contraception requirements
  • A female participant is eligible to participate if she is not pregnant, not breastfeeding, and at least 1 of the following conditions applies: Not a (woman of childbearing potential) WOCBP or a WOCBP who agrees to use a highly effective contraceptive method or be abstinent from heterosexual intercourse (as their preferred and usual lifestyle) during the intervention period and for at least 120 days after the last dose of pembrolizumab and at least 180 days after the last dose of enfortumab vedotin; whichever comes last. A female participant must agree not to donate eggs during this period as well
  • A WOCBP must have a negative highly sensitive pregnancy test within 24 hours before the first dose of study intervention

Exclusion Criteria:

  • Known additional nonurothelial malignancy that is progressing or has required active anticancer treatment ≤3 years of study randomization, with certain exceptions
  • Has ≥ N2 or metastatic disease (M1) as identified by imaging
  • Received any prior systemic treatment, chemoradiation, and/or radiation therapy for for muscle-invasive bladder cancer (MIBC) or non-muscle invasive bladder cancer (NMIBC)
  • Received prior therapy with an anti-programmed cell death protein 1 (PD-1), anti-programmed death-ligand 1 (PD-L1), or anti-programmed cell death 1 ligand 2 (PD-L2), or with an agent directed to another stimulatory or coinhibitory T-cell receptor
  • Received prior systemic anticancer therapy including investigational agents within 3 years prior to randomization
  • Received any prior radiotherapy to the bladder
  • Received a partial cystectomy of the bladder to remove any non-muscle-invasive bladder cancer (NMIBC) or MIBC
  • Received a live or live-attenuated vaccine within 30 days before the first dose of study intervention
  • Current participation in or participation in a study of an investigational agent or use of an investigational device within 4 weeks prior to the first dose of study intervention
  • Ongoing sensory or motor neuropathy Grade 2 or higher
  • Diagnosis of immunodeficiency or receipt of chronic systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior the first dose of study drug. Physiologic replacement doses of corticosteroids are permitted for participants with adrenal insufficiency.
  • Hypersensitivity to monoclonal antibodies (including pembrolizumab) and/or any of their excipients
  • Severe hypersensitivity (≥ Grade 3) to enfortumab vedotin or any excipient contained in the drug formulation of enfortumab vedotin
  • Active keratitis or corneal ulcerations. Participants with superficial punctate keratitis are allowed if the disorder is being adequately treated in the opinion of the investigator
  • Active autoimmune disease that has required systemic therapy in past 2 years (i.e., with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic therapy and is allowed
  • Has uncontrolled diabetes
  • History of (noninfectious) pneumonitis that required steroids, or current pneumonitis
  • Active infection requiring systemic therapy
  • Has had an allogeneic tissue/solid organ transplant

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: Pembrolizumab + Surgery
Participants receive 3 preoperative cycles of pembrolizumab, followed by standard of care surgery, followed by 14 cycles of postoperative pembrolizumab. Each cycle is 21 days.
Drug: Pembrolizumab
Pembrolizumab 200 mg by intravenous (IV) infusion, given on Day 1 of each 21-day cycle.
Other Names:
  • MK-3475
  • KEYTRUDA®
Procedure: 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.
Active Comparator: Arm B: Surgery alone
Participants receive standard of care surgery alone.
Procedure: 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.
Experimental: Arm C: Enfortumab Vedotin + Pembrolizumab + Surgery
Participants receive 3 preoperative cycles of enfortumab vedotin + pembrolizumab, followed by standard of care surgery, followed by 6 cycles of postoperative enfortumab vedotin + pembrolizumab, followed by 8 cycles of pembrolizumab alone. Each cycle is 21 days.
Drug: Enfortumab Vedotin
Enfortumab vedotin 1.25 mg/kg by intravenous (IV) infusion, given on Days 1 and 8 of each 21-day cycle.
Other Names:
  • ASG-22CE
  • ASG-22ME
  • Padcev

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Event-Free Survival (EFS) between Arm C and Arm B
Time Frame: Up to approximately 7.7 years
EFS is defined as the time from randomization to the first occurrence of any of the following events: progression of disease that precludes RC surgery or failure to undergo RC surgery in participants with residual disease, gross residual disease left behind at the time of surgery, local or distant recurrence as assessed by imaging and/or biopsy, or death due to any cause.
Up to approximately 7.7 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
EFS between Arm A and Arm B
Time Frame: Up to approximately 7.7 years
EFS is defined as the time from randomization to the first occurrence of any of the following events: progression of disease that precludes RC surgery or failure to undergo RC surgery in participants with residual disease, gross residual disease left behind at the time of surgery, local or distant recurrence as assessed by imaging and/or biopsy, or death due to any cause.
Up to approximately 7.7 years
Overall Survival (OS) between Arm C and Arm B
Time Frame: Up to approximately 8.4 years
OS is defined as the time from randomization to death due to any cause.
Up to approximately 8.4 years
OS between Arm A and Arm B
Time Frame: Up to approximately 8.4 years
OS is defined as the time from randomization to death due to any cause.
Up to approximately 8.4 years
Pathologic Complete Response (pCR) Rate between Arm C and Arm B
Time Frame: Up to approximately 5.7 years
Pathologic complete response rate is defined as the percentage of participants having pCR. pCR is defined as absence of viable tumor (pT0N0) in examined tissue from RC and PLND, as determined centrally.
Up to approximately 5.7 years
pCR Rate between Arm A and Arm B
Time Frame: Up to approximately 5.7 years
Pathologic complete response rate is defined as the percentage of participants having pCR. pCR is defined as absence of viable tumor (pT0N0) in examined tissue from RC and PLND, as determined centrally.
Up to approximately 5.7 years
Disease-Free Survival (DFS)
Time Frame: Up to approximately 7.7 years

DFS is defined as the time from first post-surgery baseline scan until:

  • local or distant recurrence as assessed by imaging and/or biopsy
  • Death due to any cause
Up to approximately 7.7 years
Pathologic Downstaging (pDS) Rate between Arm A and Arm B
Time Frame: Up to approximately 5.7 years
Pathologic downstaging rate is defined as the percentage of participants having pDS. pDS is defined as participants with a tumor classification of <pT2 (includes pT0, pTis, pTa, pT1) and N0 in examined tissue from RC and PLND.
Up to approximately 5.7 years
pDS Rate between Arm C and Arm B
Time Frame: Up to approximately 5.7 years
Pathologic downstaging rate is defined as the percentage of participants having pDS. pDS is defined as participants with a tumor classification of <pT2 (includes pT0, pTis, pTa, pT1) and N0 in examined tissue from RC and PLND.
Up to approximately 5.7 years
Number of Participants Experiencing Adverse Events (AEs)
Time Frame: Up to approximately 8.4 years
An AE is defined as any unfavorable and unintended sign, symptom, or disease (new or worsening) temporally associated with the use of study therapy, regardless of whether or not a causal relationship with the study therapy can be determined.
Up to approximately 8.4 years
Number of Participants Discontinuing Study Drug Due to Adverse Events (AEs)
Time Frame: Up to approximately 1 year
An AE is defined as any unfavorable and unintended sign, symptom, or disease (new or worsening) temporally associated with the use of study therapy, regardless of whether or not a causal relationship with the study therapy can be determined.
Up to approximately 1 year
Number of Participants Experiencing Perioperative Complications
Time Frame: Up to approximately 1 year
The number of participants who experience perioperative complications will be presented.
Up to approximately 1 year

Collaborators and Investigators

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

Sponsor

Merck Sharp & Dohme LLC

Collaborators

Seagen Inc.
Astellas Pharma Global Development, 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.

General Publications

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)

July 24, 2019

Primary Completion (Estimated)

May 31, 2027

Study Completion (Estimated)

December 15, 2027

Study Registration Dates

First Submitted

April 22, 2019

First Submitted That Met QC Criteria

April 22, 2019

First Posted (Actual)

April 23, 2019

Study Record Updates

Last Update Posted (Actual)

April 5, 2024

Last Update Submitted That Met QC Criteria

April 4, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 3475-905
  • MK-3475-905 (Other Identifier: Merck)
  • KEYNOTE-905 (Other Identifier: Merck)
  • EV-303 (Other Identifier: Astellas Protocol Number)
  • PHRR210911-003890 (Other Identifier: Philippine Health Research Registry (PHRR))
  • 2018-003809-26 (EudraCT Number)
  • jRCT2031220686 (Registry Identifier: Japan Registry of Clinical Trials (jRCT))

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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