AzTrials
AzTrials

Bladder CancerPhase 3KEYNOTE-B15NCT04700124

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)

A Phase 3 study testing Pembrolizumab, Enfortumab vedotin (EV) and RC + PLND in people with Bladder Cancer, run by Merck Sharp & Dohme LLC at 188 sites in 29 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial summary

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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Bladder Cancer
What is being tested?
Pembrolizumab, Enfortumab vedotin (EV) and RC + PLND
Could I receive a placebo?
No, everyone receives an active treatment
How many people
808 participants
Where
188 sitesin 29 countries
Study dates
21 Apr 2021to 18 May 2028
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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
Show all 13Show fewer
  • 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

Trial locations and contacts

188 sites in 29 countries.

188 sites in 29 countries

United States22 sites

  • University of Colorado, Anschutz Cancer Pavilion ( Site 0009)

    Aurora, Colorado, 80045

  • MidLantic Urology ( Site 0002)

    Bala-Cynwyd, Pennsylvania, 19004

  • UT Southwestern Medical Center ( Site 0003)

    Dallas, Texas, 75390

  • Duke University Medical Center ( Site 0017)

    Durham, North Carolina, 27710

  • St Joseph Heritage Healthcare-Oncology ( Site 0035)

    Fullerton, California, 92835

  • UF Health ( Site 0031)

    Gainesville, Florida, 32608

  • Saint Francis Cancer Center ( Site 0008)

    Greenville, South Carolina, 29607

  • Houston Methodist Urology Associates ( Site 0033)

    Houston, Texas, 77030

  • Indiana University Melvin and Bren Simon Cancer Center ( Site 0050)

    Indianapolis, Indiana, 46202

  • University of Iowa Hospital and Clinics ( Site 0029)

    Iowa City, Iowa, 52242

  • The University of Tennessee Medical Center ( Site 0034)

    Knoxville, Tennessee, 37920

  • UCLA Hematology/Oncology - Westwood (Building 200 Suite 140)-Department of Urology/Institute of Uro ( Site 0005)

    Los Angeles, California, 90095

  • University of Louisville, James Graham Brown Cancer Center ( Site 0022)

    Louisville, Kentucky, 40202

  • University of Wisconsin Hospital and Clinics ( Site 0037)

    Madison, Wisconsin, 53792

  • Icahn School of Medicine at Mount Sinai ( Site 0011)

    New York, New York, 10029

  • Mayo Clinic in Arizona - Phoenix ( Site 0043)

    Phoenix, Arizona, 85054

  • Oregon Health and Science University ( Site 0028)

    Portland, Oregon, 97239-3011

  • Urology of San Antonio ( Site 0020)

    San Antonio, Texas, 78229

  • University of California San Francisco ( Site 0010)

    San Francisco, California, 94158

  • Stanford University ( Site 0023)

    Stanford, California, 94305

  • White Plains Hospital ( Site 0039)

    White Plains, New York, 10601

  • Wake Forest Baptist Health ( Site 0014)

    Winston-Salem, North Carolina, 27157

Other trials in United States

Japan17 sites

  • Gifu University Hospital ( Site 1513)

    Gifu, 501-1194

  • Hamamatsu University Hospital ( Site 1511)

    Hamamatsu, Shizuoka, 431-3192

  • Hirosaki University Hospital ( Site 1501)

    Hirosaki, Aomori, 036-8563

  • Kanazawa University Hospital ( Site 1509)

    Kanazawa, Ishikawa-ken, 920-8641

  • Nagasaki University Hospital ( Site 1517)

    Nagasaki, 852-8510

  • Nagoya University Hospital ( Site 1512)

    Nagoya, Aichi-ken, 466-8560

  • Okayama University Hospital ( Site 1516)

    Okayama, 700-8558

  • Osaka Prefectural Hospital Organization Osaka International Cancer Institute ( Site 1514)

    Osaka, 541-8567

  • Osaka Metropolitan University Hospital ( Site 1515)

    Osaka, 545-8586

  • Kitasato University Hospital ( Site 1506)

    Sagamihara, Kanagawa, 252-0375

  • Tohoku University Hospital ( Site 1503)

    Sendai, Miyagi, 980-8574

  • Institute of Science Tokyo Hospital ( Site 1505)

    Tokyo, 113-8519

  • Keio University Hospital ( Site 1504)

    Tokyo, 160-8582

  • Toyama University Hospital ( Site 1510)

    Toyama, 930-0194

  • University of Tsukuba Hospital ( Site 1502)

    Tsukuba, Ibaraki, 305-8576

  • Yokohama City University Medical Center ( Site 1508)

    Yokohama, Kanagawa, 232-0024

  • Kanagawa Cancer Center ( Site 1507)

    Yokohama, Kanagawa, 241-8515

Other trials in Japan

Russia11 sites

  • Altay Regional Oncology Dispensary ( Site 0851)

    Barnaul, Altayskiy Kray, 656045

  • National Medical Research Centre of Oncology named after N.N. Blokhin ( Site 0865)

    Moscow, Moscow, 115230

  • First Moscow State Medical University n.a. I.M.Sechenov ( Site 0871)

    Moscow, Moscow, 119991

  • Volga District Medical Center ( Site 0876)

    Nizhny Novgorod, Nizhny Novgorod Oblast, 603074

  • National Medical Research Radiology Centre ( Site 0869)

    Obninsk, Kaluzskaja Oblast, 249036

  • St.Petersburg Clinical Hospital RAS ( Site 0864)

    Saint Petersburg, Sankt-Peterburg, 194017

  • St.Petersburg State Medical Univ. n.a. acad. I.P.Pavlov ( Site 0856)

    Saint Petersburg, Sankt-Peterburg, 197101

  • Scientific Research Oncology Institute n.a. N.N.Petrov ( Site 0852)

    Saint Petersburg, Sankt-Peterburg, 197758

  • Volgograd Regional Uronephrological Center ( Site 0870)

    Volzhsky, Volgograd Oblast, 404120

  • Sverdlovsk Regional Oncology Hospital ( Site 0867)

    Yekaterinburg, Sverdlovsk Oblast, 620036

  • Sverdlovsky Regional Clinical hospital #1 ( Site 0868)

    Yekaterinburg, Sverdlovsk Oblast, 620102

Other trials in Russia

France10 sites

  • CHU Jean Minjoz ( Site 0453)

    Besançon, Doubs, 25000

  • C.H. regional Unv. de Brest - Hopital La Cavale Blanche - Institut de Cancerologie et d Imagerie ( Site 0461)

    Brest, Finistere, 29200

  • CHU GRENOBLE ALPES ( Site 0468)

    La Tronche, Isere, 38700

  • Polyclinique du Bois ( Site 0458)

    Lille, Nord, 59000

  • CHU Limoges Hopital Dupuytren ( Site 0459)

    Limoges, Haute-Vienne, 87042

  • CHU La Timone ( Site 0456)

    Marseille, Bouches-du-Rhone, 13005

  • Centre Hospitalier Regional du Orleans ( Site 0463)

    Orléans, Loiret, 45067

  • Hopital Diaconesses Croix Saint Simon ( Site 0465)

    Paris, 75960

  • Institut Universitaire du Cancer Toulouse - Oncopole ( Site 0455)

    Toulouse, Haute-Garonne, 31059

  • Gustave Roussy ( Site 0467)

    Villejuif, Île-de-France Region, 94805

Other trials in France

Spain10 sites

  • Hospital Germans Trias i Pujol. ICO de Badalona ( Site 0658)

    Badalona, Barcelona, 08916

  • Hospital Universitari Vall d'Hebron-Departamento de Oncologia- VHIO ( Site 0661)

    Barcelona, 08035

  • Institut Català d'Oncologia (ICO) - Girona ( Site 0653)

    Girona, Gerona, 17007

  • Hospital Universitario Insular de Gran Canaria ( Site 0657)

    Las Palmas de Gran Canaria, Las Palmas, 35016

  • Hospital Clinico Universitario San Carlos de Madrid ( Site 0651)

    Madrid, 28040

  • Xarxa Assistencial Universitaria Manresa ( Site 0655)

    Manresa, Barcelona, 08243

  • Hospital Universitario Central de Asturias ( Site 0654)

    Oviedo, Principality of Asturias, 33011

  • CHUS - Hospital Clinico Universitario-Servicio de Oncologia ( Site 0660)

    Santiago de Compostela, La Coruna, 15706

  • Hospital Virgen del Rocio ( Site 0659)

    Seville, 41013

  • Fundación Instituto Valenciano de Oncología-Oncologico ( Site 0662)

    Valencia, Valenciana, Comunitat, 46009

Other trials in Spain

Germany9 sites

  • Vivantes Klinikum Am Urban ( Site 0519)

    Berlin, 10967

  • Universitaetsklinikum Carl Gustav Carus ( Site 0509)

    Dresden, Saxony, 01307

  • Universitaetsklinikum Freiburg ( Site 0512)

    Freiburg im Breisgau, Baden-Wurttemberg, 79106

  • Krankenhaus Martha Maria Halle-Doelau ( Site 0507)

    Halle, Saxony-Anhalt, 06120

  • Kath. Krankenhaus Marienhospital. Universitaetsklinik ( Site 0511)

    Herne, North Rhine-Westphalia, 44625

  • Universitaetsklinikum Muenster ( Site 0516)

    Münster, North Rhine-Westphalia, 48149

  • Caritas Krankenhaus St. Josef ( Site 0502)

    Regensburg, Bavaria, 93053

  • Universitaetsklinik fuer Urologie ( Site 0501)

    Tübingen, Baden-Wurttemberg, 72076

  • Universitaetsklinikum Wuerzburg ( Site 0520)

    Würzburg, Bavaria, 97080

Other trials in Germany

Italy8 sites

  • Azienda Ospedaliero Universitaria delle Marche-Clinica Oncologica ( Site 0593)

    Ancona, 60126

  • Ospedale Cannizzaro ( Site 0590)

    Catania, 95126

  • Fondazione IRCCS Istituto Nazionale dei Tumori-Struttura Complessa Oncologia Medica 1 ( Site 0588)

    Milan, Lombardy, 20133

  • IRCCS Ospedale San Raffaele ( Site 0596)

    Milan, 20132

  • AOU San Luigi Gonzaga di Orbassano ( Site 0595)

    Orbassano, Torino, 10043

  • Istituto Oncologico Veneto IRCCS-Oncologia Medica 1 ( Site 0600)

    Padova, 35128

  • Presidio Ospedaliero Santa Maria delle Grazie ( Site 0599)

    Pozzuoli, Napoli, 80078

  • Azienda Ospedaliera Universitaria Integrata Verona - Ospedale Borgo Trento ( Site 0598)

    Verona, Veneto, 37126

Other trials in Italy

Romania8 sites

  • MEMORIAL HEALTHCARE INTERNATIONAL S.R.L. ( Site 1104)

    Bucharest, Bucharest, 013823

  • Cardiomed SRL Cluj-Napoca ( Site 1101)

    Cluj-Napoca, Cluj, 400015

  • Institutul Oncologic Prof.Dr. Ion Chiricuta Cluj-Napoca ( Site 1102)

    Cluj-Napoca, Cluj, 400015

  • Institutul Oncologic Prof.Dr. Ion Chiricuta Cluj-Napoca ( Site 1103)

    Cluj-Napoca, Cluj, 400015

  • Institutul Oncologic Cluj-Oncologie Medicala ( Site 1109)

    Cluj-Napoca, 400015

  • SC Radiotherapy Center Cluj SRL ( Site 1108)

    Comuna Floresti, Cluj, 407280

  • S.C. Centrul de Oncologie Sf. Nectarie SRL ( Site 1107)

    Craiova, Dolj, 200542

  • Policlinica Oncomed SRL ( Site 1106)

    Timișoara, Timiș County, 300239

Other trials in Romania

China7 sites

  • Hunan Cancer Hospital ( Site 1403)

    Changsha, Hunan, 410013

  • SUN YAT-SEN UNIVERSITY CANCER CENTRE ( Site 1406)

    Guangzhou, Guangdong, 510060

  • Sun Yat-sen Memorial Hospital, Sun Yat-sen University ( Site 1413)

    Guangzhou, Guangdong, 510220

  • Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School-Urology ( Site 1404)

    Nanjing, Jiangsu, 210008

  • Nantong Tumor Hospital-Urology ( Site 1405)

    Nantong, Jiangsu, 226361

  • Fudan University Shanghai Cancer Center-Urology department ( Site 1401)

    Shanghai, Shanghai Municipality, 200032

  • Renji Hospital Shanghai Jiao Tong University School of Medicine ( Site 1402)

    Shanghai, Shanghai Municipality, 200127

Other trials in China

Israel7 sites

  • Rambam Health Care Campus-Oncology ( Site 0751)

    Haifa, 3109601

  • Hadassah Medical Center-Oncology ( Site 0757)

    Jerusalem, 9112001

  • Meir Medical Center-oncology ( Site 0754)

    Kfar Saba, 4428164

  • Rabin Medical Center-Oncology ( Site 0752)

    Petah Tikva, 4941492

  • Sheba Medical Center-ONCOLOGY ( Site 0753)

    Ramat Gan, 5265601

  • Sourasky Medical Center-Oncology ( Site 0755)

    Tel Aviv, 6423906

  • Yitzhak Shamir Medical Center-Oncology ( Site 0756)

    Tsrifin, 70300

Other trials in Israel

South Korea7 sites

  • Kyungpook National University Chilgok Hospital ( Site 1354)

    Daegu, Taegu-Kwangyokshi, 41404

  • Seoul National University Bundang Hospital ( Site 1355)

    Gyeonggi-do, Kyonggi-do, 13620

  • Gachon University Gil Medical Center ( Site 1356)

    Incheon, 21565

  • Chonnam National University Hwasun Hospital ( Site 1353)

    Jeollanam-do, Jeonranamdo, 58128

  • Korea University Anam Hospital ( Site 1357)

    Seoul, 02841

  • Seoul National University Hospital ( Site 1351)

    Seoul, 03080

  • Asan Medical Center ( Site 1352)

    Songpagu, Seoul, 05505

Other trials in South Korea

Ukraine7 sites

  • I.I. Mechnykov Dnipropetrovsk Regional Clinical Hospital ( Site 0959)

    Dnipro, Dnipropetrovsk Oblast, 49005

  • MI Clinical oncology dispensary of Dnipropetrovsk regional council ( Site 0954)

    Dnipro, Dnipropetrovsk Oblast, 49055

  • Regional Clinical Center of Urology and Nephrology n.a. V.I. Shapoval ( Site 0952)

    Kharkiv, Kharkiv Oblast, 61037

  • MNPE Regional Center of Oncology ( Site 0955)

    Kharkiv, Kharkiv Oblast, 61070

  • Municipal Non-profit Enterprise of Kharkiv Regional Council RCSDRPP ( Site 0965)

    Kharkiv, Kharkiv Oblast, 61166

  • Lviv Oncology Regional Treatment and Diagnostic Center ( Site 0960)

    Lviv, Lviv Oblast, 79031

  • Zhytomyr Regional Oncology Center ( Site 0961)

    Zhytomyr, Zhytomyr Oblast, 10002

Other trials in Ukraine

Argentina6 sites

  • Hospital Italiano de Buenos Aires ( Site 1554)

    ABB, Buenos Aires F.D., C1199ABB

  • Asociación de Beneficencia Hospital Sirio Libanés ( Site 1553)

    Buenos Aires, Buenos Aires F.D., C1419AHN

  • Centro de Educación Médica e Investigaciones Clínicas (CEMIC) ( Site 1558)

    Buenos Aires, Buenos Aires F.D., C1431FWO

  • Centro de Urología (CDU) ( Site 1552)

    Buenos Aires, 1120

  • Hospital Británico de Buenos Aires-Oncology ( Site 1551)

    Ciudad Autónoma de Buenos Aires, Buenos Aires, C1280AEB

  • Fundacion Estudios Clinicos-Oncology ( Site 1557)

    Rosario, Santa Fe Province, S2000DEJ

Other trials in Argentina

Poland6 sites

  • Szpital Wojewodzki im. Mikolaja Kopernika ( Site 1055)

    Koszalin, West Pomeranian Voivodeship, 75-581

  • Clinical Research Center Medic-R ( Site 1061)

    Poznan, Greater Poland Voivodeship, 61-731

  • Wojewodzki Szpital im. Sw. Ojca Pio w Przemyslu ( Site 1053)

    Przemyśl, Podkarpackie Voivodeship, 37-700

  • Mazowiecki Szpital Wojewódzki w Siedlcach-Siedleckie Centrum Onkologii ( Site 1057)

    Siedlce, Masovian Voivodeship, 08-110

  • Narodowy Instytut Onkologii ( Site 1051)

    Warsaw, Masovian Voivodeship, 02-781

  • Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wrocławiu ( Site 1058)

    Wrocław, Silesian Voivodeship, 50556

Other trials in Poland

Canada5 sites

  • Moncton Hospital ( Site 0107)

    Moncton, New Brunswick, E1C 6Z8

  • Département clinique de médecine de laboratoire du CHUM ( Site 0106)

    Montreal, Quebec, H3T 1E2

  • Ottawa Hospital Research Institute ( Site 0109)

    Ottawa, Ontario, K1H 8L6

  • BC Cancer - Vancouver Center ( Site 0110)

    Vancouver, British Columbia, V5Z 4E6

  • CancerCare Manitoba ( Site 0108)

    Winnipeg, Manitoba, R3E 0V9

Other trials in Canada

Colombia5 sites

  • Clinica Colsanitas S.A, Sede Clínica Universitaria Colombia-Center Investigator ( Site 1654)

    Bogotá, Bogota D.C., 111321

  • Fundación Valle del Lili ( Site 1656)

    Cali, Valle del Cauca Department, 760032

  • Fundacion Colombiana de Cancerología Clinica Vida ( Site 1653)

    Medellín, Antioquia, 050030

  • IMAT S.A.S ( Site 1652)

    Montería, Departamento de Córdoba, 230002

  • Fundacion Cardiovascular de Colombia ( Site 1657)

    Piedecuesta, Santander Department, 681017

Other trials in Colombia

Greece5 sites

  • General Hospital of Athens "Alexandra" ( Site 0303)

    Athens, Attica, 115 28

  • Athens Medical Center ( Site 0304)

    Athens, Attica, 151 25

  • ATTIKON GENERAL UNIVERSITY HOSPITAL ( Site 0301)

    Chaïdári, Attica, 124 62

  • University General Hospital of Larissa ( Site 0302)

    Larissa, Thessaly, 411 10

  • UNIVERSITY HOSPITAL OF PATRAS-DIVISION OF ONCOLOGY ( Site 0305)

    Pátrai, Achaia, 26504

Other trials in Greece

Australia4 sites

  • Lyell McEwin Hospital ( Site 1252)

    Elizabeth Vale, South Australia, 5112

  • Frankston Hospital-Oncology and Haematology ( Site 1258)

    Frankston, Victoria, 3199

  • Macquarie University-MQ Health Clinical Trials Unit ( Site 1259)

    Macquarie University, New South Wales, 2109

  • Mater Hospital Brisbane ( Site 1257)

    South Brisbane, Queensland, 4101

Other trials in Australia

Bulgaria4 sites

  • MHAT "Uni Hospital" OOD ( Site 1154)

    Panagyurishte, Pazardzhik, 4500

  • Complex Oncology Center Plovdiv ( Site 1151)

    Plovdiv, 4000

  • MHAT Central Onco Hospital OOD ( Site 1158)

    Plovdiv, 4000

  • MHAT Serdika ( Site 1152)

    Sofia, 1632

Other trials in Bulgaria

Croatia4 sites

  • Klinički bolnički centar Osijek ( Site 1705)

    Osijek, County of Osijek-Baranja, 31000

  • Klinički Bolnički Centar Split-Oncology and Radiotherapy ( Site 1702)

    Split, Split-Dalmatia County, 21000

  • Klinički bolnički centar Sestre milosrdnice ( Site 1703)

    Zagreb, City of Zagreb, 10000

  • Klinički bolnički centar Zagreb-Klinika za onkologiju ( Site 1701)

    Zagreb, City of Zagreb, 10000

Other trials in Croatia

Czechia4 sites

  • Fakultni nemocnice u sv. Anny v Brne ( Site 0253)

    Brno, South Moravian, 656 91

  • Fakultni nemocnice Hradec Kralove-Klinika onkologie a radioterapie ( Site 0254)

    Hradec Králové, 500 05

  • Fakultni Nemocnice Olomouc ( Site 0251)

    Olomouc, 77900

  • Fakultni Thomayerova nemocnice ( Site 0252)

    Prague, 140 59

Other trials in Czechia

Malaysia4 sites

  • Hospital Pulau Pinang ( Site 0355)

    George Town, Pulau Pinang, 10450

  • Sarawak General Hospital ( Site 0351)

    Kuching, Sarawak, 93586

  • University Malaya Medical Centre ( Site 0352)

    Lembah Pantai, Kuala Lumpur, 59100

  • Sunway Medical Centre ( Site 0353)

    Petaling Jaya, Selangor, 47500

Other trials in Malaysia

Portugal4 sites

  • Unidade Local de Saude de Coimbra - Hospitais da Universidade de Coimbra ( Site 0406)

    Coimbra, 3000-075

  • Inst. Portugues de Oncologia de Lisboa Francisco Gentil EPE ( Site 0409)

    Lisbon, 1099-023

  • Unidade Local de Saude Lisboa Ocidental - Hospital de São Francisco Xavier ( Site 0401)

    Lisbon, 1449-005

  • Unidade Local de Saude de Santo António - Hospital Santo António ( Site 0408)

    Porto, 4099-001

Other trials in Portugal

Hungary3 sites

  • Debreceni Egyetem Klinikai Kozpont ( Site 1006)

    Debrecen, 4032

  • Szegedi Tudományegyetem Szent-Györgyi Albert Klinikai Központ ( Site 1010)

    Szeged, Csongrád megye, 6720

  • Jász-Nagykun-Szolnok Vármegyei Hetényi Géza Kórház ( Site 1002)

    Szolnok, Jász-Nagykun-Szolnok, 5004

Other trials in Hungary

South Africa3 sites

  • Groote Schuur Hospital ( Site 0602)

    Cape Town, Western Cape, 7925

  • Wits Clinical Research ( Site 0603)

    Johannesburg, Gauteng, 2193

  • Steve Biko Academic Hospital ( Site 0601)

    Pretoria, Gauteng, 0002

Other trials in South Africa

Taiwan3 sites

  • Chang Gung Memorial Hospital at Kaohsiung ( Site 1203)

    Kaohsiung City, 83301

  • China Medical University Hospital ( Site 1202)

    Taichung, 404332

  • Taipei Veterans General Hospital ( Site 1201)

    Taipei, 112

Other trials in Taiwan

United Kingdom3 sites

  • Charing Cross Hospital-Oncology Research ( Site 1802)

    London, Hammersmith and Fulham, W6 8RF

  • St Bartholomew's Hospital-Centre for Experimental Cancer Medicine ( Site 1801)

    London, London, City of, EC1A 7BE

  • Torbay Hospital ( Site 1804)

    Torquay, Devon, TQ2 7AA

Other trials in United Kingdom

Philippines1 site

  • THE MEDICAL CITY ILOILO-The Medical City Iloilo - Clinical and Translational Research Institute-Ilo ( Site 0801)

    Iloilo City, Iloilo, 5000

Other trials in Philippines

Singapore1 site

  • Tan Tock Seng Hospital ( Site 0704)

    Singapore, Central Singapore, 308442

Other trials in Singapore

About this study

Official title: 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).

Conditions
Bladder Cancer
Being tested
Pembrolizumab, Enfortumab vedotin (EV), RC + PLND, Gemcitabine, Cisplatin
Keywords
Programmed cell death 1 (PD-1), Programmed Death-Ligand 1 (PD-L1), Programmed Death-Ligand 2 (PD-L2), Pelvic Lymph Node Dissection (PLND), Radical Cystectomy (RC)
Medical subject headings
Urinary Bladder Neoplasms, Parkinson Disease 4, Autosomal Dominant Lewy Body

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PembrolizumabBiological

    Also called KEYTRUDA®, MK-3475

    200 mg of Pembrolizumab IV infusion, on Day 1 Q3W for 4 cycles (each cycle length = 21 days) in preoperative phase (up to approximately 3 months) and on Day 1 Q3W for 13 cycles in postoperative phase (up to approximately 9 months). The total duration of treatment is up to approximately 1 year.

  • Enfortumab vedotin (EV)Biological

    Also called Padcev

    1.25 mg/kg of EV IV infusion, on Day 1 and Day 8 Q3W for 4 cycles (each cycle length = 21 days) in preoperative phase (up to approximately 3 months) and on Day 1 and Day 8 Q3W for 5 cycles (each cycle length = 21 days) in postoperative phase (up to approximately 4 months). The total duration of treatment is up to approximately 7 months.

  • RC + PLNDProcedure or surgery

    Also called Surgery

    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).

  • GemcitabineDrug

    Also called Gemzar

    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)

  • CisplatinDrug

    Also called Platinol®, Platinol®-AQ

    70 mg/m^2 of Cisplatin IV infusion, Day 1, Q3W for 4 cycles in preoperative phase (up to approximately 3 months)

Study groups in NCT04700124
Study groupRoleWhat they receive
Arm A: Perioperative EV+ Pembrolizumab and RC + PLNDExperimentalParticipants 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.
Receives: Biological: Pembrolizumab; Biological: Enfortumab vedotin (EV); Procedure: RC + PLND
Arm B: Standard of Care (SOC)-Neoadjuvant chemotherapy (gemcitabine + cisplatin) and RC + PLNDActive comparatorParticipants 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.
Receives: Procedure: RC + PLND; Drug: Gemcitabine; Drug: Cisplatin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Event-Free Survival (EFS)

    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.

    Measured: Up to ~68 months

Secondary outcomes (12)

  1. Pathologic Complete Response (pCR) Rate

    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.

    Measured: Up to ~47 months

  2. Overall Survival (OS)

    OS is defined as the time from randomization to death due to any cause.

    Measured: Up to ~68 months

  3. Disease Free Survival (DFS)

    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.

    Measured: From ~12 months to up to ~68 months

  4. Pathologic Downstaging (pDS) Rate

    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.

    Measured: Up to ~47 months

  5. Number of Participants Who Experienced An Adverse Event (AE) (Arm A only)

    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.

    Measured: Up to ~68 months

  6. Number of Participants Who Discontinued Study Treatment Due to An AE (Arm A only)

    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.

    Measured: Up to ~68 months

  7. Number of Participants Experiencing Perioperative Complications

    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.

    Measured: Up to ~68 months

  8. 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

    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.

    Measured: Baseline, Up to ~68 months

  9. Change from Baseline in EORTC QLQ-C30 Physical Functioning Scale

    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.

    Measured: Baseline, Up to ~68 months

  10. Change From Baseline in Urinary, Bowel and Sexual Domains per Bladder Cancer Index (BCI)

    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.

    Measured: Baseline, Up to ~68 months

  11. Change from Baseline in EuroQoL-5 Dimensions, 5-level Questionnaire (EQ-5D-5L) Visual Analogue Score (VAS)

    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.

    Measured: Baseline, Up to ~68 months

  12. Change from Baseline in EORTC QLQ-C30 Role Functioning Combined Score (Items 6-7)

    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.

    Measured: Baseline, Up to ~68 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Jan 2021
  2. Study start21 Apr 2021
  3. Primary completion27 Oct 2025
  4. Study completion18 May 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
808 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04700124
Sponsor's protocol ID
3475-B15
Other IDs
MK-3475-B15, KEYNOTE-B15, EV-304, jRCT2041210011, PHRR221021-005086, 2023-505615-21-00, U1111-1292-1300, 2020-003106-31
Acronym
KEYNOTE-B15
Status last verified
Jul 2026
First submitted
5 Jan 2021
Last updated
16 Jul 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf

Publications

  • Galsky MD, Valderrama BP, Maruzzo M, Font A, Ciuleanu T, Chatzkel J, Koie T, Hoimes CJ, Puente J, Zakharia Y, Rosenbaum E, Boehm K, Loriot Y, Bedke J, Powles TB, Necchi A, Wiechno P, Alvarez-Fernandez C, Kim TH, Oliveira N, Flaig TW, Wirtz HS, Mihm M, Huang Q, Rogiers A, Homet Moreno B, Gomez de Liano A; KEYNOTE-B15/EV-304 Investigators. Enfortumab Vedotin and Pembrolizumab in Cisplatin-Eligible Bladder Cancer. N Engl J Med. 2026 Jul 23;395(4):338-348. doi: 10.1056/NEJMoa2601486.

    PubMed 42485627

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Pembrolizumab, Enfortumab vedotin (EV) and RC + PLND in people with Bladder Cancer, run by Merck Sharp & Dohme LLC at 188 sites in 29 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 16 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 188 sites in United States, Japan, Russia, France, Spain and 24 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Event-Free Survival (EFS) (time frame: Up to ~68 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04700124, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in