Perioperative Enfortumab Vedotin (EV) Plus Pembrolizumab (MK-3475) Versus Neoadjuvant Chemotherapy for Cisplatin-Eligible Muscle Invasive Bladder Cancer (MIBC) (MK-3475-B15/ KEYNOTE-B15 / EV-304)
KEYNOTE-B15
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)
9 other identifiers
interventional
808
29 countries
188
Brief 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 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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Apr 2021
Longer than P75 for phase_3
188 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 5, 2021
CompletedFirst Posted
Study publicly available on registry
January 7, 2021
CompletedStudy Start
First participant enrolled
April 21, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 27, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
October 27, 2025
CompletedFebruary 5, 2026
February 1, 2026
4.5 years
January 5, 2021
February 4, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (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.
Up to ~68 months
Secondary Outcomes (12)
Pathologic Complete Response (pCR) Rate
Up to ~47 months
Overall Survival (OS)
Up to ~68 months
Disease Free Survival (DFS)
From ~12 months to up to ~68 months
Pathologic Downstaging (pDS) Rate
Up to ~47 months
Number of Participants Who Experienced An Adverse Event (AE) (Arm A only)
Up to ~68 months
- +7 more secondary outcomes
Study Arms (2)
Arm A: Perioperative EV+ Pembrolizumab and RC + PLND
EXPERIMENTALParticipants 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.
Arm B: Standard of Care (SOC)-Neoadjuvant chemotherapy (gemcitabine + cisplatin) and RC + PLND
ACTIVE 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.
Interventions
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.
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.
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).
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)
70 mg/m\^2 of Cisplatin IV infusion, Day 1, Q3W for 4 cycles in preoperative phase (up to approximately 3 months)
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- Has a known additional malignancy that is progressing or has required active anti-cancer treatment ≤3 years of study randomization with certain exceptions
- Has received any prior systemic treatment for MIBC or non-invasive muscle bladder cancer (NMIBC - prior treatment for NMIBC with intravesical BCG/chemotherapy is permitted) or prior therapy with an anti- programmed cell death 1 (PD-1), anti-programmed cell death ligand 1/ ligand 2 (PD-L1/L2), or anti-cytotoxic T-lymphocyte-associated protein 4 (CTLA-4)
- Has ≥N2 disease or metastatic disease (M1) as identified by imaging
- Is cisplatin-ineligible, as defined by meeting any one of the cisplatin ineligibility criteria as per protocol
- Has received prior systemic anticancer therapy including investigational agents within 3 years of randomization or any radiotherapy to the bladder
- Has undergone partial cystectomy of the bladder to remove any NMIBC or MIBC
- Has received a live or live attenuated vaccine within 30 days before the first dose of study intervention
- Has a diagnosis of immunodeficiency or has a known history of human immunodeficiency virus (HIV) infection. Hepatitis B infection or known active Hepatitis C infection
- Has a known psychiatric or substance abuse disorder
- Has had an allogenic tissue/solid organ transplant
- Has ongoing sensory or motor neuropathy Grade 2 or higher
- Has active keratitis (superficial punctate keratitis) or corneal ulcerations
- Has a history of uncontrolled diabetes defined as hemoglobin A1c (HbA1c) ≥8% or HbA1c 7% to \<8% with associated diabetes symptoms
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Merck Sharp & Dohme LLClead
- Seagen Inc.collaborator
- Astellas Pharma Inccollaborator
Study Sites (188)
Mayo Clinic in Arizona - Phoenix ( Site 0043)
Phoenix, Arizona, 85054, United States
St Joseph Heritage Healthcare-Oncology ( Site 0035)
Fullerton, California, 92835, United States
UCLA Hematology/Oncology - Westwood (Building 200 Suite 140)-Department of Urology/Institute of Uro ( Site 0005)
Los Angeles, California, 90095, United States
University of California San Francisco ( Site 0010)
San Francisco, California, 94158, United States
Stanford University ( Site 0023)
Stanford, California, 94305, United States
University of Colorado, Anschutz Cancer Pavilion ( Site 0009)
Aurora, Colorado, 80045, United States
UF Health ( Site 0031)
Gainesville, Florida, 32608, United States
Indiana University Melvin and Bren Simon Cancer Center ( Site 0050)
Indianapolis, Indiana, 46202, United States
University of Iowa Hospital and Clinics ( Site 0029)
Iowa City, Iowa, 52242, United States
University of Louisville, James Graham Brown Cancer Center ( Site 0022)
Louisville, Kentucky, 40202, United States
Icahn School of Medicine at Mount Sinai ( Site 0011)
New York, New York, 10029, United States
White Plains Hospital ( Site 0039)
White Plains, New York, 10601, United States
Duke University Medical Center ( Site 0017)
Durham, North Carolina, 27710, United States
Wake Forest Baptist Health ( Site 0014)
Winston-Salem, North Carolina, 27157, United States
Oregon Health and Science University ( Site 0028)
Portland, Oregon, 97239-3011, United States
MidLantic Urology ( Site 0002)
Bala-Cynwyd, Pennsylvania, 19004, United States
Saint Francis Cancer Center ( Site 0008)
Greenville, South Carolina, 29607, United States
The University of Tennessee Medical Center ( Site 0034)
Knoxville, Tennessee, 37920, United States
UT Southwestern Medical Center ( Site 0003)
Dallas, Texas, 75390, United States
Houston Methodist Urology Associates ( Site 0033)
Houston, Texas, 77030, United States
Urology of San Antonio ( Site 0020)
San Antonio, Texas, 78229, United States
University of Wisconsin Hospital and Clinics ( Site 0037)
Madison, Wisconsin, 53792, United States
Hospital Británico de Buenos Aires-Oncology ( Site 1551)
Ciudad Autónoma de Buenos Aires, Buenos Aires, C1280AEB, Argentina
Hospital Italiano de Buenos Aires ( Site 1554)
ABB, Buenos Aires F.D., C1199ABB, Argentina
Asociación de Beneficencia Hospital Sirio Libanés ( Site 1553)
Buenos Aires, Buenos Aires F.D., C1419AHN, Argentina
Centro de Educación Médica e Investigaciones Clínicas (CEMIC) ( Site 1558)
Buenos Aires, Buenos Aires F.D., C1431FWO, Argentina
Fundacion Estudios Clinicos-Oncology ( Site 1557)
Rosario, Santa Fe Province, S2000DEJ, Argentina
Centro de Urología (CDU) ( Site 1552)
Buenos Aires, 1120, Argentina
Macquarie University-MQ Health Clinical Trials Unit ( Site 1259)
Macquarie University, New South Wales, 2109, Australia
Mater Hospital Brisbane ( Site 1257)
South Brisbane, Queensland, 4101, Australia
Lyell McEwin Hospital ( Site 1252)
Elizabeth Vale, South Australia, 5112, Australia
Frankston Hospital-Oncology and Haematology ( Site 1258)
Frankston, Victoria, 3199, Australia
MHAT "Uni Hospital" OOD ( Site 1154)
Panagyurishte, Pazardzhik, 4500, Bulgaria
Complex Oncology Center Plovdiv ( Site 1151)
Plovdiv, 4000, Bulgaria
MHAT Central Onco Hospital OOD ( Site 1158)
Plovdiv, 4000, Bulgaria
MHAT Serdika ( Site 1152)
Sofia, 1632, Bulgaria
BC Cancer - Vancouver Center ( Site 0110)
Vancouver, British Columbia, V5Z 4E6, Canada
CancerCare Manitoba ( Site 0108)
Winnipeg, Manitoba, R3E 0V9, Canada
Moncton Hospital ( Site 0107)
Moncton, New Brunswick, E1C 6Z8, Canada
Ottawa Hospital Research Institute ( Site 0109)
Ottawa, Ontario, K1H 8L6, Canada
Jewish General Hospital ( Site 0106)
Montreal, Quebec, H3T 1E2, Canada
SUN YAT-SEN UNIVERSITY CANCER CENTRE ( Site 1406)
Guangzhou, Guangdong, 510060, China
Sun Yat-sen Memorial Hospital, Sun Yat-sen University ( Site 1413)
Guangzhou, Guangdong, 510220, China
Hunan Cancer Hospital ( Site 1403)
Changsha, Hunan, 410013, China
Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School-Urology ( Site 1404)
Nanjing, Jiangsu, 210008, China
Nantong Tumor Hospital-Urology ( Site 1405)
Nantong, Jiangsu, 226361, China
Fudan University Shanghai Cancer Center-Urology department ( Site 1401)
Shanghai, Shanghai Municipality, 200032, China
Renji Hospital Shanghai Jiao Tong University School of Medicine ( Site 1402)
Shanghai, Shanghai Municipality, 200127, China
Fundacion Colombiana de Cancerología Clinica Vida ( Site 1653)
Medellín, Antioquia, 050030, Colombia
Clinica Colsanitas S.A, Sede Clínica Universitaria Colombia-Center Investigator ( Site 1654)
Bogotá, Bogota D.C., 111321, Colombia
IMAT S.A.S ( Site 1652)
Montería, Departamento de Córdoba, 230002, Colombia
Fundación Cardiovascular de Colombia-Santander ( Site 1657)
Piedecuesta, Santander Department, 681017, Colombia
Fundación Valle del Lili ( Site 1656)
Cali, Valle del Cauca Department, 760032, Colombia
Klinički bolnički centar Sestre milosrdnice ( Site 1703)
Zagreb, City of Zagreb, 10000, Croatia
Klinički bolnički centar Zagreb-Klinika za onkologiju ( Site 1701)
Zagreb, City of Zagreb, 10000, Croatia
Klinički bolnički centar Osijek ( Site 1705)
Osijek, County of Osijek-Baranja, 31000, Croatia
Klinički Bolnički Centar Split-Oncology and Radiotherapy ( Site 1702)
Split, Split-Dalmatia County, 21000, Croatia
Fakultni nemocnice u sv. Anny v Brne ( Site 0253)
Brno, South Moravian, 656 91, Czechia
Fakultni nemocnice Hradec Kralove-Klinika onkologie a radioterapie ( Site 0254)
Hradec Králové, 500 05, Czechia
Fakultni Nemocnice Olomouc ( Site 0251)
Olomouc, 77900, Czechia
Fakultni Thomayerova nemocnice ( Site 0252)
Prague, 140 59, Czechia
CHU La Timone ( Site 0456)
Marseille, Bouches-du-Rhone, 13005, France
CHU Jean Minjoz ( Site 0453)
Besançon, Doubs, 25000, France
C.H. regional Unv. de Brest - Hopital La Cavale Blanche - Institut de Cancerologie et d Imagerie ( Site 0461)
Brest, Finistere, 29200, France
Institut Universitaire du Cancer Toulouse - Oncopole ( Site 0455)
Toulouse, Haute-Garonne, 31059, France
CHU Limoges Hopital Dupuytren ( Site 0459)
Limoges, Haute-Vienne, 87042, France
CHU GRENOBLE ALPES ( Site 0468)
La Tronche, Isere, 38700, France
Centre Hospitalier Regional du Orleans ( Site 0463)
Orléans, Loiret, 45067, France
Polyclinique du Bois ( Site 0458)
Lille, Nord, 59000, France
Hopital Diaconesses Croix Saint Simon ( Site 0465)
Paris, 75960, France
Gustave Roussy ( Site 0467)
Villejuif, Île-de-France Region, 94805, France
Universitaetsklinikum Freiburg ( Site 0512)
Freiburg im Breisgau, Baden-Wurttemberg, 79106, Germany
Universitaetsklinik fuer Urologie ( Site 0501)
Tübingen, Baden-Wurttemberg, 72076, Germany
Caritas Krankenhaus St. Josef ( Site 0502)
Regensburg, Bavaria, 93053, Germany
Universitaetsklinikum Wuerzburg ( Site 0520)
Würzburg, Bavaria, 97080, Germany
Kath. Krankenhaus Marienhospital. Universitaetsklinik ( Site 0511)
Herne, North Rhine-Westphalia, 44625, Germany
Universitaetsklinikum Muenster ( Site 0516)
Münster, North Rhine-Westphalia, 48149, Germany
Universitaetsklinikum Carl Gustav Carus ( Site 0509)
Dresden, Saxony, 01307, Germany
Krankenhaus Martha Maria Halle-Doelau ( Site 0507)
Halle, Saxony-Anhalt, 06120, Germany
Vivantes Klinikum Am Urban ( Site 0519)
Berlin, 10967, Germany
UNIVERSITY HOSPITAL OF PATRAS-DIVISION OF ONCOLOGY ( Site 0305)
Pátrai, Achaia, 26504, Greece
General Hospital of Athens "Alexandra" ( Site 0303)
Athens, Attica, 115 28, Greece
Athens Medical Center ( Site 0304)
Athens, Attica, 151 25, Greece
ATTIKON GENERAL UNIVERSITY HOSPITAL ( Site 0301)
Chaïdári, Attica, 124 62, Greece
University General Hospital of Larissa ( Site 0302)
Larissa, Thessaly, 411 10, Greece
Szegedi Tudományegyetem Szent-Györgyi Albert Klinikai Központ ( Site 1010)
Szeged, Csongrád megye, 6720, Hungary
Jász-Nagykun-Szolnok Vármegyei Hetényi Géza Kórház ( Site 1002)
Szolnok, Jász-Nagykun-Szolnok, 5004, Hungary
Debreceni Egyetem Klinikai Kozpont ( Site 1006)
Debrecen, 4032, Hungary
Rambam Health Care Campus-Oncology ( Site 0751)
Haifa, 3109601, Israel
Hadassah Medical Center-Oncology ( Site 0757)
Jerusalem, 9112001, Israel
Meir Medical Center-oncology ( Site 0754)
Kfar Saba, 4428164, Israel
Rabin Medical Center-Oncology ( Site 0752)
Petah Tikva, 4941492, Israel
Sheba Medical Center-ONCOLOGY ( Site 0753)
Ramat Gan, 5265601, Israel
Sourasky Medical Center-Oncology ( Site 0755)
Tel Aviv, 6423906, Israel
Yitzhak Shamir Medical Center-Oncology ( Site 0756)
Ẕerifin, 70300, Israel
Fondazione IRCCS Istituto Nazionale dei Tumori-Struttura Complessa Oncologia Medica 1 ( Site 0588)
Milan, Lombardy, 20133, Italy
Presidio Ospedaliero Santa Maria delle Grazie ( Site 0599)
Pozzuoli, Napoli, 80078, Italy
AOU San Luigi Gonzaga di Orbassano ( Site 0595)
Orbassano, Torino, 10043, Italy
Azienda Ospedaliera Universitaria Integrata Verona - Ospedale Borgo Trento ( Site 0598)
Verona, Veneto, 37126, Italy
Azienda Ospedaliero Universitaria delle Marche-Clinica Oncologica ( Site 0593)
Ancona, 60126, Italy
Ospedale Cannizzaro ( Site 0590)
Catania, 95126, Italy
IRCCS Ospedale San Raffaele ( Site 0596)
Milan, 20132, Italy
Istituto Oncologico Veneto IRCCS-Oncologia Medica 1 ( Site 0600)
Padua, 35128, Italy
Nagoya University Hospital ( Site 1512)
Nagoya, Aichi-ken, 466-8560, Japan
Hirosaki University Hospital ( Site 1501)
Hirosaki, Aomori, 036-8563, Japan
University of Tsukuba Hospital ( Site 1502)
Tsukuba, Ibaraki, 305-8576, Japan
Kanazawa University Hospital ( Site 1509)
Kanazawa, Ishikawa-ken, 920-8641, Japan
Kitasato University Hospital ( Site 1506)
Sagamihara, Kanagawa, 252-0375, Japan
Yokohama City University Medical Center ( Site 1508)
Yokohama, Kanagawa, 232-0024, Japan
Kanagawa Cancer Center ( Site 1507)
Yokohama, Kanagawa, 241-8515, Japan
Tohoku University Hospital ( Site 1503)
Sendai, Miyagi, 980-8574, Japan
Hamamatsu University Hospital ( Site 1511)
Hamamatsu, Shizuoka, 431-3192, Japan
Gifu University Hospital ( Site 1513)
Gifu, 501-1194, Japan
Nagasaki University Hospital ( Site 1517)
Nagasaki, 852-8510, Japan
Okayama University Hospital ( Site 1516)
Okayama, 700-8558, Japan
Osaka International Cancer Institute ( Site 1514)
Osaka, 541-8567, Japan
Osaka Metropolitan University Hospital ( Site 1515)
Osaka, 545-8586, Japan
Institute of Science Tokyo Hospital ( Site 1505)
Tokyo, 113-8519, Japan
Keio University Hospital ( Site 1504)
Tokyo, 160-8582, Japan
Toyama University Hospital ( Site 1510)
Toyama, 930-0194, Japan
University Malaya Medical Centre ( Site 0352)
Lembah Pantai, Kuala Lumpur, 59100, Malaysia
Hospital Pulau Pinang ( Site 0355)
George Town, Pulau Pinang, 10450, Malaysia
Sarawak General Hospital ( Site 0351)
Kuching, Sarawak, 93586, Malaysia
Sunway Medical Centre ( Site 0353)
Petaling Jaya, Selangor, 47500, Malaysia
THE MEDICAL CITY ILOILO-The Medical City Iloilo - Clinical and Translational Research Institute-Ilo ( Site 0801)
Iloilo City, Iloilo, 5000, Philippines
Clinical Research Center Medic-R ( Site 1061)
Poznan, Greater Poland Voivodeship, 61-731, Poland
Mazowiecki Szpital Wojewódzki w Siedlcach-Siedleckie Centrum Onkologii ( Site 1057)
Siedlce, Masovian Voivodeship, 08-110, Poland
Narodowy Instytut Onkologii ( Site 1051)
Warsaw, Masovian Voivodeship, 02-781, Poland
Wojewodzki Szpital im. Sw. Ojca Pio w Przemyslu ( Site 1053)
Przemyśl, Podkarpackie Voivodeship, 37-700, Poland
Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wrocławiu ( Site 1058)
Wrocław, Silesian Voivodeship, 50556, Poland
Szpital Wojewodzki im. Mikolaja Kopernika ( Site 1055)
Koszalin, West Pomeranian Voivodeship, 75-581, Poland
Unidade Local de Saude de Coimbra - Hospitais da Universidade de Coimbra ( Site 0406)
Coimbra, 3000-075, Portugal
Inst. Portugues de Oncologia de Lisboa Francisco Gentil EPE ( Site 0409)
Lisbon, 1099-023, Portugal
Unidade Local de Saude Lisboa Ocidental - Hospital de São Francisco Xavier ( Site 0401)
Lisbon, 1449-005, Portugal
Unidade Local de Saude de Santo António - Hospital Santo António ( Site 0408)
Porto, 4099-001, Portugal
MEMORIAL HEALTHCARE INTERNATIONAL S.R.L. ( Site 1104)
Bucharest, București, 013823, Romania
Cardiomed SRL Cluj-Napoca ( Site 1101)
Cluj-Napoca, Cluj, 400015, Romania
Institutul Oncologic Prof.Dr. Ion Chiricuta Cluj-Napoca ( Site 1102)
Cluj-Napoca, Cluj, 400015, Romania
Institutul Oncologic Prof.Dr. Ion Chiricuta Cluj-Napoca ( Site 1103)
Cluj-Napoca, Cluj, 400015, Romania
SC Radiotherapy Center Cluj SRL ( Site 1108)
Comuna Floresti, Cluj, 407280, Romania
S.C. Centrul de Oncologie Sf. Nectarie SRL ( Site 1107)
Craiova, Dolj, 200542, Romania
Policlinica Oncomed SRL ( Site 1106)
Timișoara, Timiș County, 300239, Romania
Institutul Oncologic Cluj-Oncologie Medicala ( Site 1109)
Cluj-Napoca, 400015, Romania
Altay Regional Oncology Dispensary ( Site 0851)
Barnaul, Altayskiy Kray, 656045, Russia
National Medical Research Radiology Centre ( Site 0869)
Obninsk, Kaluzskaja Oblast, 249036, Russia
National Medical Research Centre of Oncology named after N.N. Blokhin ( Site 0865)
Moscow, Moscow, 115230, Russia
First Moscow State Medical University n.a. I.M.Sechenov ( Site 0871)
Moscow, Moscow, 119991, Russia
Volga District Medical Center ( Site 0876)
Nizhny Novgorod, Nizhny Novgorod Oblast, 603074, Russia
St.Petersburg Clinical Hospital RAS ( Site 0864)
Saint Petersburg, Sankt-Peterburg, 194017, Russia
St.Petersburg State Medical Univ. n.a. acad. I.P.Pavlov ( Site 0856)
Saint Petersburg, Sankt-Peterburg, 197101, Russia
Scientific Research Oncology Institute n.a. N.N.Petrov ( Site 0852)
Saint Petersburg, Sankt-Peterburg, 197758, Russia
Sverdlovsk Regional Oncology Hospital ( Site 0867)
Yekaterinburg, Sverdlovsk Oblast, 620036, Russia
Sverdlovsky Regional Clinical hospital #1 ( Site 0868)
Yekaterinburg, Sverdlovsk Oblast, 620102, Russia
Volgograd Regional Uronephrological Center ( Site 0870)
Volzhsky, Volgograd Oblast, 404120, Russia
Tan Tock Seng Hospital ( Site 0704)
Singapore, Central Singapore, 308442, Singapore
Wits Clinical Research ( Site 0603)
Johannesburg, Gauteng, 2193, South Africa
Steve Biko Academic Hospital ( Site 0601)
Pretoria, Gauteng, 0002, South Africa
Groote Schuur Hospital ( Site 0602)
Cape Town, Western Cape, 7925, South Africa
Chonnam National University Hwasun Hospital ( Site 1353)
Jeollanam-do, Jeonranamdo, 58128, South Korea
Seoul National University Bundang Hospital ( Site 1355)
Gyeonggi-do, Kyonggi-do, 13620, South Korea
Kyungpook National University Chilgok Hospital ( Site 1354)
Daegu, Kyongsangbuk-do, 41404, South Korea
Asan Medical Center ( Site 1352)
Songpagu, Seoul, 05505, South Korea
Gachon University Gil Medical Center ( Site 1356)
Incheon, 21565, South Korea
Korea University Anam Hospital ( Site 1357)
Seoul, 02841, South Korea
Seoul National University Hospital ( Site 1351)
Seoul, 03080, South Korea
Hospital Germans Trias i Pujol. ICO de Badalona ( Site 0658)
Badalona, Barcelona, 08916, Spain
Xarxa Assistencial Universitaria Manresa ( Site 0655)
Manresa, Barcelona, 08243, Spain
Institut Català d'Oncologia (ICO) - Girona ( Site 0653)
Girona, Gerona, 17007, Spain
CHUS - Hospital Clinico Universitario-Servicio de Oncologia ( Site 0660)
Santiago de Compostela, La Coruna, 15706, Spain
Hospital Universitario Insular de Gran Canaria ( Site 0657)
Las Palmas de Gran Canaria, Las Palmas, 35016, Spain
Hospital Universitario Central de Asturias ( Site 0654)
Oviedo, Principality of Asturias, 33011, Spain
Fundación Instituto Valenciano de Oncología-Oncologico ( Site 0662)
Valencia, Valenciana, Comunitat, 46009, Spain
Hospital Universitari Vall d'Hebron-Departamento de Oncologia- VHIO ( Site 0661)
Barcelona, 08035, Spain
Hospital Clinico Universitario San Carlos de Madrid ( Site 0651)
Madrid, 28040, Spain
Hospital Virgen del Rocio ( Site 0659)
Seville, 41013, Spain
Chang Gung Memorial Hospital at Kaohsiung ( Site 1203)
Kaohsiung City, 83301, Taiwan
China Medical University Hospital ( Site 1202)
Taichung, 404332, Taiwan
Taipei Veterans General Hospital ( Site 1201)
Taipei, 112, Taiwan
I.I. Mechnykov Dnipropetrovsk Regional Clinical Hospital ( Site 0959)
Dnipro, Dnipropetrovsk Oblast, 49005, Ukraine
MI Clinical oncology dispensary of Dnipropetrovsk regional council ( Site 0954)
Dnipro, Dnipropetrovsk Oblast, 49055, Ukraine
Regional Clinical Center of Urology and Nephrology n.a. V.I. Shapoval ( Site 0952)
Kharkiv, Kharkivs’ka Oblast’, 61037, Ukraine
MNPE Regional Center of Oncology ( Site 0955)
Kharkiv, Kharkivs’ka Oblast’, 61070, Ukraine
Municipal Non-profit Enterprise of Kharkiv Regional Council RCSDRPP ( Site 0965)
Kharkiv, Kharkivs’ka Oblast’, 61166, Ukraine
Lviv Oncology Regional Treatment and Diagnostic Center ( Site 0960)
Lviv, Lviv Oblast, 79031, Ukraine
Zhytomyr Regional Oncology Center ( Site 0961)
Zhytomyr, Zhytomyr Oblast, 10002, Ukraine
Torbay Hospital ( Site 1804)
Torquay, Devon, TQ2 7AA, United Kingdom
Charing Cross Hospital-Oncology Research ( Site 1802)
London, Hammersmith and Fulham, W6 8RF, United Kingdom
St Bartholomew's Hospital-Centre for Experimental Cancer Medicine ( Site 1801)
London, London, City of, EC1A 7BE, United Kingdom
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Medical Director
Merck Sharp & Dohme LLC
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Masking Details
- Open label
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 5, 2021
First Posted
January 7, 2021
Study Start
April 21, 2021
Primary Completion
October 27, 2025
Study Completion
October 27, 2025
Last Updated
February 5, 2026
Record last verified: 2026-02
Data Sharing
- IPD Sharing
- Will share
https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf