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)

NCT ID: NCT04700124

Last Updated: 2026-02-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

808 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-04-21

Study Completion Date

2025-10-27

Brief Summary

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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).

Detailed Description

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Conditions

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Bladder Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Open label

Study Groups

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Arm A: Perioperative EV+ Pembrolizumab and RC + PLND

Participants receive 4 cycles (each cycle length = 21 days) of EV intravenous (IV) infusion plus pembrolizumab IV infusion preoperatively, followed by RC + PLND, followed by 5 cycles of adjuvant EV IV infusion plus 13 cycles of adjuvant pembrolizumab IV infusion postoperatively. The total treatment duration is up to approximately 1 year.

Group Type EXPERIMENTAL

Pembrolizumab

Intervention Type BIOLOGICAL

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)

Intervention Type BIOLOGICAL

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 + PLND

Intervention Type PROCEDURE

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).

Arm B: Standard of Care (SOC)-Neoadjuvant chemotherapy (gemcitabine + cisplatin) and RC + PLND

Participants receive 4 cycles (each cycle length = 21 days) of standard of care (SOC) chemotherapy (gemcitabine IV infusion plus cisplatin IV infusion) preoperatively, followed by RC + PLND. The total treatment duration is up to approximately 3 months.

Group Type ACTIVE_COMPARATOR

RC + PLND

Intervention Type PROCEDURE

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).

Gemcitabine

Intervention Type DRUG

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)

Cisplatin

Intervention Type DRUG

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

Interventions

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Pembrolizumab

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

Intervention Type BIOLOGICAL

Enfortumab vedotin (EV)

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

Intervention Type BIOLOGICAL

RC + PLND

Curative intent RC + PLND surgery will be administered to all participants randomized to Arm A and B after completion of preoperative systemic treatment (RC + PLND to be done approximately at 15 weeks from randomization).

Intervention Type PROCEDURE

Gemcitabine

1000 mg/m\^2 of Gemcitabine IV infusion, Day 1 and Day 8 Q3W for 4 cycles in preoperative phase (up to approximately 3 months)

Intervention Type DRUG

Cisplatin

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

Intervention Type DRUG

Other Intervention Names

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KEYTRUDA® MK-3475 Padcev Surgery Gemzar Platinol® Platinol®-AQ

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

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

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Seagen Inc.

INDUSTRY

Sponsor Role collaborator

Astellas Pharma Inc

INDUSTRY

Sponsor Role collaborator

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Medical Director

Role: STUDY_DIRECTOR

Merck Sharp & Dohme LLC

Locations

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Mayo Clinic in Arizona - Phoenix ( Site 0043)

Phoenix, Arizona, United States

Site Status

St Joseph Heritage Healthcare-Oncology ( Site 0035)

Fullerton, California, United States

Site Status

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

Los Angeles, California, United States

Site Status

University of California San Francisco ( Site 0010)

San Francisco, California, United States

Site Status

Stanford University ( Site 0023)

Stanford, California, United States

Site Status

University of Colorado, Anschutz Cancer Pavilion ( Site 0009)

Aurora, Colorado, United States

Site Status

UF Health ( Site 0031)

Gainesville, Florida, United States

Site Status

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

Indianapolis, Indiana, United States

Site Status

University of Iowa Hospital and Clinics ( Site 0029)

Iowa City, Iowa, United States

Site Status

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

Louisville, Kentucky, United States

Site Status

Icahn School of Medicine at Mount Sinai ( Site 0011)

New York, New York, United States

Site Status

White Plains Hospital ( Site 0039)

White Plains, New York, United States

Site Status

Duke University Medical Center ( Site 0017)

Durham, North Carolina, United States

Site Status

Wake Forest Baptist Health ( Site 0014)

Winston-Salem, North Carolina, United States

Site Status

Oregon Health and Science University ( Site 0028)

Portland, Oregon, United States

Site Status

MidLantic Urology ( Site 0002)

Bala-Cynwyd, Pennsylvania, United States

Site Status

Saint Francis Cancer Center ( Site 0008)

Greenville, South Carolina, United States

Site Status

The University of Tennessee Medical Center ( Site 0034)

Knoxville, Tennessee, United States

Site Status

UT Southwestern Medical Center ( Site 0003)

Dallas, Texas, United States

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Houston Methodist Urology Associates ( Site 0033)

Houston, Texas, United States

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Urology of San Antonio ( Site 0020)

San Antonio, Texas, United States

Site Status

University of Wisconsin Hospital and Clinics ( Site 0037)

Madison, Wisconsin, United States

Site Status

Hospital Británico de Buenos Aires-Oncology ( Site 1551)

Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina

Site Status

Hospital Italiano de Buenos Aires ( Site 1554)

ABB, Buenos Aires F.D., Argentina

Site Status

Asociación de Beneficencia Hospital Sirio Libanés ( Site 1553)

Buenos Aires, Buenos Aires F.D., Argentina

Site Status

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

Buenos Aires, Buenos Aires F.D., Argentina

Site Status

Fundacion Estudios Clinicos-Oncology ( Site 1557)

Rosario, Santa Fe Province, Argentina

Site Status

Centro de Urología (CDU) ( Site 1552)

Buenos Aires, , Argentina

Site Status

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

Macquarie University, New South Wales, Australia

Site Status

Mater Hospital Brisbane ( Site 1257)

South Brisbane, Queensland, Australia

Site Status

Lyell McEwin Hospital ( Site 1252)

Elizabeth Vale, South Australia, Australia

Site Status

Frankston Hospital-Oncology and Haematology ( Site 1258)

Frankston, Victoria, Australia

Site Status

MHAT "Uni Hospital" OOD ( Site 1154)

Panagyurishte, Pazardzhik, Bulgaria

Site Status

Complex Oncology Center Plovdiv ( Site 1151)

Plovdiv, , Bulgaria

Site Status

MHAT Central Onco Hospital OOD ( Site 1158)

Plovdiv, , Bulgaria

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MHAT Serdika ( Site 1152)

Sofia, , Bulgaria

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BC Cancer - Vancouver Center ( Site 0110)

Vancouver, British Columbia, Canada

Site Status

CancerCare Manitoba ( Site 0108)

Winnipeg, Manitoba, Canada

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Moncton Hospital ( Site 0107)

Moncton, New Brunswick, Canada

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Ottawa Hospital Research Institute ( Site 0109)

Ottawa, Ontario, Canada

Site Status

Jewish General Hospital ( Site 0106)

Montreal, Quebec, Canada

Site Status

SUN YAT-SEN UNIVERSITY CANCER CENTRE ( Site 1406)

Guangzhou, Guangdong, China

Site Status

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

Guangzhou, Guangdong, China

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Hunan Cancer Hospital ( Site 1403)

Changsha, Hunan, China

Site Status

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

Nanjing, Jiangsu, China

Site Status

Nantong Tumor Hospital-Urology ( Site 1405)

Nantong, Jiangsu, China

Site Status

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

Shanghai, Shanghai Municipality, China

Site Status

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

Shanghai, Shanghai Municipality, China

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Fundacion Colombiana de Cancerología Clinica Vida ( Site 1653)

Medellín, Antioquia, Colombia

Site Status

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

Bogotá, Bogota D.C., Colombia

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IMAT S.A.S ( Site 1652)

Montería, Departamento de Córdoba, Colombia

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Fundación Cardiovascular de Colombia-Santander ( Site 1657)

Piedecuesta, Santander Department, Colombia

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Fundación Valle del Lili ( Site 1656)

Cali, Valle del Cauca Department, Colombia

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Klinički bolnički centar Sestre milosrdnice ( Site 1703)

Zagreb, City of Zagreb, Croatia

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

Zagreb, City of Zagreb, Croatia

Site Status

Klinički bolnički centar Osijek ( Site 1705)

Osijek, County of Osijek-Baranja, Croatia

Site Status

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

Split, Split-Dalmatia County, Croatia

Site Status

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

Brno, South Moravian, Czechia

Site Status

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

Hradec Králové, , Czechia

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Fakultni Nemocnice Olomouc ( Site 0251)

Olomouc, , Czechia

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Fakultni Thomayerova nemocnice ( Site 0252)

Prague, , Czechia

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CHU La Timone ( Site 0456)

Marseille, Bouches-du-Rhone, France

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CHU Jean Minjoz ( Site 0453)

Besançon, Doubs, France

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

Brest, Finistere, France

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Institut Universitaire du Cancer Toulouse - Oncopole ( Site 0455)

Toulouse, Haute-Garonne, France

Site Status

CHU Limoges Hopital Dupuytren ( Site 0459)

Limoges, Haute-Vienne, France

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CHU GRENOBLE ALPES ( Site 0468)

La Tronche, Isere, France

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Centre Hospitalier Regional du Orleans ( Site 0463)

Orléans, Loiret, France

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Polyclinique du Bois ( Site 0458)

Lille, Nord, France

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Hopital Diaconesses Croix Saint Simon ( Site 0465)

Paris, , France

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Gustave Roussy ( Site 0467)

Villejuif, Île-de-France Region, France

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Universitaetsklinikum Freiburg ( Site 0512)

Freiburg im Breisgau, Baden-Wurttemberg, Germany

Site Status

Universitaetsklinik fuer Urologie ( Site 0501)

Tübingen, Baden-Wurttemberg, Germany

Site Status

Caritas Krankenhaus St. Josef ( Site 0502)

Regensburg, Bavaria, Germany

Site Status

Universitaetsklinikum Wuerzburg ( Site 0520)

Würzburg, Bavaria, Germany

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Kath. Krankenhaus Marienhospital. Universitaetsklinik ( Site 0511)

Herne, North Rhine-Westphalia, Germany

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Universitaetsklinikum Muenster ( Site 0516)

Münster, North Rhine-Westphalia, Germany

Site Status

Universitaetsklinikum Carl Gustav Carus ( Site 0509)

Dresden, Saxony, Germany

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Krankenhaus Martha Maria Halle-Doelau ( Site 0507)

Halle, Saxony-Anhalt, Germany

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Vivantes Klinikum Am Urban ( Site 0519)

Berlin, , Germany

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

Pátrai, Achaia, Greece

Site Status

General Hospital of Athens "Alexandra" ( Site 0303)

Athens, Attica, Greece

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Athens Medical Center ( Site 0304)

Athens, Attica, Greece

Site Status

ATTIKON GENERAL UNIVERSITY HOSPITAL ( Site 0301)

Chaïdári, Attica, Greece

Site Status

University General Hospital of Larissa ( Site 0302)

Larissa, Thessaly, Greece

Site Status

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

Szeged, Csongrád megye, Hungary

Site Status

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

Szolnok, Jász-Nagykun-Szolnok, Hungary

Site Status

Debreceni Egyetem Klinikai Kozpont ( Site 1006)

Debrecen, , Hungary

Site Status

Rambam Health Care Campus-Oncology ( Site 0751)

Haifa, , Israel

Site Status

Hadassah Medical Center-Oncology ( Site 0757)

Jerusalem, , Israel

Site Status

Meir Medical Center-oncology ( Site 0754)

Kfar Saba, , Israel

Site Status

Rabin Medical Center-Oncology ( Site 0752)

Petah Tikva, , Israel

Site Status

Sheba Medical Center-ONCOLOGY ( Site 0753)

Ramat Gan, , Israel

Site Status

Sourasky Medical Center-Oncology ( Site 0755)

Tel Aviv, , Israel

Site Status

Yitzhak Shamir Medical Center-Oncology ( Site 0756)

Ẕerifin, , Israel

Site Status

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

Milan, Lombardy, Italy

Site Status

Presidio Ospedaliero Santa Maria delle Grazie ( Site 0599)

Pozzuoli, Napoli, Italy

Site Status

AOU San Luigi Gonzaga di Orbassano ( Site 0595)

Orbassano, Torino, Italy

Site Status

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

Verona, Veneto, Italy

Site Status

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

Ancona, , Italy

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Ospedale Cannizzaro ( Site 0590)

Catania, , Italy

Site Status

IRCCS Ospedale San Raffaele ( Site 0596)

Milan, , Italy

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

Padua, , Italy

Site Status

Nagoya University Hospital ( Site 1512)

Nagoya, Aichi-ken, Japan

Site Status

Hirosaki University Hospital ( Site 1501)

Hirosaki, Aomori, Japan

Site Status

University of Tsukuba Hospital ( Site 1502)

Tsukuba, Ibaraki, Japan

Site Status

Kanazawa University Hospital ( Site 1509)

Kanazawa, Ishikawa-ken, Japan

Site Status

Kitasato University Hospital ( Site 1506)

Sagamihara, Kanagawa, Japan

Site Status

Yokohama City University Medical Center ( Site 1508)

Yokohama, Kanagawa, Japan

Site Status

Kanagawa Cancer Center ( Site 1507)

Yokohama, Kanagawa, Japan

Site Status

Tohoku University Hospital ( Site 1503)

Sendai, Miyagi, Japan

Site Status

Hamamatsu University Hospital ( Site 1511)

Hamamatsu, Shizuoka, Japan

Site Status

Gifu University Hospital ( Site 1513)

Gifu, , Japan

Site Status

Nagasaki University Hospital ( Site 1517)

Nagasaki, , Japan

Site Status

Okayama University Hospital ( Site 1516)

Okayama, , Japan

Site Status

Osaka International Cancer Institute ( Site 1514)

Osaka, , Japan

Site Status

Osaka Metropolitan University Hospital ( Site 1515)

Osaka, , Japan

Site Status

Institute of Science Tokyo Hospital ( Site 1505)

Tokyo, , Japan

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Keio University Hospital ( Site 1504)

Tokyo, , Japan

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Toyama University Hospital ( Site 1510)

Toyama, , Japan

Site Status

University Malaya Medical Centre ( Site 0352)

Lembah Pantai, Kuala Lumpur, Malaysia

Site Status

Hospital Pulau Pinang ( Site 0355)

George Town, Pulau Pinang, Malaysia

Site Status

Sarawak General Hospital ( Site 0351)

Kuching, Sarawak, Malaysia

Site Status

Sunway Medical Centre ( Site 0353)

Petaling Jaya, Selangor, Malaysia

Site Status

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

Iloilo City, Iloilo, Philippines

Site Status

Clinical Research Center Medic-R ( Site 1061)

Poznan, Greater Poland Voivodeship, Poland

Site Status

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

Siedlce, Masovian Voivodeship, Poland

Site Status

Narodowy Instytut Onkologii ( Site 1051)

Warsaw, Masovian Voivodeship, Poland

Site Status

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

Przemyśl, Podkarpackie Voivodeship, Poland

Site Status

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

Wrocław, Silesian Voivodeship, Poland

Site Status

Szpital Wojewodzki im. Mikolaja Kopernika ( Site 1055)

Koszalin, West Pomeranian Voivodeship, Poland

Site Status

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

Coimbra, , Portugal

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

Lisbon, , Portugal

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

Lisbon, , Portugal

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

Porto, , Portugal

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

Bucharest, București, Romania

Site Status

Cardiomed SRL Cluj-Napoca ( Site 1101)

Cluj-Napoca, Cluj, Romania

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

Cluj-Napoca, Cluj, Romania

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

Cluj-Napoca, Cluj, Romania

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SC Radiotherapy Center Cluj SRL ( Site 1108)

Comuna Floresti, Cluj, Romania

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

Craiova, Dolj, Romania

Site Status

Policlinica Oncomed SRL ( Site 1106)

Timișoara, Timiș County, Romania

Site Status

Institutul Oncologic Cluj-Oncologie Medicala ( Site 1109)

Cluj-Napoca, , Romania

Site Status

Altay Regional Oncology Dispensary ( Site 0851)

Barnaul, Altayskiy Kray, Russia

Site Status

National Medical Research Radiology Centre ( Site 0869)

Obninsk, Kaluzskaja Oblast, Russia

Site Status

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

Moscow, Moscow, Russia

Site Status

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

Moscow, Moscow, Russia

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Volga District Medical Center ( Site 0876)

Nizhny Novgorod, Nizhny Novgorod Oblast, Russia

Site Status

St.Petersburg Clinical Hospital RAS ( Site 0864)

Saint Petersburg, Sankt-Peterburg, Russia

Site Status

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

Saint Petersburg, Sankt-Peterburg, Russia

Site Status

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

Saint Petersburg, Sankt-Peterburg, Russia

Site Status

Sverdlovsk Regional Oncology Hospital ( Site 0867)

Yekaterinburg, Sverdlovsk Oblast, Russia

Site Status

Sverdlovsky Regional Clinical hospital #1 ( Site 0868)

Yekaterinburg, Sverdlovsk Oblast, Russia

Site Status

Volgograd Regional Uronephrological Center ( Site 0870)

Volzhsky, Volgograd Oblast, Russia

Site Status

Tan Tock Seng Hospital ( Site 0704)

Singapore, Central Singapore, Singapore

Site Status

Wits Clinical Research ( Site 0603)

Johannesburg, Gauteng, South Africa

Site Status

Steve Biko Academic Hospital ( Site 0601)

Pretoria, Gauteng, South Africa

Site Status

Groote Schuur Hospital ( Site 0602)

Cape Town, Western Cape, South Africa

Site Status

Chonnam National University Hwasun Hospital ( Site 1353)

Jeollanam-do, Jeonranamdo, South Korea

Site Status

Seoul National University Bundang Hospital ( Site 1355)

Gyeonggi-do, Kyonggi-do, South Korea

Site Status

Kyungpook National University Chilgok Hospital ( Site 1354)

Daegu, Kyongsangbuk-do, South Korea

Site Status

Asan Medical Center ( Site 1352)

Songpagu, Seoul, South Korea

Site Status

Gachon University Gil Medical Center ( Site 1356)

Incheon, , South Korea

Site Status

Korea University Anam Hospital ( Site 1357)

Seoul, , South Korea

Site Status

Seoul National University Hospital ( Site 1351)

Seoul, , South Korea

Site Status

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

Badalona, Barcelona, Spain

Site Status

Xarxa Assistencial Universitaria Manresa ( Site 0655)

Manresa, Barcelona, Spain

Site Status

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

Girona, Gerona, Spain

Site Status

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

Santiago de Compostela, La Coruna, Spain

Site Status

Hospital Universitario Insular de Gran Canaria ( Site 0657)

Las Palmas de Gran Canaria, Las Palmas, Spain

Site Status

Hospital Universitario Central de Asturias ( Site 0654)

Oviedo, Principality of Asturias, Spain

Site Status

Fundación Instituto Valenciano de Oncología-Oncologico ( Site 0662)

Valencia, Valenciana, Comunitat, Spain

Site Status

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

Barcelona, , Spain

Site Status

Hospital Clinico Universitario San Carlos de Madrid ( Site 0651)

Madrid, , Spain

Site Status

Hospital Virgen del Rocio ( Site 0659)

Seville, , Spain

Site Status

Chang Gung Memorial Hospital at Kaohsiung ( Site 1203)

Kaohsiung City, , Taiwan

Site Status

China Medical University Hospital ( Site 1202)

Taichung, , Taiwan

Site Status

Taipei Veterans General Hospital ( Site 1201)

Taipei, , Taiwan

Site Status

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

Dnipro, Dnipropetrovsk Oblast, Ukraine

Site Status

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

Dnipro, Dnipropetrovsk Oblast, Ukraine

Site Status

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

Kharkiv, Kharkivs’ka Oblast’, Ukraine

Site Status

MNPE Regional Center of Oncology ( Site 0955)

Kharkiv, Kharkivs’ka Oblast’, Ukraine

Site Status

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

Kharkiv, Kharkivs’ka Oblast’, Ukraine

Site Status

Lviv Oncology Regional Treatment and Diagnostic Center ( Site 0960)

Lviv, Lviv Oblast, Ukraine

Site Status

Zhytomyr Regional Oncology Center ( Site 0961)

Zhytomyr, Zhytomyr Oblast, Ukraine

Site Status

Torbay Hospital ( Site 1804)

Torquay, Devon, United Kingdom

Site Status

Charing Cross Hospital-Oncology Research ( Site 1802)

London, Hammersmith and Fulham, United Kingdom

Site Status

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

London, London, City of, United Kingdom

Site Status

Countries

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United States Argentina Australia Bulgaria Canada China Colombia Croatia Czechia France Germany Greece Hungary Israel Italy Japan Malaysia Philippines Poland Portugal Romania Russia Singapore South Africa South Korea Spain Taiwan Ukraine United Kingdom

Related Links

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Other Identifiers

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MK-3475-B15

Identifier Type: OTHER

Identifier Source: secondary_id

KEYNOTE-B15

Identifier Type: OTHER

Identifier Source: secondary_id

EV-304

Identifier Type: OTHER

Identifier Source: secondary_id

jRCT2041210011

Identifier Type: REGISTRY

Identifier Source: secondary_id

PHRR221021-005086

Identifier Type: REGISTRY

Identifier Source: secondary_id

2023-505615-21-00

Identifier Type: REGISTRY

Identifier Source: secondary_id

U1111-1292-1300

Identifier Type: REGISTRY

Identifier Source: secondary_id

2020-003106-31

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

3475-B15

Identifier Type: -

Identifier Source: org_study_id

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Investigator Grant (IG) 2022 27746
NCT06341478 RECRUITING NA