Clinical trial NCT04700124: 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)
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)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Bladder Cancer
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)
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
Collaborators: name: Seagen Inc.
name: Astellas Pharma Inc
First posted: 2021-01-07
Enrollment: 808
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


Eligibility criteria: 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

Primary outcomes:
measure: Event-Free Survival (EFS)
timeFrame: Up to ~68 months
Secondary outcomes:
measure: Pathologic Complete Response (pCR) Rate
timeFrame: Up to ~47 months
measure: Overall Survival (OS)
timeFrame: Up to ~68 months
measure: Disease Free Survival (DFS)
timeFrame: From ~12 months to up to ~68 months
measure: Pathologic Downstaging (pDS) Rate
timeFrame: Up to ~47 months
measure: Number of Participants Who Experienced An Adverse Event (AE) (Arm A only)
timeFrame: Up to ~68 months
measure: Number of Participants Who Discontinued Study Treatment Due to An AE (Arm A only)
timeFrame: Up to ~68 months
measure: Number of Participants Experiencing Perioperative Complications
timeFrame: Up to ~68 months
measure: 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
timeFrame: Baseline, Up to ~68 months
measure: Change from Baseline in EORTC QLQ-C30 Physical Functioning Scale
timeFrame: Baseline, Up to ~68 months
measure: Change From Baseline in Urinary, Bowel and Sexual Domains per Bladder Cancer Index (BCI)
timeFrame: Baseline, Up to ~68 months
measure: Change from Baseline in EuroQoL-5 Dimensions, 5-level Questionnaire (EQ-5D-5L) Visual Analogue Score (VAS)
timeFrame: Baseline, Up to ~68 months
measure: Change from Baseline in EORTC QLQ-C30 Role Functioning Combined Score (Items 6-7)
timeFrame: Baseline, Up to ~68 months
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Mayo Clinic in Arizona - Phoenix ( Site 0043)
state: Arizona
city: Fullerton
country: United States
facility: St Joseph Heritage Healthcare-Oncology ( Site 0035)
state: California
city: Los Angeles
country: United States
facility: UCLA Hematology/Oncology - Westwood (Building 200 Suite 140)-Department of Urology/Institute of Uro
state: California
city: San Francisco
country: United States
facility: University of California San Francisco ( Site 0010)
state: California
city: Stanford
country: United States
facility: Stanford University ( Site 0023)
state: California
city: Aurora
country: United States
facility: University of Colorado, Anschutz Cancer Pavilion ( Site 0009)
state: Colorado
city: Gainesville
country: United States
facility: UF Health ( Site 0031)
state: Florida
city: Indianapolis
country: United States
facility: Indiana University Melvin and Bren Simon Cancer Center ( Site 0050)
state: Indiana
city: Iowa City
country: United States
facility: University of Iowa Hospital and Clinics ( Site 0029)
state: Iowa
city: Louisville
country: United States
facility: University of Louisville, James Graham Brown Cancer Center ( Site 0022)
state: Kentucky
city: New York
country: United States
facility: Icahn School of Medicine at Mount Sinai ( Site 0011)
state: New York
city: White Plains
country: United States
facility: White Plains Hospital ( Site 0039)
state: New York
city: Durham
country: United States
facility: Duke University Medical Center ( Site 0017)
state: North Carolina
city: Winston-Salem
country: United States
facility: Wake Forest Baptist Health ( Site 0014)
state: North Carolina
city: Portland
country: United States
facility: Oregon Health and Science University ( Site 0028)
state: Oregon
city: Bala-Cynwyd
country: United States
facility: MidLantic Urology ( Site 0002)
state: Pennsylvania
city: Greenville
country: United States
facility: Saint Francis Cancer Center ( Site 0008)
state: South Carolina
city: Knoxville
country: United States
facility: The University of Tennessee Medical Center ( Site 0034)
state: Tennessee
city: Dallas
country: United States
facility: UT Southwestern Medical Center ( Site 0003)
state: Texas
city: Houston
country: United States
facility: Houston Methodist Urology Associates ( Site 0033)
state: Texas
city: San Antonio
country: United States
facility: Urology of San Antonio ( Site 0020)
state: Texas
city: Madison
country: United States
facility: University of Wisconsin Hospital and Clinics ( Site 0037)
state: Wisconsin
city: Ciudad autónoma de Buenos Aires
country: Argentina
facility: Hospital Británico de Buenos Aires-Oncology ( Site 1551)
state: Buenos Aires
city: ABB
country: Argentina
facility: Hospital Italiano de Buenos Aires ( Site 1554)
state: Caba
city: Buenos Aires
country: Argentina
facility: Centro de Educación Médica e Investigaciones Clínicas (CEMIC) ( Site 1558)
state: Caba
city: Rosario
country: Argentina
facility: Fundacion Estudios Clinicos-Oncology ( Site 1557)
state: Santa Fe
city: Buenos Aires
country: Argentina
facility: Centro de Urología (CDU) ( Site 1552)
city: Buenos Aires
country: Argentina
facility: Asociación de Beneficencia Hospital Sirio Libanés ( Site 1553)
city: Macquarie University
country: Australia
facility: Macquarie University-MQ Health Clinical Trials Unit ( Site 1259)
state: New South Wales
city: South Brisbane
country: Australia
facility: Mater Hospital Brisbane ( Site 1257)
state: Queensland
city: Elizabeth Vale
country: Australia
facility: Lyell McEwin Hospital ( Site 1252)
state: South Australia
city: Frankston
country: Australia
facility: Frankston Hospital-Oncology and Haematology ( Site 1258)
state: Victoria
city: Panagyurishte
country: Bulgaria
facility: MHAT "Uni Hospital" OOD ( Site 1154)
state: Pazardzhik
city: Plovdiv
country: Bulgaria
facility: Complex Oncology Center Plovdiv ( Site 1151)
city: Plovdiv
country: Bulgaria
facility: MHAT Central Onco Hospital OOD ( Site 1158)
city: Sofia
country: Bulgaria
facility: MHAT Serdika ( Site 1152)
city: Vancouver
country: Canada
facility: BC Cancer - Vancouver Center ( Site 0110)
state: British Columbia
city: Winnipeg
country: Canada
facility: CancerCare Manitoba ( Site 0108)
state: Manitoba
city: Moncton
country: Canada
facility: Moncton Hospital ( Site 0107)
state: New Brunswick
city: Ottawa
country: Canada
facility: Ottawa Hospital Research Institute ( Site 0109)
state: Ontario
city: Montreal
country: Canada
facility: Jewish General Hospital ( Site 0106)
state: Quebec
city: Guangzhou
country: China
facility: SUN YAT-SEN UNIVERSITY CANCER CENTRE ( Site 1406)
state: Guangdong
city: Guangzhou
country: China
facility: Sun Yat-sen Memorial Hospital, Sun Yat-sen University ( Site 1413)
state: Guangdong
city: Changsha
country: China
facility: Hunan Cancer Hospital ( Site 1403)
state: Hunan
city: Nanjing
country: China
facility: Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School-Urology ( S
state: Jiangsu
city: Nantong
country: China
facility: Nantong Tumor Hospital-Urology ( Site 1405)
state: Jiangsu
city: Shanghai
country: China
facility: Fudan University Shanghai Cancer Center-Urology department ( Site 1401)
state: Shanghai
city: Shanghai
country: China
facility: Renji Hospital Shanghai Jiao Tong University School of Medicine ( Site 1402)
state: Shanghai
city: Medellin
country: Colombia
facility: Fundación Colombiana de Cancerología Clínica Vida ( Site 1653)
state: Antioquia
city: Montería
country: Colombia
facility: Oncomédica S.A.S ( Site 1652)
state: Cordoba
city: Bogota
country: Colombia
facility: Clinica Colsanitas S.A, Sede Clínica Universitaria Colombia-Center Investigator ( Site 1654)
state: Distrito Capital De Bogota
city: Piedecuesta
country: Colombia
facility: Fundación Cardiovascular de Colombia-Santander ( Site 1657)
state: Santander
city: Cali
country: Colombia
facility: Fundacion Valle del Lili- CIC ( Site 1656)
state: Valle Del Cauca
city: Zagreb
country: Croatia
facility: Klinički bolnički centar Sestre milosrdnice ( Site 1703)
state: Grad Zagreb
city: Zagreb
country: Croatia
facility: Klinički bolnički centar Zagreb-Klinika za onkologiju ( Site 1701)
state: Grad Zagreb
city: Osijek
country: Croatia
facility: Klinički bolnički centar Osijek ( Site 1705)
state: Osjecko-baranjska Zupanija
city: Split
country: Croatia
facility: Klinički Bolnički Centar Split-Oncology and Radiotherapy ( Site 1702)
state: Splitsko-dalmatinska Zupanija
city: Brno
country: Czechia
facility: Fakultni nemocnice u sv. Anny v Brne ( Site 0253)
state: Jihomoravsky Kraj
city: Hradec Kralove
country: Czechia
facility: Fakultni nemocnice Hradec Kralove-Klinika onkologie a radioterapie ( Site 0254)
city: Olomouc
country: Czechia
facility: Fakultni Nemocnice Olomouc ( Site 0251)
city: Praha 4
country: Czechia
facility: Fakultni Thomayerova nemocnice ( Site 0252)
city: Marseille
country: France
facility: CHU La Timone ( Site 0456)
state: Bouches-du-Rhone
city: Besancon
country: France
facility: CHU Jean Minjoz ( Site 0453)
state: Doubs
city: Brest
country: France
facility: CHU de Brest -Site Hopital Morvan ( Site 0461)
state: Finistere
city: Toulouse
country: France
facility: Institut Universitaire du Cancer Toulouse - Oncopole ( Site 0455)
state: Haute-Garonne
city: Limoges
country: France
facility: CHU Limoges Hopital Dupuytren ( Site 0459)
state: Haute-Vienne
city: Villejuif
country: France
facility: Gustave Roussy ( Site 0467)
state: Ile-de-France
city: La Tronche
country: France
facility: CHU GRENOBLE ALPES ( Site 0468)
state: Isere
city: Orleans
country: France
facility: Centre Hospitalier Regional du Orleans ( Site 0463)
state: Loiret
city: Lille
country: France
facility: Polyclinique du Bois ( Site 0458)
state: Nord
city: Paris
country: France
facility: Hopital Diaconesses Croix Saint Simon ( Site 0465)
city: Freiburg
country: Germany
facility: Universitaetsklinikum Freiburg ( Site 0512)
state: Baden-Wurttemberg
city: Tuebingen
country: Germany
facility: Universitaetsklinik fuer Urologie ( Site 0501)
state: Baden-Wurttemberg
city: Regensburg
country: Germany
facility: Caritas Krankenhaus St. Josef ( Site 0502)
state: Bayern
city: Wuerzburg
country: Germany
facility: Universitaetsklinikum Wuerzburg ( Site 0520)
state: Bayern
city: Herne
country: Germany
facility: Kath. Krankenhaus Marienhospital. Universitaetsklinik ( Site 0511)
state: Nordrhein-Westfalen
city: Muenster
country: Germany
facility: Universitaetsklinikum Muenster ( Site 0516)
state: Nordrhein-Westfalen
city: Halle
country: Germany
facility: Krankenhaus Martha Maria Halle-Doelau ( Site 0507)
state: Sachsen-Anhalt
city: Dresden
country: Germany
facility: Universitaetsklinikum Carl Gustav Carus ( Site 0509)
state: Sachsen
city: Berlin
country: Germany
facility: Vivantes Klinikum Am Urban ( Site 0519)
city: Patras
country: Greece
facility: UNIVERSITY HOSPITAL OF PATRAS-DIVISION OF ONCOLOGY ( Site 0305)
state: Achaia
city: Athens
country: Greece
facility: General Hospital of Athens "Alexandra" ( Site 0303)
state: Attiki
city: Athens
country: Greece
facility: Athens Medical Center ( Site 0304)
state: Attiki
city: Chaidari
country: Greece
facility: ATTIKON GENERAL UNIVERSITY HOSPITAL ( Site 0301)
state: Attiki
city: Larissa
country: Greece
facility: University General Hospital of Larissa ( Site 0302)
state: Thessalia
city: Szeged
country: Hungary
facility: Szegedi Tudományegyetem Szent-Györgyi Albert Klinikai Központ ( Site 1010)
state: Csongrad
city: Szolnok
country: Hungary
facility: Jász-Nagykun-Szolnok Vármegyei Hetényi Géza Kórház ( Site 1002)
state: Jasz-Nagykun-Szolnok
city: Debrecen
country: Hungary
facility: Debreceni Egyetem Klinikai Kozpont ( Site 1006)
city: Haifa
country: Israel
facility: Rambam Health Care Campus-Oncology ( Site 0751)
city: Jerusalem
country: Israel
facility: Hadassah Medical Center-Oncology ( Site 0757)
city: Kfar Saba
country: Israel
facility: Meir Medical Center-oncology ( Site 0754)
city: Petah-Tikva
country: Israel
facility: Rabin Medical Center-Oncology ( Site 0752)
city: Ramat Gan
country: Israel
facility: Sheba Medical Center-ONCOLOGY ( Site 0753)
city: Tel Aviv
country: Israel
facility: Sourasky Medical Center-Oncology ( Site 0755)
city: Zerifin
country: Israel
facility: Yitzhak Shamir Medical Center-Oncology ( Site 0756)
city: Milan
country: Italy
facility: Fondazione IRCCS Istituto Nazionale dei Tumori-Struttura Complessa Oncologia Medica 1 ( Site 0588)
state: Lombardia
city: Pozzuoli
country: Italy
facility: Presidio Ospedaliero Santa Maria delle Grazie ( Site 0599)
state: Napoli
city: Orbassano
country: Italy
facility: AOU San Luigi Gonzaga di Orbassano ( Site 0595)
state: Torino
city: Verona
country: Italy
facility: Azienda Ospedaliera Universitaria Integrata Verona - Ospedale Borgo Trento ( Site 0598)
state: Veneto
city: Ancona
country: Italy
facility: Azienda Ospedaliero Universitaria delle Marche-Clinica Oncologica ( Site 0593)
city: Catania
country: Italy
facility: Ospedale Cannizzaro ( Site 0590)
city: Milano
country: Italy
facility: IRCCS Ospedale San Raffaele ( Site 0596)
city: Padova
country: Italy
facility: Istituto Oncologico Veneto IRCCS-Oncologia Medica 1 ( Site 0600)
city: Nagoya
country: Japan
facility: Nagoya University Hospital ( Site 1512)
state: Aichi
city: Hirosaki
country: Japan
facility: Hirosaki University Hospital ( Site 1501)
state: Aomori
city: Tsukuba
country: Japan
facility: University of Tsukuba Hospital ( Site 1502)
state: Ibaraki
city: Kanazawa
country: Japan
facility: Kanazawa University Hospital ( Site 1509)
state: Ishikawa
city: Sagamihara
country: Japan
facility: Kitasato University Hospital ( Site 1506)
state: Kanagawa
city: Yokohama
country: Japan
facility: Yokohama City University Medical Center ( Site 1508)
state: Kanagawa
city: Yokohama
country: Japan
facility: Kanagawa Cancer Center ( Site 1507)
state: Kanagawa
city: Sendai
country: Japan
facility: Tohoku University Hospital ( Site 1503)
state: Miyagi
city: Hamamatsu
country: Japan
facility: Hamamatsu University Hospital ( Site 1511)
state: Shizuoka
city: Gifu
country: Japan
facility: Gifu University Hospital ( Site 1513)
city: Nagasaki
country: Japan
facility: Nagasaki University Hospital ( Site 1517)
city: Okayama
country: Japan
facility: Okayama University Hospital ( Site 1516)
city: Osaka
country: Japan
facility: Osaka International Cancer Institute ( Site 1514)
city: Osaka
country: Japan
facility: Osaka Metropolitan University Hospital ( Site 1515)
city: Tokyo
country: Japan
facility: Tokyo Medical and Dental University Hospital ( Site 1505)
city: Tokyo
country: Japan
facility: Keio University Hospital ( Site 1504)
city: Toyama
country: Japan
facility: Toyama University Hospital ( Site 1510)
city: Jeollanam-do
country: Korea, Republic of
facility: Chonnam National University Hwasun Hospital ( Site 1353)
state: Jeonranamdo
city: Gyeonggi-do
country: Korea, Republic of
facility: Seoul National University Bundang Hospital ( Site 1355)
state: Kyonggi-do
city: Songpagu
country: Korea, Republic of
facility: Asan Medical Center ( Site 1352)
state: Seoul
city: Daegu
country: Korea, Republic of
facility: Kyungpook National University Chilgok Hospital ( Site 1354)
state: Taegu-Kwangyokshi
city: Incheon
country: Korea, Republic of
facility: Gachon University Gil Medical Center ( Site 1356)
city: Seoul
country: Korea, Republic of
facility: Korea University Anam Hospital ( Site 1357)
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital ( Site 1351)
city: Lembah Pantai
country: Malaysia
facility: University Malaya Medical Centre ( Site 0352)
state: Kuala Lumpur
city: George Town
country: Malaysia
facility: Hospital Pulau Pinang ( Site 0355)
state: Pulau Pinang
city: Kuching
country: Malaysia
facility: Sarawak General Hospital ( Site 0351)
state: Sarawak
city: Petaling Jaya
country: Malaysia
facility: Sunway Medical Centre ( Site 0353)
state: Selangor
city: Iloilo City
country: Philippines
facility: THE MEDICAL CITY ILOILO-The Medical City Iloilo - Clinical and Translational Research Institute-Ilo
state: Iloilo
city: Wrocław
country: Poland
facility: Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wrocławiu ( Site 1058)
state: Dolnoslaskie
city: Siedlce
country: Poland
facility: Mazowiecki Szpital Wojewódzki w Siedlcach-Siedleckie Centrum Onkologii ( Site 1057)
state: Mazowieckie
city: Warszawa
country: Poland
facility: Narodowy Instytut Onkologii ( Site 1051)
state: Mazowieckie
city: Przemysl
country: Poland
facility: Wojewodzki Szpital im. Sw. Ojca Pio w Przemyslu ( Site 1053)
state: Podkarpackie
city: Poznan
country: Poland
facility: Clinical Research Center Medic-R ( Site 1061)
state: Wielkopolskie
city: Koszalin
country: Poland
facility: Szpital Wojewodzki im. Mikolaja Kopernika ( Site 1055)
state: Zachodniopomorskie
city: Coimbra
country: Portugal
facility: Centro Hospitalar e Universitario de Coimbra ( Site 0406)
city: Lisboa
country: Portugal
facility: Inst. Portugues de Oncologia de Lisboa Francisco Gentil EPE ( Site 0409)
city: Lisboa
country: Portugal
facility: CHLO, EPE - Hospital de Sao Francisco Xavier ( Site 0401)
city: Porto
country: Portugal
facility: Hospital Geral de Santo Antonio ( Site 0408)
city: Cluj Napoca
country: Romania
facility: Institutul Oncologic Prof.Dr. Ion Chiricuta Cluj-Napoca ( Site 1102)
state: Cluj
city: Cluj-Napoca
country: Romania
facility: Cardiomed SRL Cluj-Napoca ( Site 1101)
state: Cluj
city: Cluj-Napoca
country: Romania
facility: Institutul Oncologic Prof.Dr. Ion Chiricuta Cluj-Napoca ( Site 1103)
state: Cluj
city: Comuna Floresti
country: Romania
facility: SC Radiotherapy Center Cluj SRL ( Site 1108)
state: Cluj
city: Craiova
country: Romania
facility: S.C. Centrul de Oncologie Sf. Nectarie SRL ( Site 1107)
state: Dolj
city: Timisoara
country: Romania
facility: Policlinica Oncomed SRL ( Site 1106)
state: Timis
city: Bucuresti
country: Romania
facility: SC Focus Lab Plus SRL ( Site 1104)
city: Cluj
country: Romania
facility: Institutul Oncologic Cluj-Oncologie Medicala ( Site 1109)
city: Barnaul
country: Russian Federation
facility: Altay Regional Oncology Dispensary ( Site 0851)
state: Altayskiy Kray
city: Obninsk
country: Russian Federation
facility: National Medical Research Radiology Centre ( Site 0869)
state: Kaluzskaja Oblast
city: Moscow
country: Russian Federation
facility: National Medical Research Centre of Oncology named after N.N. Blokhin ( Site 0865)
state: Moskva
city: Moscow
country: Russian Federation
facility: First Moscow State Medical University n.a. I.M.Sechenov ( Site 0871)
state: Moskva
city: Nizhny Novgorod
country: Russian Federation
facility: Volga District Medical Center ( Site 0876)
state: Nizhegorodskaya Oblast
city: Saint Petersburg
country: Russian Federation
facility: St.Petersburg Clinical Hospital RAS ( Site 0864)
state: Sankt-Peterburg
city: Saint Petersburg
country: Russian Federation
facility: St.Petersburg State Medical Univ. n.a. acad. I.P.Pavlov ( Site 0856)
state: Sankt-Peterburg
city: Saint Petersburg
country: Russian Federation
facility: Scientific Research Oncology Institute n.a. N.N.Petrov ( Site 0852)
state: Sankt-Peterburg
city: Ekaterinburg
country: Russian Federation
facility: Sverdlovsk Regional Oncology Hospital ( Site 0867)
state: Sverdlovskaya Oblast
city: Ekaterinburg
country: Russian Federation
facility: Sverdlovsky Regional Clinical hospital #1 ( Site 0868)
state: Sverdlovskaya Oblast
city: Volzhsky
country: Russian Federation
facility: Volgograd Regional Uronephrological Center ( Site 0870)
state: Volgogradskaya Oblast
city: Singapore
country: Singapore
facility: Tan Tock Seng Hospital ( Site 0704)
state: Central Singapore
city: Johannesburg
country: South Africa
facility: Wits Clinical Research ( Site 0603)
state: Gauteng
city: Pretoria
country: South Africa
facility: Steve Biko Academic Hospital ( Site 0601)
state: Gauteng
city: Cape Town
country: South Africa
facility: Groote Schuur Hospital ( Site 0602)
state: Western Cape
city: Oviedo
country: Spain
facility: Hospital Universitario Central de Asturias ( Site 0654)
state: Asturias
city: Badalona
country: Spain
facility: Hospital Germans Trias i Pujol. ICO de Badalona ( Site 0658)
state: Barcelona
city: Manresa
country: Spain
facility: Xarxa Assistencial Universitaria Manresa ( Site 0655)
state: Barcelona
city: Girona
country: Spain
facility: Institut Català d'Oncologia (ICO) - Girona ( Site 0653)
state: Gerona
city: Santiago de Compostela
country: Spain
facility: CHUS - Hospital Clinico Universitario-Servicio de Oncologia ( Site 0660)
state: La Coruna
city: Las Palmas de Gran Canaria
country: Spain
facility: Hospital Universitario Insular de Gran Canaria ( Site 0657)
state: Las Palmas
city: Valencia
country: Spain
facility: Fundación Instituto Valenciano de Oncología-Oncologico ( Site 0662)
state: Valenciana, Comunitat
city: Barcelona
country: Spain
facility: Hospital Universitari Vall d'Hebron-Departamento de Oncologia- VHIO ( Site 0661)
city: Madrid
country: Spain
facility: Hospital Clinico Universitario San Carlos de Madrid ( Site 0651)
city: Sevilla
country: Spain
facility: Hospital Virgen del Rocio ( Site 0659)
city: Kaohsiung Niao Sung Dist
country: Taiwan
facility: Chang Gung Memorial Hospital at Kaohsiung ( Site 1203)
state: Kaohsiung
city: Taichung
country: Taiwan
facility: China Medical University Hospital ( Site 1202)
city: Taipei
country: Taiwan
facility: Taipei Veterans General Hospital ( Site 1201)
city: Dnipro
country: Ukraine
facility: I.I. Mechnykov Dnipropetrovsk Regional Clinical Hospital ( Site 0959)
state: Dnipropetrovska Oblast
city: Dnipro
country: Ukraine
facility: MI Clinical oncology dispensary of Dnipropetrovsk regional council ( Site 0954)
state: Dnipropetrovska Oblast
city: Kharkiv
country: Ukraine
facility: Regional Clinical Center of Urology and Nephrology n.a. V.I. Shapoval ( Site 0952)
state: Kharkivska Oblast
city: Kharkiv
country: Ukraine
facility: MNPE Regional Center of Oncology ( Site 0955)
state: Kharkivska Oblast
city: Kharkiv
country: Ukraine
facility: Municipal Non-profit Enterprise of Kharkiv Regional Council RCSDRPP ( Site 0965)
state: Kharkivska Oblast
city: Lviv
country: Ukraine
facility: Lviv Oncology Regional Treatment and Diagnostic Center ( Site 0960)
state: Lvivska Oblast
city: Zhytomyr
country: Ukraine
facility: Zhytomyr Regional Oncology Center ( Site 0961)
state: Zhytomyrska Oblast
city: Torquay
country: United Kingdom
facility: Torbay Hospital ( Site 1804)
state: Devon
city: London
country: United Kingdom
facility: St Bartholomew's Hospital-Centre for Experimental Cancer Medicine ( Site 1801)
state: London, City Of
city: London
country: United Kingdom
facility: Imperial College Healthcare NHS Foundation Trust - St Mary's Hospital ( Site 1802)
state: London, City Of
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Director
role: STUDY_DIRECTOR
References: