Clinical trial NCT04736706: A Study of Pembrolizumab (MK-3475) in Combination With Belzutifan (MK-6482) and Lenvatinib (MK-7902), or Pembrolizumab/Quavonlimab (MK-1308A) in Combination With Lenvatinib, Versus Pembrolizumab and Lenvatinib, for Treatment of Advanced Clear Cell Renal Cell Carcinoma (MK-6482-012)
Official title: An Open-label, Randomized Phase 3 Study to Evaluate Efficacy and Safety of Pembrolizumab (MK-3475) in Combination With Belzutifan (MK-6482) and Lenvatinib (MK-7902), or MK-1308A in Combination With Lenvatinib, Versus Pembrolizumab and Lenvatinib, as First-Line Treatment in Participants With Advanced Clear Cell Renal Cell Carcinoma (ccRCC)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Carcinoma, Renal Cell
Keywords: Programmed Cell Death-1 (PD1, PD-1)
Programmed Death-Ligand 1 (PDL1, PD-L1)
Hypoxia inducible factor (HIF)
Hypoxia inducible factor 1B (HIF-1B)
Hypoxia inducible factor 2 alpha (HIF-2 alpha)
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
Collaborators: name: Eisai Inc.
First posted: 2021-02-03
Enrollment: 1653
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 goal of this study is to evaluate the efficacy and safety of pembrolizumab plus belzutifan plus lenvatinib or pembrolizumab/quavonlimab plus lenvatinib versus pembrolizumab plus lenvatinib as first-line treatment in participants with advanced clear cell renal cell carcinoma (ccRCC).

The primary hypotheses are (1) pembrolizumab plus belzutifan plus lenvatinib is superior to pembrolizumab plus lenvatinib with respect to progression-free survival (PFS) and overall survival (OS), in advanced ccRCC participants; and (2) pembrolizumab/quavonlimab plus lenvatinib is superior to pembrolizumab plus lenvatinib with respect to PFS and OS, in advanced ccRCC participants.


Eligibility criteria: Inclusion Criteria:

* Has histologically confirmed diagnosis of RCC with clear cell component.
* Has received no prior systemic therapy for advanced ccRCC
* Male participants are abstinent from heterosexual intercourse or agree to use contraception during and for at least 7 days after last dose of study intervention with belzutifan and lenvatinib.
* Female participants are not pregnant or breastfeeding and are either not a woman of child-bearing potential (WOCBP) or use a contraceptive method that is highly effective or are abstinent from heterosexual intercourse during the intervention period and for at least 120 days after pembrolizumab or pembrolizumab/quavonlimab or for at least 30 days after last dose of lenvatinib or belzutifan, whichever occurs last
* Has adequately controlled blood pressure with or without antihypertensive medications
* Has adequate organ function.
* Participants receiving bone resorptive therapy must have therapy initiated at least 2 weeks prior to randomization/allocation

Exclusion Criteria:

* Has a known additional malignancy that is progressing or has required active treatment within the past 3 years
* Has had major surgery, other than nephrectomy within 4 weeks prior to randomization
* Has known central nervous system (CNS) metastases and/or carcinomatous meningitis
* Has received prior radiotherapy within 2 weeks prior to first dose of study intervention
* Has hypoxia or requires intermittent supplemental oxygen or requires chronic supplemental oxygen
* Has clinically significant cardiac disease within 12 months from first dose of study intervention
* Has a history of interstitial lung disease
* Has symptomatic pleural effusion; a participant who is clinically stable following treatment of this condition is eligible
* Has preexisting gastrointestinal or non-gastrointestinal fistula
* Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of study treatment
* Has a known psychiatric or substance abuse disorder that would interfere with requirements of the study
* Has received a live or live-attenuated vaccine within 30 days before the first dose of study drug; killed vaccines are allowed
* Has an active autoimmune disease that has required systemic treatment in the past 2 years
* Has a history of noninfectious pneumonitis that required steroids or has current pneumonitis
* Has an active infection requiring systemic therapy
* Has a known history of human immunodeficiency virus (HIV) infection
* Has a known history of Hepatitis B
* Has radiographic evidence of intratumoral cavitation, encasement or invasion of a major blood vessel
* Has clinically significant history of bleeding within 3 months prior to randomization
* Has had an allogenic tissue/solid organ transplant

Primary outcomes:
measure: Progression Free Survival (PFS) According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Review (BICR)
timeFrame: Up to approximately 46 months
measure: Overall Survival (OS)
timeFrame: Up to approximately 66 months
Secondary outcomes:
measure: Objective Response Rate (ORR) Per RECIST 1.1 as Assessed by BICR
timeFrame: Up to approximately 46 months
measure: Duration of Response (DOR) Per RECIST 1.1 as Assessed by BICR
timeFrame: Up to approximately 66 months
measure: Number of Participants Who Experienced At least One Adverse Event (AE)
timeFrame: Up to approximately 66 months
measure: Number of Participants Who Discontinue Study Treatment Due to an AE
timeFrame: Up to approximately 66 months
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: The University of Alabama at Birmingham ( Site 0010)
state: Alabama
city: La Jolla
country: United States
facility: UC San Diego ( Site 0050)
state: California
city: Los Angeles
country: United States
facility: Cedars Sinai Medical Center ( Site 0027)
state: California
city: Orange
country: United States
facility: University of California Irvine ( Site 0029)
state: California
city: Santa Monica
country: United States
facility: UCLA Hematology Oncology Santa Monica ( Site 0048)
state: California
city: Hartford
country: United States
facility: Hartford Hospital ( Site 0024)
state: Connecticut
city: Orlando
country: United States
facility: Advent Health Hematology & Oncology ( Site 0003)
state: Florida
city: Athens
country: United States
facility: University Cancer & Blood Center, LLC ( Site 0057)
state: Georgia
city: Atlanta
country: United States
facility: Emory University Winship Cancer Institute ( Site 0012)
state: Georgia
city: Chicago
country: United States
facility: Rush University Medical Center ( Site 0040)
state: Illinois
city: Fort Wayne
country: United States
facility: Parkview Cancer Institute ( Site 0088)
state: Indiana
city: Louisville
country: United States
facility: Norton Cancer Institute - St. Matthews ( Site 0065)
state: Kentucky
city: New Orleans
country: United States
facility: Ochsner Medical Center ( Site 0049)
state: Louisiana
city: Scarborough
country: United States
facility: New England Cancer Specialists ( Site 0082)
state: Maine
city: Boston
country: United States
facility: Massachusetts General Hospital ( Site 0094)
state: Massachusetts
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center ( Site 0089)
state: Massachusetts
city: Boston
country: United States
facility: Dana Farber Cancer Institute ( Site 0093)
state: Massachusetts
city: Burlington
country: United States
facility: Lahey Hospital & Medical Center ( Site 0090)
state: Massachusetts
city: Detroit
country: United States
facility: Henry Ford Hospital ( Site 0038)
state: Michigan
city: Grand Rapids
country: United States
facility: Cancer & Hematology Centers of Western Michigan ( Site 0018)
state: Michigan
city: Saint Louis Park
country: United States
facility: HealthPartners Cancer Research Center-HealthPartners Frauenshuh Cancer Center ( Site 0005)
state: Minnesota
city: Saint Paul
country: United States
facility: Regions Hospital ( Site 0095)
state: Minnesota
city: Jackson
country: United States
facility: University of Mississippi Medical Center ( Site 0037)
state: Mississippi
city: Lebanon
country: United States
facility: Dartmouth Hitchcock Medical Center ( Site 0075)
state: New Hampshire
city: Buffalo
country: United States
facility: Roswell Park Cancer Institute ( Site 0032)
state: New York
city: Lake Success
country: United States
facility: R.J. Zuckerberg Cancer Center-Medical Oncology ( Site 0013)
state: New York
city: New York
country: United States
facility: Sidney Kimmel Center for Prostate and Urologic Cancers ( Site 0055)
state: New York
city: Portland
country: United States
facility: Oregon Health & Science University ( Site 0071)
state: Oregon
city: Charleston
country: United States
facility: Ralph H. Johnson VA Center ( Site 0073)
state: South Carolina
city: Knoxville
country: United States
facility: University of Tennessee Medical Center Knoxville ( Site 0019)
state: Tennessee
city: Nashville
country: United States
facility: Vanderbilt University Medical Center ( Site 0069)
state: Tennessee
city: Dallas
country: United States
facility: UTSW Medical Center ( Site 0015)
state: Texas
city: Wenatchee
country: United States
facility: Central Washington Health Services Association d/b/a Confluence Health ( Site 0061)
state: Washington
city: Liverpool
country: Australia
facility: Liverpool Hospital ( Site 4006)
state: New South Wales
city: Macquarie University
country: Australia
facility: Macquarie University ( Site 4007)
state: New South Wales
city: Elizabeth Vale
country: Australia
facility: Lyell McEwin Hospital ( Site 4004)
state: South Australia
city: Clayton
country: Australia
facility: Monash Health ( Site 4008)
state: Victoria
city: Murdock
country: Australia
facility: Fiona Stanley Hospital ( Site 4009)
state: Western Australia
city: Fortaleza
country: Brazil
facility: Oncocentro Ceara ( Site 0309)
state: Ceara
city: Cachoeiro de Itapemirim
country: Brazil
facility: Centro de Pesquisas Clinicas em Oncologia ( Site 0306)
state: Espirito Santo
city: Belo Horizonte
country: Brazil
facility: Centro Avançado de Tratamento Oncológico- CENATRON-Clinical Research ( Site 0303)
state: Minas Gerais
city: Natal
country: Brazil
facility: Liga Norte Riograndense Contra o Cancer ( Site 0308)
state: Rio Grande Do Norte
city: Porto Alegre
country: Brazil
facility: Hospital de Clinicas de Porto Alegre ( Site 0310)
state: Rio Grande Do Sul
city: Sao Paulo
country: Brazil
facility: Instituto do Cancer do Estado de Sao Paulo - ICESP ( Site 0302)
city: Sao Paulo
country: Brazil
facility: BP - A Beneficencia Portuguesa de São Paulo-Medical Oncology ( Site 0300)
city: Sao Paulo
country: Brazil
facility: A.C. Camargo Cancer Center ( Site 0301)
city: Calgary
country: Canada
facility: Tom Baker Cancer Centre ( Site 0119)
state: Alberta
city: Vancouver
country: Canada
facility: BC Cancer - Vancouver Center ( Site 0120)
state: British Columbia
city: Hamilton
country: Canada
facility: Hamilton Health Sciences-Juravinski Cancer Centre ( Site 0117)
state: Ontario
city: Toronto
country: Canada
facility: Sunnybrook Research Institute ( Site 0116)
state: Ontario
city: Quebec
country: Canada
facility: Centre intégré de cancérologie du CHU de Québec Université Laval, Hôpital de l'Enfant-Jésus ( Site 0
city: Temuco
country: Chile
facility: Centro Investigacion Cancer James Lind ( Site 0402)
state: Araucania
city: La Serena
country: Chile
facility: IC La Serena Research ( Site 0403)
state: Coquimbo
city: Rancagua
country: Chile
facility: Servicios Medicos Urumed ( Site 0405)
state: Lbtdr Gen Bernardo O Higgins
city: Santiago
country: Chile
facility: Fundacion Arturo Lopez Perez ( Site 0400)
state: Region M. De Santiago
city: Santiago
country: Chile
facility: Bradfordhill-Clinical Area ( Site 0401)
state: Region M. De Santiago
city: Bengbu
country: China
facility: The First Afflilated Hospital of Bengbu Medical College-Urology Surgery ( Site 6041)
state: Anhui
city: Beijing
country: China
facility: Cancer Hospital Chinese Academy of Medical Science-Oncology ( Site 6026)
state: Beijing
city: Beijing
country: China
facility: Peking University First Hospital ( Site 6011)
state: Beijing
city: Beijing
country: China
facility: Beijing Cancer hospital-Renal carcinoma and melanoma ( Site 6000)
state: Beijing
city: Chongqing
country: China
facility: Chongqing University Cancer Hospital ( Site 6009)
state: Chongqing
city: Fuzhou
country: China
facility: The First Affiliated Hospital Of Fujian Medical University-Urology ( Site 6038)
state: Fujian
city: Xiamen
country: China
facility: The First Affiliated hospital of Xiamen University-Urology ( Site 6001)
state: Fujian
city: Guangzhou
country: China
facility: SUN YAT-SEN UNIVERSITY CANCER CENTRE ( Site 6003)
state: Guangdong
city: Guangzhou
country: China
facility: The First Affiliated Hospital of Guangzhou Medical University-Urology ( Site 6036)
state: Guangdong
city: Guangzhou
country: China
facility: Guangzhou First People's Hospital ( Site 6007)
state: Guangdong
city: Guangzhou
country: China
facility: Sun Yat-sen Memorial Hospital, Sun Yat-sen University-Urology Surgery ( Site 6005)
state: Guangdong
city: Harbin
country: China
facility: Harbin Medical University Cancer Hospital-urology ( Site 6015)
state: Heilongjiang
city: Zhengzhou
country: China
facility: Henan Cancer Hospital-Urology ( Site 6006)
state: Henan
city: Wuhan
country: China
facility: Wuhan Union Hospital ( Site 6002)
state: Hubei
city: Changsha
country: China
facility: Xiangya Hospital Central South University ( Site 6034)
state: Hunan
city: Changsha
country: China
facility: Hunan Cancer Hospital ( Site 6020)
state: Hunan
city: NanJing
country: China
facility: Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School-Urology ( S
state: Jiangsu
city: Suzhou
country: China
facility: The Second Affiliated Hospital of Soochow University-Urology ( Site 6025)
state: Jiangsu
city: Nanchang
country: China
facility: The First Affiliated Hospital of Nanchang University ( Site 6019)
state: Jiangxi
city: Nanchang
country: China
facility: Jiangxi Provincial Cancer Hospital ( Site 6042)
state: Jiangxi
city: Xi'an
country: China
facility: The First Affiliated Hospital of Xi'an Jiaotong University ( Site 6014)
state: Shaanxi
city: Shanghai
country: China
facility: Renji Hospital Shanghai Jiao Tong University School of Medicine ( Site 6017)
state: Shanghai
city: Shanghai
country: China
facility: Shanghai Tenth People's Hospital ( Site 6023)
state: Shanghai
city: Cheng Du
country: China
facility: West China Hospital Sichuan University-Urology Surgery ( Site 6016)
state: Sichuan
city: Tianjin
country: China
facility: Tianjin Medical University Cancer Institute and Hospital ( Site 6029)
state: Tianjin
city: Tianjin
country: China
facility: The Second Hospital of Tianjin Medical University ( Site 6032)
state: Tianjin
city: Hangzhou
country: China
facility: The First Affiliated Hospital, Zhejiang University ( Site 6024)
state: Zhejiang
city: Jiaxing
country: China
facility: The First Hospital of Jiaxing ( Site 6033)
state: Zhejiang
city: Ningbo
country: China
facility: Ningbo First Hospital-Urology ( Site 6028)
state: Zhejiang
city: Wenzhou
country: China
facility: The First Affiliated Hospital of Wenzhou Medical University-Urology Surgery ( Site 6021)
state: Zhejiang
city: Medellin
country: Colombia
facility: Instituto de Cancerología S.A Clínica de las Americas (ICCLA) ( Site 0500)
state: Antioquia
city: Barranquilla
country: Colombia
facility: Clinica de la Costa S.A.S. ( Site 0502)
state: Atlantico
city: Valledupar
country: Colombia
facility: Sociedad de Oncología Y Hematología del Cesar S.A.S. ( Site 0505)
state: Cesar
city: Bogota
country: Colombia
facility: Administradora Country SA - Clinica del Country ( Site 0504)
state: Distrito Capital De Bogota
city: Bogotá
country: Colombia
facility: Instituto Nacional de Cancerología E.S.E. ( Site 0503)
state: Distrito Capital De Bogota
city: Pereira
country: Colombia
facility: Oncólogos del Occidente S.A ( Site 0501)
state: Risaralda
city: Piedecuesta
country: Colombia
facility: Fundacion Cardiovascular de Colombia ( Site 0506)
state: Santander
city: Zagreb
country: Croatia
facility: Klinicki Bolnicki Centar Zagreb ( Site 3200)
state: Grad Zagreb
city: Split
country: Croatia
facility: Klinički Bolnički Centar Split ( Site 3202)
state: Splitsko-dalmatinska Zupanija
city: Zagreb
country: Croatia
facility: Klinicki bolnicki centar "Sestre milosrdnice" ( Site 3201)
state: Zagrebacka Zupanija
city: Brno
country: Czechia
facility: Masarykuv onkologicky ustav ( Site 2203)
state: Brno-mesto
city: Brno
country: Czechia
facility: Fakultni nemocnice u sv. Anny v Brne ( Site 2205)
state: Jihomoravsky Kraj
city: Novy Jicin
country: Czechia
facility: Nemocnice AGEL Novy Jicin a.s. ( Site 2202)
state: Moravskoslezsky Kraj
city: Ostrava
country: Czechia
facility: Fakultni nemocnice Ostrava ( Site 2208)
state: Moravskoslezsky Kraj
city: Olomouc
country: Czechia
facility: Fakultni nemocnice Olomouc ( Site 2200)
city: Praha 4
country: Czechia
facility: Fakultni Thomayerova nemocnice ( Site 2201)
city: Praha 5
country: Czechia
facility: 2 LF UK a FN Motol ( Site 2207)
city: Herlev
country: Denmark
facility: Herlev Hospital ( Site 1700)
state: Hovedstaden
city: Odense
country: Denmark
facility: Odense University Hospital ( Site 1701)
state: Syddanmark
city: Tampere
country: Finland
facility: TAYS ( Site 1801)
state: Pirkanmaa
city: Kuopio
country: Finland
facility: Kuopion Yliopistollinen Sairaala ( Site 1803)
state: Pohjois-Savo
city: Helsinki
country: Finland
facility: HYKS ( Site 1800)
state: Uusimaa
city: Turku
country: Finland
facility: TYKS ( Site 1802)
state: Varsinais-Suomi
city: Marseille
country: France
facility: Institut Paoli Calmettes ( Site 1206)
state: Bouches-du-Rhone
city: Besancon
country: France
facility: CHU Jean Minjoz ( Site 1205)
state: Doubs
city: Toulouse
country: France
facility: Institut Claudius Regaud ( Site 1214)
state: Haute-Garonne
city: Limoges
country: France
facility: Clinique Francois Chenieux ( Site 1209)
state: Haute-Vienne
city: Angers
country: France
facility: CHU Angers ( Site 1200)
state: Maine-et-Loire
city: Beuvry
country: France
facility: Clinique Ambroise Pare Beuvry ( Site 1213)
state: Nord-Pas-de-Calais
city: Pierre Benite
country: France
facility: CH Lyon Sud Hospices Civils de Lyon ( Site 1203)
state: Rhone
city: Villejuif
country: France
facility: Gustave Roussy ( Site 1207)
state: Val-de-Marne
city: Paris
country: France
facility: Hopital Tenon ( Site 1212)
city: Tuebingen
country: Germany
facility: Universitaetsklinik fuer Urologie ( Site 1300)
state: Baden-Wurttemberg
city: Schwerin
country: Germany
facility: Helios Kliniken Schwerin GmbH ( Site 1302)
state: Mecklenburg-Vorpommern
city: Berlin
country: Germany
facility: Charite Universitaetsmedizin Berlin ( Site 1301)
city: Salcaja
country: Guatemala
facility: Centro Medico Integral de Cancerologia CEMIC ( Site 0701)
state: Quetzaltenango
city: Guatemala
country: Guatemala
facility: Oncomedica ( Site 0700)
city: Guatemala
country: Guatemala
facility: Grupo Angeles SA ( Site 0705)
city: Guatemala
country: Guatemala
facility: Sanatorio Nuestra Senora del Pilar ( Site 0702)
city: Guatemala
country: Guatemala
facility: Medi-K Cayala ( Site 0703)
city: Quetzaltenango
country: Guatemala
facility: Centro Regional de Sub Especialidades Medicas SA ( Site 0704)
city: Kecskemét
country: Hungary
facility: Bacs-Kiskun Megyei Korhaz-Onkoradiologiai Kozpont ( Site 2308)
state: Bacs-Kiskun
city: Gyula
country: Hungary
facility: Bekes Megyei Kozponti Korhaz - Pandy Kalman Tagkorhaza ( Site 2309)
state: Bekes
city: Szolnok
country: Hungary
facility: Jász-Nagykun-Szolnok Vármegyei Hetényi Géza Kórház ( Site 2300)
state: Jasz-Nagykun-Szolnok
city: Szombathely
country: Hungary
facility: Markusovszky Egyetemi Oktatokorhaz ( Site 2303)
state: Vas
city: Budapest
country: Hungary
facility: Orszagos Onkologiai Intezet ( Site 2304)
city: Debrecen
country: Hungary
facility: Debreceni Egyetem Klinikai Kozpont ( Site 2301)
city: Dublin
country: Ireland
facility: Beaumont Hospital ( Site 6101)
city: Dublin
country: Ireland
facility: Tallaght University Hospital ( Site 6100)
city: Modena
country: Italy
facility: Azienda Ospedaliero - Universitaria Policlinico di Modena ( Site 1404)
state: Emilia-Romagna
city: Milano
country: Italy
facility: Ospedale San Raffaele-Oncologia Medica ( Site 1417)
state: Lombardia
city: Rome
country: Italy
facility: Fondazione Policlinico Universitario A. Gemelli ( Site 1414)
state: Roma
city: Bari
country: Italy
facility: Azienda Ospedaliera Policlinico di Bari ( Site 1411)
city: Milano
country: Italy
facility: Fondazione IRCCS Istituto Nazionale dei Tumori di Milano ( Site 1409)
city: Napoli
country: Italy
facility: Istituto Nazionale Tumori Fondazione Pascale ( Site 1412)
city: Terni
country: Italy
facility: Azienda Ospedaliera S. Maria di Terni ( Site 1410)
city: Toyoake
country: Japan
facility: Fujita Health University ( Site 5003)
state: Aichi
city: Chiba-shi
country: Japan
facility: Chiba cancer center ( Site 5021)
state: Chiba
city: Kashiwa
country: Japan
facility: National Cancer Center Hospital East ( Site 5000)
state: Chiba
city: Toon
country: Japan
facility: Ehime University Hospital ( Site 5020)
state: Ehime
city: Sapporo
country: Japan
facility: Sapporo Medical University Hospital ( Site 5008)
state: Hokkaido
city: Sapporo
country: Japan
facility: Hokkaido University Hospital ( Site 5013)
state: Hokkaido
city: Yokohama
country: Japan
facility: Kanagawa cancer center ( Site 5016)
state: Kanagawa
city: Kashihara
country: Japan
facility: Nara Medical University Hospital ( Site 5002)
state: Nara
city: Osakasayama
country: Japan
facility: Kindai University Hospital- Osakasayama Campus-Urology ( Site 5010)
state: Osaka
city: Suita
country: Japan
facility: Osaka University Hospital ( Site 5012)
state: Osaka
city: Hidaka-city
country: Japan
facility: Saitama Medical University International Medical Center ( Site 5015)
state: Saitama
city: Hamamatsu
country: Japan
facility: Hamamatsu University School of Medicine University Hospital ( Site 5004)
state: Shizuoka
city: Bunkyō
country: Japan
facility: Tokyo Medical And Dental University Medical Hospital-Urology ( Site 5009)
state: Tokyo
city: Minato-ku
country: Japan
facility: Toranomon Hospital ( Site 5001)
state: Tokyo
city: Toyoma
country: Japan
facility: Toyama University Hospital ( Site 5014)
state: Toyama
city: Fukuoka
country: Japan
facility: Kyushu University Hospital ( Site 5005)
city: Kumamoto
country: Japan
facility: Kumamoto University ( Site 5022)
city: Niigata
country: Japan
facility: Niigata University Medical & Dental Hospital ( Site 5024)
city: Okayama
country: Japan
facility: Okayama University Hospital ( Site 5017)
city: Tokushima
country: Japan
facility: Tokushima University Hospital-Department of Urology ( Site 5019)
city: Tokyo
country: Japan
facility: Nippon Medical School Hospital ( Site 5006)
city: Tokyo
country: Japan
facility: Tokyo Women's Medical University Adachi Medical Center ( Site 5023)
city: Tokyo
country: Japan
facility: Keio university hospital ( Site 5011)
city: Goyang-si
country: Korea, Republic of
facility: National Cancer Center ( Site 4202)
state: Kyonggi-do
city: Daejeon
country: Korea, Republic of
facility: Chungnam National University Hospital ( Site 4205)
state: Taejon-Kwangyokshi
city: Seoul
country: Korea, Republic of
facility: Korea University Anam Hospital ( Site 4206)
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital ( Site 4201)
city: Seoul
country: Korea, Republic of
facility: Severance Hospital Yonsei University Health System ( Site 4204)
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center ( Site 4203)
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center ( Site 4200)
city: Johor Bahru
country: Malaysia
facility: Hospital Sultan Ismail ( Site 4303)
state: Johor
city: Putrajaya
country: Malaysia
facility: Institut Kanser Negara - National Cancer Institute ( Site 4302)
state: Wilayah Persekutuan Putrajaya
city: Kuala Lumpur
country: Malaysia
facility: Hospital Kuala Lumpur ( Site 4301)
city: Kuala Lumpur
country: Malaysia
facility: Universiti Malaya Medical Centre ( Site 4300)
city: Guadalajara
country: Mexico
facility: Hospital Civil de Guadalajara Fray Antonio Alcalde ( Site 0610)
state: Jalisco
city: Monterrey
country: Mexico
facility: I CAN Oncology SA de SV ( Site 0601)
state: Nuevo Leon
city: Santiago de Queretaro
country: Mexico
facility: Hospital H+ Queretaro-Cuidados Oncológicos ( Site 0608)
state: Queretaro
city: Cdmx
country: Mexico
facility: Instituto Nacional de Cancerologia ( Site 0602)
city: Oaxaca
country: Mexico
facility: Centro de Investigacion Clinica de Oaxaca ( Site 0605)
city: Lorenskog
country: Norway
facility: Akershus universitetssykehus ( Site 2000)
state: Akershus
city: Kristiansand
country: Norway
facility: Soerlandet sykehus HF Kristiansand ( Site 2007)
state: Aust-Agder
city: Bergen
country: Norway
facility: Helse Bergen HF - Haukeland Universitetssykehus ( Site 2002)
state: Hordaland
city: Gralum
country: Norway
facility: Sykehuset Østfold HF Kalnes ( Site 2003)
state: Ostfold
city: Trondheim
country: Norway
facility: St. Olavs Hospital HF ( Site 2005)
state: Sor-Trondelag
city: Oslo
country: Norway
facility: Oslo Universitetssykehus Radiumhospitalet ( Site 2001)
city: Manila
country: Philippines
facility: Manila Doctors Hospital ( Site 4601)
state: National Capital Region
city: Pasig City
country: Philippines
facility: The Medical City ( Site 4602)
state: National Capital Region
city: San Juan
country: Philippines
facility: Cardinal Santos Medical Center ( Site 4603)
state: National Capital Region
city: Bydgoszcz
country: Poland
facility: Centrum Onkologii im. Prof. Franciszka Lukaszczyka-Ambulatorium Chemioterapii ( Site 2420)
state: Kujawsko-pomorskie
city: Radom
country: Poland
facility: Radomskie Centrum Onkologii ( Site 2418)
state: Mazowieckie
city: Warszawa
country: Poland
facility: Luxmed Onkologia sp. z o. o. ( Site 2412)
state: Mazowieckie
city: Warszawa
country: Poland
facility: Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie ( Site 2405)
state: Mazowieckie
city: Konin
country: Poland
facility: Przychodnia Lekarska KOMED ( Site 2419)
state: Wielkopolskie
city: Poznan
country: Poland
facility: Uniwersytecki Szpital Kliniczny w Poznaniu ( Site 2406)
state: Wielkopolskie
city: Koszalin
country: Poland
facility: Szpital Wojewodzki im. Mikolaja Kopernika ( Site 2407)
state: Zachodniopomorskie
city: Alba Iulia
country: Romania
facility: Spitalul Judetean de Urgenta Alba Iulia ( Site 2502)
state: Alba
city: Craiova
country: Romania
facility: S.C. Centrul de Oncologie Sf. Nectarie SRL ( Site 2501)
state: Dolj
city: Timisoara
country: Romania
facility: Policlinica Oncomed SRL ( Site 2506)
state: Timis
city: Bucuresti
country: Romania
facility: S.C.Focus Lab Plus S.R.L ( Site 2503)
city: Barnaul
country: Russian Federation
facility: Altay Regional Oncology Dispensary ( Site 2610)
state: Altayskiy Kray
city: Ivanovo
country: Russian Federation
facility: Ivanovo Regional Oncology Dispensary ( Site 2615)
state: Ivanovskaya Oblast
city: Krasnoyarsk
country: Russian Federation
facility: Krasnoyarsk Regional Clinical Oncological Dispensary ( Site 2609)
state: Krasnoyarskiy Kray
city: Moscow
country: Russian Federation
facility: The Loginov Moscow Clinical Scientific Center ( Site 2604)
state: Moskva
city: Moscow
country: Russian Federation
facility: Moscow Oncological Clinical Dispensary #1 ( Site 2619)
state: Moskva
city: Nizhniy Novgorod
country: Russian Federation
facility: Nizhniy Novgorod Region Oncology Dispensary ( Site 2621)
state: Nizhegorodskaya Oblast
city: Nizhny Novgorod
country: Russian Federation
facility: FBHI Privolzhsky District Medical Center of the FMBA ( Site 2611)
state: Nizhegorodskaya Oblast
city: Saint Petersburg
country: Russian Federation
facility: Scientific Research Oncology Institute n.a. N.N.Petrov ( Site 2617)
state: Sankt-Peterburg
city: Sankt-Petersburg
country: Russian Federation
facility: City clinical oncological dispensary ( Site 2605)
state: Sankt-Peterburg
city: Belgrade
country: Serbia
facility: Klinicki centar Srbije. ( Site 3333)
state: Beograd
city: Nis
country: Serbia
facility: Klinicki centar Nis ( Site 3322)
state: Nisavski Okrug
city: Sremska Kamenica
country: Serbia
facility: Institut za onkologiju Vojvodine ( Site 3311)
state: Sremski Okrug
city: Port Elizabeth
country: South Africa
facility: Cancer Care Langenhoven Drive Oncology Centre ( Site 3009)
state: Eastern Cape
city: Johannesburg
country: South Africa
facility: Wits Clinical Research ( Site 3012)
state: Gauteng
city: Johannesburg
country: South Africa
facility: Sandton Oncology Medical Group PTY LTD ( Site 3000)
state: Gauteng
city: Pretoria
country: South Africa
facility: Univ. Pretoria and Steve Biko Academic Hospitals ( Site 3002)
state: Gauteng
city: Pretoria
country: South Africa
facility: Life Wilgers Hospital ( Site 3004)
state: Gauteng
city: Pretoria
country: South Africa
facility: Mary Potter Oncology Centre, Little Company of Mary Hospital ( Site 3001)
state: Gauteng
city: Vereeniging
country: South Africa
facility: Vaal Triangle Oncology Centre ( Site 3010)
state: Gauteng
city: Cape Town
country: South Africa
facility: Groote Schuur Hospital ( Site 3011)
state: Western Cape
city: Kraaifontein
country: South Africa
facility: Cape Town Oncology Trials Pty Ltd ( Site 3006)
state: Western Cape
city: Rondebosch
country: South Africa
facility: Cancercare Rondebosch Oncology ( Site 3005)
state: Western Cape
city: L Hospitalet De Llobregat
country: Spain
facility: Instituto Catalan de Oncologia - ICO ( Site 1502)
state: Barcelona
city: Santander
country: Spain
facility: Hospital Universitario Marques de Valdecilla ( Site 1501)
state: Cantabria
city: Girona
country: Spain
facility: Institut Català d'Oncologia (ICO) - Girona ( Site 1500)
state: Gerona
city: Madrid
country: Spain
facility: Hospital Clinico San Carlos ( Site 1503)
city: Madrid
country: Spain
facility: Hospital Universitario 12 de Octubre ( Site 1505)
city: Malaga
country: Spain
facility: Hospital Universitario Virgen de la Victoria ( Site 1504)
city: Jonkoping
country: Sweden
facility: Lanssjukhuset Ryhov ( Site 2103)
state: Jonkopings Lan
city: Stockholm
country: Sweden
facility: Karolinska Universitetssjukhuset Solna ( Site 2100)
state: Stockholms Lan
city: Uppsala
country: Sweden
facility: Akademiska Sjukhuset ( Site 2105)
state: Uppsala Lan
city: Umea
country: Sweden
facility: Norrlands Universitetssjukhus ( Site 2106)
state: Vasterbottens Lan
city: Goteborg
country: Sweden
facility: Sahlgrenska Universitetssjukhuset ( Site 2102)
state: Vastra Gotalands Lan
city: Kaohsiung
country: Taiwan
facility: Chang Gung Medical Foundation. Kaohsiung Branch ( Site 4405)
city: Taichung
country: Taiwan
facility: Taichung Veterans General Hospital ( Site 4403)
city: Tainan
country: Taiwan
facility: National Cheng Kung University Hospital ( Site 4404)
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital ( Site 4401)
city: Taipei
country: Taiwan
facility: Taipei Veterans General Hospital ( Site 4402)
city: Taoyuan
country: Taiwan
facility: Chang Gung Medical Foundation-Linkou Branch-Urology ( Site 4406)
city: Bangkok
country: Thailand
facility: Ramathibodi Hospital. ( Site 4500)
state: Krung Thep Maha Nakhon
city: Bangkok
country: Thailand
facility: Siriraj Hospital ( Site 4501)
state: Krung Thep Maha Nakhon
city: Ankara
country: Turkey
facility: Ankara Universitesi Tip Fakultesi ( Site 2902)
city: Ankara
country: Turkey
facility: Hacettepe Universitesi Tıp Fakultesi ( Site 2903)
city: Edirne
country: Turkey
facility: Trakya University Medical Faculty Balkan Oncology Hospital ( Site 2906)
city: Istanbul
country: Turkey
facility: Istanbul Universitesi Cerrahpasa Tip Fakultesi ( Site 2900)
city: Istanbul
country: Turkey
facility: TC Saglik Bakanligi Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi-oncology ( Site 2901)
city: Izmir
country: Turkey
facility: Ege Universitesi Tip Fakultesi Hastanesi ( Site 2904)
city: Izmir
country: Turkey
facility: Dokuz Eylul Universitesi Tip Fakultesi Hastanesi ( Site 2905)
city: Cherkasy
country: Ukraine
facility: Cherkasy Regional Oncology Dispensary ( Site 2704)
state: Cherkaska Oblast
city: Chernihiv
country: Ukraine
facility: Chernihiv Medical Center of Modern Oncology ( Site 2709)
state: Chernihivska Oblast
city: Dnipropetrovsk
country: Ukraine
facility: ME І.І. Mechnykov Dnipro Regional Clinical Hospital ( Site 2710)
state: Dnipropetrovska Oblast
city: Dnipro
country: Ukraine
facility: Clinical oncology dispensary of Dnipro ( Site 2700)
state: Dnipropetrovska Oblast
city: Ivano-Frankivsk
country: Ukraine
facility: Ivano-Frankivsk Regional Hospital-Urology department ( Site 2707)
state: Ivano-Frankivska Oblast
city: Ivano-Frankivsk
country: Ukraine
facility: Ivano-Frankivsk Regional Oncology Clinical Dispensary ( Site 2711)
state: Ivano-Frankivska Oblast
city: Kharkiv
country: Ukraine
facility: Regional Oncology Center of Kharkiv ( Site 2708)
state: Kharkivska Oblast
city: Kharkiv
country: Ukraine
facility: Reg. Clinical Center of Urology and Nephrology n.a. V. I. Shapoval ( Site 2715)
state: Kharkivska Oblast
city: Kyiv
country: Ukraine
facility: Kyiv City Clinical Oncology Center ( Site 2706)
state: Kyivska Oblast
city: Lviv
country: Ukraine
facility: Lviv State Regional Oncological Center ( Site 2712)
state: Lvivska Oblast
city: Cambridge
country: United Kingdom
facility: Addenbrookes Hospital ( Site 3110)
state: Cambridgeshire
city: London
country: United Kingdom
facility: Barts Health NHS Trust - St Bartholomew s Hospital ( Site 3116)
state: England
city: Northwood
country: United Kingdom
facility: Mount Vernon Cancer Centre ( Site 3101)
state: London, City Of
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Director
role: STUDY_DIRECTOR
References: