Clinical trial NCT04586231: A Study of Belzutifan (MK-6482) in Combination With Lenvatinib Versus Cabozantinib for Treatment of Renal Cell Carcinoma (MK-6482-011)
Official title: An Open-label, Randomized, Phase 3 Study of MK-6482 in Combination With Lenvatinib (MK-7902) vs Cabozantinib in Participants With Advanced Renal Cell Carcinoma Who Have Progressed After Prior Anti-PD-1/L1 Therapy
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Carcinoma, Renal Cell
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
Collaborators: name: Eisai Inc.
First posted: 2020-10-14
Enrollment: 708
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: This study will compare the efficacy and safety of belzutifan + lenvatinib versus cabozantinib in participants with advanced renal cell carcinoma (RCC) with clear cell component after prior therapy.

The primary hypothesis is that belzutifan + lenvatinib is superior to cabozantinib in terms of progression-free survival or overall survival.


Eligibility criteria: Inclusion Criteria:

* Unresectable, locally advanced or metastatic clear cell renal cell carcinoma (RCC).
* Disease progression on or after an anti-programmed cell death-1/ligand 1 (PD-1/L1) therapy as either first or second-line treatment for locally advanced/metastatic RCC or as adjuvant treatment or neoadjuvant/adjuvant with progression on or within 6 months of last dose.
* Measurable disease per RECIST 1.1 criteria as assessed by local study investigator.
* Karnofsky performance status (KPS) score of at least 70% assessed within 10 days before randomization.
* Received no more than 2 prior systemic regimens including: one anti-PD-1/L1 containing adjuvant or neoadjuvant/adjuvant regimens with progression on or within 6 months from the last dose of that regimen OR one or 2 regimens for locoregional/advanced disease
* Received only 1 prior antiPD-1/L1 therapy for adjuvant, neoadjuvant/adjuvant or locally advanced/metastatic RCC.
* A male participant is eligible to participate if he is abstinent from heterosexual intercourse or agrees to use contraception during the intervention period and for at least 7 days after the last dose of belzutifan or lenvatinib in the belzutifan+lenvatinib arm, whichever occurs last, and 23 days after the last dose of cabozantinib.
* A female participant is eligible to participate if they are not pregnant, not breastfeeding, and at least 1 of the following conditions applies: Not a woman of childbearing potential (WOCBP) or a WOCBP who agrees to follow the contraceptive guidance during the intervention period and for at least 30 days after the last dose of study intervention in the belzutifan+ lenvatinib arm, or 120 days after the last dose of study intervention in the cabozantinib arm.
* Adequately controlled blood pressure.
* Adequate organ function.

Exclusion Criteria:

* A pulse oximeter reading \<92% at rest, requires intermittent supplemental oxygen, or requires chronic supplemental oxygen.
* Known additional malignancy that is progressing or has required active treatment within the past 3 years except for basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ (eg, breast carcinoma, cervical cancer in situ) that have undergone potentially curative therapy.
* Known central nervous system (CNS) metastases and/or carcinomatous meningitis.
* Clinically significant cardiac disease within 6 months of first dose of study intervention.
* Prolongation of QTc interval to \>480 ms.
* Symptomatic pleural effusion (e.g.,cough, dyspnea, pleuritic chest pain) that is not clinically stable.
* Pre-existing ≥Grade 3 gastrointestinal or nongastrointestinal fistula.
* Moderate to severe hepatic impairment.
* History of significant bleeding within 3 months before randomization.
* History of solid organ transplantation.
* Known psychiatric or substance abuse disorder that would interfere with cooperation with the requirements of the study.
* Unable to swallow orally administered medication or has a gastrointestinal disorder affecting absorption (e.g., gastrectomy, partial bowel obstruction, malabsorption).
* Known hypersensitivity or allergy to the active pharmaceutical ingredients or any component of the study intervention formulations.
* Received colony-stimulating factors \[eg, granulocyte colony-stimulating factor (G-CSF), granulocyte macrophage colony-stimulating factor (GMCSF) or recombinant erythropoietin (EPO)\] within 28 days before randomization.
* Prior treatment with belzutifan or another hypoxia-inducible factor (HIF)-2α inhibitor.
* Prior treatment with lenvatinib.
* Prior treatment with cabozantinib.
* Currently participating in a study of an investigational agent or using an investigational device.
* Active infection requiring systemic therapy.
* History of human immunodeficiency virus (HIV) infection.
* History of hepatitis B or known active hepatitis C infection.

Primary outcomes:
measure: Progression-Free Survival (PFS) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Review (BICR)
timeFrame: Up to approximately 34 months
measure: Overall Survival (OS)
timeFrame: Up to approximately 44 months
Secondary outcomes:
measure: Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Review (BICR)
timeFrame: Up to approximately 24 months
measure: Duration of Response (DOR) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Review (BICR)
timeFrame: Up to approximately 44 months
measure: Number of Participants Who Experienced One or More Adverse Events (AEs)
timeFrame: Up to approximately 44 months
measure: Number of Participants Who Discontinued Study Treatment Due to an Adverse Event (AE)
timeFrame: Up to approximately 44 months
Other outcomes:
Locations:
city: Chandler
country: United States
facility: Ironwood Cancer & Research Centers ( Site 0077)
state: Arizona
city: Los Angeles
country: United States
facility: Cedars Sinai Medical Center ( Site 0027)
state: California
city: Los Angeles
country: United States
facility: UCLA Hematology/Oncology - Santa Monica ( Site 0048)
state: California
city: Orange
country: United States
facility: St. Joseph Hospital-The Center for Cancer Prevention and Treatment ( Site 0095)
state: California
city: Orange
country: United States
facility: UC Irvine Health ( Site 0029)
state: California
city: Santa Monica
country: United States
facility: Providence Saint John's Health Center ( Site 0083)
state: California
city: Washington
country: United States
facility: Georgetown University Medical Center ( Site 0006)
state: District of Columbia
city: Orlando
country: United States
facility: AdventHealth Orlando-AdventHealth Medical Group Hematology & Oncology at Orlando ( Site 0003)
state: Florida
city: Orlando
country: United States
facility: Orlando Health, Inc. ( Site 0035)
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 Hospital ( Site 0012)
state: Georgia
city: Chicago
country: United States
facility: Rush University Medical Center ( Site 0040)
state: Illinois
city: Peoria
country: United States
facility: Illinois Cancer Care, PC ( Site 0008)
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: Tulane University School of Medicine ( Site 0098)
state: Louisiana
city: Burlington
country: United States
facility: Lahey Hospital & Medical Center ( Site 0090)
state: Massachusetts
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: Jackson
country: United States
facility: University of Mississippi Medical Ctr ( Site 0037)
state: Mississippi
city: Lincoln
country: United States
facility: Cancer Partners of Nebraska ( Site 0086)
state: Nebraska
city: New Brunswick
country: United States
facility: Rutgers Cancer Institute of New Jersey ( Site 0078)
state: New Jersey
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: Memorial Sloan Kettering Cancer Center ( Site 0055)
state: New York
city: Charlotte
country: United States
facility: Levine Cancer Institute ( Site 0004)
state: North Carolina
city: Durham
country: United States
facility: Duke Cancer Institute ( Site 0096)
state: North Carolina
city: Allentown
country: United States
facility: Lehigh Valley Hospital- Cedar Crest-Oncology Clinical Trials ( Site 0056)
state: Pennsylvania
city: Dallas
country: United States
facility: University of Texas, Southwestern Medical Center ( Site 0015)
state: Texas
city: Salt Lake City
country: United States
facility: Huntsman Cancer Institute-HCI Clinical Trials Office ( Site 7001)
state: Utah
city: Burlington
country: United States
facility: University of Vermont Medical Center ( Site 0001)
state: Vermont
city: Roanoke
country: United States
facility: Blue Ridge Cancer Care - Roanoke ( Site 0043)
state: Virginia
city: Seattle
country: United States
facility: Seattle Cancer Care Alliance-Renal/Melanoma/MCC ( Site 0093)
state: Washington
city: Wenatchee
country: United States
facility: Confluence Health | Wenatchee Valley Hospital & Clinics ( Site 0061)
state: Washington
city: Caba
country: Argentina
facility: Centro de Urología (CDU) ( Site 0803)
state: Buenos Aires
city: Ciudad autónoma de Buenos Aires
country: Argentina
facility: Hospital Británico de Buenos Aires-Oncology ( Site 0801)
state: Buenos Aires
city: Ciudad Autónoma de Buenos Aires
country: Argentina
facility: Instituto Alexander Fleming ( Site 0800)
state: Buenos Aires
city: Rosario
country: Argentina
facility: Sanatorio Británico-Clinical Oncology Department ( Site 0802)
state: Santa Fe
city: Rosario
country: Argentina
facility: Sanatorio Parque ( Site 0806)
state: Santa Fe
city: Buenos Aires
country: Argentina
facility: Asociación de Beneficencia Hospital Sirio Libanés ( Site 0804)
city: St Leonards
country: Australia
facility: GenesisCare North Shore ( Site 4011)
state: New South Wales
city: Elizabeth Vale
country: Australia
facility: Lyell McEwin Hospital ( Site 4004)
state: South Australia
city: Frankston
country: Australia
facility: Peninsula Health Frankston Hospital ( Site 4001)
state: Victoria
city: Melbourne
country: Australia
facility: Peter MacCallum Cancer Centre-Parkville Cancer Clinical Trials Unit (PCCTU) ( Site 4010)
state: Victoria
city: Linz
country: Austria
facility: Ordensklinikum Linz GmbH Elisabethinen-Urologie ( Site 1001)
state: Oberosterreich
city: Graz
country: Austria
facility: Medizinische Universitätsklinik Graz ( Site 1051)
state: Steiermark
city: Vienna
country: Austria
facility: Klinik Ottakring-1.Medizinische Abteilung - Zentrum für Onkologie und Hämatologie ( Site 1031)
state: Wien
city: Wien
country: Austria
facility: Krankenhaus der Barmherzigen Brüder Wien ( Site 1041)
city: Wien
country: Austria
facility: Medizinische Universität Wien ( Site 1021)
city: Anderlecht
country: Belgium
facility: Institut Jules Bordet ( Site 1103)
state: Bruxelles-Capitale, Region De
city: Brussels
country: Belgium
facility: Cliniques Universitaires Saint Luc - Bruxelles ( Site 1105)
state: Bruxelles-Capitale, Region De
city: Charleroi
country: Belgium
facility: Grand Hopital de Charleroi ( Site 1104)
state: Hainaut
city: Gent
country: Belgium
facility: UZ Gent ( Site 1100)
state: Oost-Vlaanderen
city: Leuven
country: Belgium
facility: UZ Leuven ( Site 1101)
state: Vlaams-Brabant
city: Liege
country: Belgium
facility: CHU de Liege ( Site 1102)
city: Natal
country: Brazil
facility: Liga Norte Riograndense Contra o Cancer ( Site 0313)
state: Rio Grande Do Norte
city: Porto Alegre
country: Brazil
facility: Centro Gaucho Integrado de Oncologia ( Site 0304)
state: Rio Grande Do Sul
city: Sao Paulo
country: Brazil
facility: BP - A Beneficencia Portuguesa de São Paulo-Medical Oncology ( Site 0311)
city: Sao Paulo
country: Brazil
facility: Hospital Paulistano - Amil Clinical Research ( Site 0308)
city: Calgary
country: Canada
facility: Tom Baker Cancer Centre ( Site 0109)
state: Alberta
city: Edmonton
country: Canada
facility: Cross Cancer Institute ( Site 0111)
state: Alberta
city: Vancouver
country: Canada
facility: BC Cancer Vancouver-Clinical Trials Unit ( Site 0110)
state: British Columbia
city: Moncton
country: Canada
facility: The Moncton Hospital ( Site 0101)
state: New Brunswick
city: Hamilton
country: Canada
facility: Hamilton Health Sciences-Juravinski Cancer Centre ( Site 0114)
state: Ontario
city: Kingston
country: Canada
facility: Kingston Health Sciences Centre ( Site 0105)
state: Ontario
city: Ottawa
country: Canada
facility: The Ottawa Hospital - General Campus-The Ottawa Hospital Cancer Centre ( Site 0116)
state: Ontario
city: Toronto
country: Canada
facility: Sunnybrook Health Sciences - Odette Cancer Centre ( Site 0113)
state: Ontario
city: Greenfield Park
country: Canada
facility: CISSS de la Monteregie-Centre ( Site 0103)
state: Quebec
city: Sherbrooke
country: Canada
facility: CIUSSS de l Estrie - CHUS - Centre Hosp. Univ. Sherbrooke ( Site 0102)
state: Quebec
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: James Lind Centro de Investigación del Cáncer ( Site 0402)
state: Araucania
city: Santiago
country: Chile
facility: Bradfordhill-Clinical Area ( Site 0400)
state: Region M. De Santiago
city: Medellin
country: Colombia
facility: Fundación Colombiana de Cancerología Clínica Vida ( Site 0505)
state: Antioquia
city: Valledupar
country: Colombia
facility: Sociedad De Oncologia Y Hematologia Del Cesar-Oncology ( Site 0508)
state: Cesar
city: Bogotá
country: Colombia
facility: Instituto Nacional de Cancerología-Clinical Oncology ( Site 0500)
state: Cundinamarca
city: Piedecuesta
country: Colombia
facility: Fundación Cardiovascular de Colombia ( Site 0501)
state: Santander
city: Brno
country: Czechia
facility: Masarykuv onkologicky ustav-Klinika komplexni onkologicke pece ( Site 2203)
state: Brno-mesto
city: České Budějovice
country: Czechia
facility: Nemocnice České Budějovice-Onkologicke oddeleni ( Site 2204)
state: Jihocesky Kraj
city: Prague
country: Czechia
facility: Fakultni Thomayerova nemocnice-Onkologicka klinika 1. LF UK ( Site 2200)
state: Praha 4
city: Praha
country: Czechia
facility: Fakultni nemocnice v Motole-Onkologicka klinika 2. LF UK a FN Motol ( Site 2205)
state: Praha 5
city: Hradec Kralove
country: Czechia
facility: Fakultni nemocnice Hradec Kralove-Klinika onkologie a radioterapie ( Site 2201)
city: Tampere
country: Finland
facility: Tampereen yliopistollinen sairaala ( Site 1801)
state: Pirkanmaa
city: Helsinki
country: Finland
facility: HYKS ( Site 1800)
state: Uusimaa
city: Turku
country: Finland
facility: TYKS ( Site 1802)
state: Varsinais-Suomi
city: Reims
country: France
facility: Institut Jean Godinot ( Site 1216)
state: Ain
city: Nice
country: France
facility: Centre Antoine Lacassagne ( Site 1217)
state: Alpes-Maritimes
city: Strasbourg
country: France
facility: Institut de cancérologie Strasbourg Europe (ICANS) ( Site 1218)
state: Alsace
city: Bordeaux
country: France
facility: CHU de Bordeaux- Hopital Saint Andre ( Site 1209)
state: Gironde
city: Toulouse
country: France
facility: Institut Claudius Regaud ( Site 1215)
state: Haute-Garonne
city: Limoges
country: France
facility: Clinique Francois Chenieux ( Site 1210)
state: Haute-Vienne
city: Saint Herblain
country: France
facility: Institut de Cancerologie de l Ouest Centre Rene Gauducheau ( Site 1201)
state: Loire-Atlantique
city: Angers
country: France
facility: Institut de Cancerologie de l Ouest Site Paul Papin ( Site 1200)
state: Maine-et-Loire
city: Paris
country: France
facility: Hopital Tenon ( Site 1213)
city: Freiburg
country: Germany
facility: Klinik fuer Urologie ( Site 1303)
state: Baden-Wurttemberg
city: Heidelberg
country: Germany
facility: NCT-Department of Medical Oncology ( Site 1320)
state: Baden-Wurttemberg
city: Nuremberg
country: Germany
facility: Klinikum Nuernberg Nord ( Site 1300)
state: Bayern
city: Frankfurt am Main
country: Germany
facility: Universitaetsklinikum Frankfurt ( Site 1301)
state: Hessen
city: Aachen
country: Germany
facility: Universitaetsklinikum Aachen AOER ( Site 1317)
state: Nordrhein-Westfalen
city: Homburg/ Saar
country: Germany
facility: Universitaetsklinikum des Saarlandes ( Site 1305)
state: Saarland
city: Halle
country: Germany
facility: Krankenhaus Martha Maria Halle-Doelau ( Site 1314)
state: Sachsen-Anhalt
city: Erfurt
country: Germany
facility: Helios Klinikum Erfurt GmbH ( Site 1315)
state: Thuringen
city: Berlin
country: Germany
facility: Charite Universitaetsmedizin Berlin ( Site 1321)
city: Berlin
country: Germany
facility: HELIOS Klinikum Berlin-Buch ( Site 1311)
city: Patras
country: Greece
facility: UNIVERSITY HOSPITAL OF PATRAS-DIVISION OF ONCOLOGY ( Site 3302)
state: Achaia
city: Athens
country: Greece
facility: Alexandra General Hospital of Athens-ONCOLOGY DEPT. ( Site 3304)
state: Attiki
city: Athens
country: Greece
facility: Athens Medical Center ( Site 3303)
state: Attiki
city: Chaidari
country: Greece
facility: ATTIKON GENERAL UNIVERSITY HOSPITAL ( Site 3301)
state: Attiki
city: Thessaloniki
country: Greece
facility: European Interbalkan Medical Center-Oncology Department ( Site 3300)
city: Dublin 7
country: Ireland
facility: Mater Misericordiae University Hospital ( Site 3201)
state: Dublin
city: Dublin
country: Ireland
facility: Tallaght University Hospital ( Site 3200)
city: Dublin
country: Ireland
facility: Mater Private Hospital - Dublin ( Site 3202)
city: Meldola
country: Italy
facility: Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori ( Site 1407)
state: Forli-Cesena
city: Rozzano
country: Italy
facility: Istituto Clinico Humanitas Research Hospital ( Site 1406)
state: Milano
city: Orbassano
country: Italy
facility: Ospedale San Luigi Gonzaga ( Site 1405)
state: Torino
city: Arezzo
country: Italy
facility: Medical Oncology Ospedale San Donato ( Site 1404)
city: Bari
country: Italy
facility: Azienda Ospedaliera Policlinico di Bari ( Site 1402)
city: Milano
country: Italy
facility: IRCCS Ospedale San Raffaele ( Site 1409)
city: Milano
country: Italy
facility: Fondazione IRCCS Istituto Nazionale dei Tumori di Milano ( Site 1400)
city: Pavia
country: Italy
facility: Istituti Clinici Scientifici Maugeri Spa ( Site 1403)
city: Roma
country: Italy
facility: Fondazione Policlinico Universitario Agostino Gemelli-Medical Oncology ( Site 1410)
city: Terni
country: Italy
facility: Azienda Ospedaliera S. Maria di Terni ( Site 1401)
city: Verona
country: Italy
facility: Ospedale Maggiore Borgo Trento ( Site 1408)
city: Toyoake
country: Japan
facility: Fujita Health University ( Site 5003)
state: Aichi
city: Kashiwa
country: Japan
facility: National Cancer Center Hospital East ( Site 5000)
state: Chiba
city: Sakura
country: Japan
facility: Toho University Sakura Medical Center ( Site 5014)
state: Chiba
city: Sapporo
country: Japan
facility: Sapporo Medical University Hospital ( Site 5008)
state: Hokkaido
city: Kobe
country: Japan
facility: Kobe City Medical Center General Hospital ( Site 5017)
state: Hyogo
city: Yokohama
country: Japan
facility: Yokohama City University Hospital ( Site 5007)
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: Hamamatsu
country: Japan
facility: Hamamatsu University School of Medicine University Hospital ( Site 5004)
state: Shizuoka
city: Bunkyo-ku
country: Japan
facility: Tokyo Medical and Dental University Hospital ( Site 5009)
state: Tokyo
city: Minato-ku
country: Japan
facility: Toranomon Hospital ( Site 5001)
state: Tokyo
city: Fukuoka
country: Japan
facility: Kyushu University Hospital ( Site 5005)
city: Niigata
country: Japan
facility: Niigata University Medical & Dental Hospital ( Site 5013)
city: Osaka
country: Japan
facility: Osaka International Cancer Institute ( Site 5016)
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 5015)
city: Tokyo
country: Japan
facility: Keio university hospital ( Site 5011)
city: Hwasun
country: Korea, Republic of
facility: Chonnam National University Hwasun Hospital-Oncology ( Site 4203)
state: Jeonranamdo
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center ( Site 4200)
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center ( Site 4201)
city: Leeuwarden
country: Netherlands
facility: Medisch Centrum Leeuwarden ( Site 1905)
state: Fryslan
city: Sittard-Geleen
country: Netherlands
facility: Zuyderland Medical Centre-Trialbureau Interne Geneeskunde ( Site 1904)
state: Limburg
city: Breda
country: Netherlands
facility: Amphia Hospital Location Molengracht ( Site 1912)
state: Noord-Brabant
city: Amsterdam
country: Netherlands
facility: Antoni van Leeuwenhoek Ziekenhuis ( Site 1901)
state: Noord-Holland
city: Den Haag
country: Netherlands
facility: Haga Ziekenhuis locatie Leyweg-Oncology ( Site 1917)
state: Zuid-Holland
city: Rotterdam
country: Netherlands
facility: Erasmus MC ( Site 1913)
state: Zuid-Holland
city: Schiedam
country: Netherlands
facility: Franciscus Gasthuis & Vlietland, Locatie Vlietland ( Site 1909)
state: Zuid-Holland
city: Utrecht
country: Netherlands
facility: Universitair Medisch Centrum Utrecht ( Site 1910)
city: Bydgoszcz
country: Poland
facility: Centrum Onkologii im. Prof. Franciszka Lukaszczyka ( Site 2402)
state: Kujawsko-pomorskie
city: Krakow
country: Poland
facility: Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - O-Klinika Onkologii Klinicznej ( Site 240
state: Malopolskie
city: Warszawa
country: Poland
facility: Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie ( Site 2400)
state: Mazowieckie
city: Poznan
country: Poland
facility: Uniwersytecki Szpital Kliniczny w Poznaniu ( Site 2401)
state: Wielkopolskie
city: Cluj Napoca
country: Romania
facility: Institutul Oncologic Prof.Dr. Ion Chiricuta Cluj-Napoca ( Site 2500)
state: Cluj
city: Cluj Napoca
country: Romania
facility: Institutul Oncologic Prof.Dr. Ion Chiricuta Cluj-Napoca ( Site 2501)
state: Cluj
city: Craiova
country: Romania
facility: Centrul de Oncologie "Sfântul Nectarie" ( Site 2502)
state: Dolj
city: Ivanovo
country: Russian Federation
facility: Ivanovo Regional Oncology Dispensary ( Site 2616)
state: Ivanovskaya Oblast
city: Krasnogorsk
country: Russian Federation
facility: MEDSI Clinical Hospital on Pyatnitsky Highway-Departmentof Antitumor Drug therapy ( Site 2618)
state: Moskovskaya Oblast
city: Moscow
country: Russian Federation
facility: Hadassah Medical-Oncology department ( Site 2609)
state: Moskovskaya Oblast
city: Moscow
country: Russian Federation
facility: FSBI United Hospital with Polyclinic ( Site 2613)
state: Moskva
city: Moscow
country: Russian Federation
facility: SHI of Moscow City Oncology Clinical Hospital - 62 ( Site 2614)
state: Moskva
city: Volzhsky
country: Russian Federation
facility: Volgograd Regional Uronephrological Center ( Site 2615)
state: Volgogradskaya Oblast
city: Yaroslavl
country: Russian Federation
facility: Yaroslavl Regional Cancer Hospital-Oncology ( Site 2619)
state: Yaroslavskaya Oblast
city: A Coruna
country: Spain
facility: Complejo Hospitalario Universitario A Coruna ( Site 1502)
state: La Coruna
city: Madrid
country: Spain
facility: Hospital Universitario 12 de Octubre-Medical Oncology ( Site 1508)
state: Madrid, Comunidad De
city: Barcelona
country: Spain
facility: Hospital Universitari Vall d'Hebron-Departamento de Oncologia- VHIO ( Site 1507)
city: Barcelona
country: Spain
facility: Hospital Clinic i Provincial ( Site 1500)
city: Barcelona
country: Spain
facility: Hospital Santa Creu i Sant Pau ( Site 1501)
city: Madrid
country: Spain
facility: Hospital General Universitario Gregorio Maranon ( Site 1505)
city: Madrid
country: Spain
facility: Hospital Clinico San Carlos ( Site 1504)
city: Sevilla
country: Spain
facility: Hospital Virgen del Rocio ( Site 1503)
city: Geneva
country: Switzerland
facility: Hopitaux Universitaires de Geneve HUG ( Site 1602)
state: Geneve
city: Chur
country: Switzerland
facility: Kantonsspital Graubuenden ( Site 1600)
state: Grisons
city: Bellinzona
country: Switzerland
facility: Istituto Oncologica della Svizzera Italiana (IOSI) ( Site 1604)
state: Ticino
city: Zuerich
country: Switzerland
facility: Universitaetsspital Zuerich ( Site 1601)
state: Zurich
city: Aberdeen
country: United Kingdom
facility: Aberdeen Royal Infirmary-Department of Oncology ( Site 3105)
state: Aberdeen City
city: Bath
country: United Kingdom
facility: Royal United Hospital Bath England ( Site 3108)
state: Bath And North East Somerset
city: Nottingham
country: United Kingdom
facility: Nottingham University Hospitals NHS Trust. City Hospital Campus ( Site 3106)
state: England
city: Southend
country: United Kingdom
facility: Southend University Hospital ( Site 3112)
state: Essex
city: London
country: United Kingdom
facility: Imperial Healthcare NHS Trust Charing Cross Hospital ( Site 3107)
state: London, City Of
city: Northwood
country: United Kingdom
facility: Mount Vernon Cancer Centre ( Site 3101)
state: London, City Of
city: Taunton
country: United Kingdom
facility: Musgrove Park Hospital ( Site 3103)
state: Somerset
city: Swansea
country: United Kingdom
facility: Singleton Hospital ( Site 3111)
state: Wales
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Director
role: STUDY_DIRECTOR
References: