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Brief Title: Study of Pembrolizumab (MK-3475) Plus Chemotherapy Versus Placebo Plus Chemotherapy for HR+/HER2- Locally Recurrent Inoperable or Metastatic Breast Cancer (MK-3475-B49/KEYNOTE-B49)
Official Title: A Randomized, Double-blind, Placebo-controlled, Phase 3 Study of Pembrolizumab Plus Chemotherapy Versus Placebo Plus Chemotherapy for the Treatment of Chemotherapy-Candidate Hormone Receptor-Positive, Human Epidermal Growth Factor Receptor 2-Negative (HR+/HER2-) Locally Recurrent Inoperable or Metastatic Breast Cancer (KEYNOTE-B49)
Study ID: NCT04895358
Brief Summary: The safety and efficacy of pembrolizumab plus the investigator's choice of chemotherapy will be assessed compared to placebo plus the investigator's choice of chemotherapy in the treatment of chemotherapy-candidate hormone receptor-positive, human epidermal growth factor receptor 2-negative (HR+/HER2-) locally recurrent inoperable or metastatic breast cancer. The primary hypotheses are that the combination of pembrolizumab and chemotherapy is superior to placebo and chemotherapy in regards to Progression-Free Survival (PFS) or overall survival (OS) in participants with programmed cell death-ligand 1 (PD-L1) combined positive score (CPS) ≥1 and ≥10.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
University of Alabama at Birmingham-Medicine ( Site 0065), Birmingham, Alabama, United States
Arizona Oncology Associates-Arizona Oncology ( Site 0049), Tucson, Arizona, United States
Pacific Cancer Care ( Site 0023), Monterey, California, United States
UCSF Medical Center at Mission Bay ( Site 0043), San Francisco, California, United States
Georgetown University Medical Center-Department of Medicine and Oncology ( Site 0026), Washington, District of Columbia, United States
MedStar Washington Hospital Center ( Site 0063), Washington, District of Columbia, United States
Baptist MD Anderson Cancer Center ( Site 0013), Jacksonville, Florida, United States
Miami Cancer Institute at Baptist Health, Inc. ( Site 0070), Miami, Florida, United States
Miami Cancer Institute - Plantation ( Site 0076), Plantation, Florida, United States
University Cancer & Blood Center, LLC ( Site 0032), Athens, Georgia, United States
Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital-Research ( Site 0028), Marietta, Georgia, United States
University of Illinois at Chicago ( Site 0061), Chicago, Illinois, United States
Edward-Elmhurst Healthcare, Elmhurst Hospital-Nancy W. Knowles Cancer Center ( Site 0067), Elmhurst, Illinois, United States
Edward-Elmhurst Healthcare, Edward Hospital-Edward Cancer Center ( Site 0066), Naperville, Illinois, United States
Edward-Elmhurst Healthcare, Edward Hospital - Plainfield-Edward Cancer Center - Plainfield ( Site 00, Plainfield, Illinois, United States
Orchard Healthcare Research Inc. ( Site 0037), Skokie, Illinois, United States
Parkview Research Center at Parkview Regional Medical Center ( Site 0071), Fort Wayne, Indiana, United States
McFarland Clinic, PC ( Site 0041), Ames, Iowa, United States
Louisiana State University Health Sciences Shreveport ( Site 0072), Shreveport, Louisiana, United States
CHRISTUS Highland-Oncology Research ( Site 0073), Shreveport, Louisiana, United States
New England Cancer Specialists ( Site 0007), Scarborough, Maine, United States
Greater Baltimore Medical Center-Medical Oncology/Hematology ( Site 0062), Baltimore, Maryland, United States
MFSMC-HJWCI ( Site 0064), Baltimore, Maryland, United States
MedStar Good Samaritan Hospital-Oncology Research ( Site 0069), Baltimore, Maryland, United States
University of Massachusetts Medical School-Division of Hematology/Oncology ( Site 0052), Worcester, Massachusetts, United States
Henry Ford Hospital ( Site 0003), Detroit, Michigan, United States
Oncology Hematology West, PC dba Nebraska Cancer Specialists ( Site 0009), Omaha, Nebraska, United States
Broome Oncology ( Site 0018), Johnson City, New York, United States
Hematology Oncology Associates of Rockland ( Site 0044), Nyack, New York, United States
Waverly Hematology Oncology ( Site 0015), Cary, North Carolina, United States
Sanford Fargo Medical Center ( Site 0040), Fargo, North Dakota, United States
Providence Portland Medical Center ( Site 0038), Portland, Oregon, United States
Oregon Health and Science University ( Site 0031), Portland, Oregon, United States
St Francis Cancer Center ( Site 0058), Greenville, South Carolina, United States
Sanford Cancer Center ( Site 0021), Sioux Falls, South Dakota, United States
University of Tennessee Medical Center ( Site 0039), Knoxville, Tennessee, United States
Bon Secours St. Francis Medical Center-Oncology Research ( Site 0020), Midlothian, Virginia, United States
Kadlec Clinic Hematology and Oncology ( Site 0055), Kennewick, Washington, United States
Medical Oncology Associates, PS ( Site 0010), Spokane, Washington, United States
Northwest Medical Specialties, PLLC ( Site 0008), Tacoma, Washington, United States
North Star Lodge ( Site 0035), Yakima, Washington, United States
Centro de Oncología e Investigación de Buenos Aires ( Site 0400), Berazategui, Buenos Aires, Argentina
Hospital Británico de Buenos Aires-Oncology ( Site 0404), Ciudad autónoma de Buenos Aires, Buenos Aires, Argentina
Instituto de Investigaciones Clínicas Mar del Plata ( Site 0412), Mar del Plata, Buenos Aires, Argentina
Hospital Aleman-Oncology ( Site 0402), Buenos Aires, Caba, Argentina
Centro de Educación Médica e Investigaciones Clínicas (CEMIC) ( Site 0403), Buenos Aires, Caba, Argentina
Sanatorio de La Mujer ( Site 0405), Rosario, Santa Fe, Argentina
Sanatorio Parque ( Site 0407), Rosario, Santa Fe, Argentina
Instituto de Oncología de Rosario ( Site 0401), Rosario, Santa Fe, Argentina
Hospital Italiano de Córdoba ( Site 0409), Cordoba, , Argentina
Fundación CEMAIC ( Site 0410), Cordoba, , Argentina
Instituto San Marcos ( Site 0408), San Juan, , Argentina
Macquarie University-MQ Health Clinical Trials Unit ( Site 2102), Macquarie Park, New South Wales, Australia
Westmead Hospital-Department of Medical Oncology ( Site 2101), Westmead, New South Wales, Australia
Frankston Hospital-Oncology and Haematology ( Site 2103), Frankston, Victoria, Australia
Breast Cancer Research Centre-WA ( Site 2104), Nedlands, Western Australia, Australia
Landesklinikum Wiener Neustadt-Innere Medizin, Hämatologie und internistische Onkologie ( Site 1604), Wiener Neustadt, Niederosterreich, Austria
Medizinische Universität Graz-Innere Medizin Klin. Abt. Onkologie ( Site 1609), Graz, Steiermark, Austria
Medizinische Universitaet Innsbruck ( Site 1602), Innsbruck, Tirol, Austria
Medizinische Universität Wien ( Site 1601), Vienna, Wien, Austria
Uniklinikum Salzburg-Universitätsklinik für Innere Medizin III der PMU mit Hämatologie, internistis, Salzburg, , Austria
Hospital de Câncer de Recife ( Site 0211), Recife, Pernambuco, Brazil
Instituto de Oncologia Saint Gallen ( Site 0206), Santa Cruz do Sul, Rio Grande Do Sul, Brazil
Clínica de Oncologia Reichow ( Site 0210), Blumenau, Santa Catarina, Brazil
YNOVA Pesquisa Clínica ( Site 0203), Florianópolis, Santa Catarina, Brazil
Instituto Nacional de Câncer - INCA-Pesquisa Clinica HC3 ( Site 0208), Rio de Janeiro, , Brazil
Instituto de Educação, Pesquisa e Gestão em Saúde ( Site 0202), Rio de Janeiro, , Brazil
Tom Baker Cancer Center ( Site 0107), Calgary, Alberta, Canada
North York General Hospital ( Site 0108), Toronto, Ontario, Canada
Princess Margaret Cancer Centre ( Site 0101), Toronto, Ontario, Canada
Jewish General Hospital ( Site 0110), Montreal, Quebec, Canada
Centre Hospitalier de l'Université de Montréal ( Site 0105), Montréal, Quebec, Canada
Hopital Du Saint-Sacrement ( Site 0109), Quebec City, Quebec, Canada
Centre integre universitaire de sante et de services sociaux de la Mauricie-et-du-centre-du-quebec (, Trois-Rivières, Quebec, Canada
Centro Investigación del Cáncer James Lind ( Site 0513), Temuco, Araucania, Chile
FALP ( Site 0501), Santiago, Region M. De Santiago, Chile
Oncovida ( Site 0514), Santiago, Region M. De Santiago, Chile
Clínica RedSalud Vitacura ( Site 0515), Santiago, Region M. De Santiago, Chile
Instituto Nacional del Cancer-CR Investigación ( Site 0511), Santiago, Region M. De Santiago, Chile
Bradfordhill ( Site 0500), Santiago, Region M. De Santiago, Chile
Anhui Cancer Hospital-medical oncology ( Site 2632), Hefei, Anhui, China
Cancer Hospital Chinese Academy of Medical Science ( Site 2635), Beijing, Beijing, China
Beijing Cancer hospital-Department of Breast Cancer ( Site 2605), Beijing, Beijing, China
Beijing Peking Union Medical College Hospital-Medical Oncology ( Site 2610), Beijing, Beijing, China
The First Affiliated hospital of Xiamen University-Breast Surgery ( Site 2613), Xiamen, Fujian, China
The First People's Hospital of Foshan-Oncology Department of Breast Cancer ( Site 2620), Foshan, Guangdong, China
SUN YAT-SEN UNIVERSITY CANCER CENTRE-oncology breast ( Site 2616), Guangzhou, Guangdong, China
Sun Yat-sen Memorial Hospital, Sun Yat-sen University-Breast Oncology Center ( Site 2641), Guangzhou, Guangdong, China
Peking University Shenzhen Hospital-Oncology Department ( Site 2601), Shenzhen, Guangdong, China
Guangxi Medical University Affiliated Tumor Hospital-Oncology Dept. of Breast and Bone Soft Tissue (, Nanning, Guangxi, China
Henan Cancer Hospital-Galactophore Department ( Site 2615), Zhengzhou, Henan, China
Wuhan Union Hospital Cancer Center-Cancer Center ( Site 2629), Wuhan, Hubei, China
Xiangya Hospital Central South University-Breast department ( Site 2621), Changsha, Hunan, China
Hunan Cancer Hospital ( Site 2608), Changsha, Hunan, China
Jiangsu provincial people's hospital-Oncology Department ( Site 2607), Nanjing, Jiangsu, China
The Third Hospital of Nanchang-Oncology Dept ( Site 2628), Nanchang, Jiangxi, China
Jilin Cancer Hospital-oncology department ( Site 2619), Changchun, Jilin, China
The First Affiliated Hospital of Xian Jiaotong University wa-Oncology ( Site 2604), Xi'an, Shaanxi, China
Shandong Cancer Hospital-Breast surgery ( Site 2623), Jinan, Shandong, China
Fudan University Shanghai Cancer Center-Oncology ( Site 2600), Shanghai, Shanghai, China
Renji Hospital Shanghai Jiao Tong University School of Medicine-Breast surgery ( Site 2626), Shanghai, Shanghai, China
West China Hospital Sichuan University-Head and Neck Oncology ( Site 2630), Cheng Du, Sichuan, China
Tianjin Medical University Cancer Institute and Hospital-Department of Breast Cancer ( Site 2612), Tianjin, Tianjin, China
Xinjiang Medical University Cancer Hospital - Urumqi-galactophore department ( Site 2624), Urumqi, Xinjiang, China
Zhejiang Cancer Hospital-Breast Oncology ( Site 2622), Hangzhou, Zhejiang, China
Taizhou Hospital of Zhejiang Province ( Site 2636), Linhai, Zhejiang, China
The First Affiliated Hospital of Wenzhou Medical University-Thyroid and breast surgery ( Site 2625), Wenzhou, Zhejiang, China
Fundación Colombiana de Cancerología Clínica Vida ( Site 0605), Medellín, Antioquia, Colombia
Instituto de Cancerología-Oncology ( Site 0606), Medellín, Antioquia, Colombia
Clinica de la Costa S.A.S. ( Site 0601), Barranquilla, Atlantico, Colombia
Sociedad De Oncologia Y Hematologia Del Cesar-Oncology ( Site 0603), Valledupar, Cesar, Colombia
Oncomedica S.A.-Oncomedica S.A ( Site 0604), Montería, Cordoba, Colombia
Clinica Colsanitas S.A, Sede Clínica Universitaria Colombia ( Site 0607), Bogota, Distrito Capital De Bogota, Colombia
Institut Paoli-Calmettes ( Site 0913), Marseille, Bouches-du-Rhone, France
Centre François Baclesse ( Site 0920), Caen, Calvados, France
CHU Besançon ( Site 0918), Besançon, Franche-Comte, France
Institut Claudius Regaud ( Site 0902), Toulouse, Haute-Garonne, France
Gustave Roussy ( Site 0914), Villejuif, Ile-de-France, France
Centre de Cancérologie du Grand Montpellier ( Site 0912), Montpellier, Languedoc-Roussillon, France
Institut de Cancérologie de l'Ouest ( Site 0907), Saint Herblain, Loire-Atlantique, France
Institut de Cancérologie de l'Ouest ( Site 0915), ANGERS cedex 02, Maine-et-Loire, France
Centre Oscar Lambret ( Site 0921), Lille, Nord, France
Centre Jean Perrin - Centre Régional de Lutte contre le Cancer d'Auvergne ( Site 0901), Clermont-Ferrand, Puy-de-Dome, France
CENTRE LEON BERARD ( Site 0919), Lyon, Rhone-Alpes, France
Centre de Lutte Contre le Cancer - Centre Henri Becquerel Normandie Rouen ( Site 0904), Rouen, Seine-Maritime, France
Centre Hospitalier Universitaire de Poitiers-Pôle régional de cancérologie ( Site 0922), Poitiers, Vienne, France
Institut Curie ( Site 0900), Paris, , France
Universitaetsklinikum Erlangen-Klinik für Gynäkologie und Geburtshilfe ( Site 1202), Erlangen, Bayern, Germany
Gynaekologisches Zentrum Bonn ( Site 1201), Bonn, Nordrhein-Westfalen, Germany
Universitaetsklinikum Duesseldorf-Klinik für Frauenheilkunde & Geburtshilfe ( Site 1204), Düsseldorf, Nordrhein-Westfalen, Germany
Kliniken Essen-Mitte, Evangelische Huyssens-Stiftung-Klinike für Senologie/ Brustzentrum ( Site 1200, Essen, Nordrhein-Westfalen, Germany
Universitaetsklinikum Carl Gustav Carus Dresden-Klinik und Poliklinik für Frauenheilkunde und Gebur, Dresden, Sachsen, Germany
Vivantes Klinikum Am Urban-Haematologie und Onkologie ( Site 1203), Berlin, , Germany
General Hospital of Athens Laiko-First Department of Internal Medicine ( Site 0305), Athens, Attiki, Greece
Alexandra Hospital-ONCOLGOY DEPT. ( Site 0302), Athens, Attiki, Greece
Hygeia Hospital-3rd Oncology Department ( Site 0304), Marousi, Attiki, Greece
University General Hospital of Heraklion-Internal Medicine-Oncology ( Site 0303), Heraklion, Irakleio, Greece
Euromedica General Clinic Thessaloniki-Oncology Unit ( Site 0301), Thessaloniki, , Greece
CELAN,S.A ( Site 0151), Guatemala, , Guatemala
Gastrosoluciones ( Site 0156), Guatemala, , Guatemala
INTEGRA Cancer Institute ( Site 0155), Guatemala, , Guatemala
Centro Medico Integral De Cancerología (CEMIC) ( Site 0154), Quetzaltenango, , Guatemala
Bacs-Kiskun Megyei Korhaz-Onkoradiologiai Kozpont ( Site 2804), Kecskemét, Bacs-Kiskun, Hungary
Pécsi Tudományegyetem Klinikai Központ-Onkoterápiás Intézet ( Site 2807), Pécs, Baranya, Hungary
Szegedi Tudományegyetem Szent-Györgyi Albert Klinikai Központ-Onkoterapias Klinika ( Site 2805), Szeged, Csongrad, Hungary
St. James's Hospital ( Site 1530), Dublin, , Ireland
St. Vincent's University Hospital-Medical Oncology Research Department ( Site 1531), Dublin, , Ireland
Assuta Ashdod Medical Center ( Site 1703), Ashdod, , Israel
Soroka Medical Center-Oncology ( Site 1702), Be'er Sheva, , Israel
Bnai Zion Medical Center-Oncology ( Site 1704), Haifa, , Israel
Sheba Medical Center-ONCOLOGY ( Site 1700), Ramat Gan, , Israel
Sourasky Medical Center-Oncology ( Site 1701), Tel Aviv, , Israel
Fondazione Policlinico Universitario Agostino Gemelli-Medical Oncology ( Site 1113), Roma, Lazio, Italy
Ospedale San Raffaele-Oncologia Medica ( Site 1110), Milano, Lombardia, Italy
Ospedale San Gerardo-ASST Monza-Research Unit Phase 1 ( Site 1115), Monza, Lombardia, Italy
Humanitas-U.O di Oncologia medica ed Ematologia ( Site 1114), Rozzano, Milano, Italy
Instituto Tumori Giovanni Paolo II-ONCOLOGIA MEDICA ( Site 1112), Bari, , Italy
Ospedale Cannizzaro ( Site 1118), Catania, , Italy
Istituto Europeo di Oncologia IRCCS-Divisione di Senologia Medica ( Site 1111), Milano, , Italy
Istituto Nazionale Tumori IRCCS Fondazione Pascale ( Site 1116), Napoli, , Italy
Istituto Oncologico Veneto IRCCS ( Site 1117), Padova, , Italy
Hyogo Medical University Hospital ( Site 2201), Nishinomiya, Hyogo, Japan
St. Marianna University School of Medicine Hospital ( Site 2205), Kawasaki, Kanagawa, Japan
Kitasato University Hospital ( Site 2204), Sagamihara, Kanagawa, Japan
Osaka University Hospital ( Site 2211), Suita, Osaka, Japan
Saitama Medical University International Medical Center ( Site 2208), Hidaka-city, Saitama, Japan
Tokyo Medical University Hospital ( Site 2206), Shinjuku-ku, Tokyo, Japan
Chiba University Hospital ( Site 2212), Chiba, , Japan
National Hospital Organization Kyushu Cancer Center ( Site 2209), Fukuoka, , Japan
Fukushima Medical University ( Site 2200), Fukushima, , Japan
Kumamoto University ( Site 2203), Kumamoto, , Japan
St. Luke's International Hospital ( Site 2207), Tokyo, , Japan
Juntendo University Hospital ( Site 2210), Tokyo, , Japan
National Cancer Center-Center for Breast Cancer ( Site 2404), Goyang-si, Kyonggi-do, Korea, Republic of
Seoul National University Bundang Hospital ( Site 2406), Seongnam, Kyonggi-do, Korea, Republic of
Seoul National University Hospital-Internal Medicine ( Site 2403), Seoul, , Korea, Republic of
Severance Hospital, Yonsei University Health System ( Site 2400), Seoul, , Korea, Republic of
Asan Medical Center ( Site 2402), Seoul, , Korea, Republic of
Samsung Medical Center-Division of Hematology/Oncology ( Site 2401), Seoul, , Korea, Republic of
University Malaya Medical Centre ( Site 2505), Lembah Pantai, Kuala Lumpur, Malaysia
Hospital Pulau Pinang ( Site 2504), George Town, Pulau Pinang, Malaysia
Sarawak General Hospital-Radiotherapy Unit ( Site 2501), Kuching, Sarawak, Malaysia
Hospital Kuala Lumpur-Radiotherapy and Oncology ( Site 2506), Kuala Lumpur, , Malaysia
Pantai Hospital Kuala Lumpur-Cancer Centre ( Site 2503), Kuala Lumpur, , Malaysia
Samadhi Centro Oncológico ( Site 0258), México, Distrito Federal, Mexico
Hospital Civil Fray Antonio Alcalde-Oncology ( Site 0262), Guadalajara, Jalisco, Mexico
Filios Alta Medicina ( Site 0253), Monterrey, Nuevo Leon, Mexico
Centro Estatal de Cancerologia-Investigación ( Site 0256), Chihuahua, , Mexico
Centro de Investigacion Clinica de Oaxaca ( Site 0252), Oaxaca, , Mexico
Radboudumc-Medical Oncology ( Site 1360), Nijmegen, Gelderland, Netherlands
Maastricht UMC+-Medical Oncology ( Site 1353), Maastricht, Limburg, Netherlands
Jeroen Bosch Hospital ( Site 1359), Den Bosch, Noord-Brabant, Netherlands
Elisabeth-TweeSteden Ziekenhuis-Internal Medicine ( Site 1357), Tilburg, Noord-Brabant, Netherlands
Nederlands Kanker Instituut - Antoni van Leeuwenhoek (NKI-AVL) ( Site 1351), Amsterdam, Noord-Holland, Netherlands
Meander Medisch Centrum ( Site 1358), Amersfoort, Utrecht, Netherlands
Leids Universitair Medisch Centrum-Medical Oncology ( Site 1356), Leiden, Zuid-Holland, Netherlands
Haaglanden MC - locatie Antoniushove-Medical oncology ( Site 1355), Leidschendam, Zuid-Holland, Netherlands
Franciscus Gasthuis & Vlietland, Locatie Vlietland ( Site 1354), Schiedam, Zuid-Holland, Netherlands
East Avenue Medical Center ( Site 0802), Quezon City, National Capital Region, Philippines
CARDINAL SANTOS MEDICAL CENTER-Research Room ( Site 0800), San Juan, National Capital Region, Philippines
Centrum Onkologii im. Prof. Franciszka Lukaszczyka-Ambulatorium Chemioterapii ( Site 1813), Bydgoszcz, Kujawsko-pomorskie, Poland
Pratia MCM Krakow ( Site 1809), Krakow, Malopolskie, Poland
Mazowiecki Szpital Wojewódzki w Siedlcach-Siedleckie Centrum Onkologii ( Site 1818), Siedlce, Mazowieckie, Poland
Lux med onkologia sp. z o.o. ( Site 1808), Warsaw, Mazowieckie, Poland
Luxmed Onkologia sp. z o. o. ( Site 1820), Warszawa, Mazowieckie, Poland
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - P-Klinika Nowotworów Piersi i Chirurgii (, Warszawa, Mazowieckie, Poland
Wojskowy Instytut Medyczny-Klinika Onkologii ( Site 1803), Warszawa, Mazowieckie, Poland
Mazowiecki Szpital Onkologiczny-BREAST CANCER ( Site 1821), Wieliszew, Mazowieckie, Poland
Wojewodzki Szpital im. Sw. Ojca Pio w Przemyslu ( Site 1819), Przemysl, Podkarpackie, Poland
Bialostockie Centrum Onkologii-Oddzial Onkologii Klinicznej ( Site 1812), Bialystok, Podlaskie, Poland
Narodowy Instytut Onkologii - Oddzial w Gliwicach-Breast Unit ( Site 1811), Gliwice, Slaskie, Poland
Szpital Wojewódzki im. Mikoaja Kopernika w Koszalinie-Oddzial Dzienny Chemioterapii ( Site 1815), Koszalin, Zachodniopomorskie, Poland
Champalimaud Foundation ( Site 1006), Lisbon, Lisboa, Portugal
Centro Hospitalar Universitário Lisboa Norte, E.P.E. - Hospital de Santa Maria ( Site 1004), Lisbon, Lisboa, Portugal
UNIDADE LOCAL DE SAUDE DE MATOSINHOS ( Site 1007), Matosinhos, Porto, Portugal
Centro Hospitalar do Porto - Hospital de Santo António-Oncology Service ( Site 1003), Porto, , Portugal
Instituto Português de Oncologia do Porto Francisco Gentil, EPE ( Site 1005), Porto, , Portugal
Cardiomed SRL Cluj-Napoca ( Site 2902), Cluj-Napoca, Cluj, Romania
Institutul Oncologic-Day Hospital Unit ( Site 2905), Cluj-Napoca, Cluj, Romania
Centrul de Oncologie "Sfântul Nectarie"-Medical Oncology ( Site 2901), Craiova, Dolj, Romania
Oncopremium Team-Oncology ( Site 2903), Baia Mare, Maramures, Romania
Sigmedical Services SRL ( Site 2904), Suceava, , Romania
Arkhangelsk Clinical Oncological Dispensary-Chemotherapy department ( Site 1902), Arkhangelsk, Arkhangel Skaya Oblast, Russian Federation
Podolsk Regional Clinical Hospital ( Site 1907), Podolsk, Moskovskaya Oblast, Russian Federation
Moscow Clinical Research Center-Chemotherapy department ( Site 1903), Moscow, Moskva, Russian Federation
Fed State Budgetary Inst N.N. Blokhin Med Center of Oncology MHRF ( Site 1901), Moscow, Moskva, Russian Federation
Central Clinical Hospital of the Presidential Administrative Department ( Site 1904), Moscow, Moskva, Russian Federation
Nizhegorodsky Regional Oncology Dispensary-chemotherapy ( Site 1912), Nizhniy Novgorod, Nizhegorodskaya Oblast, Russian Federation
Ryazan Regional Clinical Oncology Center-Oncology #1 ( Site 1906), Ryazan, Ryazanskaya Oblast, Russian Federation
N.N.Petrov Research Institute of Oncology ( Site 1900), Saint Petersburg, Sankt-Peterburg, Russian Federation
St. Petersburg Clinical Hospital of Russian Academy Of Sciences-Medical Oncology ( Site 1905), St. Petersburg, Sankt-Peterburg, Russian Federation
Hospital Quiron Barcelona ( Site 1326), Barcelona, Cataluna, Spain
HOSPITAL GENERAL UNIVERSITARIO GREGORIO MARAÑON ( Site 1333), Madrid, Madrid, Comunidad De, Spain
Hospital Universitario Ramón y Cajal-Medical Oncology ( Site 1320), Madrid, Madrid, Comunidad De, Spain
HOSPITAL UNIVERSITARIO QUIRONSALUD MADRID-ONCOLOGIA MEDICA ( Site 1323), Pozuelo de Alarcon, Madrid, Spain
Fundación Instituto Valenciano de Oncología-Oncologico ( Site 1332), Valencia, Valenciana, Comunitat, Spain
Karolinska Universitetssjukhuset Solna-Tema Cancer - ME Bröst- endokrina tumörer och sarkom ( Site 1, Stockholm, Stockholms Lan, Sweden
Södra Älvsborg Sjukhus ( Site 1406), Borås, Vastra Gotalands Lan, Sweden
Ege University Medicine of Faculty ( Site 2004), Bornova, Izmir, Turkey
I.E.U. Medical Point Hastanesi-Oncology ( Site 2016), Izmir, Karsiyaka, Izmir, Turkey
Baskent University Dr. Turgut Noyan Research and Training Center ( Site 2013), Adana, , Turkey
Hacettepe Universitesi-oncology hospital ( Site 2000), Ankara, , Turkey
Memorial Ankara Hastanesi-Medical Oncology ( Site 2002), Ankara, , Turkey
Gazi Universitesi-Oncology ( Site 2010), Ankara, , Turkey
ANKARA ŞEHİR HASTANESİ-Medical Oncology ( Site 2014), Ankara, , Turkey
Akdeniz Universitesi Hastanesi-Medical Oncology ( Site 2009), Antalya, , Turkey
Istanbul Universitesi Cerrahpasa-Medical Oncology ( Site 2012), Istanbul, , Turkey
TC Saglik Bakanligi Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi-oncology ( Site 2005), Istanbul, , Turkey
İnönü Üniversitesi Turgut Özal Tıp Merkezi Eğitim ve Araştırma Hastanesi-Medical Oncology Department, Malatya, , Turkey
The Royal Cornwall Hospital ( Site 1507), Truro, Cornwall, United Kingdom
Leicester Royal Infirmary-HOPE Clinical Trials Unit ( Site 1502), Leicester, England, United Kingdom
St Bartholomew's Hospital ( Site 1508), London, England, United Kingdom
The Christie ( Site 1510), Manchester, England, United Kingdom
Blackpool Victoria Hospital ( Site 1503), Blackpool, Lancashire, United Kingdom
North West Cancer Centre ( Site 1511), Londonderry, London, City Of, United Kingdom
Guy's & St Thomas' NHS Foundation Trust ( Site 1501), London, London, City Of, United Kingdom
Name: Medical Director
Affiliation: Merck Sharp & Dohme LLC
Role: STUDY_DIRECTOR