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Brief Title: Study of Pembrolizumab (MK-3475) Versus Placebo in Combination With Neoadjuvant Chemotherapy & Adjuvant Endocrine Therapy in the Treatment of Early-Stage Estrogen Receptor-Positive, Human Epidermal Growth Factor Receptor 2-Negative (ER+/HER2-) Breast Cancer (MK-3475-756/KEYNOTE-756)
Official Title: A Randomized, Double-Blind, Phase III Study of Pembrolizumab Versus Placebo in Combination With Neoadjuvant Chemotherapy and Adjuvant Endocrine Therapy for the Treatment of High-Risk Early-Stage Estrogen Receptor-Positive, Human Epidermal Growth Factor Receptor 2-Negative (ER+/HER2-) Breast Cancer (KEYNOTE-756)
Study ID: NCT03725059
Brief Summary: The purpose of this study is to assess the efficacy and safety of pembrolizumab (MK-3475) versus placebo in combination with neoadjuvant (pre-surgery) chemotherapy and adjuvant (post-surgery) endocrine therapy in the treatment of adults who have high-risk early-stage estrogen receptor-positive, human epidermal growth factor receptor 2-negative (ER+/HER2-) breast cancer. The primary study hypotheses are: 1) pembrolizumab is superior to placebo, both in combination with the protocol-specified neoadjuvant anticancer therapy, as assessed by pathological Complete Response (pCR) rate defined by the local pathologist, and 2) pembrolizumab is superior to placebo (both in combination with the protocol-specified neoadjuvant and adjuvant anticancer therapies) as assessed by Event-Free Survival (EFS) as determined by the investigator. The study is considered to have met its primary objective if pembrolizumab is superior to placebo with respect to either pCR (ypT0/Tis ypN0) or EFS.
Detailed Description: Study participants will receive 8 cycles of neoadjuvant study treatment and then will undergo surgery for their breast cancer. After surgery, participants will receive 9 cycles of study treatment and up to 10 years of variable endocrine therapy. Each cycle is 21 days long.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Southern Cancer Center, PC ( Site 8003), Daphne, Alabama, United States
Cancer Treatment Centers of America at Western Regional Medical Center ( Site 0001), Goodyear, Arizona, United States
Arizona Oncology Associates PC- HOPE ( Site 8008), Tucson, Arizona, United States
Cedars Sinai Medical Center Samuel Oschin Comp. Cancer Institute ( Site 0079), Los Angeles, California, United States
El Camino Hospital Cancer Center ( Site 0004), Mountain View, California, United States
Stanford Cancer Center ( Site 0072), Palo Alto, California, United States
UC Davis Comprehensive Cancer Center ( Site 0073), Sacramento, California, United States
University of Colorado Cancer Center ( Site 0008), Aurora, Colorado, United States
Baptist MD Anderson Cancer Center ( Site 0014), Jacksonville, Florida, United States
Southeastern Regional Medical Center, Inc. ( Site 0075), Newnan, Georgia, United States
The University of Chicago Medical Center ( Site 0080), Chicago, Illinois, United States
Orchard Healthcare Research Inc. ( Site 0020), Skokie, Illinois, United States
Midwestern Regional Medical Center, Inc. ( Site 0077), Zion, Illinois, United States
Goshen Center for Cancer Care ( Site 0021), Goshen, Indiana, United States
MercyOne Waterloo Cancer Center ( Site 0016), Waterloo, Iowa, United States
James Graham Brown Cancer Center ( Site 0022), Louisville, Kentucky, United States
Maryland Oncology Hematology, P.A. ( Site 8007), Bethesda, Maryland, United States
Massachusetts General Hospital ( Site 0024), Boston, Massachusetts, United States
MGH - North Shore Cancer Center ( Site 0081), Danvers, Massachusetts, United States
MGH Newton-Wellesley Hospital's Vernon Cancer Center ( Site 0082), Newton, Massachusetts, United States
Henry Ford Health System ( Site 0028), Detroit, Michigan, United States
Mayo Clinic and Medical School (Rochester) ( Site 0029), Rochester, Minnesota, United States
St. Vincent Frontier Cancer Center ( Site 0033), Billings, Montana, United States
Oncology Hematology West, PC dba Nebraska Cancer Specialists ( Site 0039), Omaha, Nebraska, United States
Holy Name Medical Center ( Site 0041), Teaneck, New Jersey, United States
Weill Cornell Medical College ( Site 0043), New York, New York, United States
CTCA Southwestern ( Site 0074), Tulsa, Oklahoma, United States
OHSU Knight Cancer Institute ( Site 0051), Portland, Oregon, United States
Northwest Cancer Specialists, P.C. ( Site 8000), Tigard, Oregon, United States
Geisinger Medical Center ( Site 0052), Danville, Pennsylvania, United States
Fox Chase Cancer Center ( Site 0078), Philadelphia, Pennsylvania, United States
Cancer Treatment Centers of America-Eastern Regional Medical Center ( Site 0076), Philadelphia, Pennsylvania, United States
Medical University of South Carolina ( Site 0053), Charleston, South Carolina, United States
Tennessee Oncology, PLLC/The Sarah Cannon Research Institute ( Site 7000), Nashville, Tennessee, United States
Texas Oncology-Austin Central ( Site 8004), Austin, Texas, United States
Texas Oncology-Dallas Presbyterian Hospital ( Site 8002), Dallas, Texas, United States
Texas Oncology-Baylor Charles A. Sammons Cancer Center ( Site 8009), Dallas, Texas, United States
Texas Oncology-Memorial City ( Site 8012), Houston, Texas, United States
University of Texas-MD Anderson Cancer Center ( Site 0083), Houston, Texas, United States
Texas Oncology- Plano East ( Site 8010), Plano, Texas, United States
Texas Oncology-Tyler ( Site 8006), Tyler, Texas, United States
Bon Secours St. Francis Medical Center Oncology Research ( Site 0064), Midlothian, Virginia, United States
Virginia Oncology Associates ( Site 8001), Norfolk, Virginia, United States
Kadlec Clinic Hematology and Oncology ( Site 0070), Kennewick, Washington, United States
Medical Oncology Associates (Summit Cancer Centers) ( Site 0066), Spokane, Washington, United States
Chris OBrien Lifehouse ( Site 2107), Camperdown, New South Wales, Australia
Royal North Shore Hospital ( Site 2100), Sydney, New South Wales, Australia
Westmead Hospital ( Site 2101), Sydney, New South Wales, Australia
Mater Misericordiae Ltd ( Site 2106), South Brisbane, Queensland, Australia
Frankston Hospital ( Site 2103), Frankston, Victoria, Australia
Peter MacCallum Cancer Centre ( Site 2102), Melbourne, Victoria, Australia
Imelda Ziekenhuis Bonheiden ( Site 0703), Bonheiden, Antwerpen, Belgium
UZ Antwerpen - Medical Oncology ( Site 0709), Edegem, Antwerpen, Belgium
Institut Jules Bordet ( Site 0710), Anderlecht, Bruxelles-Capitale, Region De, Belgium
Cliniques Universitaires Saint-Luc ( Site 0701), Brussels, Bruxelles-Capitale, Region De, Belgium
CHC MontLegia ( Site 0707), Liège, Liege, Belgium
Jessa Ziekenhuis Campus Virga Jesse ( Site 0704), Hasselt, Limburg, Belgium
CHU UCL Namur Site de Godinne ( Site 0706), Yvoir, Namur, Belgium
AZ Maria Middelares Gent ( Site 0700), Gent, Oost-Vlaanderen, Belgium
UZ Leuven ( Site 0702), Leuven, Vlaams-Brabant, Belgium
AZ Groeninge ( Site 0705), Kortrijk, West-Vlaanderen, Belgium
Hospital Araujo Jorge Associacao de Combate ao Cancer de Goias ( Site 0205), Goiania, Goias, Brazil
ONCOSITE - Centro de Pesquisa Clinica em Oncologia ( Site 0206), Ijui, Rio Grande Do Sul, Brazil
Associacao Hospitalar Moinhos de Vento ( Site 0201), Porto Alegre, Rio Grande Do Sul, Brazil
Uniao Brasileira de Educacao e Assistencia Hospital Sao Lucas da Pucrs ( Site 0202), Porto Alegre, Rio Grande Do Sul, Brazil
CEPON - Centro de Pesquisas Oncologicas ( Site 0208), Florianopolis, Santa Catarina, Brazil
Centro de Novos Tratamentos Itajai - Clinica de Neoplasias Litoral ( Site 0207), Itajai, Santa Catarina, Brazil
Núcleo de Pesquisa Clínica da Rede São Camilo ( Site 0210), São Paulo, Sao Paulo, Brazil
Instituto Nacional de Cancer - INCA HC III ( Site 0200), Rio de Janeiro, , Brazil
Instituto do Cancer do Estado de Sao Paulo - ICESP ( Site 0209), Sao Paulo, , Brazil
Clinica de Pesquisas e Ctro de Estudos Onc. Ginecol. e Mamaria Ltda ( Site 0204), Sao Paulo, , Brazil
Cross Cancer Institute ( Site 0115), Edmonton, Alberta, Canada
BC Cancer-Vancouver Center ( Site 0116), Vancouver, British Columbia, Canada
Princess Margaret Cancer Centre ( Site 0112), Toronto, Ontario, Canada
CISSS de la Monteregie-Centre ( Site 0108), Greenfield Park, Quebec, Canada
Hopital Maisonneuve-Rosemont CIUSSS de l Est de L Ile de Montreal ( Site 0111), Montreal, Quebec, Canada
Centre Hospitalier de l Universite de Montreal - CHUM ( Site 0114), Montreal, Quebec, Canada
Jewish General Hospital ( Site 0103), Montreal, Quebec, Canada
Centre Hospitalier Regional de Trois-Rivieres ( Site 0106), Trois-Rivières, Quebec, Canada
CHU de Quebec Universite Laval - Hopital du Saint-Sacrement ( Site 0101), Quebec, , Canada
Anhui Provincial Hospital ( Site 3224), Heifei, Anhui, China
Ruijin Hosp,Shanghai Jiao Tong University School of Medicine ( Site 3215), Shanghai, Anhui, China
Cancer Hospital Chinese Academy of Medical Sciences ( Site 3208), Beijing, Beijing, China
Fujian Medical University Union Hospital-1 Bingfanglou-Oncology ( Site 3207), Fuzhou Fujian, Fujian, China
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University ( Site 3213), Guangzhou, Guangdong, China
Fourth Hospital Of Hebei Medical University ( Site 3216), Shijia Zhuang, Hebei, China
Harbin Medical University Cancer Hospital ( Site 3200), Harbin, Heilongjiang, China
Henan Cancer Hospital ( Site 3212), Zhengzhou, Henan, China
Hubei Cancer Hospital ( Site 3211), Wuhan, Hubei, China
Hunan Cancer Hospital ( Site 3214), Changsha, Hunan, China
The First Affiliated Hospital of Zhejiang University ( Site 3203), Hangzhou, Jiangsu, China
The First Hospital of Jilin University ( Site 3201), Changchun, Jilin, China
Fudan University Shanghai Cancer Center ( Site 3205), Shanghai, Shanghai, China
The First Affiliated Hospital of Xi an Jiaotong University ( Site 3220), XI An, Shanxi, China
Tianjin Medical University Cancer Institute & Hospital ( Site 3209), Tianjin, Tianjin, China
Cancer Hospital Affiliated to Xinjiang Medical University ( Site 3219), Urumqi, Xinjiang, China
Zhejiang Provincial People's Hospital ( Site 3225), Hangzhou, Zhejiang, China
Zhejiang Cancer Hospital.... ( Site 3210), Hangzhou, Zhejiang, China
Clínica Vida Fundación - Sede Poblado ( Site 0405), Medellin, Antioquia, Colombia
Rodrigo Botero SAS ( Site 0407), Medellin, Antioquia, Colombia
Clinica de la Costa Ltda. ( Site 0400), Barranquilla, Atlantico, Colombia
Oncomedica S.A. ( Site 0401), Monteria, Cordoba, Colombia
Centro de Investigacion Clinica del Country ( Site 0402), Bogota, Distrito Capital De Bogota, Colombia
Fundacion Universitaria Sanitas ( Site 0403), Bogota, Distrito Capital De Bogota, Colombia
Centro Medico Imbanaco de Cali S.A ( Site 0406), Cali, Valle Del Cauca, Colombia
Hospital Metropolitano - Sede Lindora ( Site 4203), Santa Ana, San Jose, Costa Rica
Centre Francois Baclesse ( Site 0927), Caen, Calvados, France
Centre Georges Francois Leclerc ( Site 0920), Dijon, Cote-d Or, France
Institut Claudius Regaud IUCT Oncopole ( Site 0903), Toulouse, Haute-Garonne, France
Institut Curie - Centre Rene Huguenin ( Site 0917), Saint-Cloud, Hauts-de-Seine, France
Centre de Cancerologie du Grand Montpellier ( Site 0925), Montpellier, Herault, France
CHR-METZ-THIONVILLE - Hopital de Mercy ( Site 0919), Metz, Moselle, France
Centre Oscar Lambret ( Site 0911), Lille, Nord-Pas-de-Calais, France
Institut Sainte Catherine ( Site 0916), Avignon, Provence-Alpes-Cote-d Azur, France
Centre Jean Perrin ( Site 0909), Clermont Ferrand Cedex, Puy-de-Dome, France
Clinique Victor Hugo ( Site 0906), Le Mans, Sarthe, France
Institut Gustave Roussy ( Site 0926), Villejuif, Val-de-Marne, France
Institut Curie ( Site 0900), Paris, , France
Hopital Saint-Louis ( Site 0908), Paris, , France
Hopital Tenon ( Site 0914), Paris, , France
Medizinische Management GmbH ( Site 1012), Friedrichshafen, Baden-Wurttemberg, Germany
Universitaetsklinikum Erlangen ( Site 1001), Erlangen, Bayern, Germany
Klinikum der Universitaet Muenchen - Grosshadern ( Site 1000), Muenchen, Bayern, Germany
Sana Klinikum Offenbach GmbH ( Site 1002), Offenbach, Hessen, Germany
HELIOS Dr. Horst Schmidt Kliniken Wiesbaden ( Site 1004), Wiesbaden, Hessen, Germany
Gynaekologisch-onkologische Praxis Hannover ( Site 1013), Hannover, Niedersachsen, Germany
Gynaekologisches Zentrum ( Site 1003), Bonn, Nordrhein-Westfalen, Germany
Kliniken Essen Mitte Gmbh Evang. Huyssens Stiftung ( Site 1006), Essen, Nordrhein-Westfalen, Germany
Frauenklinik St. Louise ( Site 1014), Paderborn, Nordrhein-Westfalen, Germany
Caritas Klinikum Saarbruecken St. Theresia ( Site 1009), Saarbruecken, Saarland, Germany
Universitaetsklinikum Carl Gustav Carus ( Site 1008), Dresden, Sachsen, Germany
MVZ Nordhausen gGmbH - Praxis Dr. Grafe ( Site 1005), Nordhausen, Thuringen, Germany
Bacs-Kiskun Megyei Korhaz ( Site 2913), Kecskemet, Bacs-Kiskun, Hungary
Pecsi Tudomanyegyetem Klinikai Kozpont ( Site 2905), Pecs, Baranya, Hungary
Borsod-Abauj-Zemplen Megyei Korhaz es Egyetemi OktatoKorhaz ( Site 2904), Miskolc, Borsod-Abauj-Zemplen, Hungary
Szent Margit Korhaz ( Site 2901), Budapest, , Hungary
Orszagos Onkologiai Intezet ( Site 2908), Budapest, , Hungary
Uzsoki Utcai Korhaz ( Site 2902), Budapest, , Hungary
Debreceni Egyetem Klinikai Kozpont ( Site 2907), Debrecen, , Hungary
Somogy Megyei Kaposi Mor Oktato Korhaz ( Site 2915), Kaposvar, , Hungary
Bon Secours Hospital ( Site 1554), Cork, , Ireland
St. James s Hospital ( Site 1553), Dublin, , Ireland
HaEmek Medical Center ( Site 1712), Afula, , Israel
Assuta Ashdod Public ( Site 1704), Ashdod, , Israel
Soroka Medical Center ( Site 1701), Beer Sheva, , Israel
Rambam Health Care Campus-Oncology Division ( Site 1705), Haifa, , Israel
Shaare Zedek Medical Center ( Site 1708), Jerusalem, , Israel
Hadassah Ein Karem - Sharett Institute of Oncology ( Site 1700), Jerusalem, , Israel
Meir Medical Center ( Site 1710), Kfar-Saba, , Israel
Holy Family Hospital ( Site 1711), Nazareth, , Israel
Rabin Medical Center ( Site 1702), Petah Tikva, , Israel
Chaim Sheba Medical Center. ( Site 1707), Ramat Gan, , Israel
Kaplan Medical Center ( Site 1703), Rehovot, , Israel
Sourasky Medical Center ( Site 1706), Tel Aviv, , Israel
Assuta Medical Center ( Site 1709), Tel Aviv, , Israel
Aichi Cancer Center Hospital ( Site 2601), Nagoya, Aichi, Japan
National Cancer Center Hospital East ( Site 2613), Kashiwa, Chiba, Japan
National Hospital Organization Hokkaido Cancer Center ( Site 2607), Sapporo, Hokkaido, Japan
Hyogo College of Medicine Hospital ( Site 2600), Nishinomiya, Hyogo, Japan
Kitasato University Hospital ( Site 2616), Sagamihara, Kanagawa, Japan
Saitama Medical University International Medical Center ( Site 2606), Hidaka, Saitama, Japan
Saitama Cancer Center ( Site 2612), Kitaadachi-gun, Saitama, Japan
Shizuoka Cancer Center Hospital and Research Institute ( Site 2611), Sunto-gun, Shizuoka, Japan
Chiba Cancer Center ( Site 2605), Chiba, , Japan
Fukushima Medical University Hospital ( Site 2610), Fukushima, , Japan
Hiroshima City Hiroshima Citizens Hospital ( Site 2603), Hiroshima, , Japan
Kumamoto University Hospital ( Site 2602), Kumamoto, , Japan
National Hospital Organization - Osaka National Hospital - Institute For Clinical Research ( Site 26, Osaka, , Japan
Toranomon Hospital ( Site 2608), Tokyo, , Japan
The Cancer Institute Hospital of JFCR ( Site 2604), Tokyo, , Japan
Showa University Hospital ( Site 2615), Tokyo, , Japan
National Cancer Center ( Site 2204), Goyang-si, Kyonggi-do, Korea, Republic of
Asan Medical Center ( Site 2202), Songpagu, Seoul, Korea, Republic of
Seoul National University Hospital ( Site 2200), Seoul, , Korea, Republic of
Severance Hospital Yonsei University Health System ( Site 2201), Seoul, , Korea, Republic of
Samsung Medical Center ( Site 2203), Seoul, , Korea, Republic of
Tauranga Hospital ( Site 2302), Tauranga, Bay Of Plenty, New Zealand
Canterbury Regional Cancer & Blood Services ( Site 2303), Christchurch, Canterbury, New Zealand
Capital & Coast District Health Board - Wellington Hospital ( Site 2301), Wellington, , New Zealand
Dolnoslaskie Centrum Onkologii. ( Site 1820), Wrocław, Dolnoslaskie, Poland
Centrum Onkologii im. Prof. Franciszka Lukaszczyka ( Site 1800), Bydgoszcz, Kujawsko-pomorskie, Poland
Instytut Centrum Zdrowia Matki Polki ( Site 1821), Lodz, Lodzkie, Poland
Mazowiecki Szpital Specjalistyczny im. dr Jozefa Psarskiego ( Site 1814), Ostroleka, Mazowieckie, Poland
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy w Warszawie (, Warszawa, Mazowieckie, Poland
Mazowiecki Szpital Onkologiczny ( Site 1803), Wieliszew, Mazowieckie, Poland
Bialostockie Centrum Onkologii ( Site 1819), Bialystok, Podlaskie, Poland
Wojewodzkie Centrum Onkologii Copernicus ( Site 1817), Gdansk, Pomorskie, Poland
Szpitale Pomorskie Sp. z o.o. ( Site 1818), Gdynia, Pomorskie, Poland
Beskidzkie Centrum Onkologii im. Jana Pawla II ( Site 1810), Bielsko-Biala, Slaskie, Poland
Wojewodzki Szpital Specjalistyczny nr 4 w Bytomiu ( Site 1807), Bytom, Slaskie, Poland
Narodowy Instytut Onkologii - Oddzial w Gliwicach ( Site 1801), Gliwice, Slaskie, Poland
Fundacao Champalimaud ( Site 2500), Lisboa, Aveiro, Portugal
CHLN Hospital Santa Maria ( Site 2501), Lisboa, , Portugal
Hospital Geral de Santo Antonio ( Site 2503), Porto, , Portugal
Inst. Portugues de Oncologia de Porto Francisco Gentil EPE ( Site 2502), Porto, , Portugal
UPR Comprehensive Cancer Center ( Site 6200), San Juan, , Puerto Rico
Arkhangelsk Clinical Oncological Dispensary ( Site 1901), Arkhangelsk, Arkhangel Skaya Oblast, Russian Federation
Republican Clinical Oncology Dispensary of Republic of Bashkortostan ( Site 1909), Ufa, Baskortostan, Respublika, Russian Federation
N.N. Blokhin NMRCO ( Site 1908), Moscow, Moskva, Russian Federation
Central Clinical Hospital with outpatient Clinic ( Site 1907), Moscow, Moskva, Russian Federation
Medical Rehabilitation Center ( Site 1912), Moscow, Moskva, Russian Federation
Ryazan Regional Clinical Oncology Dispensary ( Site 1910), Ryazan, Ryazanskaya Oblast, Russian Federation
Railway Hospital of OJSC ( Site 1913), Saint Petersburg, Sankt-Peterburg, Russian Federation
Scientific Research Oncology Institute n.a. N.N.Petrov ( Site 1900), Saint Petersburg, Sankt-Peterburg, Russian Federation
Republican Clinical Oncology Dispensary of Tatarstan MoH ( Site 1903), Kazan, Tatarstan, Respublika, Russian Federation
Tomsk Scientific Research Institute of Oncology ( Site 1905), Tomsk, Tomskaya Oblast, Russian Federation
Instituto Catalan de Oncologia ICO - Hospital Duran i Reynals ( Site 1363), Hospitalet de Llobregat, Barcelona, Spain
Hospital Teresa Herrera - Chuac ( Site 1358), A Coruna, La Coruna, Spain
Hospital General Universitario Gregorio Maranon ( Site 1367), Madrid, Madrid, Comunidad De, Spain
Hospital Quiron de Madrid ( Site 1351), Pozuelo de Alarcon, Madrid, Spain
Hospital Clinico Universitario de Valencia ( Site 1355), Valencia, Valenciana, Comunitat, Spain
Instituto Oncologico Baselga.Hospital Quiron. ( Site 1352), Barcelona, , Spain
Hospital Vall D Hebron ( Site 1357), Barcelona, , Spain
Hospital Clinic I Provincial de Barcelona ( Site 1353), Barcelona, , Spain
Complejo Hospitalario de Jaen ( Site 1364), Jaen, , Spain
Hospital Ruber Internacional ( Site 1370), Madrid, , Spain
Hospital Clinico San Carlos ( Site 1354), Madrid, , Spain
Hospital Universitario 12 de Octubre ( Site 1356), Madrid, , Spain
Hospital Universitario Virgen del Rocio ( Site 1360), Sevilla, , Spain
Hospital General Arnau de Vilanova de Valencia ( Site 1369), Valencia, , Spain
China Medical University Hospital ( Site 2401), Taichung, , Taiwan
National Cheng Kung University Hospital ( Site 2400), Tainan, , Taiwan
National Taiwan University Hospital ( Site 2404), Taipei, , Taiwan
Koo Foundation Sun Yat-Sen Cancer Center ( Site 2403), Taipei, , Taiwan
Linkou Chang Gung Memorial Hospital ( Site 2402), Taoyuan, , Taiwan
Dnipropetrovsk City Multidiscipline Clinical Hosp. 4 of DRC ( Site 2702), Dnipro, Dnipropetrovska Oblast, Ukraine
MI Kryviy Rih Center of Dnipropetrovsk Regional Council ( Site 2700), Kryviy Rih, Dnipropetrovska Oblast, Ukraine
MI Precarpathian Clinical Oncology Center ( Site 2707), Ivano-Frankivsk, Ivano-Frankivska Oblast, Ukraine
Communal non profit enterprise Regional Clinical Oncology Center ( Site 2721), Kharkiv, Kharkivska Oblast, Ukraine
Communal nonprofit enterprise "Kherson Regional Oncology Dispensary" of Kherson Regional Council (, Antonivka Village, Khersonska Oblast, Ukraine
Khmelnitskiy Regional Onkology Dispensary ( Site 2704), Khmelnitskiy, Khmelnytska Oblast, Ukraine
National Cancer Institute of the MoH of Ukraine ( Site 2719), Kyiv, Kyivska Oblast, Ukraine
MI Odesa Regional Clinical Hospital ( Site 2701), Odesa, Odeska Oblast, Ukraine
MI Odessa Regional Oncological Centre ( Site 2714), Odesa, Odeska Oblast, Ukraine
Medical center of the Limited Liability Company Yulis ( Site 2720), Zaporizhzhia, Zaporizka Oblast, Ukraine
Kyiv City Clinical Oncology Centre ( Site 2716), Kyiv, , Ukraine
University Hospitals Bristol NHS Foundation Trust ( Site 1503), Bristol, Bristol, City Of, United Kingdom
Nottingham University Hospitals NHS Trust ( Site 1504), Nottingham, England, United Kingdom
Colchester General Hospital ( Site 1508), Colchester, Essex, United Kingdom
Barts Health NHS Trust ( Site 1500), London, London, City Of, United Kingdom
Guy's Hospital ( Site 1501), London, London, City Of, United Kingdom
St. Georges University Hospital NHS Foundation Trust ( Site 1505), London, London, City Of, United Kingdom
Birmingham & Solihull Heartlands Hospital NHS ( Site 1506), Solihull, , United Kingdom
Royal Cornwall Hospital ( Site 1502), Truro, , United Kingdom
Name: Medical Director
Affiliation: Merck Sharp & Dohme LLC
Role: STUDY_DIRECTOR