Spots Global Cancer Trial Database for Pembrolizumab (MK-3475) Plus Chemotherapy Versus Placebo Plus Chemotherapy in Participants Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma (MK-3475-859/KEYNOTE-859)
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Trial Identification
Brief Title: Pembrolizumab (MK-3475) Plus Chemotherapy Versus Placebo Plus Chemotherapy in Participants Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma (MK-3475-859/KEYNOTE-859)
Official Title: A Phase 3, Randomized, Double-blind Clinical Study of Pembrolizumab (MK-3475) Plus Chemotherapy Versus Placebo Plus Chemotherapy as First-line Treatment in Participants With HER2 Negative, Previously Untreated, Unresectable or Metastatic Gastric Orgastroesophageal Junction Adenocarcinoma (KEYNOTE-859)
Study ID: NCT03675737
Conditions
Study Description
Brief Summary: The purpose of this study is to evaluate the efficacy of pembrolizumab (MK-3745) in combination with chemotherapy (Cisplatin combined with 5-Fluorouracil \[FP regimen\] or oxaliplatin combined with capecitabine \[CAPOX regimen\]) versus placebo in combination with chemotherapy (FP or CAPOX regimens) in the treatment of human epidermal growth factor receptor 2 (HER2) negative advanced gastric or GEJ adenocarcinoma in adult participants. The primary hypotheses of this study are that pembrolizumab plus chemotherapy is superior to placebo plus chemotherapy in terms of overall survival (OS).
Detailed Description:
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
UCLA Hematology/Oncology - Westwood (Building 200 Suite 120) ( Site 0124), Los Angeles, California, United States
UC Irvine Health/Division of Hematology Oncology, Dept of Medicine ( Site 0128), Orange, California, United States
University of Miami, Sylvester Comprehensive Cancer Center ( Site 0113), Miami, Florida, United States
Greater Baltimore Medical Center ( Site 0102), Baltimore, Maryland, United States
Minnesota Oncology Hematology, PA ( Site 8000), Minneapolis, Minnesota, United States
University of Rochester ( Site 0122), Rochester, New York, United States
Cancer Treatment Centers of America - Philadelphia ( Site 0112), Philadelphia, Pennsylvania, United States
Allegheny General Hospital ( Site 0118), Pittsburgh, Pennsylvania, United States
Oncology & Hematology Assoc. SW Virginia, Inc., DBA Blue Ridge Cancer Care ( Site 8001), Roanoke, Virginia, United States
Wenatchee Valley Clinic [Wenatchee, WA] ( Site 0116), Wenatchee, Washington, United States
Instituto Medico Alexander Fleming ( Site 0307), Buenos Aires, Caba, Argentina
Instituto de Investigaciones Metabolicas ( Site 0312), Buenos Aires, , Argentina
Fundacion Favaloro - Hospital Universitario ( Site 0302), Buenos Aires, , Argentina
Centro Oncologico Riojano Integral ( Site 0313), La Rioja, , Argentina
Instituto San Marcos ( Site 0311), San Juan, , Argentina
Liverpool Hospital ( Site 2301), Liverpool, New South Wales, Australia
Southern Medical Day Care Centre ( Site 2303), Wollongong, New South Wales, Australia
Box Hill Hospital ( Site 2300), Box Hill, Victoria, Australia
Instituto do Cancer do Ceara ( Site 0407), Fortaleza, Ceara, Brazil
CIONC - Centro Integrado de Oncologia de Curitiba ( Site 0405), Curitiba, Parana, Brazil
Hospital de Caridade de Ijui ( Site 0402), Ijui, Rio Grande Do Sul, Brazil
Hospital Nossa Senhora da Conceicao ( Site 0403), Porto Alegre, Rio Grande Do Sul, Brazil
CEPON - Centro de Pesquisas Oncologicas ( Site 0400), Florianopolis, Santa Catarina, Brazil
Instituto Nacional do Cancer Jose Alencar Gomes da Silva INCA ( Site 0401), Rio de Janeiro, , Brazil
IBCC - Instituto Brasileiro de Controle do Cancer ( Site 0404), Sao Paulo, , Brazil
BC Cancer - Abbotsford ( Site 0206), Abbotsford, British Columbia, Canada
Sunnybrook Research Institute ( Site 0202), Toronto, Ontario, Canada
Princess Margaret Cancer Centre ( Site 0203), Toronto, Ontario, Canada
McGill University Health Centre ( Site 0208), Montreal, Quebec, Canada
Instituto Clinico Oncologico del Sur ( Site 0500), Temuco, Araucania, Chile
Fundacion Arturo Lopez Perez FALP ( Site 0501), Santiago, Region M. De Santiago, Chile
Sociedad Oncovida S.A. ( Site 0508), Santiago, Region M. De Santiago, Chile
Pontificia Universidad Catolica de Chile ( Site 0502), Santiago, Region M. De Santiago, Chile
Cancer Hospital Chinese Academy of Medical Sciences ( Site 2421), Beijing, Beijing, China
Peking Union Medical College Hospital ( Site 2425), Beijing, Beijing, China
Fujian Medical University Union Hospital ( Site 2410), Fuzhou, Fujian, China
Fujian Provincial Cancer Hospital ( Site 2414), Fuzhou, Fujian, China
900 Hospital of the Joint ( Site 2418), Fuzhou, Fujian, China
The First Affiliated Hospital of Xiamen University ( Site 2430), Xiamen, Fujian, China
Zhongshan Hospital Xiamen University ( Site 2447), Xiamen, Fujian, China
Guangdong General Hospital ( Site 2431), Guangzhou, Guangdong, China
Peking University Shenzhen Hospital ( Site 2442), Shenzhen, Guangdong, China
Fourth Hospital Of Hebei Medical University ( Site 2436), Shijiazhuang, Hebei, China
Harbin Medical University Cancer Hospital ( Site 2401), Harbin, Heilongjiang, China
Henan Cancer Hospital ( Site 2415), Zhengzhou, Henan, China
Hubei Cancer Hospital ( Site 2434), Wuhan, Hubei, China
Xiangya Hospital Central-South University ( Site 2419), Changsha, Hunan, China
Hunan Cancer Hospital ( Site 2439), Changsha, Hunan, China
Changzhou Cancer Hospital-Changzhou Fourth Peoples Hospital ( Site 2441), Changzhou, Jiangsu, China
The 81st Hospital of PLA ( Site 2413), Nanjing, Jiangsu, China
Jiangsu Cancer Hospital ( Site 2432), Nanjing, Jiangsu, China
Yancheng First People s Hospital ( Site 2426), Yancheng, Jiangsu, China
The First Affiliated Hospital of Nanchang University ( Site 2440), Nanchang, Jiangxi, China
The First Hospital of Jilin University ( Site 2416), Chang chun, Jilin, China
The Affiliated Hospital of Qingdao University ( Site 2405), Qingdao, Shandong, China
Shanghai East Hospital ( Site 2403), Shanghai, Shanghai, China
Zhongshan Hospital affiliated to Fudan University ( Site 2407), Shanghai, Shanghai, China
1st Affil hosp of Med College of Xi'an Jiaotong University ( Site 2428), XiAn, Shanxi, China
Cancer Hospital Affiliated to Xinjiang Medical University ( Site 2420), Urumqi, Xinjiang, China
Zhejiang Provincial People's Hospital ( Site 2446), Hangzhou, Zhejiang, China
Sir Run Run Show Hospital ( Site 2427), Hangzhou, Zhejiang, China
Zhejiang Cancer Hospital ( Site 2417), Hangzhou, Zhejiang, China
Sociedad de Oncología Y Hematología del Cesar S.A.S. ( Site 0608), Valledupar, Cesar, Colombia
Oncomedica S.A. ( Site 0606), Monteria, Cordoba, Colombia
Instituto Nacional de Cancerologia E.S.E ( Site 0605), Bogota, Distrito Capital De Bogota, Colombia
Centro Medico Imbanaco de Cali S.A ( Site 0604), Cali, Valle Del Cauca, Colombia
CIMCA Centro de Investigacion y Manejo del Cancer ( Site 3001), San Jose, , Costa Rica
Policlinico San Bosco ( Site 3002), San Jose, , Costa Rica
ICIMED - Instituto de Investigacion en Ciencias Medicas ( Site 3000), San Jose, , Costa Rica
Masarykuv onkologicky ustav ( Site 3103), Brno, Jihomoravsky Kraj, Czechia
FN Ostrava ( Site 3105), Ostrava, Moravskoslezsky Kraj, Czechia
Fakultni nemocnice Plzen ( Site 3102), Plzen, Plzensky Kraj, Czechia
Nemocnice AGEL Novy Jicin a.s. ( Site 3104), Novy Jicin, , Czechia
Fakultni nemocnice Olomouc ( Site 3100), Olomouc, , Czechia
Fakultni Thomayerova nemocnice ( Site 3101), Praha 4, , Czechia
Rigshospitalet ( Site 3202), Copenhagen, Hovedstaden, Denmark
Aalborg University Hospital ( Site 3204), Aalborg, Nordjylland, Denmark
Odense Universitets Hospital ( Site 3201), Odense, Syddanmark, Denmark
CHU de Rouen ( Site 1006), Rouen, Ain, France
CHU-Jean Minjoz ( Site 1002), Besancon, Doubs, France
C.H.R.U. de Brest - Hopital Morvan ( Site 1007), Brest, Finistere, France
Centre Oscar Lambret ( Site 1003), Lille, Nord, France
Institut de Cancerologie de l Ouest Centre Rene Gauducheau ( Site 1004), Saint-Herblain, Val-de-Marne, France
Institut Gustave Roussy ( Site 1000), Villejuif, Val-de-Marne, France
CHU Hopital Saint Antoine ( Site 1001), Paris, , France
SLK-Kliniken Heilbronn ( Site 1104), Heilbronn, Baden-Wurttemberg, Germany
Universitaetsklinikum Leipzig ( Site 1114), Leipzig, Sachsen, Germany
Charite Universitaetsmedizin Berlin ( Site 1101), Berlin, , Germany
Facharztzentrum Eppendorf ( Site 1121), Hamburg, , Germany
Asklepios Klinik Altona ( Site 1100), Hamburg, , Germany
Celan SA ( Site 0705), Guatemala, , Guatemala
Oncomedica ( Site 0702), Guatemala, , Guatemala
Grupo Angeles SA ( Site 0701), Guatemala, , Guatemala
MEDI-K CAYALA ( Site 0704), Guatemala, , Guatemala
Centro Regional de Sub Especialidades Medicas SA ( Site 0703), Quetzaltenango, , Guatemala
Prince of Wales Hospital ( Site 2503), Hong Kong, , Hong Kong
Princess Margaret Hospital. ( Site 2502), Hong Kong, , Hong Kong
Queen Mary Hospital ( Site 2501), Hong Kong, , Hong Kong
Bacs-Kiskun Megyei Korhaz ( Site 3306), Kecskemet, Bacs-Kiskun, Hungary
Jasz-Nagykun-Szolnok Megyei Hetenyi Gyula Korhaz-Rendelointezet ( Site 3302), Szolnok, Jasz-Nagykun-Szolnok, Hungary
Semmelweis Egyetem.. ( Site 3305), Budapest, , Hungary
Orszagos Onkologiai Intezet ( Site 3303), Budapest, , Hungary
University of Debrecen Medical Center Clinic of Oncology ( Site 3300), Debrecen, , Hungary
St. James s Hospital ( Site 1200), Dublin, , Ireland
Beaumont Hospital ( Site 2101), Dublin, , Ireland
Tallaght University Hospital ( Site 1202), Dublin, , Ireland
Chaim Sheba Medical Center ( Site 1304), Ramat Gan, Tel Aviv, Israel
Edith Wolfson Medical Center ( Site 1307), Holon, Tell Abib, Israel
Sourasky Medical Center ( Site 1306), Tel Aviv, Tell Abib, Israel
Hadassah Ein Karem Jerusalem ( Site 1301), Jerusalem, Yerushalayim, Israel
Soroka University Medical Center ( Site 1305), Beer Sheva, , Israel
Rambam Medical Center ( Site 1303), Haifa, , Israel
Meir Medical Center ( Site 1308), Kfar Saba, , Israel
Rabin Medical Center ( Site 1302), Petah Tikva, , Israel
Istituto Europeo di Oncologia ( Site 1411), Milano, Lombardia, Italy
Istituto Nazionale dei Tumori Fondazione IRCSS ( Site 1402), Milano, , Italy
Istituto Oncologico Veneto ( Site 1412), Padova, , Italy
Azienda Ospedaliera San Camillo Forlanini ( Site 1413), Roma, , Italy
Aichi Cancer Center Hospital ( Site 2619), Nagoya, Aichi, Japan
National Cancer Center Hospital East ( Site 2617), Kashiwa, Chiba, Japan
Hyogo Cancer Center ( Site 2604), Akashi, Hyogo, Japan
Kobe City Medical Center General Hospital ( Site 2603), Kobe, Hyogo, Japan
Ibaraki Prefectural Central Hospital ( Site 2610), Kasama, Ibaraki, Japan
Kagawa University Hospital ( Site 2615), Kita-gun, Kagawa, Japan
Kitasato University Hospital ( Site 2618), Sagamihara, Kanagawa, Japan
Kanagawa Cancer Center ( Site 2614), Yokohama, Kanagawa, Japan
Kansai Medical University Hospital ( Site 2608), Hirakata, Osaka, Japan
Kindai University Hospital ( Site 2616), Osakasayama, Osaka, Japan
Osaka University Hospital ( Site 2600), Suita, Osaka, Japan
Saitama Cancer Center ( Site 2601), Kitaadachi-gun, Saitama, Japan
National Hospital Organization Kyushu Cancer Center ( Site 2612), Fukuoka, , Japan
Hiroshima City Hiroshima Citizens Hospital ( Site 2611), Hiroshima, , Japan
Kumamoto University Hospital ( Site 2602), Kumamoto, , Japan
Niigata Cancer Center Hospital ( Site 2613), Niigata, , Japan
Osaka International Cancer Institute ( Site 2607), Osaka, , Japan
National Cancer Center Hospital ( Site 2606), Tokyo, , Japan
Tokyo Metropolitan Komagome Hospital ( Site 2605), Tokyo, , Japan
The Cancer Institute Hospital of JFCR ( Site 2609), Tokyo, , Japan
Seoul National University Hospital ( Site 2803), Seoul, , Korea, Republic of
Severance Hospital Yonsei University Health System ( Site 2800), Seoul, , Korea, Republic of
Asan Medical Center ( Site 2802), Seoul, , Korea, Republic of
Samsung Medical Center ( Site 2801), Seoul, , Korea, Republic of
Hospital Civil de Guadalajara Fray Antonio Alcalde ( Site 0808), Guadalajara, Jalisco, Mexico
Christus Muguerza Clinica Vidriera ( Site 0802), Monterrey, Nuevo Leon, Mexico
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran ( Site 0806), Ciudad de Mexico, , Mexico
Medical Care and Research S.A. de C.V. ( Site 0809), Merida, , Mexico
Instituto Nacional de Cancerologia. ( Site 0804), Mexico City, , Mexico
Auckland City Hospital ( Site 2700), Auckland, Northland, New Zealand
Clinica Ricardo Palma Instituto de Oncologia y Radioterapia ( Site 0908), Lima, , Peru
Instituto Nacional de Enfermedades Neoplasicas ( Site 0901), Lima, , Peru
Hospital Nacional Arzobispo Loayza ( Site 0902), Lima, , Peru
Clinica San Gabriel ( Site 0907), Lima, , Peru
Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego ( Site 1506), Wroclaw, Dolnoslaskie, Poland
Dolnoslaskie Centrum Onkologii we Wroclawiu ( Site 1504), Wroclaw, Dolnoslaskie, Poland
Szpital Uniwersytecki w Krakowie ( Site 1503), Krakow, Malopolskie, Poland
Magodent Szpital Elblaska ( Site 1509), Warszawa, Mazowieckie, Poland
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy w Warszawie (, Warszawa, Mazowieckie, Poland
Przychodnia Lekarska Komed ( Site 1514), Konin, Wielkopolskie, Poland
Regionalny Szpital Specjalistyczny im Wl. Bieganskiego w Grudziadzu ( Site 1505), Grudziadz, , Poland
Chelyabinsk Regional Clinical Oncology Dispensary-Chemotherapy ( Site 1608), Chelyabinsk, Chelyabinskaya Oblast, Russian Federation
SBHI Leningrad Regional Clinical Hospital ( Site 1616), Saint Petersburg, Leningradskaya Oblast, Russian Federation
Blokhin National Medical Oncology ( Site 1604), Moscow, Moskva, Russian Federation
Central Clinical Hospital with Polyclinic ( Site 1614), Moscow, Moskva, Russian Federation
SBHI Samara Regional Clinical Oncology Dispensary ( Site 1609), Samara, Samarskaya Oblast, Russian Federation
City Clinical Oncology Center ( Site 1603), Saint Petersburg, Sankt-Peterburg, Russian Federation
Cancer Care Langenhoven Drive Oncology Centre ( Site 1708), Port Elizabeth, Eastern Cape, South Africa
Universitas Annex National Hospital ( Site 1701), Bloemfontein, Free State, South Africa
Sandton Oncology Medical Group PTY LTD ( Site 1700), Johannesburg, Gauteng, South Africa
Wits Clinical Research ( Site 1707), Parktown-Johannesburg, Gauteng, South Africa
Tshwane District Hospital ( Site 1702), Pretoria, Gauteng, South Africa
The Oncology Centre Overport and Umhlanga ( Site 1705), Durban, Kwazulu-Natal, South Africa
Cancercare Rondebosch Oncology ( Site 1709), Cape Town, Western Cape, South Africa
Groote Schuur Hospital ( Site 1706), Cape Town, Western Cape, South Africa
Outeniqua Cancercare Oncology Unit ( Site 1704), George, Western Cape, South Africa
Cape Town Oncology Trials Pty Ltd ( Site 1703), Kraaifontein, Western Cape, South Africa
Hospital General Universitario de Elche ( Site 1803), Elche, Alicante, Spain
Hospital Universitario General de Asturias ( Site 1802), Oviedo, Asturias, Spain
Institut Catala d Oncologia Hospital Germans Trias i Pujol ( Site 1806), Badalona, Barcelona, Spain
Hospital Universitario Marques de Valdecilla ( Site 1804), Santander, Cantabria, Spain
HOSPITAL UNIVERSITARIO QUIRONSALUD MADRID-ONCOLOGIA MEDICA ( Site 1805), Pozuelo de Alarcon, Madrid, Spain
Hospital General Universitari Vall d Hebron ( Site 1801), Barcelona, , Spain
Universitaetsspital Basel ( Site 1900), Basel, Basel-Stadt, Switzerland
Hopitaux Universitaires de Geneve HUG ( Site 1907), Geneva, Geneve, Switzerland
Kantonsspital Graubuenden ( Site 1903), Chur, Grisons, Switzerland
Kantonsspital St. Gallen ( Site 1901), St. Gallen, Sankt Gallen, Switzerland
Istituto Oncologica della Svizzera Italiana (IOSI) ( Site 1905), Bellinzona, Ticino, Switzerland
Universitaetsspital Zuerich ( Site 1902), Zuerich, Zurich, Switzerland
Luzern Kantonsspital ( Site 1904), Luzern, , Switzerland
Chang Gung Medical Foundation. Kaohsiung Branch ( Site 2902), Kaohsiung, , Taiwan
National Cheng Kung University Hospital ( Site 2901), Tainan, , Taiwan
National Taiwan University Hospital ( Site 2900), Taipei, , Taiwan
Mackay Memorial Hospital ( Site 2903), Taipei, , Taiwan
Adana Sehir Hastanesi ( Site 2002), Adana, , Turkey
Hacettepe University Medical Faculty ( Site 2017), Ankara, , Turkey
Abdurrahman Yurtaslan Onkoloji Egitim ve Arastirma Hastanesi ( Site 2006), Ankara, , Turkey
Trakya Universitesi Tip Fakultesi ( Site 2015), Edirne, , Turkey
Ataturk Universitesi Tip Fakultesi Hastanesi ( Site 2000), Erzurum, , Turkey
Istanbul Universitesi Cerrahpasa Tip Fakultesi ( Site 2001), Istanbul, , Turkey
Dokuz Eylul Universitesi Tip Fakultesi Hastanesi ( Site 2011), Izmir, , Turkey
Malatya Inonu Universitesi Tip Fakultesi Hastanesi ( Site 2009), Malatya, , Turkey
Sakarya Universitesi Egitim ve Arastirma Hastanesi ( Site 2012), Sakarya, , Turkey
City Clinical Hosp.4 of DCC ( Site 2201), Dnipro, Dnipropetrovska Oblast, Ukraine
MI Kryviy Rih Center of Dnipropetrovsk Regional Council ( Site 2200), Kryviy Rih, Dnipropetrovska Oblast, Ukraine
MI Precarpathian Clinical Oncology Center ( Site 2204), Ivano-Frankivsk, Ivano-Frankivska Oblast, Ukraine
Communal non profit enterprise Regional Clinical Oncology Center ( Site 2208), Kharkiv, Kharkivska Oblast, Ukraine
Clinic of National Cancer Institute ( Site 2203), Kyiv, Kyivska Oblast, Ukraine
Medical and Diagnostic Centre LLC Dobryi Prognoz ( Site 2205), Kyiv, Kyivska Oblast, Ukraine
Lviv State Oncology Regional Treatment and Diagnostic Center ( Site 2210), Lviv, Lvivska Oblast, Ukraine
MI Odessa Regional Oncological Centre ( Site 2212), Odesa, Odeska Oblast, Ukraine
Medical Centre LLC Oncolife ( Site 2202), Zaporizhzhya, Zaporizka Oblast, Ukraine
Kyiv City Clinical Oncology Centre ( Site 2213), Kyiv, , Ukraine
South Devon Healthcare Foundation Trust. Torbay Hospital ( Site 1205), Torquay, Devon, United Kingdom
Castle Hill Hospital ( Site 1201), Cottingham, East Riding Of Yorkshire, United Kingdom
University College London Hospital ( Site 1211), London, London, City Of, United Kingdom
St. Georges University Hospital NHS Foundation Trust ( Site 1204), London, London, City Of, United Kingdom
Contact Details
Name: Medical Director
Affiliation: Merck Sharp & Dohme LLC
Role: STUDY_DIRECTOR
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