Pembrolizumab (MK-3475) Plus Chemotherapy Versus Placebo Plus Chemotherapy in Participants Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma (MK-3475-859/KEYNOTE-859)

January 12, 2024 updated by: Merck Sharp & Dohme LLC

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)

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).

Study Overview

Study Type

Interventional

Enrollment (Actual)

1579

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Buenos Aires, Argentina, C1012AAR
        • Instituto de Investigaciones Metabolicas ( Site 0312)
      • Buenos Aires, Argentina, C1093AAS
        • Fundacion Favaloro - Hospital Universitario ( Site 0302)
      • La Rioja, Argentina, F5300COE
        • Centro Oncologico Riojano Integral ( Site 0313)
      • San Juan, Argentina, J5400EBB
        • Instituto San Marcos ( Site 0311)
    • Caba
      • Buenos Aires, Caba, Argentina, C1426ANZ
        • Instituto Medico Alexander Fleming ( Site 0307)
    • New South Wales
      • Liverpool, New South Wales, Australia, 2170
        • Liverpool Hospital ( Site 2301)
      • Wollongong, New South Wales, Australia, 2500
        • Southern Medical Day Care Centre ( Site 2303)
    • Victoria
      • Box Hill, Victoria, Australia, 3128
        • Box Hill Hospital ( Site 2300)
      • Rio de Janeiro, Brazil, 20231-050
        • Instituto Nacional do Cancer Jose Alencar Gomes da Silva INCA ( Site 0401)
      • Sao Paulo, Brazil, 03102-002
        • IBCC - Instituto Brasileiro de Controle do Cancer ( Site 0404)
    • Ceara
      • Fortaleza, Ceara, Brazil, 60430-230
        • Instituto do Cancer do Ceara ( Site 0407)
    • Parana
      • Curitiba, Parana, Brazil, 80810-050
        • CIONC - Centro Integrado de Oncologia de Curitiba ( Site 0405)
    • Rio Grande Do Sul
      • Ijui, Rio Grande Do Sul, Brazil, 98700 000
        • Hospital de Caridade de Ijui ( Site 0402)
      • Porto Alegre, Rio Grande Do Sul, Brazil, 91350-200
        • Hospital Nossa Senhora da Conceicao ( Site 0403)
    • Santa Catarina
      • Florianopolis, Santa Catarina, Brazil, 88034-000
        • CEPON - Centro de Pesquisas Oncologicas ( Site 0400)
    • British Columbia
      • Abbotsford, British Columbia, Canada, V2S 0C2
        • BC Cancer - Abbotsford ( Site 0206)
    • Ontario
      • Toronto, Ontario, Canada, M4N 3M5
        • Sunnybrook Research Institute ( Site 0202)
      • Toronto, Ontario, Canada, M5G 2M9
        • Princess Margaret Cancer Centre ( Site 0203)
    • Quebec
      • Montreal, Quebec, Canada, H4A 3J1
        • McGill University Health Centre ( Site 0208)
    • Araucania
      • Temuco, Araucania, Chile, 4810469
        • Instituto Clinico Oncologico del Sur ( Site 0500)
    • Region M. De Santiago
      • Santiago, Region M. De Santiago, Chile, 7500921
        • Fundacion Arturo Lopez Perez FALP ( Site 0501)
      • Santiago, Region M. De Santiago, Chile, 7510032
        • Sociedad Oncovida S.A. ( Site 0508)
      • Santiago, Region M. De Santiago, Chile, 7620002
        • Pontificia Universidad Catolica de Chile ( Site 0502)
    • Beijing
      • Beijing, Beijing, China, 100021
        • Cancer Hospital Chinese Academy of Medical Sciences ( Site 2421)
      • Beijing, Beijing, China, 100730
        • Peking Union Medical College Hospital ( Site 2425)
    • Fujian
      • Fuzhou, Fujian, China, 350001
        • Fujian Medical University Union Hospital ( Site 2410)
      • Fuzhou, Fujian, China, 350014
        • Fujian Provincial Cancer Hospital ( Site 2414)
      • Fuzhou, Fujian, China, 350025
        • 900 Hospital of the Joint ( Site 2418)
      • Xiamen, Fujian, China, 361003
        • The First Affiliated Hospital of Xiamen University ( Site 2430)
      • Xiamen, Fujian, China, 361004
        • Zhongshan Hospital Xiamen University ( Site 2447)
    • Guangdong
      • Guangzhou, Guangdong, China, 510080
        • Guangdong General Hospital ( Site 2431)
      • Shenzhen, Guangdong, China, 518036
        • Peking University Shenzhen Hospital ( Site 2442)
    • Hebei
      • Shijiazhuang, Hebei, China, 050011
        • Fourth Hospital Of Hebei Medical University ( Site 2436)
    • Heilongjiang
      • Harbin, Heilongjiang, China, 150081
        • Harbin Medical University Cancer Hospital ( Site 2401)
    • Henan
      • Zhengzhou, Henan, China, 450008
        • Henan Cancer Hospital ( Site 2415)
    • Hubei
      • Wuhan, Hubei, China, 430079
        • Hubei Cancer Hospital ( Site 2434)
    • Hunan
      • Changsha, Hunan, China, 410008
        • Xiangya Hospital Central-South University ( Site 2419)
      • Changsha, Hunan, China, 410013
        • Hunan Cancer Hospital ( Site 2439)
    • Jiangsu
      • Changzhou, Jiangsu, China, 213032
        • Changzhou Cancer Hospital-Changzhou Fourth Peoples Hospital ( Site 2441)
      • Nanjing, Jiangsu, China, 210009
        • Jiangsu Cancer Hospital ( Site 2432)
      • Nanjing, Jiangsu, China, 210002
        • The 81st Hospital of PLA ( Site 2413)
      • Yancheng, Jiangsu, China, 224000
        • Yancheng First People s Hospital ( Site 2426)
    • Jiangxi
      • Nanchang, Jiangxi, China, 330006
        • The First Affiliated Hospital of Nanchang University ( Site 2440)
    • Jilin
      • Chang chun, Jilin, China, 130021
        • The First Hospital of Jilin University ( Site 2416)
    • Shandong
      • Qingdao, Shandong, China, 266061
        • The Affiliated Hospital of Qingdao University ( Site 2405)
    • Shanghai
      • Shanghai, Shanghai, China, 200120
        • Shanghai East Hospital ( Site 2403)
      • Shanghai, Shanghai, China, 210000
        • Zhongshan Hospital affiliated to Fudan University ( Site 2407)
    • Shanxi
      • XiAn, Shanxi, China, 710061
        • 1st Affil hosp of Med College of Xi'an Jiaotong University ( Site 2428)
    • Xinjiang
      • Urumqi, Xinjiang, China, 830001
        • Cancer Hospital Affiliated to Xinjiang Medical University ( Site 2420)
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310014
        • Zhejiang Provincial People's Hospital ( Site 2446)
      • Hangzhou, Zhejiang, China, 310016
        • Sir Run Run Show Hospital ( Site 2427)
      • Hangzhou, Zhejiang, China, 310022
        • Zhejiang Cancer Hospital ( Site 2417)
    • Cesar
      • Valledupar, Cesar, Colombia, 200001
        • Sociedad de Oncología Y Hematología del Cesar S.A.S. ( Site 0608)
    • Cordoba
      • Monteria, Cordoba, Colombia, 230002
        • Oncomedica S.A. ( Site 0606)
    • Distrito Capital De Bogota
      • Bogota, Distrito Capital De Bogota, Colombia, 110321
        • Instituto Nacional de Cancerologia E.S.E ( Site 0605)
    • Valle Del Cauca
      • Cali, Valle Del Cauca, Colombia, 760042
        • Centro Medico Imbanaco de Cali S.A ( Site 0604)
      • San Jose, Costa Rica, 10103
        • CIMCA Centro de Investigacion y Manejo del Cancer ( Site 3001)
      • San Jose, Costa Rica, 10103
        • Policlinico San Bosco ( Site 3002)
      • San Jose, Costa Rica, 10108
        • ICIMED - Instituto de Investigacion en Ciencias Medicas ( Site 3000)
      • Novy Jicin, Czechia, 74101
        • Nemocnice AGEL Novy Jicin a.s. ( Site 3104)
      • Olomouc, Czechia, 779 00
        • Fakultni nemocnice Olomouc ( Site 3100)
      • Praha 4, Czechia, 140 59
        • Fakultni Thomayerova nemocnice ( Site 3101)
    • Jihomoravsky Kraj
      • Brno, Jihomoravsky Kraj, Czechia, 65653
        • Masarykuv onkologicky ustav ( Site 3103)
    • Moravskoslezsky Kraj
      • Ostrava, Moravskoslezsky Kraj, Czechia, 708 52
        • FN Ostrava ( Site 3105)
    • Plzensky Kraj
      • Plzen, Plzensky Kraj, Czechia, 304 60
        • Fakultni nemocnice Plzen ( Site 3102)
    • Hovedstaden
      • Copenhagen, Hovedstaden, Denmark, 2100
        • Rigshospitalet ( Site 3202)
    • Nordjylland
      • Aalborg, Nordjylland, Denmark, 9000
        • Aalborg University Hospital ( Site 3204)
    • Syddanmark
      • Odense, Syddanmark, Denmark, 5000
        • Odense Universitets Hospital ( Site 3201)
      • Paris, France, 75012
        • CHU Hopital Saint Antoine ( Site 1001)
    • Ain
      • Rouen, Ain, France, 76000
        • CHU de Rouen ( Site 1006)
    • Doubs
      • Besancon, Doubs, France, 25030
        • CHU-Jean Minjoz ( Site 1002)
    • Finistere
      • Brest, Finistere, France, 29200
        • C.H.R.U. de Brest - Hopital Morvan ( Site 1007)
    • Nord
      • Lille, Nord, France, 59000
        • Centre Oscar Lambret ( Site 1003)
    • Val-de-Marne
      • Saint-Herblain, Val-de-Marne, France, 44805
        • Institut de Cancerologie de l Ouest Centre Rene Gauducheau ( Site 1004)
      • Villejuif, Val-de-Marne, France, 94805
        • Institut Gustave Roussy ( Site 1000)
      • Berlin, Germany, 13353
        • Charite Universitaetsmedizin Berlin ( Site 1101)
      • Hamburg, Germany, 20249
        • Facharztzentrum Eppendorf ( Site 1121)
      • Hamburg, Germany, 22763
        • Asklepios Klinik Altona ( Site 1100)
    • Baden-Wurttemberg
      • Heilbronn, Baden-Wurttemberg, Germany, 74078
        • SLK-Kliniken Heilbronn ( Site 1104)
    • Sachsen
      • Leipzig, Sachsen, Germany, 04103
        • Universitaetsklinikum Leipzig ( Site 1114)
      • Guatemala, Guatemala, 01010
        • Celan SA ( Site 0705)
      • Guatemala, Guatemala, 01010
        • Oncomedica ( Site 0702)
      • Guatemala, Guatemala, 01015
        • Grupo Angeles SA ( Site 0701)
      • Guatemala, Guatemala, 01016
        • MEDI-K CAYALA ( Site 0704)
      • Quetzaltenango, Guatemala, 09001
        • Centro Regional de Sub Especialidades Medicas SA ( Site 0703)
      • Hong Kong, Hong Kong
        • Prince of Wales Hospital ( Site 2503)
      • Hong Kong, Hong Kong
        • Princess Margaret Hospital. ( Site 2502)
      • Hong Kong, Hong Kong
        • Queen Mary Hospital ( Site 2501)
      • Budapest, Hungary, 1083
        • Semmelweis Egyetem.. ( Site 3305)
      • Budapest, Hungary, 1122
        • Orszagos Onkologiai Intezet ( Site 3303)
      • Debrecen, Hungary, 4032
        • University of Debrecen Medical Center Clinic of Oncology ( Site 3300)
    • Bacs-Kiskun
      • Kecskemet, Bacs-Kiskun, Hungary, 6000
        • Bacs-Kiskun Megyei Korhaz ( Site 3306)
    • Jasz-Nagykun-Szolnok
      • Szolnok, Jasz-Nagykun-Szolnok, Hungary, 5004
        • Jasz-Nagykun-Szolnok Megyei Hetenyi Gyula Korhaz-Rendelointezet ( Site 3302)
      • Dublin, Ireland, D08 W9RT
        • St. James s Hospital ( Site 1200)
      • Dublin, Ireland, D09V2N0
        • Beaumont Hospital ( Site 2101)
      • Dublin, Ireland, D24 NR0A
        • Tallaght University Hospital ( Site 1202)
      • Beer Sheva, Israel, 8410101
        • Soroka University Medical Center ( Site 1305)
      • Haifa, Israel, 3109601
        • Rambam Medical Center ( Site 1303)
      • Kfar Saba, Israel, 4428164
        • Meir Medical Center ( Site 1308)
      • Petah Tikva, Israel, 4941492
        • Rabin Medical Center ( Site 1302)
    • Tel Aviv
      • Ramat Gan, Tel Aviv, Israel, 5266202
        • Chaim Sheba Medical Center ( Site 1304)
    • Tell Abib
      • Holon, Tell Abib, Israel, 5822012
        • Edith Wolfson Medical Center ( Site 1307)
      • Tel Aviv, Tell Abib, Israel, 6423906
        • Sourasky Medical Center ( Site 1306)
    • Yerushalayim
      • Jerusalem, Yerushalayim, Israel, 9112001
        • Hadassah Ein Karem Jerusalem ( Site 1301)
      • Milano, Italy, 20133
        • Istituto Nazionale dei Tumori Fondazione IRCSS ( Site 1402)
      • Padova, Italy, 35128
        • Istituto Oncologico Veneto ( Site 1412)
      • Roma, Italy, 00152
        • Azienda Ospedaliera San Camillo Forlanini ( Site 1413)
    • Lombardia
      • Milano, Lombardia, Italy, 20141
        • Istituto Europeo di Oncologia ( Site 1411)
      • Fukuoka, Japan, 811-1395
        • National Hospital Organization Kyushu Cancer Center ( Site 2612)
      • Hiroshima, Japan, 730-8518
        • Hiroshima City Hiroshima Citizens Hospital ( Site 2611)
      • Kumamoto, Japan, 860-8556
        • Kumamoto University Hospital ( Site 2602)
      • Niigata, Japan, 951-8566
        • Niigata Cancer Center Hospital ( Site 2613)
      • Osaka, Japan, 541-8567
        • Osaka International Cancer Institute ( Site 2607)
      • Tokyo, Japan, 104-0045
        • National Cancer Center Hospital ( Site 2606)
      • Tokyo, Japan, 113-8677
        • Tokyo Metropolitan Komagome Hospital ( Site 2605)
      • Tokyo, Japan, 135-8550
        • The Cancer Institute Hospital of JFCR ( Site 2609)
    • Aichi
      • Nagoya, Aichi, Japan, 464-8681
        • Aichi Cancer Center Hospital ( Site 2619)
    • Chiba
      • Kashiwa, Chiba, Japan, 277-8577
        • National Cancer Center Hospital East ( Site 2617)
    • Hyogo
      • Akashi, Hyogo, Japan, 673-8558
        • Hyogo Cancer Center ( Site 2604)
      • Kobe, Hyogo, Japan, 650-0047
        • Kobe City Medical Center General Hospital ( Site 2603)
    • Ibaraki
      • Kasama, Ibaraki, Japan, 309-1793
        • Ibaraki Prefectural Central Hospital ( Site 2610)
    • Kagawa
      • Kita-gun, Kagawa, Japan, 761-0793
        • Kagawa University Hospital ( Site 2615)
    • Kanagawa
      • Sagamihara, Kanagawa, Japan, 252-0375
        • Kitasato University Hospital ( Site 2618)
      • Yokohama, Kanagawa, Japan, 241-8515
        • Kanagawa Cancer Center ( Site 2614)
    • Osaka
      • Hirakata, Osaka, Japan, 573-1191
        • Kansai Medical University Hospital ( Site 2608)
      • Osakasayama, Osaka, Japan, 589-8511
        • Kindai University Hospital ( Site 2616)
      • Suita, Osaka, Japan, 565-0871
        • Osaka University Hospital ( Site 2600)
    • Saitama
      • Kitaadachi-gun, Saitama, Japan, 362-0806
        • Saitama Cancer Center ( Site 2601)
      • Seoul, Korea, Republic of, 03080
        • Seoul National University Hospital ( Site 2803)
      • Seoul, Korea, Republic of, 03722
        • Severance Hospital Yonsei University Health System ( Site 2800)
      • Seoul, Korea, Republic of, 05505
        • Asan Medical Center ( Site 2802)
      • Seoul, Korea, Republic of, 06351
        • Samsung Medical Center ( Site 2801)
      • Ciudad de Mexico, Mexico, 14080
        • Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran ( Site 0806)
      • Merida, Mexico, 97070
        • Medical Care and Research S.A. de C.V. ( Site 0809)
      • Mexico City, Mexico, 14080
        • Instituto Nacional de Cancerologia. ( Site 0804)
    • Jalisco
      • Guadalajara, Jalisco, Mexico, 44280
        • Hospital Civil de Guadalajara Fray Antonio Alcalde ( Site 0808)
    • Nuevo Leon
      • Monterrey, Nuevo Leon, Mexico, 64570
        • Christus Muguerza Clinica Vidriera ( Site 0802)
    • Northland
      • Auckland, Northland, New Zealand, 1023
        • Auckland City Hospital ( Site 2700)
      • Lima, Peru, 15036
        • Clinica Ricardo Palma Instituto de Oncologia y Radioterapia ( Site 0908)
      • Lima, Peru, 15038
        • Instituto Nacional de Enfermedades Neoplasicas ( Site 0901)
      • Lima, Peru, 15082
        • Hospital Nacional Arzobispo Loayza ( Site 0902)
      • Lima, Peru, 15088
        • Clinica San Gabriel ( Site 0907)
      • Grudziadz, Poland, 86-300
        • Regionalny Szpital Specjalistyczny im Wl. Bieganskiego w Grudziadzu ( Site 1505)
    • Dolnoslaskie
      • Wroclaw, Dolnoslaskie, Poland, 50-556
        • Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego ( Site 1506)
      • Wroclaw, Dolnoslaskie, Poland, 53-413
        • Dolnoslaskie Centrum Onkologii we Wroclawiu ( Site 1504)
    • Malopolskie
      • Krakow, Malopolskie, Poland, 31-501
        • Szpital Uniwersytecki w Krakowie ( Site 1503)
    • Mazowieckie
      • Warszawa, Mazowieckie, Poland, 02-781
        • Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy w Warszawie (
      • Warszawa, Mazowieckie, Poland, 01-748
        • Magodent Szpital Elblaska ( Site 1509)
    • Wielkopolskie
      • Konin, Wielkopolskie, Poland, 62-500
        • Przychodnia Lekarska Komed ( Site 1514)
    • Chelyabinskaya Oblast
      • Chelyabinsk, Chelyabinskaya Oblast, Russian Federation, 454087
        • Chelyabinsk Regional Clinical Oncology Dispensary-Chemotherapy ( Site 1608)
    • Leningradskaya Oblast
      • Saint Petersburg, Leningradskaya Oblast, Russian Federation, 194291
        • SBHI Leningrad Regional Clinical Hospital ( Site 1616)
    • Moskva
      • Moscow, Moskva, Russian Federation, 115478
        • Blokhin National Medical Oncology ( Site 1604)
      • Moscow, Moskva, Russian Federation, 121359
        • Central Clinical Hospital with Polyclinic ( Site 1614)
    • Samarskaya Oblast
      • Samara, Samarskaya Oblast, Russian Federation, 443031
        • SBHI Samara Regional Clinical Oncology Dispensary ( Site 1609)
    • Sankt-Peterburg
      • Saint Petersburg, Sankt-Peterburg, Russian Federation, 198255
        • City Clinical Oncology Center ( Site 1603)
    • Eastern Cape
      • Port Elizabeth, Eastern Cape, South Africa, 6045
        • Cancer Care Langenhoven Drive Oncology Centre ( Site 1708)
    • Free State
      • Bloemfontein, Free State, South Africa, 9301
        • Universitas Annex National Hospital ( Site 1701)
    • Gauteng
      • Johannesburg, Gauteng, South Africa, 2196
        • Sandton Oncology Medical Group PTY LTD ( Site 1700)
      • Parktown-Johannesburg, Gauteng, South Africa, 2193
        • Wits Clinical Research ( Site 1707)
      • Pretoria, Gauteng, South Africa, 0002
        • Tshwane District Hospital ( Site 1702)
    • Kwazulu-Natal
      • Durban, Kwazulu-Natal, South Africa, 4091
        • The Oncology Centre Overport and Umhlanga ( Site 1705)
    • Western Cape
      • Cape Town, Western Cape, South Africa, 7700
        • Cancercare Rondebosch Oncology ( Site 1709)
      • Cape Town, Western Cape, South Africa, 7925
        • Groote Schuur Hospital ( Site 1706)
      • George, Western Cape, South Africa, 6530
        • Outeniqua Cancercare Oncology Unit ( Site 1704)
      • Kraaifontein, Western Cape, South Africa, 7570
        • Cape Town Oncology Trials Pty Ltd ( Site 1703)
      • Barcelona, Spain, 08035
        • Hospital General Universitari Vall d Hebron ( Site 1801)
    • Alicante
      • Elche, Alicante, Spain, 03203
        • Hospital General Universitario de Elche ( Site 1803)
    • Asturias
      • Oviedo, Asturias, Spain, 33011
        • Hospital Universitario General de Asturias ( Site 1802)
    • Barcelona
      • Badalona, Barcelona, Spain, 08916
        • Institut Catala d Oncologia Hospital Germans Trias i Pujol ( Site 1806)
    • Cantabria
      • Santander, Cantabria, Spain, 39008
        • Hospital Universitario Marques de Valdecilla ( Site 1804)
    • Madrid
      • Pozuelo de Alarcon, Madrid, Spain, 28223
        • HOSPITAL UNIVERSITARIO QUIRONSALUD MADRID-ONCOLOGIA MEDICA ( Site 1805)
      • Luzern, Switzerland, 6000
        • Luzern Kantonsspital ( Site 1904)
    • Basel-Stadt
      • Basel, Basel-Stadt, Switzerland, 4056
        • Universitaetsspital Basel ( Site 1900)
    • Geneve
      • Geneva, Geneve, Switzerland, 1211
        • Hopitaux Universitaires de Geneve HUG ( Site 1907)
    • Grisons
      • Chur, Grisons, Switzerland, 7000
        • Kantonsspital Graubuenden ( Site 1903)
    • Sankt Gallen
      • St. Gallen, Sankt Gallen, Switzerland, 9007
        • Kantonsspital St. Gallen ( Site 1901)
    • Ticino
      • Bellinzona, Ticino, Switzerland, 6500
        • Istituto Oncologica della Svizzera Italiana (IOSI) ( Site 1905)
    • Zurich
      • Zuerich, Zurich, Switzerland, 8091
        • Universitaetsspital Zuerich ( Site 1902)
      • Kaohsiung, Taiwan, 83301
        • Chang Gung Medical Foundation. Kaohsiung Branch ( Site 2902)
      • Tainan, Taiwan, 70457
        • National Cheng Kung University Hospital ( Site 2901)
      • Taipei, Taiwan, 100225
        • National Taiwan University Hospital ( Site 2900)
      • Taipei, Taiwan, 104
        • Mackay Memorial Hospital ( Site 2903)
      • Adana, Turkey, 01370
        • Adana Sehir Hastanesi ( Site 2002)
      • Ankara, Turkey, 06200
        • Abdurrahman Yurtaslan Onkoloji Egitim ve Arastirma Hastanesi ( Site 2006)
      • Ankara, Turkey, 06100
        • Hacettepe University Medical Faculty ( Site 2017)
      • Edirne, Turkey, 22030
        • Trakya Universitesi Tip Fakultesi ( Site 2015)
      • Erzurum, Turkey, 25240
        • Ataturk Universitesi Tip Fakultesi Hastanesi ( Site 2000)
      • Istanbul, Turkey, 34098
        • Istanbul Universitesi Cerrahpasa Tip Fakultesi ( Site 2001)
      • Izmir, Turkey, 35340
        • Dokuz Eylul Universitesi Tip Fakultesi Hastanesi ( Site 2011)
      • Malatya, Turkey, 44280
        • Malatya Inonu Universitesi Tip Fakultesi Hastanesi ( Site 2009)
      • Sakarya, Turkey, 54000
        • Sakarya Universitesi Egitim ve Arastirma Hastanesi ( Site 2012)
      • Kyiv, Ukraine, 03115
        • Kyiv City Clinical Oncology Centre ( Site 2213)
    • Dnipropetrovska Oblast
      • Dnipro, Dnipropetrovska Oblast, Ukraine, 49102
        • City Clinical Hosp.4 of DCC ( Site 2201)
      • Kryviy Rih, Dnipropetrovska Oblast, Ukraine, 50048
        • MI Kryviy Rih Center of Dnipropetrovsk Regional Council ( Site 2200)
    • Ivano-Frankivska Oblast
      • Ivano-Frankivsk, Ivano-Frankivska Oblast, Ukraine, 76018
        • MI Precarpathian Clinical Oncology Center ( Site 2204)
    • Kharkivska Oblast
      • Kharkiv, Kharkivska Oblast, Ukraine, 61070
        • Communal non profit enterprise Regional Clinical Oncology Center ( Site 2208)
    • Kyivska Oblast
      • Kyiv, Kyivska Oblast, Ukraine, 03022
        • Clinic of National Cancer Institute ( Site 2203)
      • Kyiv, Kyivska Oblast, Ukraine, 03126
        • Medical and Diagnostic Centre LLC Dobryi Prognoz ( Site 2205)
    • Lvivska Oblast
      • Lviv, Lvivska Oblast, Ukraine, 79031
        • Lviv State Oncology Regional Treatment and Diagnostic Center ( Site 2210)
    • Odeska Oblast
      • Odesa, Odeska Oblast, Ukraine, 65055
        • MI Odessa Regional Oncological Centre ( Site 2212)
    • Zaporizka Oblast
      • Zaporizhzhya, Zaporizka Oblast, Ukraine, 69104
        • Medical Centre LLC Oncolife ( Site 2202)
    • Devon
      • Torquay, Devon, United Kingdom, TQ2 7AA
        • South Devon Healthcare Foundation Trust. Torbay Hospital ( Site 1205)
    • East Riding Of Yorkshire
      • Cottingham, East Riding Of Yorkshire, United Kingdom, HU16 5JQ
        • Castle Hill Hospital ( Site 1201)
    • London, City Of
      • London, London, City Of, United Kingdom, NW1 2PG
        • University College London Hospital ( Site 1211)
      • London, London, City Of, United Kingdom, SW17 0QT
        • St. Georges University Hospital NHS Foundation Trust ( Site 1204)
    • California
      • Los Angeles, California, United States, 90095
        • UCLA Hematology/Oncology - Westwood (Building 200 Suite 120) ( Site 0124)
      • Orange, California, United States, 92868
        • UC Irvine Health/Division of Hematology Oncology, Dept of Medicine ( Site 0128)
    • Florida
      • Miami, Florida, United States, 33136
        • University of Miami, Sylvester Comprehensive Cancer Center ( Site 0113)
    • Maryland
      • Baltimore, Maryland, United States, 21204
        • Greater Baltimore Medical Center ( Site 0102)
    • Minnesota
      • Minneapolis, Minnesota, United States, 55404
        • Minnesota Oncology Hematology, PA ( Site 8000)
    • New York
      • Rochester, New York, United States, 14642
        • University of Rochester ( Site 0122)
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19124
        • Cancer Treatment Centers of America - Philadelphia ( Site 0112)
      • Pittsburgh, Pennsylvania, United States, 15212
        • Allegheny General Hospital ( Site 0118)
    • Virginia
      • Roanoke, Virginia, United States, 24014
        • Oncology & Hematology Assoc. SW Virginia, Inc., DBA Blue Ridge Cancer Care ( Site 8001)
    • Washington
      • Wenatchee, Washington, United States, 98801
        • Wenatchee Valley Clinic [Wenatchee, WA] ( Site 0116)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria

  • Has histologically or cytologically confirmed diagnosis of locally advanced unresectable or metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma with known programmed cell death ligand 1 (PD-L1) expression status
  • Has human epidermal growth factor receptor 2 (HER2) negative cancer
  • Male participants must agree to use contraception during the treatment period and through 95 days after the last dose of chemotherapy, refrain from donating sperm, and be abstinent from heterosexual intercourse, as their preferred and usual lifestyle, and agree to remain abstinent or must agree to use contraception per study protocol unless confirmed to be azoospermic during this period
  • Female participants who are not pregnant, not breastfeeding, and at least one of the following conditions applies: not a woman of childbearing potential (WOCBP) OR is a WOCBP who agrees to use contraception or be abstinent from heterosexual intercourse, as their preferred and usual lifestyle, during the treatment period and through 180 days after the last dose of chemotherapy or through 120 days after the last dose of pembrolizumab, whichever is last, and agrees not to donate eggs to others or freeze/store for her own use for the purpose of reproduction during this period
  • Has measurable disease per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) as assessed by investigator assessment
  • Has provided archival tumor tissue sample or newly obtained core or excisional biopsy of a tumor lesion not previously irradiated
  • Has provided tumor tissue sample deemed adequate for PD-L1 biomarker analysis
  • Has provided tumor tissue sample for microsatellite instability (MSI) biomarker analysis
  • Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 within 3 days prior to the start of study intervention
  • Has adequate organ function as demonstrated by laboratory testing within 10 days prior to the start of study treatment

Exclusion Criteria

  • Has squamous cell or undifferentiated gastric cancer
  • Has had major surgery, open biopsy, or significant traumatic injury within 28 days prior to randomization, anticipation of the need for major surgery during the course of study intervention, or has not recovered adequately from the toxicity and/or complications from previous surgery
  • Has preexisting peripheral neuropathy >Grade 1
  • Is a WOCBP who has a positive urine pregnancy test within 24 hours for urine or within 72 hours for serum prior to randomization or treatment allocation
  • Has had previous therapy for locally advanced, unresectable or metastatic gastric/GEJ cancer. Participants may have received prior neoadjuvant and/or adjuvant therapy as long as it was completed ≥6 months prior to randomization
  • Has received prior therapy with an anti-programmed cell death (PD)-1, anti-PD-L1 or anti-programmed cell death ligand 2 (PD-L2) agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (e.g., cytotoxic T-lymphocyte-associated protein 4 (CTLA-4), OX- 40, CD137)
  • Has received prior systemic anticancer therapy including investigational agents within 4 weeks prior to randomization or has not recovered from all adverse events (AEs) due to any previous therapies to ≤Grade 1 or baseline
  • Has received prior radiotherapy within 2 weeks prior to study start or has not recovered from all previous radiation-related toxicities, required corticosteroids, and have not had radiation pneumonitis. A 1-week washout is permitted for palliative radiation (≤2 weeks of radiotherapy) to non-central nervous system (CNS) disease
  • Has received a live or live-attenuated vaccine within 30 days prior to the first dose of study treatment
  • Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to the first dose of study treatment
  • 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 additional malignancy that is progressing or has required active treatment within the past 5 years with the exception of 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
  • Has known active CNS metastases and/or carcinomatous meningitis
  • Has severe hypersensitivity (≥Grade 3) to pembrolizumab and/or any of its excipients
  • Has an active autoimmune disease that has required systemic treatment in past 2 years
  • Has a history of (non-infectious) 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 (defined as Hepatitis B surface antigen [HBsAg] reactive) or known active Hepatitis C virus (defined as Hepatitis C virus [HCV] ribonucleic acid [RNA] detected qualitatively) infection
  • Has a known history of active tuberculosis
  • Has hypokalemia (serum potassium less than the lower limit of normal)
  • Has hypomagnesemia (serum magnesium less than the lower limit of normal)
  • Has hypocalcemia (serum calcium less than the lower limit of normal)
  • Has a history or current evidence of any condition (eg, known deficiency of the enzyme dihydropyrimidine dehydrogenase), therapy, or laboratory abnormality that might confound the results of the study, interfere with the participant's participation for the full duration of the study, or is not in the best interest of the participant to participate, in the opinion of the treating investigator
  • Has a known psychiatric or substance abuse disorder that would interfere with the participant's ability to cooperate with the requirements of the study
  • Is pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the study, starting with the screening visit through 180 days after the last dose of chemotherapy or through 120 days after the last dose of pembrolizumab, whichever is last
  • Has had an allogenic tissue/solid organ transplant
  • Has a known severe hypersensitivity (≥ Grade 3) to any of the study chemotherapy agents (including, but not limited to, infusional 5-fluorouracil or oral capecitabine) and/or to any of their excipients
  • For participants taking cisplatin: has Grade ≥2 audiometric hearing loss

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Pembrolizumab + Chemotherapy (FP or CAPOX regimen)

Participants receive pembrolizumab 200 mg intravenously (IV) on Day 1 of each 21-day cycle (Q3W) for up to 35 cycles (approximately 2 years) + physicians' choice of either cisplatin 80 mg/m^2 IV on Day 1 Q3W and 5-fluorouracil (5FU) 800 mg/m^2/day via continuous IV infusion on Days 1 to 5 Q3W (FP regimen) OR oxaliplatin 130 mg/m^2 IV on Day 1 Q3W + capecitabine 1000 mg/m^2 orally twice a day (BID) on Days 1 to 14 Q3W (CAPOX regimen).

Participants who complete up to 35 administrations of pembrolizumab (approximately 2 years) or achieve a complete response (CR) but experience progression of disease (PD), can initiate a second course of pembrolizumab for up to 17 cycles (approximately 1 additional year).

Administered as an IV infusion on Day 1 Q3W
Other Names:
  • MK-3475
  • KEYTRUDA®
Administered as an IV infusion on Day 1 Q3W
Other Names:
  • PLATINOL®
Administered as a continuous IV infusion on Days 1-5 Q3W
Other Names:
  • 5FU
  • ADRUCIL®
Administered as an IV infusion on Day 1 Q3W
Other Names:
  • ELOXATIN®
Administered orally BID on Days 1 to 14 Q3W
Other Names:
  • XELODA®
Active Comparator: Placebo + Chemotherapy (FP or CAPOX regimen)
Participants receive placebo on Day 1 Q3W for up to 35 cycles (approximately 2 years) + physicians' choice of either cisplatin 80 mg/m^2 IV on Day 1 Q3W and 5FU 800 mg/m^2/day via continuous IV infusion on Days 1 to 5 Q3W (FP regimen) OR oxaliplatin 130 mg/m^2 IV on Day 1 Q3W + capecitabine 1000 mg/m^2 orally BID on Days 1 to 14 Q3W (CAPOX regimen).
Administered as an IV infusion on Day 1 Q3W
Other Names:
  • PLATINOL®
Administered as a continuous IV infusion on Days 1-5 Q3W
Other Names:
  • 5FU
  • ADRUCIL®
Administered as an IV infusion on Day 1 Q3W
Administered as an IV infusion on Day 1 Q3W
Other Names:
  • ELOXATIN®
Administered orally BID on Days 1 to 14 Q3W
Other Names:
  • XELODA®

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Survival (OS) in All Participants
Time Frame: Up to 45.9 months
OS was defined as the time from randomization to death due to any cause. Participants without documented death at the time of the analysis were censored at the date of the last follow-up. OS was estimated using the product-limit (Kaplan-Meier) method for censored data.
Up to 45.9 months
Overall Survival (OS) In Participants With Programmed Cell Death Ligand 1 (PD-L1) Combined Positive Score (CPS) ≥1
Time Frame: Up to 45.9 months
OS was defined as the time from randomization to death due to any cause. Participants without documented death at the time of the analysis were censored at the date of the last follow-up. OS was estimated using the product-limit (Kaplan-Meier) method for censored data.
Up to 45.9 months
Overall Survival (OS) In Participants With Programmed Cell Death Ligand 1 (PD-L1) Combined Positive Score (CPS) ≥10
Time Frame: Up to 45.9 months
OS was defined as the time from randomization to death due to any cause. Participants without documented death at the time of the analysis were censored at the date of the last follow-up. OS was estimated using the product-limit (Kaplan-Meier) method for censored data.
Up to 45.9 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression Free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) Assessed by Blinded Independent Central Review (BICR) in All Participants
Time Frame: Up to 49.5 months
PFS was defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurred first. Per RECIST 1.1 as assessed by BICR, PD was defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also have demonstrated an absolute increase of ≥5 mm. The appearance of ≥1 new lesions was also considered PD. PFS was estimated using the product-limit (Kaplan-Meier) method for censored data.
Up to 49.5 months
Progression Free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) Assessed by Blinded Independent Central Review (BICR) in Participants With Programmed Cell Death Ligand 1 (PD-L1) Combined Positive Score (CPS) ≥1
Time Frame: Up to 49.5 months
PFS was defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurred first. Per RECIST 1.1 as assessed by BICR, PD was defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also have demonstrated an absolute increase of ≥5 mm. The appearance of ≥1 new lesions was also considered PD. PFS was estimated using the product-limit (Kaplan-Meier) method for censored data.
Up to 49.5 months
Progression Free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) Assessed by Blinded Independent Central Review (BICR) in Participants With Programmed Cell Death Ligand 1 (PD-L1) Combined Positive Score (CPS) ≥10
Time Frame: Up to 49.5 months
PFS was defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurred first. Per RECIST 1.1 as assessed by BICR, PD was defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also have demonstrated an absolute increase of ≥5 mm. The appearance of ≥1 new lesions was also considered PD. PFS was estimated using the product-limit (Kaplan-Meier) method for censored data.
Up to 49.5 months
Objective Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) Assessed by Blinded Independent Central Review (BICR) in All Participants
Time Frame: Up to 49.5 months
ORR was defined as the percentage of the participants who had a confirmed Complete Response (CR: disappearance of all target lesions) or Partial Response (PR: ≥30% decrease in the sum of diameters (SOD) of target lesions, taking as reference the baseline SOD) according to RECIST 1.1 as assessed by BICR.
Up to 49.5 months
Objective Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) Assessed by Blinded Independent Central Review (BICR) in Participants With Programmed Cell Death Ligand 1 (PD-L1) Combined Positive Score (CPS) ≥1
Time Frame: Up to 49.5 months
ORR was defined as the percentage of the participants who had a confirmed Complete Response (CR: disappearance of all target lesions) or Partial Response (PR: ≥30% decrease in the sum of diameters (SOD) of target lesions, taking as reference the baseline SOD) according to RECIST 1.1 as assessed by BICR.
Up to 49.5 months
Objective Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) Assessed by Blinded Independent Central Review (BICR) in Participants With Programmed Cell Death Ligand 1 (PD-L1) Combined Positive Score (CPS) ≥10
Time Frame: Up to 49.5 months
ORR was defined as the percentage of the participants who had a confirmed Complete Response (CR: disappearance of all target lesions) or Partial Response (PR: ≥30% decrease in the sum of diameters (SOD) of target lesions, taking as reference the baseline SOD) according to RECIST 1.1 as assessed by BICR.
Up to 49.5 months
Duration of Response (DOR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) Assessed by Blinded Independent Central Review (BICR) in All Participants
Time Frame: Up to 49.5 months
DOR was defined as the time from first documented evidence of a confirmed Complete Response (CR) or Partial Response (PR) until progressive disease (PD) or death, whichever occurred first. Per RECIST 1.1 as assessed by BICR, CR was the disappearance of all target lesions and PR was ≥30% decrease in the sum of diameters (SOD) of target lesions, taking as reference the baseline SOD. PD was defined as ≥20% increase in the SOD of target lesions according to RECIST 1.1. In addition to the relative increase of 20%, the SOD must also have demonstrated an absolute increase of ≥5 mm. The appearance of ≥1 new lesions was also considered PD. DOR for participants who had not progressed or died at the time of analysis was censored at the date of the last tumor assessment. DOR was estimated using the product-limit (Kaplan-Meier) method for censored data.
Up to 49.5 months
Duration of Response (DOR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) Assessed by Blinded Independent Central Review (BICR) in Participants With Programmed Cell Death Ligand 1 (PD-L1) Combined Positive Score (CPS) ≥1
Time Frame: Up to 49.5 months
DOR was defined as the time from first documented evidence of a confirmed Complete Response (CR) or Partial Response (PR) until progressive disease (PD) or death, whichever occurred first. Per RECIST 1.1 as assessed by BICR, CR was the disappearance of all target lesions and PR was ≥30% decrease in the sum of diameters (SOD) of target lesions, taking as reference the baseline SOD. PD was defined as ≥20% increase in the SOD of target lesions according to RECIST 1.1. In addition to the relative increase of 20%, the SOD must also have demonstrated an absolute increase of ≥5 mm. The appearance of ≥1 new lesions was also considered PD. DOR for participants who had not progressed or died at the time of analysis was censored at the date of the last tumor assessment. DOR was estimated using the product-limit (Kaplan-Meier) method for censored data.
Up to 49.5 months
Duration of Response (DOR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) Assessed by Blinded Independent Central Review (BICR) in Participants With Programmed Cell Death Ligand 1 (PD-L1) Combined Positive Score (CPS) ≥10
Time Frame: Up to 49.5 months
DOR was defined as the time from first documented evidence of a confirmed Complete Response (CR) or Partial Response (PR) until progressive disease (PD) or death, whichever occurred first. Per RECIST 1.1 as assessed by BICR, CR was the disappearance of all target lesions and PR was ≥30% decrease in the sum of diameters (SOD) of target lesions, taking as reference the baseline SOD. PD was defined as ≥20% increase in the SOD of target lesions according to RECIST 1.1. In addition to the relative increase of 20%, the SOD must also have demonstrated an absolute increase of ≥5 mm. The appearance of ≥1 new lesions was also considered PD. DOR for participants who had not progressed or died at the time of analysis was censored at the date of the last tumor assessment. DOR was estimated using the product-limit (Kaplan-Meier) method for censored data.
Up to 49.5 months
Number of Participants Who Experienced an Adverse Event (AE)
Time Frame: Up to 36.7 months
An AE was defined as any untoward medical occurrence, in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The number of participants with at least one AE is presented.
Up to 36.7 months
Number of Participants Who Discontinued Study Treatment Due To an Adverse Event (AE)
Time Frame: Up to 33.7 months
An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The number of participants who discontinued study treatment due to an AE is presented.
Up to 33.7 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Director: Medical Director, Merck Sharp & Dohme LLC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 8, 2018

Primary Completion (Actual)

October 3, 2022

Study Completion (Estimated)

September 28, 2024

Study Registration Dates

First Submitted

September 17, 2018

First Submitted That Met QC Criteria

September 17, 2018

First Posted (Actual)

September 18, 2018

Study Record Updates

Last Update Posted (Actual)

January 17, 2024

Last Update Submitted That Met QC Criteria

January 12, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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