AzTrials
AzTrials

Gastric NeoplasmsPhase 3NCT03615326

Pembrolizumab/Placebo Plus Trastuzumab Plus Chemotherapy in Human Epidermal Growth Factor Receptor 2 Positive (HER2+) Advanced Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma (MK-3475-811/KEYNOTE-811)

A Phase 3 study testing Pembrolizumab, Cisplatin and 5-FU in people with Gastric Neoplasms and Gastroesophageal Junction Adenocarcinoma, run by Merck Sharp & Dohme LLC at 192 sites in 20 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The study will compare the efficacy and safety of pembrolizumab plus trastuzumab in combination with standard of care (SOC) chemotherapy versus trastuzumab in combination with SOC chemotherapy in participants with HER2-positive gastric cancer. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Pembrolizumab, Cisplatin and 5-FU
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
738 participants
Where
192 sitesin 20 countries
Study dates
5 Oct 2018to 12 Nov 2025
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Histologically or cytologically confirmed diagnosis of previously untreated, locally advanced unresectable or metastatic human epidermal growth factor receptor 2 (HER2) positive gastric or gastroesophageal junction (GEJ) adenocarcinoma
  • HER2-positive defined as either immunohistochemistry (IHC) 3+ or IHC 2+ in combination with in-situ hybridization positive (ISH+) or fluorescent in-situ hybridization (FISH), as assessed by central review on primary or metastatic tumor
  • Has measurable disease as defined by Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) as determined by the site investigator
  • Male participants must agree to use approved contraception
  • Female participants who are not pregnant or breastfeeding, and who are either not a woman of childbearing potential (WOCBP), or are a WOCBP who agrees to use approved contraception
  • Has a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) Performance Scale within 3 days prior to the first dose of trial treatment
  • Has a life expectancy of greater than 6 months
  • Has adequate organ function

Who cannot join

  • Has had previous therapy for locally advanced unresectable or metastatic gastric/GEJ cancer
  • Has had major surgery, open biopsy or significant traumatic injury within 28 days prior to randomization, or anticipation of the need for major surgery during the course of study treatment
  • Has had radiotherapy within 14 days of randomization
  • Has a known additional malignancy that is progressing or has required active treatment within the past 5 years
  • Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis
  • Has an active autoimmune disease that has required systemic treatment in past 2 years
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  • Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy
  • Has a history of (non-infectious) pneumonitis that required steroids or current pneumonitis
  • Has a known history of active tuberculosis (TB; Mycobacterium tuberculosis)
  • Has an active infection requiring systemic therapy
  • Has poorly controlled diarrhea
  • Accumulation of pleural, ascitic, or pericardial fluid requiring drainage or diuretic drugs within 2 weeks prior to enrollment. If the participant is receiving diuretic drugs for other reasons, it is acceptable
  • Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the participant's participation for the full duration of the trial, or is not in the best interest of the participant to participate, in the opinion of the treating investigator
  • Has peripheral neuropathy > Grade 1
  • Has a known psychiatric or substance abuse disorder that would interfere with cooperation with the requirements of the trial
  • A WOCBP who has a positive urine pregnancy test within 24 hours prior to randomization or treatment allocation
  • Has active or clinically significant cardiac disease
  • Has a known history of Human Immunodeficiency Virus (HIV) (HIV 1/2 antibodies)
  • Has a known history of Hepatitis B (defined as Hepatitis B surface antigen [HBsAg] reactive) or known active Hepatitis C virus (defined as HCV RNA [qualitative] is detected) infection
  • Has severe hypersensitivity (≥Grade 3) to pembrolizumab, trastuzumab, study chemotherapy agents and/or to any excipients, murine proteins, or platinum-containing products
  • Has had an allogeneic tissue/solid organ transplant
  • Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti 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, Cluster of Differentiation 137 [CD137])

Trial locations and contacts

192 sites in 20 countries.

192 sites in 20 countries

Japan30 sites

  • Hyogo Cancer Center ( Site 2619)

    Akashi, Hyōgo, 673-8558

  • Chiba Cancer Center ( Site 2623)

    Chiba, 260-8717

  • National Hospital Organization Kyushu Cancer Center ( Site 2609)

    Fukuoka, 811-1395

  • Gifu University Hospital ( Site 2621)

    Gifu, 501-1194

  • Kansai Medical University Hospital ( Site 2618)

    Hirakata, Osaka, 573-1191

  • Hiroshima City Hiroshima Citizens Hospital ( Site 2625)

    Hiroshima, 730-8518

  • Ibaraki Prefectural Central Hospital ( Site 2611)

    Kasama, Ibaraki, 309-1793

  • National Cancer Center Hospital East ( Site 2605)

    Kashiwa, Chiba, 277-8577

  • Kagawa University Hospital ( Site 2604)

    Kita-gun, Kagawa-ken, 761-0793

  • Saitama Cancer Center ( Site 2620)

    Kitaadachi-gun, Saitama, 362-0806

  • Kobe City Medical Center General Hospital ( Site 2614)

    Kobe, Hyōgo, 650-0047

  • Kumamoto University Hospital ( Site 2601)

    Kumamoto, 860-8556

  • National Hospital Organization Shikoku Cancer Center ( Site 2615)

    Matsuyama, Ehime, 791-0280

  • Kyorin University Hospital ( Site 2608)

    Mitaka, Tokyo, 181-8611

  • Aichi Cancer Center Hospital ( Site 2617)

    Nagoya, Aichi-ken, 464-8681

  • Niigata Cancer Center Hospital ( Site 2622)

    Niigata, 951-8566

  • Gunma Prefectural Cancer Center ( Site 2602)

    Ohta, Gunma, 373-8550

  • National Hospital Organization - Osaka National Hospital - Institute For Clinical Research ( Site 26

    Osaka, 540-0006

  • Osaka International Cancer Institute ( Site 2613)

    Osaka, 541-8567

  • Osaka General Medical Center ( Site 2624)

    Osaka, 558-8558

  • Osaki Citizen Hospital ( Site 2626)

    Ōsaki, Miyagi, 989-6183

  • Kindai University Hospital ( Site 2616)

    Sayama, Osaka, 589-8511

  • Osaka University Hospital ( Site 2600)

    Suita, Osaka, 565-0871

  • Shizuoka Cancer Center Hospital and Research Institute ( Site 2607)

    Sunto-gun, Shizuoka, 411-8777

  • National Cancer Center Hospital ( Site 2612)

    Tokyo, 104-0045

  • Toranomon Hospital ( Site 2628)

    Tokyo, 105-8470

  • Tokyo Metropolitan Komagome Hospital ( Site 2606)

    Tokyo, 113-8677

  • The Cancer Institute Hospital of JFCR ( Site 2610)

    Tokyo, 135-8550

  • Tochigi Cancer Center ( Site 2627)

    Utsunomiya, Tochigi, 320-0834

  • Kanagawa Cancer Center ( Site 2603)

    Yokohama, Kanagawa, 241-8515

Other trials in Japan

United States23 sites

  • Beth Israel Deaconess Medical Center ( Site 0070)

    Boston, Massachusetts, 02215

  • Dana-Farber Cancer Institute [Boston, MA] ( Site 0010)

    Boston, Massachusetts, 02215

  • Levine Cancer Institute ( Site 0015)

    Charlotte, North Carolina, 28204

  • Duke Cancer Institute ( Site 0042)

    Durham, North Carolina, 27710

  • Memorial Sloan-Kettering Cancer Center at West Harrison ( Site 0065)

    Harrison, New York, 10604

  • University of Texas MD Anderson Cancer Center ( Site 0001)

    Houston, Texas, 77030

  • UCLA Hematology/Oncology - Westwood (Building 200 Suite 120) ( Site 0045)

    Los Angeles, California, 90095

  • University of Miami Sylvester Comprehensive Cancer Center - Plantation ( Site 0026)

    Miami, Florida, 33136

  • Memorial Sloan Kettering Cancer Center- Monmouth ( Site 0071)

    Middletown, New Jersey, 07748

  • Minnesota Oncology Hematology, PA ( Site 8001)

    Minneapolis, Minnesota, 55404

  • Pacific Cancer Care ( Site 0063)

    Monterey, California, 93940

  • Memorial Sloan-Kettering Cancer Center ( Site 0017)

    New York, New York, 10065

  • Southeastern Regional Medical Center, Inc. ( Site 0058)

    Newnan, Georgia, 30265

  • UC Irvine Medical Center/Chao Family Comprehensive Cancer Center ( Site 0050)

    Orange, California, 92868

  • Cancer Treatment Centers of America-Eastern Regional Medical Center ( Site 0025)

    Philadelphia, Pennsylvania, 19124

  • Allegheny General Hospital ( Site 0053)

    Pittsburgh, Pennsylvania, 15212

  • Oncology & Hematology Assoc. SW Virginia, Inc., DBA Blue Ridge Cancer Care ( Site 8000)

    Roanoke, Virginia, 24014

  • University of Rochester ( Site 0041)

    Rochester, New York, 14642

  • Seattle Cancer Care Alliance ( Site 0038)

    Seattle, Washington, 98109

  • Sanford Hematology Oncology-Sioux Falls SD ( Site 0004)

    Sioux Falls, South Dakota, 57104

  • Washington University School of Medicine ( Site 0040)

    St Louis, Missouri, 63110

  • CTCA Southwestern ( Site 0060)

    Tulsa, Oklahoma, 74133

  • Midwestern Regional Medical Center, Inc. ( Site 0059)

    Zion, Illinois, 60099

Other trials in United States

China19 sites

  • Peking Union Medical College Hospital ( Site 2419)

    Beijing, Beijing Municipality, 100032

  • Fifth Medical Center of CPLA General Hospital ( Site 2415)

    Beijing, Beijing Municipality, 100071

  • Beijing Cancer Hospital ( Site 2413)

    Beijing, Beijing Municipality, 100142

  • The First Hospital Of Jilin University ( Site 2402)

    Changchun, Jilin, 130021

  • Xiangya Hospital Central-South University ( Site 2426)

    Changsha, Hunan, 410008

  • Fujian Provincial Cancer Hospital ( Site 2418)

    Fuzhou, Fujian, 350014

  • 900 Hospital of the Joint ( Site 2420)

    Fuzhou, Fujian, 350025

  • Guangdong General Hospital ( Site 2433)

    Guangzhou, Guangdong, 510080

  • The First Affiliated Hospital.Zhejiang University ( Site 2408)

    Hangzhou, Zhejiang, 310003

  • Sir Run Run Shaw Hospital ( Site 2412)

    Hangzhou, Zhejiang, 310016

  • Zhejiang Cancer Hospital ( Site 2409)

    Hangzhou, Zhejiang, 310022

  • Harbin Medical University Cancer Hospital ( Site 2407)

    Harbin, Heilongjiang, 150081

  • Jiangsu Cancer Hospital ( Site 2432)

    Nanjing, Jiangsu, 210009

  • Shanghai General Hospital ( Site 2404)

    Shanghai, Anhui, 200080

  • Fudan University Shanghai Cancer Center ( Site 2424)

    Shanghai, Shanghai Municipality, 200032

  • Zhongshan Hospital affiliated to Fudan University ( Site 2401)

    Shanghai, Shanghai Municipality, 200032

  • Cancer Hospital Affiliated to Xinjiang Medical University ( Site 2430)

    Ürümqi, Xinjiang, 830001

  • The First Affiliated Hospital of Xiamen University ( Site 2431)

    Xiamen, Fujian, 361003

  • Henan Cancer Hospital ( Site 2400)

    Zhengzhou, Henan, 450008

Other trials in China

Germany11 sites

  • Charite-Universitaetsmedizin Berlin Campus Virchow-Klinikum ( Site 1026)

    Berlin, 13353

  • Klinikum Bremen Nord ( Site 1017)

    Bremen, 28211

  • Universitaetsklinikum Carl Gustav Carus der Technischen Univ ( Site 1001)

    Dresden, Saxony, 01307

  • Facharztzentrum Eppendorf ( Site 1025)

    Hamburg, 20249

  • Asklepios Klinik Altona ( Site 1000)

    Hamburg, 22763

  • Medizinische Hochschule Hannover ( Site 1019)

    Hanover, Lower Saxony, 30625

  • SLK-Kliniken Heilbronn ( Site 1015)

    Heilbronn, Baden-Wurttemberg, 74078

  • Universitaetsklinikum Leipzig AOeR ( Site 1007)

    Leipzig, Saxony, 04103

  • Klinikum Ludwigsburg ( Site 1014)

    Ludwigsburg, Baden-Wurttemberg

  • Klinikum rechts der Isar der Technischen Universitaet ( Site 1027)

    Munich, Bavaria, 81675

  • Innere Medizin I, Universitaetsklinikum Tuebingen ( Site 1020)

    Tübingen, Baden-Wurttemberg, 72076

Other trials in Germany

Ukraine11 sites

  • City Clinical Hosp.4 of DCC ( Site 2102)

    Dnipro, Dnipropetrovsk Oblast, 49102

  • MI Precarpathian Clinical Oncology Center ( Site 2105)

    Ivano-Frankivsk, Ivano-Frankivsk Oblast, 76018

  • Communal non profit enterprise Regional Clinical Oncology Center ( Site 2112)

    Kharkiv, Kharkiv Oblast, 61070

  • Medical Center Asklepion LLC ( Site 2115)

    Khodosovka, Kyivska Oblast, 08173

  • MI Kryviy Rih Center of Dnipropetrovsk Regional Council ( Site 2101)

    Kryviy Rih, Dnipropetrovsk Oblast, 50048

  • Clinic of National Cancer Institute ( Site 2104)

    Kyiv, Kyivska Oblast, 03022

  • Medical and Diagnostic Centre LLC Dobryi Prognoz ( Site 2114)

    Kyiv, Kyivska Oblast, 03126

  • Kyiv City Clinical Oncology Centre ( Site 2110)

    Kyiv, 03115

  • Lviv State Oncology Regional Treatment and Diagnostic Center ( Site 2106)

    Lviv, Lviv Oblast, 79031

  • MI Odessa Regional Oncological Centre ( Site 2108)

    Odesa, Odesa Oblast, 65055

  • Medical Centre LLC Oncolife ( Site 2103)

    Zaporizhzhya, Zaporizhzhia Oblast, 69104

Other trials in Ukraine

United Kingdom10 sites

  • Castle Hill Hospital ( Site 1501)

    Cottingham, East Riding Of Yorkshire, HU16 5JQ

  • Royal Hospital in Derby ( Site 1514)

    Derby, Derbyshire, DE22 3NE

  • Ninewells Hospital and Medical School ( Site 1504)

    Dundee, Dundee City, DD1 9SY

  • University College London Hospital NHS Foundation Trust ( Site 1508)

    London, London, City of, NW1 2PG

  • St Georges University Hospitals NHS Foundation Trust. ( Site 1500)

    London, London, City of, SW17 0QT

  • Royal Marsden NHS Foundation Trust ( Site 1512)

    London, SW3 6JJ

  • The Christie Hospital NHS Foundation Trust ( Site 1503)

    Manchester, M20 4BX

  • Mount Vernon Cancer Centre ( Site 1507)

    Northwood, HA6 2RN

  • Royal Marsden Hospital ( Site 1510)

    Sutton, Surrey, SM2 5PT

  • Manor Hospital Walsall England ( Site 1515)

    Walsall, WS2 9PS

Other trials in United Kingdom

France9 sites

  • Hopital Jean Minjoz Besancon ( Site 0901)

    Besançon, Doubs, 25030

  • C.H.R.U. de Brest - Hopital Morvan ( Site 0913)

    Brest, Finistere, 29200

  • Centre Oscar Lambret ( Site 0911)

    Lille, Nord, 59000

  • Centre Leon Berard ( Site 0904)

    Lyon, Rhone, 69008

  • CHU Hopital Saint Antoine ( Site 0905)

    Paris, 75012

  • CHU de Rouen ( Site 0912)

    Rouen, Ain, 76000

  • Institut de Cancerologie de l Ouest Centre Rene Gauducheau ( Site 0902)

    Saint-Herblain, Val-de-Marne, 44805

  • HUS Hopital Hautepierre ( Site 0910)

    Strasbourg, Bas-Rhin, 67098

  • Institut Gustave Roussy ( Site 0900)

    Villejuif, Val-de-Marne, 94805

Other trials in France

Turkey (Türkiye)9 sites

  • Adana Sehir Hastanesi ( Site 2002)

    Adana, 01370

  • Hacettepe Universitesi Tip Fakultesi Hastanesi ( Site 2017)

    Ankara, 06100

  • Abdurrahman Yurtaslan Onkoloji Egitim ve Arastirma Hastanesi ( Site 2006)

    Ankara, 06200

  • Trakya Universitesi Tip Fakultesi ( Site 2015)

    Edirne, 22030

  • Ataturk Universitesi Tip Fakultesi Hastanesi ( Site 2000)

    Erzurum, 25240

  • Istanbul Universitesi Cerrahpasa Tip Fakultesi ( Site 2001)

    Istanbul, 34098

  • Dokuz Eylul Universitesi Tip Fakultesi Hastanesi ( Site 2011)

    Izmir, 35340

  • Malatya Inonu Universitesi Tip Fakultesi Hastanesi ( Site 2009)

    Malatya, 44280

  • Sakarya Universitesi Egitim ve Arastirma Hastanesi ( Site 2012)

    Sakarya, 54290

Other trials in Turkey (Türkiye)

Brazil8 sites

  • CIONC - Centro Integrado de Oncologia de Curitiba ( Site 0205)

    Curitiba, Paraná, 80810-050

  • CEPON - Centro de Pesquisas Oncologicas ( Site 0200)

    Florianópolis, Santa Catarina, 88034-000

  • Instituto do Cancer do Ceara ( Site 0208)

    Fortaleza, Ceará, 60430-230

  • Hospital de Caridade de Ijui ( Site 0202)

    Ijuí, Rio Grande do Sul, 98700 000

  • Hospital Nossa Senhora da Conceicao ( Site 0203)

    Porto Alegre, Rio Grande do Sul, 91350-200

  • Instituto Nacional do Cancer Jose Alencar Gomes da Silva INCA ( Site 0201)

    Rio de Janeiro, 20231-050

  • Hospital Sao Rafael ( Site 0209)

    Salvador, Estado de Bahia, 41253-190

  • IBCC - Instituto Brasileiro de Controle do Cancer ( Site 0204)

    São Paulo, 03102-002

Other trials in Brazil

Israel8 sites

  • Soroka University Medical Center ( Site 1603)

    Beersheba, 8410101

  • Rambam Health Care Campus ( Site 1606)

    Haifa, 3109601

  • Edith Wolfson Medical Center ( Site 1605)

    Holon, 5822012

  • Hadassah Ein Kerem Medical Center ( Site 1604)

    Jerusalem, 9112001

  • Meir Medical Center ( Site 1609)

    Kfar Saba, 4428132

  • Rabin Medical Center ( Site 1602)

    Petah Tikva, 4941492

  • Chaim Sheba Medical Center. ( Site 1607)

    Ramat Gan, 5265601

  • Sourasky Medical Center ( Site 1601)

    Tel Aviv, 6423906

Other trials in Israel

Italy8 sites

  • Humanitas Gavazzeni ( Site 1106)

    Bergamo, 24125

  • Universita Magna Graecia di Catanzaro ( Site 1107)

    Catanzaro, 88100

  • IEO Istituto Europeo di Oncologia ( Site 1105)

    Milan, 20141

  • Azienda Ospedaliero - Universitaria Policlinico di Modena ( Site 1102)

    Modena, 41124

  • A.O.U. Universita degli Studi della Campania-Luigi Vanvitelli ( Site 1103)

    Naples, 80131

  • Istituto Oncologico Veneto ( Site 1101)

    Padova, 35128

  • Ospedale Civile Spirito Santo ( Site 1104)

    Pescara, 65100

  • AUOP Ospedale Santa Chiara ( Site 1100)

    Pisa, Tuscany, 56126

Other trials in Italy

Poland8 sites

  • Beskidzkie Centrum Onkologii im. Jana Pawla II ( Site 1710)

    Bielsko-Biala, Silesian Voivodeship, 43-300

  • Szpital Morski im. PCK. Szpitale Pomorskie Sp. Z o.o ( Site 1715)

    Gdynia, Pomeranian Voivodeship, 81-519

  • Przychodnia Lekarska Komed ( Site 1716)

    Konin, Greater Poland Voivodeship, 62-500

  • Szpital Specjalistyczny w Koscierzynie Sp. z o.o. ( Site 1708)

    Kościerzyna, Pomeranian Voivodeship, 83-400

  • Samodzielny Publiczny Szpital Kliniczny Nr 1 w Lublinie ( Site 1709)

    Lublin, Lublin Voivodeship, 20-080

  • Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy w Warszawie (

    Warsaw, Masovian Voivodeship, 02-781

  • Uniwersytecki Szpital Kliniczny im. J. M. Radeckiego we Wroclawiu ( Site 1705)

    Wroclaw, Lower Silesian Voivodeship, 50-556

  • Dolnoslaskie Centrum Onkologii. ( Site 1712)

    Wroclaw, Lower Silesian Voivodeship, 53-413

Other trials in Poland

Russia8 sites

  • Chelyabinsk Regional Clinical Oncological Dispensary ( Site 1815)

    Chelyabinsk, Chelyabinsk Oblast, 454087

  • Blokhin National Medical Oncology ( Site 1805)

    Moscow, Moscow, 115478

  • Podolsky City Clinical Hospital ( Site 1817)

    Podolsk, Moscow Oblast, 142110

  • Leningrad Regional Oncology Center ( Site 1800)

    Saint Petersburg, Sankt-Peterburg, 188663

  • Scientific Research Oncology Institute n.a. N.N.Petrov ( Site 1801)

    Saint Petersburg, Sankt-Peterburg, 197758

  • St Petersburg City Clinical Oncology Dispensary ( Site 1812)

    Saint Petersburg, Sankt-Peterburg, 198255

  • Medical University REAVIZ ( Site 1816)

    Samara, Samara Oblast, 443011

  • Republican Clinical Oncology Dispensary of Republic of Bashkortostan ( Site 1807)

    Ufa, Baskortostan, Respublika, 450054

Other trials in Russia

Spain7 sites

  • Hospital Germans Trias i Pujol. ICO de Badalona ( Site 1410)

    Badalona, Barcelona, 08916

  • Hospital General Universitari Vall d Hebron ( Site 1401)

    Barcelona, 08035

  • Hospital General Universitario de Elche ( Site 1404)

    Elche, Alicante, 03203

  • Hospital Universitario Ramon y Cajal ( Site 1400)

    Madrid, 28034

  • Hospital Universitario Central de Asturias ( Site 1402)

    Oviedo, Principality of Asturias, 33011

  • Hospital Universitario Quiron Madrid ( Site 1407)

    Pozuelo de Alarcón, Madrid, 28223

  • Hospital Universitario Marques de Valdecilla ( Site 1405)

    Santander, Cantabria, 39008

Other trials in Spain

Guatemala6 sites

  • Celan SA ( Site 0504)

    Guatemala City, 01010

  • Oncomedica ( Site 0500)

    Guatemala City, 01010

  • Grupo Angeles SA ( Site 0501)

    Guatemala City, 01015

  • Nucare Center ( Site 0506)

    Guatemala City, 01015

  • Medi-K Cayala ( Site 0505)

    Guatemala City, 01016

  • Centro Regional de Sub Especialidades Medicas SA ( Site 0502)

    Quetzaltenango, 09001

Other trials in Guatemala

Chile5 sites

  • Fundacion Arturo Lopez Perez FALP ( Site 0302)

    Santiago, Region M. de Santiago, 7500921

  • Pontificia Universidad Catolica de Chile ( Site 0301)

    Santiago, Region M. de Santiago, 7620002

  • Instituto Nacional del Cancer ( Site 0303)

    Santiago, Region M. de Santiago, 8380455

  • Clinica Universidad Catolica del Maule ( Site 0305)

    Talca, Maule Region, 3460000

  • Centro Investigación del Cáncer James Lind ( Site 0300)

    Temuco, Araucania, 4780000

Other trials in Chile

Australia4 sites

  • Monash Health ( Site 2202)

    Clayton, Victoria, 3168

  • Liverpool Hospital ( Site 2206)

    Liverpool, New South Wales, 2170

  • Westmead Hospital ( Site 2200)

    Westmead, New South Wales, 2145

  • Southern Medical Day Care Centre ( Site 2207)

    Wollongong, New South Wales, 2500

Other trials in Australia

South Korea4 sites

  • Seoul National University Hospital ( Site 2703)

    Seoul, 03080

  • Severance Hospital Yonsei University Health System ( Site 2700)

    Seoul, 03722

  • Asan Medical Center ( Site 2702)

    Seoul, 05505

  • Samsung Medical Center ( Site 2701)

    Seoul, 06351

Other trials in South Korea

Ireland3 sites

  • Saint James's Hospital ( Site 1505)

    Dublin, D08NHY1

  • Beaumont Hospital ( Site 1506)

    Dublin, D09 V2N0

  • Tallaght University Hospital ( Site 1513)

    Dublin, D24 NR0A

Other trials in Ireland

New Zealand1 site

  • Auckland City Hospital ( Site 2300)

    Auckland, 1023

Other trials in New Zealand

About this study

Official title: A Phase III, Randomized, Double-blind Trial Comparing Trastuzumab Plus Chemotherapy and Pembrolizumab With Trastuzumab Plus Chemotherapy and Placebo as First-line Treatment in Participants With HER2 Positive Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (KEYNOTE 811)

The study will compare the efficacy and safety of pembrolizumab plus trastuzumab in combination with standard of care (SOC) chemotherapy versus trastuzumab in combination with SOC chemotherapy in participants with HER2-positive gastric cancer. The primary hypotheses of the study are that pembrolizumab plus trastuzumab in combination with chemotherapy is superior to trastuzumab plus chemotherapy in terms of 1) progression free survival (PFS) per Response Evaluation Criteria in Solid Tumors 1.1 (RECIST 1.1) as assessed by blinded independent central review (BICR), and 2) overall survival (OS).

Read the detailed description

Pembrolizumab (200 mg) or placebo will be administered intravenously [IV] on day 1 of each 3-week cycle. Trastuzumab (8 mg/kg loading dose, 6 mg/kg maintenance dose) will be administered IV on day 1 of each 3-week cycle. SOC chemotherapy for the global cohort will either be FP (80 mg/m^2 cisplatin administered IV on Day 1 of each 3-week cycle and 800 mg/m^2 5-fluorouracil [5-FU] administered IV on Days 1-5 of each 3-week cycle) or CAPOX (1000 mg/m^2 capecitabine administered orally twice daily [BID] on days 1-14 of each 3-week cycle and 130 mg/m^2 oxaliplatin administered IV on Day 1 of each 3-week cycle). A Japan cohort will receive SOX chemotherapy consisting of S-1 (tegafur, 5-chloro-2,4-dihydroxypyridine [CDHP], and potassium oxonate [Oxo]) administered orally BID according to Body Surface Area (BSA) on Days 1-14 of each 3-week cycle and oxaliplatin (130 mg/m^2) administered IV on Day 1 each 3-week cycle.

Being tested
Pembrolizumab, Placebo, Cisplatin, 5-FU, Oxaliplatin
Keywords
programmed cell death receptor 1 (PD-1), programmed cell death ligand 1 (PD-L1), anti-PD-1, anti PD-1, GEJ, Gastric Cancer
Medical subject headings
Stomach Neoplasms, Parkinson Disease 4, Autosomal Dominant Lewy Body

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PembrolizumabBiological

    Also called Keytruda®, MK-3475

    200 mg on Day 1 of each 3-week cycle as an IV infusion.

  • PlaceboBiological

    Solution for IV infusion on Day 1 of each 3-week cycle.

  • CisplatinDrug

    80 mg/m^2 on Day 1 of each 3-week cycle as an IV infusion, administered as part of FP chemotherapy regimen.

  • 5-FUDrug

    800 mg/m^2/day continuous on Days 1-5 of each 3-week cycle (120 hours or per local standard), administered as part of FP chemotherapy regimen.

  • OxaliplatinDrug

    130 mg/m^2 on Day 1 of each 3-week cycle over 2 hours as an IV infusion, administered as part of CAPOX chemotherapy regimen and as part of SOX chemotherapy regimen.

  • CapecitabineDrug

    1000 mg/m^2 as oral capsules BID on Days 1-14 of each 3-week cycle, administered as part of CAPOX chemotherapy regimen.

  • S-1Drug

    Combination product of tegafur, CDHP, and Oxo. Oral capsules BID on Days 1-14 of each 3-week cycle based on body surface area (BSA): <1.25 m^2 BSA =40 mg, 1.25 to <1.5 m^2 BSA=50 mg, ≥1.5 m^2 BSA=60 mg. Administered as part of SOX chemotherapy regimen.

  • TrastuzumabBiological

    Also called Herceptin®

    8 mg/kg loading dose and then 6 mg/kg maintenance dose administered IV on day 1 of each 3-week cycle.

Study groups in NCT03615326
Study groupRoleWhat they receive
Global Pembrolizumab + Standard of Care First CourseExperimentalParticipants received 200 mg pembrolizumab IV every 3 weeks (Q3W) plus trastuzumab (8 mg/kg loading dose, 6 mg/kg maintenance thereafter) IV Q3W in combination with investigator's choice of FP or CAPOX chemotherapy.
Receives: Biological: Pembrolizumab; Drug: Cisplatin; Drug: 5-FU; Drug: Oxaliplatin; Drug: Capecitabine; Biological: Trastuzumab
Global Standard of CareActive comparatorParticipants received matched placebo to pembrolizumab IV Q3W plus trastuzumab (8mg/kg loading dose, 6mg/kg maintenance thereafter) IV Q3W in combination with investigator's choice of FP or CAPOX chemotherapy.
Receives: Biological: Placebo; Drug: Cisplatin; Drug: 5-FU; Drug: Oxaliplatin; Drug: Capecitabine; Biological: Trastuzumab
Japan Pembrolizumab + Trastuzumab + S-1 Plus OxaliplatinExperimentalParticipants received 200 mg pembrolizumab IV every 3 weeks (Q3W) plus trastuzumab (8 mg/kg loading dose, 6 mg/kg maintenance thereafter) IV Q3W in combination with SOX chemotherapy.
Receives: Biological: Pembrolizumab; Drug: Oxaliplatin; Drug: S-1; Biological: Trastuzumab
Japan Trastuzumab + S-1 Plus OxaliplatinExperimentalParticipants received matched placebo to pembrolizumab IV Q3W plus trastuzumab (8mg/kg loading dose, 6mg/kg maintenance thereafter) IV Q3W in combination with SOX chemotherapy.
Receives: Biological: Placebo; Drug: Oxaliplatin; Drug: S-1; Biological: Trastuzumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Progression Free Survival (PFS) Per RECIST 1.1 Assessed by BICR

    PFS is defined as the time from randomization to the first documented disease progression per RECIST 1.1 as assessed by BICR or death due to any cause, whichever occurs first. Per RECIST 1.1, progressive disease (PD) is defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered progression. PFS was determined for first course pembrolizumab in the Global Cohort. Per statistical analysis plan, participants in the Japan-specific SOX Cohort were not included in the efficacy analysis.

    Measured: Up to 46 months

  2. Overall Survival (OS)

    OS is defined as the time from randomization to death due to any cause. OS was determined for first course pembrolizumab in the Global Cohort. Per statistical analysis plan, participants in the Japan-specific SOX Cohort were not included in the efficacy analysis.

    Measured: Up to 63 months

Secondary outcomes (4)

  1. Objective Response Rate (ORR) Per RECIST 1.1 Assessed by BICR

    ORR is defined as the percentage of participants who have a Complete Response ([CR], disappearance of all evidence of disease) or Partial Response ([PR], regression of measurable disease and no new sites) per RECIST 1.1 as assessed by blinded independent central review (BICR). ORR was determined for first course pembrolizumab in the Global Cohort. Per statistical analysis plan, participants in the Japan-specific SOX Cohort were not included in the efficacy analysis.

    Measured: Up to 63 months

  2. Duration of Response (DOR) Per RECIST 1.1 Assessed by BICR

    For participants who demonstrate CR or PR, DOR is defined as the time from first response (CR or PR) to subsequent disease progression or death from any cause, whichever occurs first. DOR was determined for first course pembrolizumab in the Global Cohort. Per statistical analysis plan, participants in the Japan-specific SOX Cohort were not included in the efficacy analysis.

    Measured: Up to 63 months

  3. Number of Participants Who Experienced an Adverse Event (AE)

    An AE is any untoward medical occurrence in a participant that is temporally associated with the use of study treatment, whether or not considered related to the study treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study treatment. The number of participants who experienced an AE is reported for each treatment arm. Per statistical analysis plan, data from the second course of pembrolizumab was not included in the safety analysis.

    Measured: Up to 63 months

  4. Number of Participants Who Discontinued Study Treatment Due to AEs

    An AE is any untoward medical occurrence in a participant that is temporally associated with the use of study treatment, whether or not considered related to the study treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study treatment. The number of participants who discontinued study treatment due to an AE is reported for each treatment arm. Per statistical analysis plan, data from the second course of pembrolizumab was not included in the safety analysis.

    Measured: Up to 63 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Aug 2018
  2. Study start5 Oct 2018
  3. Primary completion20 Mar 2024
  4. Study completion12 Nov 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
738 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03615326
Sponsor's protocol ID
3475-811
Other IDs
MK-3475-811, 184142, 2023-508253-98-00, U1111-1297-9360, 2018-000224-34, 2018, 2023
Status last verified
Aug 2026
First submitted
31 Jul 2018
Last updated
26 Aug 2026
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf

Publications

  • Janjigian YY, Kawazoe A, Bai Y, Xu J, Lonardi S, Metges JP, Yanez P, Wyrwicz LS, Shen L, Ostapenko Y, Bilici M, Chung HC, Shitara K, Qin SK, Van Cutsem E, Tabernero J, Li K, Shih CS, Bhagia P, Rha SY; KEYNOTE-811 Investigators. Pembrolizumab plus trastuzumab and chemotherapy for HER2-positive gastric or gastro-oesophageal junction adenocarcinoma: interim analyses from the phase 3 KEYNOTE-811 randomised placebo-controlled trial. Lancet. 2023 Dec 9;402(10418):2197-2208. doi: 10.1016/S0140-6736(23)02033-0. Epub 2023 Oct 20.

    PubMed 37871604

  • Janjigian YY, Kawazoe A, Bai Y, Xu J, Lonardi S, Metges JP, Yanez P, Wyrwicz LS, Shen L, Ostapenko Y, Bilici M, Chung HC, Shitara K, Qin S, Van Cutsem E, Tabernero J, Luo S, Mahave M, Tang Y, Lowery M, Monteiro MMF, Xu L, Shih CS, Sharan KP, Bhagia P, Rha SY. Pembrolizumab in HER2-Positive Gastric Cancer. N Engl J Med. 2024 Oct 10;391(14):1360-1362. doi: 10.1056/NEJMc2408121. Epub 2024 Sep 14. No abstract available.

    PubMed 39282917

  • Janjigian YY, Kawazoe A, Yanez P, Li N, Lonardi S, Kolesnik O, Barajas O, Bai Y, Shen L, Tang Y, Wyrwicz LS, Xu J, Shitara K, Qin S, Van Cutsem E, Tabernero J, Li L, Shah S, Bhagia P, Chung HC. The KEYNOTE-811 trial of dual PD-1 and HER2 blockade in HER2-positive gastric cancer. Nature. 2021 Dec;600(7890):727-730. doi: 10.1038/s41586-021-04161-3. Epub 2021 Dec 15.

    PubMed 34912120

  • Chung HC, Bang YJ, S Fuchs C, Qin SK, Satoh T, Shitara K, Tabernero J, Van Cutsem E, Alsina M, Cao ZA, Lu J, Bhagia P, Shih CS, Janjigian YY. First-line pembrolizumab/placebo plus trastuzumab and chemotherapy in HER2-positive advanced gastric cancer: KEYNOTE-811. Future Oncol. 2021 Feb;17(5):491-501. doi: 10.2217/fon-2020-0737. Epub 2020 Nov 10.

    PubMed 33167735

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Pembrolizumab, Cisplatin and 5-FU in people with Gastric Neoplasms and Gastroesophageal Junction Adenocarcinoma, run by Merck Sharp & Dohme LLC at 192 sites in 20 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 192 sites in Japan, United States, China, Germany, Ukraine and 15 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 17 Mar 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression Free Survival (PFS) Per RECIST 1.1 Assessed by BICR (time frame: Up to 46 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03615326, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2026.

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