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 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)
6 other identifiers
interventional
738
20 countries
192
Brief 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. 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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Oct 2018
Longer than P75 for phase_3
192 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 31, 2018
CompletedFirst Posted
Study publicly available on registry
August 3, 2018
CompletedStudy Start
First participant enrolled
October 5, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 20, 2024
CompletedResults Posted
Study results publicly available
March 17, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
November 12, 2025
CompletedDecember 11, 2025
November 1, 2025
5.5 years
July 31, 2018
March 4, 2025
November 24, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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.
Up to 46 months
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.
Up to 63 months
Secondary Outcomes (4)
Objective Response Rate (ORR) Per RECIST 1.1 Assessed by BICR
Up to 63 months
Duration of Response (DOR) Per RECIST 1.1 Assessed by BICR
Up to 63 months
Number of Participants Who Experienced an Adverse Event (AE)
Up to 63 months
Number of Participants Who Discontinued Study Treatment Due to AEs
Up to 63 months
Study Arms (4)
Global Pembrolizumab + Standard of Care First Course
EXPERIMENTALParticipants 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.
Global Standard of Care
ACTIVE 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.
Japan Pembrolizumab + Trastuzumab + S-1 Plus Oxaliplatin
EXPERIMENTALParticipants 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.
Japan Trastuzumab + S-1 Plus Oxaliplatin
EXPERIMENTALParticipants received matched placebo to pembrolizumab IV Q3W plus trastuzumab (8mg/kg loading dose, 6mg/kg maintenance thereafter) IV Q3W in combination with SOX chemotherapy.
Interventions
200 mg on Day 1 of each 3-week cycle as an IV infusion.
Solution for IV infusion on Day 1 of each 3-week cycle.
80 mg/m\^2 on Day 1 of each 3-week cycle as an IV infusion, administered as part of FP chemotherapy regimen.
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.
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.
1000 mg/m\^2 as oral capsules BID on Days 1-14 of each 3-week cycle, administered as part of CAPOX chemotherapy regimen.
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.
8 mg/kg loading dose and then 6 mg/kg maintenance dose administered IV on day 1 of each 3-week cycle.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
- 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
- +7 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (192)
UCLA Hematology/Oncology - Westwood (Building 200 Suite 120) ( Site 0045)
Los Angeles, California, 90095, United States
Pacific Cancer Care ( Site 0063)
Monterey, California, 93940, United States
UC Irvine Medical Center/Chao Family Comprehensive Cancer Center ( Site 0050)
Orange, California, 92868, United States
University of Miami Sylvester Comprehensive Cancer Center - Plantation ( Site 0026)
Miami, Florida, 33136, United States
Southeastern Regional Medical Center, Inc. ( Site 0058)
Newnan, Georgia, 30265, United States
Midwestern Regional Medical Center, Inc. ( Site 0059)
Zion, Illinois, 60099, United States
Beth Israel Deaconess Medical Center ( Site 0070)
Boston, Massachusetts, 02215, United States
Dana-Farber Cancer Institute [Boston, MA] ( Site 0010)
Boston, Massachusetts, 02215, United States
Minnesota Oncology Hematology, PA ( Site 8001)
Minneapolis, Minnesota, 55404, United States
Washington University School of Medicine ( Site 0040)
St Louis, Missouri, 63110, United States
Memorial Sloan Kettering Cancer Center- Monmouth ( Site 0071)
Middletown, New Jersey, 07748, United States
Memorial Sloan-Kettering Cancer Center at West Harrison ( Site 0065)
Harrison, New York, 10604, United States
Memorial Sloan-Kettering Cancer Center ( Site 0017)
New York, New York, 10065, United States
University of Rochester ( Site 0041)
Rochester, New York, 14642, United States
Levine Cancer Institute ( Site 0015)
Charlotte, North Carolina, 28204, United States
Duke Cancer Institute ( Site 0042)
Durham, North Carolina, 27710, United States
CTCA Southwestern ( Site 0060)
Tulsa, Oklahoma, 74133, United States
Cancer Treatment Centers of America-Eastern Regional Medical Center ( Site 0025)
Philadelphia, Pennsylvania, 19124, United States
Allegheny General Hospital ( Site 0053)
Pittsburgh, Pennsylvania, 15212, United States
Sanford Hematology Oncology-Sioux Falls SD ( Site 0004)
Sioux Falls, South Dakota, 57104, United States
University of Texas MD Anderson Cancer Center ( Site 0001)
Houston, Texas, 77030, United States
Oncology & Hematology Assoc. SW Virginia, Inc., DBA Blue Ridge Cancer Care ( Site 8000)
Roanoke, Virginia, 24014, United States
Seattle Cancer Care Alliance ( Site 0038)
Seattle, Washington, 98109, United States
Liverpool Hospital ( Site 2206)
Liverpool, New South Wales, 2170, Australia
Westmead Hospital ( Site 2200)
Westmead, New South Wales, 2145, Australia
Southern Medical Day Care Centre ( Site 2207)
Wollongong, New South Wales, 2500, Australia
Monash Health ( Site 2202)
Clayton, Victoria, 3168, Australia
Instituto do Cancer do Ceara ( Site 0208)
Fortaleza, Ceará, 60430-230, Brazil
Hospital Sao Rafael ( Site 0209)
Salvador, Estado de Bahia, 41253-190, Brazil
CIONC - Centro Integrado de Oncologia de Curitiba ( Site 0205)
Curitiba, Paraná, 80810-050, Brazil
Hospital de Caridade de Ijui ( Site 0202)
Ijuí, Rio Grande do Sul, 98700 000, Brazil
Hospital Nossa Senhora da Conceicao ( Site 0203)
Porto Alegre, Rio Grande do Sul, 91350-200, Brazil
CEPON - Centro de Pesquisas Oncologicas ( Site 0200)
Florianópolis, Santa Catarina, 88034-000, Brazil
Instituto Nacional do Cancer Jose Alencar Gomes da Silva INCA ( Site 0201)
Rio de Janeiro, 20231-050, Brazil
IBCC - Instituto Brasileiro de Controle do Cancer ( Site 0204)
São Paulo, 03102-002, Brazil
Clinica Universidad Catolica del Maule ( Site 0305)
Talca, Maule Region, 3460000, Chile
Fundacion Arturo Lopez Perez FALP ( Site 0302)
Santiago, Region M. de Santiago, 7500921, Chile
Pontificia Universidad Catolica de Chile ( Site 0301)
Santiago, Region M. de Santiago, 7620002, Chile
Instituto Nacional del Cancer ( Site 0303)
Santiago, Region M. de Santiago, 8380455, Chile
Centro Investigación del Cáncer James Lind ( Site 0300)
Temuco, Región de la Araucanía, 4780000, Chile
Shanghai General Hospital ( Site 2404)
Shanghai, Anhui, 200080, China
Peking Union Medical College Hospital ( Site 2419)
Beijing, Beijing Municipality, 100032, China
Fifth Medical Center of CPLA General Hospital ( Site 2415)
Beijing, Beijing Municipality, 100071, China
Beijing Cancer Hospital ( Site 2413)
Beijing, Beijing Municipality, 100142, China
Fujian Provincial Cancer Hospital ( Site 2418)
Fuzhou, Fujian, 350014, China
900 Hospital of the Joint ( Site 2420)
Fuzhou, Fujian, 350025, China
The First Affiliated Hospital of Xiamen University ( Site 2431)
Xiamen, Fujian, 361003, China
Guangdong General Hospital ( Site 2433)
Guangzhou, Guangdong, 510080, China
Harbin Medical University Cancer Hospital ( Site 2407)
Harbin, Heilongjiang, 150081, China
Henan Cancer Hospital ( Site 2400)
Zhengzhou, Henan, 450008, China
Xiangya Hospital Central-South University ( Site 2426)
Changsha, Hunan, 410008, China
Jiangsu Cancer Hospital ( Site 2432)
Nanjing, Jiangsu, 210009, China
The First Hospital Of Jilin University ( Site 2402)
Changchun, Jilin, 130021, China
Fudan University Shanghai Cancer Center ( Site 2424)
Shanghai, Shanghai Municipality, 200032, China
Zhongshan Hospital affiliated to Fudan University ( Site 2401)
Shanghai, Shanghai Municipality, 200032, China
Cancer Hospital Affiliated to Xinjiang Medical University ( Site 2430)
Ürümqi, Xinjiang, 830001, China
The First Affiliated Hospital.Zhejiang University ( Site 2408)
Hangzhou, Zhejiang, 310003, China
Sir Run Run Shaw Hospital ( Site 2412)
Hangzhou, Zhejiang, 310016, China
Zhejiang Cancer Hospital ( Site 2409)
Hangzhou, Zhejiang, 310022, China
CHU de Rouen ( Site 0912)
Rouen, Ain, 76000, France
HUS Hopital Hautepierre ( Site 0910)
Strasbourg, Bas-Rhin, 67098, France
Hopital Jean Minjoz Besancon ( Site 0901)
Besançon, Doubs, 25030, France
C.H.R.U. de Brest - Hopital Morvan ( Site 0913)
Brest, Finistere, 29200, France
Centre Oscar Lambret ( Site 0911)
Lille, Nord, 59000, France
Centre Leon Berard ( Site 0904)
Lyon, Rhone, 69008, France
Institut de Cancerologie de l Ouest Centre Rene Gauducheau ( Site 0902)
Saint-Herblain, Val-de-Marne, 44805, France
Institut Gustave Roussy ( Site 0900)
Villejuif, Val-de-Marne, 94805, France
CHU Hopital Saint Antoine ( Site 0905)
Paris, 75012, France
SLK-Kliniken Heilbronn ( Site 1015)
Heilbronn, Baden-Wurttemberg, 74078, Germany
Klinikum Ludwigsburg ( Site 1014)
Ludwigsburg, Baden-Wurttemberg, Germany
Innere Medizin I, Universitaetsklinikum Tuebingen ( Site 1020)
Tübingen, Baden-Wurttemberg, 72076, Germany
Klinikum rechts der Isar der Technischen Universitaet ( Site 1027)
Munich, Bavaria, 81675, Germany
Medizinische Hochschule Hannover ( Site 1019)
Hanover, Lower Saxony, 30625, Germany
Universitaetsklinikum Carl Gustav Carus der Technischen Univ ( Site 1001)
Dresden, Saxony, 01307, Germany
Universitaetsklinikum Leipzig AOeR ( Site 1007)
Leipzig, Saxony, 04103, Germany
Charite-Universitaetsmedizin Berlin Campus Virchow-Klinikum ( Site 1026)
Berlin, 13353, Germany
Klinikum Bremen Nord ( Site 1017)
Bremen, 28211, Germany
Facharztzentrum Eppendorf ( Site 1025)
Hamburg, 20249, Germany
Asklepios Klinik Altona ( Site 1000)
Hamburg, 22763, Germany
Celan SA ( Site 0504)
Guatemala City, 01010, Guatemala
Oncomedica ( Site 0500)
Guatemala City, 01010, Guatemala
Grupo Angeles SA ( Site 0501)
Guatemala City, 01015, Guatemala
Nucare Center ( Site 0506)
Guatemala City, 01015, Guatemala
Medi-K Cayala ( Site 0505)
Guatemala City, 01016, Guatemala
Centro Regional de Sub Especialidades Medicas SA ( Site 0502)
Quetzaltenango, 09001, Guatemala
Saint James's Hospital ( Site 1505)
Dublin, D08NHY1, Ireland
Beaumont Hospital ( Site 1506)
Dublin, D09 V2N0, Ireland
Tallaght University Hospital ( Site 1513)
Dublin, D24 NR0A, Ireland
Soroka University Medical Center ( Site 1603)
Beersheba, 8410101, Israel
Rambam Health Care Campus ( Site 1606)
Haifa, 3109601, Israel
Edith Wolfson Medical Center ( Site 1605)
Holon, 5822012, Israel
Hadassah Ein Kerem Medical Center ( Site 1604)
Jerusalem, 9112001, Israel
Meir Medical Center ( Site 1609)
Kfar Saba, 4428132, Israel
Rabin Medical Center ( Site 1602)
Petah Tikva, 4941492, Israel
Chaim Sheba Medical Center. ( Site 1607)
Ramat Gan, 5265601, Israel
Sourasky Medical Center ( Site 1601)
Tel Aviv, 6423906, Israel
AUOP Ospedale Santa Chiara ( Site 1100)
Pisa, Tuscany, 56126, Italy
Humanitas Gavazzeni ( Site 1106)
Bergamo, 24125, Italy
Universita Magna Graecia di Catanzaro ( Site 1107)
Catanzaro, 88100, Italy
IEO Istituto Europeo di Oncologia ( Site 1105)
Milan, 20141, Italy
Azienda Ospedaliero - Universitaria Policlinico di Modena ( Site 1102)
Modena, 41124, Italy
A.O.U. Universita degli Studi della Campania-Luigi Vanvitelli ( Site 1103)
Naples, 80131, Italy
Istituto Oncologico Veneto ( Site 1101)
Padua, 35128, Italy
Ospedale Civile Spirito Santo ( Site 1104)
Pescara, 65100, Italy
Aichi Cancer Center Hospital ( Site 2617)
Nagoya, Aichi-ken, 464-8681, Japan
National Cancer Center Hospital East ( Site 2605)
Kashiwa, Chiba, 277-8577, Japan
National Hospital Organization Shikoku Cancer Center ( Site 2615)
Matsuyama, Ehime, 791-0280, Japan
Gunma Prefectural Cancer Center ( Site 2602)
Ohta, Gunma, 373-8550, Japan
Hyogo Cancer Center ( Site 2619)
Akashi, Hyōgo, 673-8558, Japan
Kobe City Medical Center General Hospital ( Site 2614)
Kobe, Hyōgo, 650-0047, Japan
Ibaraki Prefectural Central Hospital ( Site 2611)
Kasama, Ibaraki, 309-1793, Japan
Kagawa University Hospital ( Site 2604)
Kita-gun, Kagawa-ken, 761-0793, Japan
Kanagawa Cancer Center ( Site 2603)
Yokohama, Kanagawa, 241-8515, Japan
Osaki Citizen Hospital ( Site 2626)
Ōsaki, Miyagi, 989-6183, Japan
Kansai Medical University Hospital ( Site 2618)
Hirakata, Osaka, 573-1191, Japan
Kindai University Hospital ( Site 2616)
Sayama, Osaka, 589-8511, Japan
Osaka University Hospital ( Site 2600)
Suita, Osaka, 565-0871, Japan
Saitama Cancer Center ( Site 2620)
Kitaadachi-gun, Saitama, 362-0806, Japan
Shizuoka Cancer Center Hospital and Research Institute ( Site 2607)
Sunto-gun, Shizuoka, 411-8777, Japan
Tochigi Cancer Center ( Site 2627)
Utsunomiya, Tochigi, 320-0834, Japan
Kyorin University Hospital ( Site 2608)
Mitaka, Tokyo, 181-8611, Japan
Chiba Cancer Center ( Site 2623)
Chiba, 260-8717, Japan
National Hospital Organization Kyushu Cancer Center ( Site 2609)
Fukuoka, 811-1395, Japan
Gifu University Hospital ( Site 2621)
Gifu, 501-1194, Japan
Hiroshima City Hiroshima Citizens Hospital ( Site 2625)
Hiroshima, 730-8518, Japan
Kumamoto University Hospital ( Site 2601)
Kumamoto, 860-8556, Japan
Niigata Cancer Center Hospital ( Site 2622)
Niigata, 951-8566, Japan
National Hospital Organization - Osaka National Hospital - Institute For Clinical Research ( Site 26
Osaka, 540-0006, Japan
Osaka International Cancer Institute ( Site 2613)
Osaka, 541-8567, Japan
Osaka General Medical Center ( Site 2624)
Osaka, 558-8558, Japan
National Cancer Center Hospital ( Site 2612)
Tokyo, 104-0045, Japan
Toranomon Hospital ( Site 2628)
Tokyo, 105-8470, Japan
Tokyo Metropolitan Komagome Hospital ( Site 2606)
Tokyo, 113-8677, Japan
The Cancer Institute Hospital of JFCR ( Site 2610)
Tokyo, 135-8550, Japan
Auckland City Hospital ( Site 2300)
Auckland, 1023, New Zealand
Przychodnia Lekarska Komed ( Site 1716)
Konin, Greater Poland Voivodeship, 62-500, Poland
Uniwersytecki Szpital Kliniczny im. J. M. Radeckiego we Wroclawiu ( Site 1705)
Wroclaw, Lower Silesian Voivodeship, 50-556, Poland
Dolnoslaskie Centrum Onkologii. ( Site 1712)
Wroclaw, Lower Silesian Voivodeship, 53-413, Poland
Samodzielny Publiczny Szpital Kliniczny Nr 1 w Lublinie ( Site 1709)
Lublin, Lublin Voivodeship, 20-080, Poland
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy w Warszawie (
Warsaw, Masovian Voivodeship, 02-781, Poland
Szpital Morski im. PCK. Szpitale Pomorskie Sp. Z o.o ( Site 1715)
Gdynia, Pomeranian Voivodeship, 81-519, Poland
Szpital Specjalistyczny w Koscierzynie Sp. z o.o. ( Site 1708)
Kościerzyna, Pomeranian Voivodeship, 83-400, Poland
Beskidzkie Centrum Onkologii im. Jana Pawla II ( Site 1710)
Bielsko-Biala, Silesian Voivodeship, 43-300, Poland
Republican Clinical Oncology Dispensary of Republic of Bashkortostan ( Site 1807)
Ufa, Baskortostan, Respublika, 450054, Russia
Chelyabinsk Regional Clinical Oncological Dispensary ( Site 1815)
Chelyabinsk, Chelyabinsk Oblast, 454087, Russia
Blokhin National Medical Oncology ( Site 1805)
Moscow, Moscow, 115478, Russia
Podolsky City Clinical Hospital ( Site 1817)
Podolsk, Moscow Oblast, 142110, Russia
Medical University REAVIZ ( Site 1816)
Samara, Samara Oblast, 443011, Russia
Leningrad Regional Oncology Center ( Site 1800)
Saint Petersburg, Sankt-Peterburg, 188663, Russia
Scientific Research Oncology Institute n.a. N.N.Petrov ( Site 1801)
Saint Petersburg, Sankt-Peterburg, 197758, Russia
St Petersburg City Clinical Oncology Dispensary ( Site 1812)
Saint Petersburg, Sankt-Peterburg, 198255, Russia
Seoul National University Hospital ( Site 2703)
Seoul, 03080, South Korea
Severance Hospital Yonsei University Health System ( Site 2700)
Seoul, 03722, South Korea
Asan Medical Center ( Site 2702)
Seoul, 05505, South Korea
Samsung Medical Center ( Site 2701)
Seoul, 06351, South Korea
Hospital General Universitario de Elche ( Site 1404)
Elche, Alicante, 03203, Spain
Hospital Germans Trias i Pujol. ICO de Badalona ( Site 1410)
Badalona, Barcelona, 08916, Spain
Hospital Universitario Marques de Valdecilla ( Site 1405)
Santander, Cantabria, 39008, Spain
Hospital Universitario Quiron Madrid ( Site 1407)
Pozuelo de Alarcón, Madrid, 28223, Spain
Hospital Universitario Central de Asturias ( Site 1402)
Oviedo, Principality of Asturias, 33011, Spain
Hospital General Universitari Vall d Hebron ( Site 1401)
Barcelona, 08035, Spain
Hospital Universitario Ramon y Cajal ( Site 1400)
Madrid, 28034, Spain
Adana Sehir Hastanesi ( Site 2002)
Adana, 01370, Turkey (Türkiye)
Hacettepe Universitesi Tip Fakultesi Hastanesi ( Site 2017)
Ankara, 06100, Turkey (Türkiye)
Abdurrahman Yurtaslan Onkoloji Egitim ve Arastirma Hastanesi ( Site 2006)
Ankara, 06200, Turkey (Türkiye)
Trakya Universitesi Tip Fakultesi ( Site 2015)
Edirne, 22030, Turkey (Türkiye)
Ataturk Universitesi Tip Fakultesi Hastanesi ( Site 2000)
Erzurum, 25240, Turkey (Türkiye)
Istanbul Universitesi Cerrahpasa Tip Fakultesi ( Site 2001)
Istanbul, 34098, Turkey (Türkiye)
Dokuz Eylul Universitesi Tip Fakultesi Hastanesi ( Site 2011)
Izmir, 35340, Turkey (Türkiye)
Malatya Inonu Universitesi Tip Fakultesi Hastanesi ( Site 2009)
Malatya, 44280, Turkey (Türkiye)
Sakarya Universitesi Egitim ve Arastirma Hastanesi ( Site 2012)
Sakarya, 54290, Turkey (Türkiye)
City Clinical Hosp.4 of DCC ( Site 2102)
Dnipro, Dnipropetrovsk Oblast, 49102, Ukraine
MI Kryviy Rih Center of Dnipropetrovsk Regional Council ( Site 2101)
Kryviy Rih, Dnipropetrovsk Oblast, 50048, Ukraine
MI Precarpathian Clinical Oncology Center ( Site 2105)
Ivano-Frankivsk, Ivano-Frankivsk Oblast, 76018, Ukraine
Communal non profit enterprise Regional Clinical Oncology Center ( Site 2112)
Kharkiv, Kharkivs’ka Oblast’, 61070, Ukraine
Medical Center Asklepion LLC ( Site 2115)
Khodosovka, Kyivska Oblast, 08173, Ukraine
Clinic of National Cancer Institute ( Site 2104)
Kyiv, Kyivska Oblast, 03022, Ukraine
Medical and Diagnostic Centre LLC Dobryi Prognoz ( Site 2114)
Kyiv, Kyivska Oblast, 03126, Ukraine
Lviv State Oncology Regional Treatment and Diagnostic Center ( Site 2106)
Lviv, Lviv Oblast, 79031, Ukraine
MI Odessa Regional Oncological Centre ( Site 2108)
Odesa, Odesa Oblast, 65055, Ukraine
Medical Centre LLC Oncolife ( Site 2103)
Zaporizhzhya, Zaporizhzhia Oblast, 69104, Ukraine
Kyiv City Clinical Oncology Centre ( Site 2110)
Kyiv, 03115, Ukraine
Royal Hospital in Derby ( Site 1514)
Derby, Derbyshire, DE22 3NE, United Kingdom
Ninewells Hospital and Medical School ( Site 1504)
Dundee, Dundee City, DD1 9SY, United Kingdom
Castle Hill Hospital ( Site 1501)
Cottingham, East Riding Of Yorkshire, HU16 5JQ, United Kingdom
University College London Hospital NHS Foundation Trust ( Site 1508)
London, London, City of, NW1 2PG, United Kingdom
St Georges University Hospitals NHS Foundation Trust. ( Site 1500)
London, London, City of, SW17 0QT, United Kingdom
Royal Marsden Hospital ( Site 1510)
Sutton, Surrey, SM2 5PT, United Kingdom
Royal Marsden NHS Foundation Trust ( Site 1512)
London, SW3 6JJ, United Kingdom
The Christie Hospital NHS Foundation Trust ( Site 1503)
Manchester, M20 4BX, United Kingdom
Mount Vernon Cancer Centre ( Site 1507)
Northwood, HA6 2RN, United Kingdom
Manor Hospital Walsall England ( Site 1515)
Walsall, WS2 9PS, United Kingdom
Related Publications (4)
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.
PMID: 37871604RESULTJanjigian 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.
PMID: 39282917RESULTJanjigian 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.
PMID: 34912120DERIVEDChung 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.
PMID: 33167735DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Senior Vice President, Global Clinical Development
- Organization
- Merck Sharp & Dohme LLC
Study Officials
- STUDY DIRECTOR
Medical Director
Merck Sharp & Dohme LLC
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 31, 2018
First Posted
August 3, 2018
Study Start
October 5, 2018
Primary Completion
March 20, 2024
Study Completion
November 12, 2025
Last Updated
December 11, 2025
Results First Posted
March 17, 2025
Record last verified: 2025-11
Data Sharing
- IPD Sharing
- Will share
https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf