Pembrolizumab (MK-3475) Plus Chemotherapy Versus Placebo Plus Chemotherapy in Participants Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma (MK-3475-859/KEYNOTE-859)
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)
7 other identifiers
interventional
1,579
32 countries
212
Brief Summary
The purpose of this study is to evaluate the efficacy of pembrolizumab (MK-3745) in combination with chemotherapy (Cisplatin combined with 5-Fluorouracil \[FP regimen\] or oxaliplatin combined with capecitabine \[CAPOX regimen\]) versus placebo in combination with chemotherapy (FP or CAPOX regimens) in the treatment of human epidermal growth factor receptor 2 (HER2) negative advanced gastric or GEJ adenocarcinoma in adult participants. The primary hypotheses of this study are that pembrolizumab plus chemotherapy is superior to placebo plus chemotherapy in terms of overall survival (OS). Once a participant has achieved the study objective or the study has ended, the participant will be discontinued from this study and enrolled in an extension study (Keynote 587; NCT03486873) to continue protocol-defined assessments and treatment.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Nov 2018
Longer than P75 for phase_3
212 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
September 17, 2018
CompletedFirst Posted
Study publicly available on registry
September 18, 2018
CompletedStudy Start
First participant enrolled
November 8, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 3, 2022
CompletedResults Posted
Study results publicly available
October 12, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
March 3, 2025
CompletedFebruary 27, 2026
February 1, 2026
3.9 years
September 17, 2018
September 20, 2023
February 4, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Overall Survival (OS) in All Participants
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
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
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 Outcomes (11)
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
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
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
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
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
Up to 49.5 months
- +6 more secondary outcomes
Study Arms (2)
Pembrolizumab + Chemotherapy (FP or CAPOX regimen)
EXPERIMENTALParticipants 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).
Placebo + Chemotherapy (FP or CAPOX regimen)
ACTIVE COMPARATORParticipants 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).
Interventions
Administered as an IV infusion on Day 1 Q3W
Administered as an IV infusion on Day 1 Q3W
Administered as a continuous IV infusion on Days 1-5 Q3W
Administered as an IV infusion on Day 1 Q3W
Administered orally BID on Days 1 to 14 Q3W
Administered as an IV infusion on Day 1 Q3W
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
- +14 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (215)
UCLA Hematology/Oncology - Westwood (Building 200 Suite 120) ( Site 0124)
Los Angeles, California, 90095, United States
UC Irvine Health/Division of Hematology Oncology, Dept of Medicine ( Site 0128)
Orange, California, 92868, United States
University of Miami, Sylvester Comprehensive Cancer Center ( Site 0113)
Miami, Florida, 33136, United States
Greater Baltimore Medical Center ( Site 0102)
Baltimore, Maryland, 21204, United States
Minnesota Oncology Hematology, PA ( Site 8000)
Minneapolis, Minnesota, 55404, United States
University of Rochester ( Site 0122)
Rochester, New York, 14642, United States
Cancer Treatment Centers of America - Philadelphia ( Site 0112)
Philadelphia, Pennsylvania, 19124, United States
Allegheny General Hospital ( Site 0118)
Pittsburgh, Pennsylvania, 15212, United States
Oncology & Hematology Assoc. SW Virginia, Inc., DBA Blue Ridge Cancer Care ( Site 8001)
Roanoke, Virginia, 24014, United States
Wenatchee Valley Clinic [Wenatchee, WA] ( Site 0116)
Wenatchee, Washington, 98801, United States
Instituto Medico Alexander Fleming ( Site 0307)
Buenos Aires, Buenos Aires F.D., C1426ANZ, Argentina
Instituto de Investigaciones Metabolicas ( Site 0312)
Buenos Aires, C1012AAR, Argentina
Fundacion Favaloro - Hospital Universitario ( Site 0302)
Buenos Aires, C1093AAS, Argentina
Centro Oncologico Riojano Integral ( Site 0313)
La Rioja, F5300COE, Argentina
Instituto San Marcos ( Site 0311)
San Juan, J5400EBB, Argentina
Liverpool Hospital ( Site 2301)
Liverpool, New South Wales, 2170, Australia
Southern Medical Day Care Centre ( Site 2303)
Wollongong, New South Wales, 2500, Australia
Box Hill Hospital ( Site 2300)
Box Hill, Victoria, 3128, Australia
Instituto do Cancer do Ceara ( Site 0407)
Fortaleza, Ceará, 60430-230, Brazil
CIONC - Centro Integrado de Oncologia de Curitiba ( Site 0405)
Curitiba, Paraná, 80810-050, Brazil
Hospital de Caridade de Ijui ( Site 0402)
Ijuí, Rio Grande do Sul, 98700 000, Brazil
Hospital Nossa Senhora da Conceicao ( Site 0403)
Porto Alegre, Rio Grande do Sul, 91350-200, Brazil
CEPON - Centro de Pesquisas Oncologicas ( Site 0400)
Florianópolis, Santa Catarina, 88034-000, Brazil
Instituto Nacional do Cancer Jose Alencar Gomes da Silva INCA ( Site 0401)
Rio de Janeiro, 20231-050, Brazil
IBCC - Instituto Brasileiro de Controle do Cancer ( Site 0404)
São Paulo, 03102-002, Brazil
BC Cancer - Abbotsford ( Site 0206)
Abbotsford British Columbia, British Columbia, V2S 0C2, Canada
Sunnybrook Research Institute ( Site 0202)
Toronto, Ontario, M4N 3M5, Canada
Princess Margaret Cancer Centre ( Site 0203)
Toronto, Ontario, M5G 2M9, Canada
McGill University Health Centre ( Site 0208)
Montreal, Quebec, H4A 3J1, Canada
Fundacion Arturo Lopez Perez FALP ( Site 0501)
Santiago, Region M. de Santiago, 7500921, Chile
Sociedad Oncovida S.A. ( Site 0508)
Santiago, Region M. de Santiago, 7510032, Chile
Pontificia Universidad Catolica de Chile ( Site 0502)
Santiago, Region M. de Santiago, 7620002, Chile
Instituto Clinico Oncologico del Sur ( Site 0500)
Temuco, Región de la Araucanía, 4810469, Chile
Cancer Hospital Chinese Academy of Medical Sciences ( Site 2421)
Beijing, Beijing Municipality, 100021, China
Peking Union Medical College Hospital ( Site 2425)
Beijing, Beijing Municipality, 100730, China
Fujian Medical University Union Hospital ( Site 2410)
Fuzhou, Fujian, 350001, China
Fujian Provincial Cancer Hospital ( Site 2414)
Fuzhou, Fujian, 350014, China
900 Hospital of the Joint ( Site 2418)
Fuzhou, Fujian, 350025, China
The First Affiliated Hospital of Xiamen University ( Site 2430)
Xiamen, Fujian, 361003, China
Zhongshan Hospital Xiamen University ( Site 2447)
Xiamen, Fujian, 361004, China
Guangdong General Hospital ( Site 2431)
Guangzhou, Guangdong, 510080, China
Peking University Shenzhen Hospital ( Site 2442)
Shenzhen, Guangdong, 518036, China
Fourth Hospital Of Hebei Medical University ( Site 2436)
Shijiazhuang, Hebei, 050011, China
Harbin Medical University Cancer Hospital ( Site 2401)
Harbin, Heilongjiang, 150081, China
Henan Cancer Hospital ( Site 2415)
Zhengzhou, Henan, 450008, China
Hubei Cancer Hospital ( Site 2434)
Wuhan, Hubei, 430079, China
Xiangya Hospital Central-South University ( Site 2419)
Changsha, Hunan, 410008, China
Hunan Cancer Hospital ( Site 2439)
Changsha, Hunan, 410013, China
Changzhou Cancer Hospital-Changzhou Fourth Peoples Hospital ( Site 2441)
Changzhou, Jiangsu, 213032, China
The 81st Hospital of PLA ( Site 2413)
Nanjing, Jiangsu, 210002, China
Jiangsu Cancer Hospital ( Site 2432)
Nanjing, Jiangsu, 210009, China
Yancheng First People s Hospital ( Site 2426)
Yancheng, Jiangsu, 224000, China
The First Affiliated Hospital of Nanchang University ( Site 2440)
Nanchang, Jiangxi, 330006, China
The First Hospital of Jilin University ( Site 2416)
Changchun, Jilin, 130021, China
The Affiliated Hospital of Qingdao University ( Site 2405)
Qingdao, Shandong, 266061, China
Shanghai East Hospital ( Site 2403)
Shanghai, Shanghai Municipality, 200120, China
Zhongshan Hospital affiliated to Fudan University ( Site 2407)
Shanghai, Shanghai Municipality, 210000, China
1st Affil hosp of Med College of Xi'an Jiaotong University ( Site 2428)
XiAn, Shanxi, 710061, China
Cancer Hospital Affiliated to Xinjiang Medical University ( Site 2420)
Ürümqi, Xinjiang, 830001, China
Zhejiang Provincial People's Hospital ( Site 2446)
Hangzhou, Zhejiang, 310014, China
Sir Run Run Show Hospital ( Site 2427)
Hangzhou, Zhejiang, 310016, China
Zhejiang Cancer Hospital ( Site 2417)
Hangzhou, Zhejiang, 310022, China
Instituto Nacional de Cancerologia E.S.E ( Site 0605)
Bogotá, Bogota D.C., 110321, Colombia
Sociedad de Oncología Y Hematología del Cesar S.A.S. ( Site 0608)
Valledupar, Cesar Department, 200001, Colombia
Oncomedica S.A. ( Site 0606)
Montería, Departamento de Córdoba, 230002, Colombia
Centro Medico Imbanaco de Cali S.A ( Site 0604)
Cali, Valle del Cauca Department, 760042, Colombia
CIMCA Centro de Investigacion y Manejo del Cancer ( Site 3001)
San José, 10103, Costa Rica
Policlinico San Bosco ( Site 3002)
San José, 10103, Costa Rica
ICIMED - Instituto de Investigacion en Ciencias Medicas ( Site 3000)
San José, 10108, Costa Rica
FN Ostrava ( Site 3105)
Ostrava, Moravskoslezský kraj, 708 52, Czechia
Fakultni nemocnice Plzen ( Site 3102)
Pilsen, Plzeň Region, 304 60, Czechia
Masarykuv onkologicky ustav ( Site 3103)
Brno, South Moravian, 65653, Czechia
Nemocnice AGEL Novy Jicin a.s. ( Site 3104)
Nový Jičín, 74101, Czechia
Fakultni nemocnice Olomouc ( Site 3100)
Olomouc, 779 00, Czechia
Fakultni Thomayerova nemocnice ( Site 3101)
Prague, 140 59, Czechia
Rigshospitalet ( Site 3202)
Copenhagen, Capital Region, 2100, Denmark
Aalborg University Hospital ( Site 3204)
Aalborg, North Denmark, 9000, Denmark
Odense Universitets Hospital ( Site 3201)
Odense, Region Syddanmark, 5000, Denmark
CHU de Rouen ( Site 1006)
Rouen, Ain, 76000, France
CHU-Jean Minjoz ( Site 1002)
Besançon, Doubs, 25030, France
C.H.R.U. de Brest - Hopital Morvan ( Site 1007)
Brest, Finistere, 29200, France
Centre Oscar Lambret ( Site 1003)
Lille, Nord, 59000, France
Institut de Cancerologie de l Ouest Centre Rene Gauducheau ( Site 1004)
Saint-Herblain, Val-de-Marne, 44805, France
Institut Gustave Roussy ( Site 1000)
Villejuif, Val-de-Marne, 94805, France
CHU Hopital Saint Antoine ( Site 1001)
Paris, 75012, France
SLK-Kliniken Heilbronn ( Site 1104)
Heilbronn, Baden-Wurttemberg, 74078, Germany
Universitaetsklinikum Leipzig ( Site 1114)
Leipzig, Saxony, 04103, Germany
Charite Universitaetsmedizin Berlin ( Site 1101)
Berlin, 13353, Germany
Facharztzentrum Eppendorf ( Site 1121)
Hamburg, 20249, Germany
Asklepios Klinik Altona ( Site 1100)
Hamburg, 22763, Germany
Celan SA ( Site 0705)
Guatemala City, 01010, Guatemala
Oncomedica ( Site 0702)
Guatemala City, 01010, Guatemala
Grupo Angeles SA ( Site 0701)
Guatemala City, 01015, Guatemala
MEDI-K CAYALA ( Site 0704)
Guatemala City, 01016, Guatemala
Centro Regional de Sub Especialidades Medicas SA ( Site 0703)
Quetzaltenango, 09001, Guatemala
Prince of Wales Hospital ( Site 2503)
Hong Kong, Hong Kong
Princess Margaret Hospital. ( Site 2502)
Hong Kong, Hong Kong
Queen Mary Hospital ( Site 2501)
Hong Kong, Hong Kong
Bacs-Kiskun Megyei Korhaz ( Site 3306)
Kecskemét, Bács-Kiskun county, 6000, Hungary
Jasz-Nagykun-Szolnok Megyei Hetenyi Gyula Korhaz-Rendelointezet ( Site 3302)
Szolnok, Jász-Nagykun-Szolnok, 5004, Hungary
Semmelweis Egyetem.. ( Site 3305)
Budapest, 1083, Hungary
Orszagos Onkologiai Intezet ( Site 3303)
Budapest, 1122, Hungary
University of Debrecen Medical Center Clinic of Oncology ( Site 3300)
Debrecen, 4032, Hungary
St. James s Hospital ( Site 1200)
Dublin, D08 W9RT, Ireland
Beaumont Hospital ( Site 2101)
Dublin, D09V2N0, Ireland
Tallaght University Hospital ( Site 1202)
Dublin, D24 NR0A, Ireland
Hadassah Ein Karem Jerusalem ( Site 1301)
Jerusalem, Jerusalem, 9112001, Israel
Chaim Sheba Medical Center ( Site 1304)
Ramat Gan, Tel Aviv, 5266202, Israel
Edith Wolfson Medical Center ( Site 1307)
Holon, Tell Abib, 5822012, Israel
Sourasky Medical Center ( Site 1306)
Tel Aviv, Tell Abib, 6423906, Israel
Soroka University Medical Center ( Site 1305)
Beersheba, 8410101, Israel
Rambam Medical Center ( Site 1303)
Haifa, 3109601, Israel
Meir Medical Center ( Site 1308)
Kfar Saba, 4428164, Israel
Rabin Medical Center ( Site 1302)
Petah Tikva, 4941492, Israel
Istituto Europeo di Oncologia ( Site 1411)
Milan, Lombardy, 20141, Italy
Istituto Nazionale dei Tumori Fondazione IRCSS ( Site 1402)
Milan, 20133, Italy
Istituto Oncologico Veneto ( Site 1412)
Padua, 35128, Italy
Azienda Ospedaliera San Camillo Forlanini ( Site 1413)
Roma, 00152, Italy
Aichi Cancer Center Hospital ( Site 2619)
Nagoya, Aichi-ken, 464-8681, Japan
National Cancer Center Hospital East ( Site 2617)
Kashiwa, Chiba, 277-8577, Japan
Hyogo Cancer Center ( Site 2604)
Akashi, Hyōgo, 673-8558, Japan
Kobe City Medical Center General Hospital ( Site 2603)
Kobe, Hyōgo, 650-0047, Japan
Ibaraki Prefectural Central Hospital ( Site 2610)
Kasama, Ibaraki, 309-1793, Japan
Kagawa University Hospital ( Site 2615)
Kita-gun, Kagawa-ken, 761-0793, Japan
Kitasato University Hospital ( Site 2618)
Sagamihara, Kanagawa, 252-0375, Japan
Kanagawa Cancer Center ( Site 2614)
Yokohama, Kanagawa, 241-8515, Japan
Kansai Medical University Hospital ( Site 2608)
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 2601)
Kitaadachi-gun, Saitama, 362-0806, Japan
National Hospital Organization Kyushu Cancer Center ( Site 2612)
Fukuoka, 811-1395, Japan
Hiroshima City Hiroshima Citizens Hospital ( Site 2611)
Hiroshima, 730-8518, Japan
Kumamoto University Hospital ( Site 2602)
Kumamoto, 860-8556, Japan
Niigata Cancer Center Hospital ( Site 2613)
Niigata, 951-8566, Japan
Osaka International Cancer Institute ( Site 2607)
Osaka, 541-8567, Japan
National Cancer Center Hospital ( Site 2606)
Tokyo, 104-0045, Japan
Tokyo Metropolitan Komagome Hospital ( Site 2605)
Tokyo, 113-8677, Japan
The Cancer Institute Hospital of JFCR ( Site 2609)
Tokyo, 135-8550, Japan
Hospital Civil de Guadalajara Fray Antonio Alcalde ( Site 0808)
Guadalajara, Jalisco, 44280, Mexico
Christus Muguerza Clinica Vidriera ( Site 0802)
Monterrey, Nuevo León, 64570, Mexico
Instituto Nacional de Cancerologia. ( Site 0804)
Mexico City, 14080, Mexico
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran ( Site 0806)
Mexico City, 14080, Mexico
Medical Care and Research S.A. de C.V. ( Site 0809)
Mérida, 97070, Mexico
Auckland City Hospital ( Site 2700)
Auckland, Northland, 1023, New Zealand
Clinica Ricardo Palma Instituto de Oncologia y Radioterapia ( Site 0908)
Lima, 15036, Peru
Instituto Nacional de Enfermedades Neoplasicas ( Site 0901)
Lima, 15038, Peru
Hospital Nacional Arzobispo Loayza ( Site 0902)
Lima, 15082, Peru
Clinica San Gabriel ( Site 0907)
Lima, 15088, Peru
Przychodnia Lekarska Komed ( Site 1514)
Konin, Greater Poland Voivodeship, 62-500, Poland
Szpital Uniwersytecki w Krakowie ( Site 1503)
Krakow, Lesser Poland Voivodeship, 31-501, Poland
Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego ( Site 1506)
Wroclaw, Lower Silesian Voivodeship, 50-556, Poland
Dolnoslaskie Centrum Onkologii we Wroclawiu ( Site 1504)
Wroclaw, Lower Silesian Voivodeship, 53-413, Poland
Magodent Szpital Elblaska ( Site 1509)
Warsaw, Masovian Voivodeship, 01-748, Poland
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy w Warszawie (
Warsaw, Masovian Voivodeship, 02-781, Poland
Regionalny Szpital Specjalistyczny im Wl. Bieganskiego w Grudziadzu ( Site 1505)
Grudziądz, 86-300, Poland
Chelyabinsk Regional Clinical Oncology Dispensary-Chemotherapy ( Site 1608)
Chelyabinsk, Chelyabinsk Oblast, 454087, Russia
SBHI Leningrad Regional Clinical Hospital ( Site 1616)
Saint Petersburg, Leningradskaya Oblast', 194291, Russia
Blokhin National Medical Oncology ( Site 1604)
Moscow, Moscow, 115478, Russia
Central Clinical Hospital with Polyclinic ( Site 1614)
Moscow, Moscow, 121359, Russia
SBHI Samara Regional Clinical Oncology Dispensary ( Site 1609)
Samara, Samara Oblast, 443031, Russia
City Clinical Oncology Center ( Site 1603)
Saint Petersburg, Sankt-Peterburg, 198255, Russia
Cancer Care Langenhoven Drive Oncology Centre ( Site 1708)
Port Elizabeth, Eastern Cape, 6045, South Africa
Universitas Annex National Hospital ( Site 1701)
Bloemfontein, Free State, 9301, South Africa
Sandton Oncology Medical Group PTY LTD ( Site 1700)
Johannesburg, Gauteng, 2196, South Africa
Wits Clinical Research ( Site 1707)
Parktown-Johannesburg, Gauteng, 2193, South Africa
Tshwane District Hospital ( Site 1702)
Pretoria, Gauteng, 0002, South Africa
The Oncology Centre Overport and Umhlanga ( Site 1705)
Durban, KwaZulu-Natal, 4091, South Africa
Cancercare Rondebosch Oncology ( Site 1709)
Cape Town, Western Cape, 7700, South Africa
Groote Schuur Hospital ( Site 1706)
Cape Town, Western Cape, 7925, South Africa
Outeniqua Cancercare Oncology Unit ( Site 1704)
George, Western Cape, 6530, South Africa
Cape Town Oncology Trials Pty Ltd ( Site 1703)
Kraaifontein, Western Cape, 7570, South Africa
Seoul National University Hospital ( Site 2803)
Seoul, 03080, South Korea
Severance Hospital Yonsei University Health System ( Site 2800)
Seoul, 03722, South Korea
Asan Medical Center ( Site 2802)
Seoul, 05505, South Korea
Samsung Medical Center ( Site 2801)
Seoul, 06351, South Korea
Hospital General Universitario de Elche ( Site 1803)
Elche, Alicante, 03203, Spain
Institut Catala d Oncologia Hospital Germans Trias i Pujol ( Site 1806)
Badalona, Barcelona, 08916, Spain
Hospital Universitario Marques de Valdecilla ( Site 1804)
Santander, Cantabria, 39008, Spain
HOSPITAL UNIVERSITARIO QUIRONSALUD MADRID-ONCOLOGIA MEDICA ( Site 1805)
Pozuelo de Alarcón, Madrid, 28223, Spain
Hospital Universitario General de Asturias ( Site 1802)
Oviedo, Principality of Asturias, 33011, Spain
Hospital General Universitari Vall d Hebron ( Site 1801)
Barcelona, 08035, Spain
Universitaetsspital Basel ( Site 1900)
Basel, Canton of Basel-City, 4056, Switzerland
Hopitaux Universitaires de Geneve HUG ( Site 1907)
Geneva, Canton of Geneva, 1211, Switzerland
Kantonsspital St. Gallen ( Site 1901)
Sankt Gallen, Canton of St. Gallen, 9007, Switzerland
Universitaetsspital Zuerich ( Site 1902)
Zurich, Canton of Zurich, 8091, Switzerland
Istituto Oncologica della Svizzera Italiana (IOSI) ( Site 1905)
Bellinzona, Canton Ticino, 6500, Switzerland
Kantonsspital Graubuenden ( Site 1903)
Chur, Kanton Graubünden, 7000, Switzerland
Luzern Kantonsspital ( Site 1904)
Lucerne, 6000, Switzerland
Chang Gung Medical Foundation. Kaohsiung Branch ( Site 2902)
Kaohsiung City, 83301, Taiwan
National Cheng Kung University Hospital ( Site 2901)
Tainan, 70457, Taiwan
National Taiwan University Hospital ( Site 2900)
Taipei, 100225, Taiwan
Mackay Memorial Hospital ( Site 2903)
Taipei, 104, Taiwan
Adana Sehir Hastanesi ( Site 2002)
Adana, 01370, Turkey (Türkiye)
Hacettepe University Medical Faculty ( 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, 54000, Turkey (Türkiye)
City Clinical Hosp.4 of DCC ( Site 2201)
Dnipro, Dnipropetrovsk Oblast, 49102, Ukraine
MI Kryviy Rih Center of Dnipropetrovsk Regional Council ( Site 2200)
Kryviy Rih, Dnipropetrovsk Oblast, 50048, Ukraine
MI Precarpathian Clinical Oncology Center ( Site 2204)
Ivano-Frankivsk, Ivano-Frankivsk Oblast, 76018, Ukraine
Communal non profit enterprise Regional Clinical Oncology Center ( Site 2208)
Kharkiv, Kharkivs’ka Oblast’, 61070, Ukraine
Clinic of National Cancer Institute ( Site 2203)
Kyiv, Kyivska Oblast, 03022, Ukraine
Medical and Diagnostic Centre LLC Dobryi Prognoz ( Site 2205)
Kyiv, Kyivska Oblast, 03126, Ukraine
Lviv State Oncology Regional Treatment and Diagnostic Center ( Site 2210)
Lviv, Lviv Oblast, 79031, Ukraine
MI Odessa Regional Oncological Centre ( Site 2212)
Odesa, Odesa Oblast, 65055, Ukraine
Medical Centre LLC Oncolife ( Site 2202)
Zaporizhzhya, Zaporizhzhia Oblast, 69104, Ukraine
Kyiv City Clinical Oncology Centre ( Site 2213)
Kyiv, 03115, Ukraine
South Devon Healthcare Foundation Trust. Torbay Hospital ( Site 1205)
Torquay, Devon, TQ2 7AA, United Kingdom
Castle Hill Hospital ( Site 1201)
Cottingham, East Riding Of Yorkshire, HU16 5JQ, United Kingdom
University College London Hospital ( Site 1211)
London, London, City of, NW1 2PG, United Kingdom
St. Georges University Hospital NHS Foundation Trust ( Site 1204)
London, London, City of, SW17 0QT, United Kingdom
Related Publications (4)
Rha SY, Oh DY, Yanez P, Bai Y, Ryu MH, Lee J, Rivera F, Alves GV, Garrido M, Shiu KK, Fernandez MG, Li J, Lowery MA, Cil T, Cruz FM, Qin S, Luo S, Pan H, Wainberg ZA, Yin L, Bordia S, Bhagia P, Wyrwicz LS; KEYNOTE-859 investigators. Pembrolizumab plus chemotherapy versus placebo plus chemotherapy for HER2-negative advanced gastric cancer (KEYNOTE-859): a multicentre, randomised, double-blind, phase 3 trial. Lancet Oncol. 2023 Nov;24(11):1181-1195. doi: 10.1016/S1470-2045(23)00515-6. Epub 2023 Oct 21.
PMID: 37875143RESULTQin S, Bai Y, Li J, Pan H, Luo S, Qu Y, Ye F, Yang L, Liu T, Li W, Chen X, Yang J, Ying J, Lin X, Zhao L, Liang X, Mao Y, Guo R, Zuo Y, Bordia S, Li S. First-Line Pembrolizumab Plus Chemotherapy for HER2-Negative Advanced Gastric Cancer: China Subgroup Analysis of the Randomized Phase 3 KEYNOTE-859 Study. Adv Ther. 2025 Apr;42(4):1892-1906. doi: 10.1007/s12325-024-03069-4. Epub 2025 Mar 1.
PMID: 40025394RESULTYasui H, Aizawa M, Yamaguchi K, Kawazoe A, Hara H, Tsuda M, Shoji H, Sugimoto N, Shibata N, Amagai K, Choda Y, Iwagami S, Esaki T, Kadowaki S, Shiratori S, Han S, Bordia S, Shitara K. First-line pembrolizumab plus chemotherapy for participants in Japan with gastric or gastroesophageal junction adenocarcinoma: subgroup analysis of the phase 3 KEYNOTE-859 study. Int J Clin Oncol. 2025 Oct;30(10):2003-2011. doi: 10.1007/s10147-025-02847-6. Epub 2025 Aug 1.
PMID: 40750941DERIVEDTabernero J, Bang YJ, Van Cutsem E, Fuchs CS, Janjigian YY, Bhagia P, Li K, Adelberg D, Qin SK. KEYNOTE-859: a Phase III study of pembrolizumab plus chemotherapy in gastric/gastroesophageal junction adenocarcinoma. Future Oncol. 2021 Aug;17(22):2847-2855. doi: 10.2217/fon-2021-0176. Epub 2021 May 12.
PMID: 33975465DERIVED
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
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 17, 2018
First Posted
September 18, 2018
Study Start
November 8, 2018
Primary Completion
October 3, 2022
Study Completion
March 3, 2025
Last Updated
February 27, 2026
Results First Posted
October 12, 2023
Record last verified: 2026-02
Data Sharing
- IPD Sharing
- Will share
https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf