Clinical trial NCT03675737: Pembrolizumab (MK-3475) Plus Chemotherapy Versus Placebo Plus Chemotherapy in Participants Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma (MK-3475-859/KEYNOTE-859)
Official title: A Phase 3, Randomized, Double-blind Clinical Study of Pembrolizumab (MK-3475) Plus Chemotherapy Versus Placebo Plus Chemotherapy as First-line Treatment in Participants With HER2 Negative, Previously Untreated, Unresectable or Metastatic Gastric Orgastroesophageal Junction Adenocarcinoma (KEYNOTE-859)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Stomach Neoplasms
Keywords: programmed cell death 1 (PD-1, PD1)
programmed cell death ligand 1 (PD-L1, PDL1)
programmed cell death ligand 2 (PD-L2, PDL2)
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2018-09-18
Enrollment: 1579
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


Eligibility criteria: Inclusion Criteria

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

Exclusion Criteria

* Has squamous cell or undifferentiated gastric cancer
* Has had major surgery, open biopsy, or significant traumatic injury within 28 days prior to randomization, anticipation of the need for major surgery during the course of study intervention, or has not recovered adequately from the toxicity and/or complications from previous surgery
* Has preexisting peripheral neuropathy \>Grade 1
* Is a WOCBP who has a positive urine pregnancy test within 24 hours for urine or within 72 hours for serum prior to randomization or treatment allocation
* Has had previous therapy for locally advanced, unresectable or metastatic gastric/GEJ cancer. Participants may have received prior neoadjuvant and/or adjuvant therapy as long as it was completed ≥6 months prior to randomization
* Has received prior therapy with an anti-programmed cell death (PD)-1, anti-PD-L1 or anti-programmed cell death ligand 2 (PD-L2) agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (e.g., cytotoxic T-lymphocyte-associated protein 4 (CTLA-4), OX- 40, CD137)
* Has received prior systemic anticancer therapy including investigational agents within 4 weeks prior to randomization or has not recovered from all adverse events (AEs) due to any previous therapies to ≤Grade 1 or baseline
* Has received prior radiotherapy within 2 weeks prior to study start or has not recovered from all previous radiation-related toxicities, required corticosteroids, and have not had radiation pneumonitis. A 1-week washout is permitted for palliative radiation (≤2 weeks of radiotherapy) to non-central nervous system (CNS) disease
* Has received a live or live-attenuated vaccine within 30 days prior to the first dose of study treatment
* Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to the first dose of study treatment
* Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of study treatment
* Has a known additional malignancy that is progressing or has required active treatment within the past 5 years with the exception of basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ (eg, breast carcinoma, cervical cancer in situ) that have undergone potentially curative therapy
* Has known active CNS metastases and/or carcinomatous meningitis
* Has severe hypersensitivity (≥Grade 3) to pembrolizumab and/or any of its excipients
* Has an active autoimmune disease that has required systemic treatment in past 2 years
* Has a history of (non-infectious) pneumonitis that required steroids or has current pneumonitis
* Has an active infection requiring systemic therapy
* Has a known history of human immunodeficiency virus (HIV) infection
* Has a known history of Hepatitis B (defined as Hepatitis B surface antigen \[HBsAg\] reactive) or known active Hepatitis C virus (defined as Hepatitis C virus \[HCV\] ribonucleic acid \[RNA\] detected qualitatively) infection
* Has a known history of active tuberculosis
* Has hypokalemia (serum potassium less than the lower limit of normal)
* Has hypomagnesemia (serum magnesium less than the lower limit of normal)
* Has hypocalcemia (serum calcium less than the lower limit of normal)
* Has a history or current evidence of any condition (eg, known deficiency of the enzyme dihydropyrimidine dehydrogenase), therapy, or laboratory abnormality that might confound the results of the study, interfere with the participant's participation for the full duration of the study, or is not in the best interest of the participant to participate, in the opinion of the treating investigator
* Has a known psychiatric or substance abuse disorder that would interfere with the participant's ability to cooperate with the requirements of the study
* Is pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the study, starting with the screening visit through 180 days after the last dose of chemotherapy or through 120 days after the last dose of pembrolizumab, whichever is last
* Has had an allogenic tissue/solid organ transplant
* Has a known severe hypersensitivity (≥ Grade 3) to any of the study chemotherapy agents (including, but not limited to, infusional 5-fluorouracil or oral capecitabine) and/or to any of their excipients
* For participants taking cisplatin: has Grade ≥2 audiometric hearing loss

Primary outcomes:
measure: Overall Survival (OS) in All Participants
timeFrame: Up to 45.9 months
measure: Overall Survival (OS) In Participants With Programmed Cell Death Ligand 1 (PD-L1) Combined Positive Score (CPS) ≥1
timeFrame: Up to 45.9 months
measure: Overall Survival (OS) In Participants With Programmed Cell Death Ligand 1 (PD-L1) Combined Positive Score (CPS) ≥10
timeFrame: Up to 45.9 months
Secondary outcomes:
measure: 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
timeFrame: Up to 49.5 months
measure: 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
timeFrame: Up to 49.5 months
measure: 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
timeFrame: Up to 49.5 months
measure: 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
timeFrame: Up to 49.5 months
measure: 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
timeFrame: Up to 49.5 months
measure: Objective Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) Assessed by Blinded Independent Central Review (BICR) in Participants With Programmed Cell Death Ligand 1 (PD-L1) Combined Positive Score (CPS) ≥10
timeFrame: Up to 49.5 months
measure: Duration of Response (DOR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) Assessed by Blinded Independent Central Review (BICR) in All Participants
timeFrame: Up to 49.5 months
measure: Duration of Response (DOR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) Assessed by Blinded Independent Central Review (BICR) in Participants With Programmed Cell Death Ligand 1 (PD-L1) Combined Positive Score (CPS) ≥1
timeFrame: Up to 49.5 months
measure: Duration of Response (DOR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) Assessed by Blinded Independent Central Review (BICR) in Participants With Programmed Cell Death Ligand 1 (PD-L1) Combined Positive Score (CPS) ≥10
timeFrame: Up to 49.5 months
measure: Number of Participants Who Experienced an Adverse Event (AE)
timeFrame: Up to 36.7 months
measure: Number of Participants Who Discontinued Study Treatment Due To an Adverse Event (AE)
timeFrame: Up to 33.7 months
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: UCLA Hematology/Oncology - Westwood (Building 200 Suite 120) ( Site 0124)
state: California
city: Orange
country: United States
facility: UC Irvine Health/Division of Hematology Oncology, Dept of Medicine ( Site 0128)
state: California
city: Miami
country: United States
facility: University of Miami, Sylvester Comprehensive Cancer Center ( Site 0113)
state: Florida
city: Baltimore
country: United States
facility: Greater Baltimore Medical Center ( Site 0102)
state: Maryland
city: Minneapolis
country: United States
facility: Minnesota Oncology Hematology, PA ( Site 8000)
state: Minnesota
city: Rochester
country: United States
facility: University of Rochester ( Site 0122)
state: New York
city: Philadelphia
country: United States
facility: Cancer Treatment Centers of America - Philadelphia ( Site 0112)
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Allegheny General Hospital ( Site 0118)
state: Pennsylvania
city: Roanoke
country: United States
facility: Oncology & Hematology Assoc. SW Virginia, Inc., DBA Blue Ridge Cancer Care ( Site 8001)
state: Virginia
city: Wenatchee
country: United States
facility: Wenatchee Valley Clinic [Wenatchee, WA] ( Site 0116)
state: Washington
city: Buenos Aires
country: Argentina
facility: Instituto Medico Alexander Fleming ( Site 0307)
state: Caba
city: Buenos Aires
country: Argentina
facility: Instituto de Investigaciones Metabolicas ( Site 0312)
city: Buenos Aires
country: Argentina
facility: Fundacion Favaloro - Hospital Universitario ( Site 0302)
city: La Rioja
country: Argentina
facility: Centro Oncologico Riojano Integral ( Site 0313)
city: San Juan
country: Argentina
facility: Instituto San Marcos ( Site 0311)
city: Liverpool
country: Australia
facility: Liverpool Hospital ( Site 2301)
state: New South Wales
city: Wollongong
country: Australia
facility: Southern Medical Day Care Centre ( Site 2303)
state: New South Wales
city: Box Hill
country: Australia
facility: Box Hill Hospital ( Site 2300)
state: Victoria
city: Fortaleza
country: Brazil
facility: Instituto do Cancer do Ceara ( Site 0407)
state: Ceara
city: Curitiba
country: Brazil
facility: CIONC - Centro Integrado de Oncologia de Curitiba ( Site 0405)
state: Parana
city: Ijui
country: Brazil
facility: Hospital de Caridade de Ijui ( Site 0402)
state: Rio Grande Do Sul
city: Porto Alegre
country: Brazil
facility: Hospital Nossa Senhora da Conceicao ( Site 0403)
state: Rio Grande Do Sul
city: Florianopolis
country: Brazil
facility: CEPON - Centro de Pesquisas Oncologicas ( Site 0400)
state: Santa Catarina
city: Rio de Janeiro
country: Brazil
facility: Instituto Nacional do Cancer Jose Alencar Gomes da Silva INCA ( Site 0401)
city: Sao Paulo
country: Brazil
facility: IBCC - Instituto Brasileiro de Controle do Cancer ( Site 0404)
city: Abbotsford
country: Canada
facility: BC Cancer - Abbotsford ( Site 0206)
state: British Columbia
city: Toronto
country: Canada
facility: Sunnybrook Research Institute ( Site 0202)
state: Ontario
city: Toronto
country: Canada
facility: Princess Margaret Cancer Centre ( Site 0203)
state: Ontario
city: Montreal
country: Canada
facility: McGill University Health Centre ( Site 0208)
state: Quebec
city: Temuco
country: Chile
facility: Instituto Clinico Oncologico del Sur ( Site 0500)
state: Araucania
city: Santiago
country: Chile
facility: Fundacion Arturo Lopez Perez FALP ( Site 0501)
state: Region M. De Santiago
city: Santiago
country: Chile
facility: Sociedad Oncovida S.A. ( Site 0508)
state: Region M. De Santiago
city: Santiago
country: Chile
facility: Pontificia Universidad Catolica de Chile ( Site 0502)
state: Region M. De Santiago
city: Beijing
country: China
facility: Cancer Hospital Chinese Academy of Medical Sciences ( Site 2421)
state: Beijing
city: Beijing
country: China
facility: Peking Union Medical College Hospital ( Site 2425)
state: Beijing
city: Fuzhou
country: China
facility: Fujian Medical University Union Hospital ( Site 2410)
state: Fujian
city: Fuzhou
country: China
facility: Fujian Provincial Cancer Hospital ( Site 2414)
state: Fujian
city: Fuzhou
country: China
facility: 900 Hospital of the Joint ( Site 2418)
state: Fujian
city: Xiamen
country: China
facility: The First Affiliated Hospital of Xiamen University ( Site 2430)
state: Fujian
city: Xiamen
country: China
facility: Zhongshan Hospital Xiamen University ( Site 2447)
state: Fujian
city: Guangzhou
country: China
facility: Guangdong General Hospital ( Site 2431)
state: Guangdong
city: Shenzhen
country: China
facility: Peking University Shenzhen Hospital ( Site 2442)
state: Guangdong
city: Shijiazhuang
country: China
facility: Fourth Hospital Of Hebei Medical University ( Site 2436)
state: Hebei
city: Harbin
country: China
facility: Harbin Medical University Cancer Hospital ( Site 2401)
state: Heilongjiang
city: Zhengzhou
country: China
facility: Henan Cancer Hospital ( Site 2415)
state: Henan
city: Wuhan
country: China
facility: Hubei Cancer Hospital ( Site 2434)
state: Hubei
city: Changsha
country: China
facility: Xiangya Hospital Central-South University ( Site 2419)
state: Hunan
city: Changsha
country: China
facility: Hunan Cancer Hospital ( Site 2439)
state: Hunan
city: Changzhou
country: China
facility: Changzhou Cancer Hospital-Changzhou Fourth Peoples Hospital ( Site 2441)
state: Jiangsu
city: Nanjing
country: China
facility: The 81st Hospital of PLA ( Site 2413)
state: Jiangsu
city: Nanjing
country: China
facility: Jiangsu Cancer Hospital ( Site 2432)
state: Jiangsu
city: Yancheng
country: China
facility: Yancheng First People s Hospital ( Site 2426)
state: Jiangsu
city: Nanchang
country: China
facility: The First Affiliated Hospital of Nanchang University ( Site 2440)
state: Jiangxi
city: Chang chun
country: China
facility: The First Hospital of Jilin University ( Site 2416)
state: Jilin
city: Qingdao
country: China
facility: The Affiliated Hospital of Qingdao University ( Site 2405)
state: Shandong
city: Shanghai
country: China
facility: Shanghai East Hospital ( Site 2403)
state: Shanghai
city: Shanghai
country: China
facility: Zhongshan Hospital affiliated to Fudan University ( Site 2407)
state: Shanghai
city: XiAn
country: China
facility: 1st Affil hosp of Med College of Xi'an Jiaotong University ( Site 2428)
state: Shanxi
city: Urumqi
country: China
facility: Cancer Hospital Affiliated to Xinjiang Medical University ( Site 2420)
state: Xinjiang
city: Hangzhou
country: China
facility: Zhejiang Provincial People's Hospital ( Site 2446)
state: Zhejiang
city: Hangzhou
country: China
facility: Sir Run Run Show Hospital ( Site 2427)
state: Zhejiang
city: Hangzhou
country: China
facility: Zhejiang Cancer Hospital ( Site 2417)
state: Zhejiang
city: Valledupar
country: Colombia
facility: Sociedad de Oncología Y Hematología del Cesar S.A.S. ( Site 0608)
state: Cesar
city: Monteria
country: Colombia
facility: Oncomedica S.A. ( Site 0606)
state: Cordoba
city: Bogota
country: Colombia
facility: Instituto Nacional de Cancerologia E.S.E ( Site 0605)
state: Distrito Capital De Bogota
city: Cali
country: Colombia
facility: Centro Medico Imbanaco de Cali S.A ( Site 0604)
state: Valle Del Cauca
city: San Jose
country: Costa Rica
facility: CIMCA Centro de Investigacion y Manejo del Cancer ( Site 3001)
city: San Jose
country: Costa Rica
facility: Policlinico San Bosco ( Site 3002)
city: San Jose
country: Costa Rica
facility: ICIMED - Instituto de Investigacion en Ciencias Medicas ( Site 3000)
city: Brno
country: Czechia
facility: Masarykuv onkologicky ustav ( Site 3103)
state: Jihomoravsky Kraj
city: Ostrava
country: Czechia
facility: FN Ostrava ( Site 3105)
state: Moravskoslezsky Kraj
city: Plzen
country: Czechia
facility: Fakultni nemocnice Plzen ( Site 3102)
state: Plzensky Kraj
city: Novy Jicin
country: Czechia
facility: Nemocnice AGEL Novy Jicin a.s. ( Site 3104)
city: Olomouc
country: Czechia
facility: Fakultni nemocnice Olomouc ( Site 3100)
city: Praha 4
country: Czechia
facility: Fakultni Thomayerova nemocnice ( Site 3101)
city: Copenhagen
country: Denmark
facility: Rigshospitalet ( Site 3202)
state: Hovedstaden
city: Aalborg
country: Denmark
facility: Aalborg University Hospital ( Site 3204)
state: Nordjylland
city: Odense
country: Denmark
facility: Odense Universitets Hospital ( Site 3201)
state: Syddanmark
city: Rouen
country: France
facility: CHU de Rouen ( Site 1006)
state: Ain
city: Besancon
country: France
facility: CHU-Jean Minjoz ( Site 1002)
state: Doubs
city: Brest
country: France
facility: C.H.R.U. de Brest - Hopital Morvan ( Site 1007)
state: Finistere
city: Lille
country: France
facility: Centre Oscar Lambret ( Site 1003)
state: Nord
city: Saint-Herblain
country: France
facility: Institut de Cancerologie de l Ouest Centre Rene Gauducheau ( Site 1004)
state: Val-de-Marne
city: Villejuif
country: France
facility: Institut Gustave Roussy ( Site 1000)
state: Val-de-Marne
city: Paris
country: France
facility: CHU Hopital Saint Antoine ( Site 1001)
city: Heilbronn
country: Germany
facility: SLK-Kliniken Heilbronn ( Site 1104)
state: Baden-Wurttemberg
city: Leipzig
country: Germany
facility: Universitaetsklinikum Leipzig ( Site 1114)
state: Sachsen
city: Berlin
country: Germany
facility: Charite Universitaetsmedizin Berlin ( Site 1101)
city: Hamburg
country: Germany
facility: Facharztzentrum Eppendorf ( Site 1121)
city: Hamburg
country: Germany
facility: Asklepios Klinik Altona ( Site 1100)
city: Guatemala
country: Guatemala
facility: Celan SA ( Site 0705)
city: Guatemala
country: Guatemala
facility: Oncomedica ( Site 0702)
city: Guatemala
country: Guatemala
facility: Grupo Angeles SA ( Site 0701)
city: Guatemala
country: Guatemala
facility: MEDI-K CAYALA ( Site 0704)
city: Quetzaltenango
country: Guatemala
facility: Centro Regional de Sub Especialidades Medicas SA ( Site 0703)
city: Hong Kong
country: Hong Kong
facility: Prince of Wales Hospital ( Site 2503)
city: Hong Kong
country: Hong Kong
facility: Princess Margaret Hospital. ( Site 2502)
city: Hong Kong
country: Hong Kong
facility: Queen Mary Hospital ( Site 2501)
city: Kecskemet
country: Hungary
facility: Bacs-Kiskun Megyei Korhaz ( Site 3306)
state: Bacs-Kiskun
city: Szolnok
country: Hungary
facility: Jasz-Nagykun-Szolnok Megyei Hetenyi Gyula Korhaz-Rendelointezet ( Site 3302)
state: Jasz-Nagykun-Szolnok
city: Budapest
country: Hungary
facility: Semmelweis Egyetem.. ( Site 3305)
city: Budapest
country: Hungary
facility: Orszagos Onkologiai Intezet ( Site 3303)
city: Debrecen
country: Hungary
facility: University of Debrecen Medical Center Clinic of Oncology ( Site 3300)
city: Dublin
country: Ireland
facility: St. James s Hospital ( Site 1200)
city: Dublin
country: Ireland
facility: Beaumont Hospital ( Site 2101)
city: Dublin
country: Ireland
facility: Tallaght University Hospital ( Site 1202)
city: Ramat Gan
country: Israel
facility: Chaim Sheba Medical Center ( Site 1304)
state: Tel Aviv
city: Holon
country: Israel
facility: Edith Wolfson Medical Center ( Site 1307)
state: Tell Abib
city: Tel Aviv
country: Israel
facility: Sourasky Medical Center ( Site 1306)
state: Tell Abib
city: Jerusalem
country: Israel
facility: Hadassah Ein Karem Jerusalem ( Site 1301)
state: Yerushalayim
city: Beer Sheva
country: Israel
facility: Soroka University Medical Center ( Site 1305)
city: Haifa
country: Israel
facility: Rambam Medical Center ( Site 1303)
city: Kfar Saba
country: Israel
facility: Meir Medical Center ( Site 1308)
city: Petah Tikva
country: Israel
facility: Rabin Medical Center ( Site 1302)
city: Milano
country: Italy
facility: Istituto Europeo di Oncologia ( Site 1411)
state: Lombardia
city: Milano
country: Italy
facility: Istituto Nazionale dei Tumori Fondazione IRCSS ( Site 1402)
city: Padova
country: Italy
facility: Istituto Oncologico Veneto ( Site 1412)
city: Roma
country: Italy
facility: Azienda Ospedaliera San Camillo Forlanini ( Site 1413)
city: Nagoya
country: Japan
facility: Aichi Cancer Center Hospital ( Site 2619)
state: Aichi
city: Kashiwa
country: Japan
facility: National Cancer Center Hospital East ( Site 2617)
state: Chiba
city: Akashi
country: Japan
facility: Hyogo Cancer Center ( Site 2604)
state: Hyogo
city: Kobe
country: Japan
facility: Kobe City Medical Center General Hospital ( Site 2603)
state: Hyogo
city: Kasama
country: Japan
facility: Ibaraki Prefectural Central Hospital ( Site 2610)
state: Ibaraki
city: Kita-gun
country: Japan
facility: Kagawa University Hospital ( Site 2615)
state: Kagawa
city: Sagamihara
country: Japan
facility: Kitasato University Hospital ( Site 2618)
state: Kanagawa
city: Yokohama
country: Japan
facility: Kanagawa Cancer Center ( Site 2614)
state: Kanagawa
city: Hirakata
country: Japan
facility: Kansai Medical University Hospital ( Site 2608)
state: Osaka
city: Osakasayama
country: Japan
facility: Kindai University Hospital ( Site 2616)
state: Osaka
city: Suita
country: Japan
facility: Osaka University Hospital ( Site 2600)
state: Osaka
city: Kitaadachi-gun
country: Japan
facility: Saitama Cancer Center ( Site 2601)
state: Saitama
city: Fukuoka
country: Japan
facility: National Hospital Organization Kyushu Cancer Center ( Site 2612)
city: Hiroshima
country: Japan
facility: Hiroshima City Hiroshima Citizens Hospital ( Site 2611)
city: Kumamoto
country: Japan
facility: Kumamoto University Hospital ( Site 2602)
city: Niigata
country: Japan
facility: Niigata Cancer Center Hospital ( Site 2613)
city: Osaka
country: Japan
facility: Osaka International Cancer Institute ( Site 2607)
city: Tokyo
country: Japan
facility: National Cancer Center Hospital ( Site 2606)
city: Tokyo
country: Japan
facility: Tokyo Metropolitan Komagome Hospital ( Site 2605)
city: Tokyo
country: Japan
facility: The Cancer Institute Hospital of JFCR ( Site 2609)
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital ( Site 2803)
city: Seoul
country: Korea, Republic of
facility: Severance Hospital Yonsei University Health System ( Site 2800)
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center ( Site 2802)
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center ( Site 2801)
city: Guadalajara
country: Mexico
facility: Hospital Civil de Guadalajara Fray Antonio Alcalde ( Site 0808)
state: Jalisco
city: Monterrey
country: Mexico
facility: Christus Muguerza Clinica Vidriera ( Site 0802)
state: Nuevo Leon
city: Ciudad de Mexico
country: Mexico
facility: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran ( Site 0806)
city: Merida
country: Mexico
facility: Medical Care and Research S.A. de C.V. ( Site 0809)
city: Mexico City
country: Mexico
facility: Instituto Nacional de Cancerologia. ( Site 0804)
city: Auckland
country: New Zealand
facility: Auckland City Hospital ( Site 2700)
state: Northland
city: Lima
country: Peru
facility: Clinica Ricardo Palma Instituto de Oncologia y Radioterapia ( Site 0908)
city: Lima
country: Peru
facility: Instituto Nacional de Enfermedades Neoplasicas ( Site 0901)
city: Lima
country: Peru
facility: Hospital Nacional Arzobispo Loayza ( Site 0902)
city: Lima
country: Peru
facility: Clinica San Gabriel ( Site 0907)
city: Wroclaw
country: Poland
facility: Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego ( Site 1506)
state: Dolnoslaskie
city: Wroclaw
country: Poland
facility: Dolnoslaskie Centrum Onkologii we Wroclawiu ( Site 1504)
state: Dolnoslaskie
city: Krakow
country: Poland
facility: Szpital Uniwersytecki w Krakowie ( Site 1503)
state: Malopolskie
city: Warszawa
country: Poland
facility: Magodent Szpital Elblaska ( Site 1509)
state: Mazowieckie
city: Warszawa
country: Poland
facility: Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy w Warszawie (
state: Mazowieckie
city: Konin
country: Poland
facility: Przychodnia Lekarska Komed ( Site 1514)
state: Wielkopolskie
city: Grudziadz
country: Poland
facility: Regionalny Szpital Specjalistyczny im Wl. Bieganskiego w Grudziadzu ( Site 1505)
city: Chelyabinsk
country: Russian Federation
facility: Chelyabinsk Regional Clinical Oncology Dispensary-Chemotherapy ( Site 1608)
state: Chelyabinskaya Oblast
city: Saint Petersburg
country: Russian Federation
facility: SBHI Leningrad Regional Clinical Hospital ( Site 1616)
state: Leningradskaya Oblast
city: Moscow
country: Russian Federation
facility: Blokhin National Medical Oncology ( Site 1604)
state: Moskva
city: Moscow
country: Russian Federation
facility: Central Clinical Hospital with Polyclinic ( Site 1614)
state: Moskva
city: Samara
country: Russian Federation
facility: SBHI Samara Regional Clinical Oncology Dispensary ( Site 1609)
state: Samarskaya Oblast
city: Saint Petersburg
country: Russian Federation
facility: City Clinical Oncology Center ( Site 1603)
state: Sankt-Peterburg
city: Port Elizabeth
country: South Africa
facility: Cancer Care Langenhoven Drive Oncology Centre ( Site 1708)
state: Eastern Cape
city: Bloemfontein
country: South Africa
facility: Universitas Annex National Hospital ( Site 1701)
state: Free State
city: Johannesburg
country: South Africa
facility: Sandton Oncology Medical Group PTY LTD ( Site 1700)
state: Gauteng
city: Parktown-Johannesburg
country: South Africa
facility: Wits Clinical Research ( Site 1707)
state: Gauteng
city: Pretoria
country: South Africa
facility: Tshwane District Hospital ( Site 1702)
state: Gauteng
city: Durban
country: South Africa
facility: The Oncology Centre Overport and Umhlanga ( Site 1705)
state: Kwazulu-Natal
city: Cape Town
country: South Africa
facility: Cancercare Rondebosch Oncology ( Site 1709)
state: Western Cape
city: Cape Town
country: South Africa
facility: Groote Schuur Hospital ( Site 1706)
state: Western Cape
city: George
country: South Africa
facility: Outeniqua Cancercare Oncology Unit ( Site 1704)
state: Western Cape
city: Kraaifontein
country: South Africa
facility: Cape Town Oncology Trials Pty Ltd ( Site 1703)
state: Western Cape
city: Elche
country: Spain
facility: Hospital General Universitario de Elche ( Site 1803)
state: Alicante
city: Oviedo
country: Spain
facility: Hospital Universitario General de Asturias ( Site 1802)
state: Asturias
city: Badalona
country: Spain
facility: Institut Catala d Oncologia Hospital Germans Trias i Pujol ( Site 1806)
state: Barcelona
city: Santander
country: Spain
facility: Hospital Universitario Marques de Valdecilla ( Site 1804)
state: Cantabria
city: Pozuelo de Alarcon
country: Spain
facility: HOSPITAL UNIVERSITARIO QUIRONSALUD MADRID-ONCOLOGIA MEDICA ( Site 1805)
state: Madrid
city: Barcelona
country: Spain
facility: Hospital General Universitari Vall d Hebron ( Site 1801)
city: Basel
country: Switzerland
facility: Universitaetsspital Basel ( Site 1900)
state: Basel-Stadt
city: Geneva
country: Switzerland
facility: Hopitaux Universitaires de Geneve HUG ( Site 1907)
state: Geneve
city: Chur
country: Switzerland
facility: Kantonsspital Graubuenden ( Site 1903)
state: Grisons
city: St. Gallen
country: Switzerland
facility: Kantonsspital St. Gallen ( Site 1901)
state: Sankt Gallen
city: Bellinzona
country: Switzerland
facility: Istituto Oncologica della Svizzera Italiana (IOSI) ( Site 1905)
state: Ticino
city: Zuerich
country: Switzerland
facility: Universitaetsspital Zuerich ( Site 1902)
state: Zurich
city: Luzern
country: Switzerland
facility: Luzern Kantonsspital ( Site 1904)
city: Kaohsiung
country: Taiwan
facility: Chang Gung Medical Foundation. Kaohsiung Branch ( Site 2902)
city: Tainan
country: Taiwan
facility: National Cheng Kung University Hospital ( Site 2901)
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital ( Site 2900)
city: Taipei
country: Taiwan
facility: Mackay Memorial Hospital ( Site 2903)
city: Adana
country: Turkey
facility: Adana Sehir Hastanesi ( Site 2002)
city: Ankara
country: Turkey
facility: Hacettepe University Medical Faculty ( Site 2017)
city: Ankara
country: Turkey
facility: Abdurrahman Yurtaslan Onkoloji Egitim ve Arastirma Hastanesi ( Site 2006)
city: Edirne
country: Turkey
facility: Trakya Universitesi Tip Fakultesi ( Site 2015)
city: Erzurum
country: Turkey
facility: Ataturk Universitesi Tip Fakultesi Hastanesi ( Site 2000)
city: Istanbul
country: Turkey
facility: Istanbul Universitesi Cerrahpasa Tip Fakultesi ( Site 2001)
city: Izmir
country: Turkey
facility: Dokuz Eylul Universitesi Tip Fakultesi Hastanesi ( Site 2011)
city: Malatya
country: Turkey
facility: Malatya Inonu Universitesi Tip Fakultesi Hastanesi ( Site 2009)
city: Sakarya
country: Turkey
facility: Sakarya Universitesi Egitim ve Arastirma Hastanesi ( Site 2012)
city: Dnipro
country: Ukraine
facility: City Clinical Hosp.4 of DCC ( Site 2201)
state: Dnipropetrovska Oblast
city: Kryviy Rih
country: Ukraine
facility: MI Kryviy Rih Center of Dnipropetrovsk Regional Council ( Site 2200)
state: Dnipropetrovska Oblast
city: Ivano-Frankivsk
country: Ukraine
facility: MI Precarpathian Clinical Oncology Center ( Site 2204)
state: Ivano-Frankivska Oblast
city: Kharkiv
country: Ukraine
facility: Communal non profit enterprise Regional Clinical Oncology Center ( Site 2208)
state: Kharkivska Oblast
city: Kyiv
country: Ukraine
facility: Clinic of National Cancer Institute ( Site 2203)
state: Kyivska Oblast
city: Kyiv
country: Ukraine
facility: Medical and Diagnostic Centre LLC Dobryi Prognoz ( Site 2205)
state: Kyivska Oblast
city: Lviv
country: Ukraine
facility: Lviv State Oncology Regional Treatment and Diagnostic Center ( Site 2210)
state: Lvivska Oblast
city: Odesa
country: Ukraine
facility: MI Odessa Regional Oncological Centre ( Site 2212)
state: Odeska Oblast
city: Zaporizhzhya
country: Ukraine
facility: Medical Centre LLC Oncolife ( Site 2202)
state: Zaporizka Oblast
city: Kyiv
country: Ukraine
facility: Kyiv City Clinical Oncology Centre ( Site 2213)
city: Torquay
country: United Kingdom
facility: South Devon Healthcare Foundation Trust. Torbay Hospital ( Site 1205)
state: Devon
city: Cottingham
country: United Kingdom
facility: Castle Hill Hospital ( Site 1201)
state: East Riding Of Yorkshire
city: London
country: United Kingdom
facility: University College London Hospital ( Site 1211)
state: London, City Of
city: London
country: United Kingdom
facility: St. Georges University Hospital NHS Foundation Trust ( Site 1204)
state: London, City Of
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Director
role: STUDY_DIRECTOR
References:
citation: 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.
citation: Tabernero 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.