Clinical trial NCT03615326: 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)
Official title: A Phase III, Randomized, Double-blind Trial Comparing Trastuzumab Plus Chemotherapy and Pembrolizumab With Trastuzumab Plus Chemotherapy and Placebo as First-line Treatment in Participants With HER2 Positive Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (KEYNOTE 811)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Gastric Neoplasms
Gastroesophageal Junction Adenocarcinoma
Keywords: programmed cell death receptor 1 (PD-1)
programmed cell death ligand 1 (PD-L1)
anti-PD-1
anti PD-1
GEJ
Gastric Cancer
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2018-08-03
Enrollment: 738
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 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).

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

Eligibility criteria: Inclusion Criteria:

Inclusion criteria include, but are not limited to:

* 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

Exclusion Criteria:

Exclusion criteria include, but are not limited to:

* 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
* A WOCBP who has a positive urine pregnancy test within 24 hours prior to randomization or treatment allocation
* Has active or clinically significant cardiac disease
* Has a known history of Human Immunodeficiency Virus (HIV) (HIV 1/2 antibodies)
* Has a known history of Hepatitis B (defined as Hepatitis B surface antigen \[HBsAg\] reactive) or known active Hepatitis C virus (defined as HCV RNA \[qualitative\] is detected) infection
* Has severe hypersensitivity (≥Grade 3) to pembrolizumab, trastuzumab, study chemotherapy agents and/or to any excipients, murine proteins, or platinum-containing products
* Has had an allogeneic tissue/solid organ transplant
* Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti PD L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (e.g., cytotoxic T-lymphocyte-associated protein 4 \[CTLA-4\], OX 40, Cluster of Differentiation 137 \[CD137\])

Primary outcomes:
measure: Progression Free Survival (PFS) Per RECIST 1.1 Assessed by BICR
timeFrame: Up to 46 months
measure: Overall Survival (OS)
timeFrame: Up to 63 months
Secondary outcomes:
measure: Objective Response Rate (ORR) Per RECIST 1.1 Assessed by BICR
timeFrame: Up to 63 months
measure: Duration of Response (DOR) Per RECIST 1.1 Assessed by BICR
timeFrame: Up to 63 months
measure: Number of Participants Who Experienced an Adverse Event (AE)
timeFrame: Up to 63 months
measure: Number of Participants Who Discontinued Study Treatment Due to AEs
timeFrame: Up to 63 months
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: UCLA Hematology/Oncology - Westwood (Building 200 Suite 120) ( Site 0045)
state: California
city: Monterey
country: United States
facility: Pacific Cancer Care ( Site 0063)
state: California
city: Orange
country: United States
facility: UC Irvine Medical Center/Chao Family Comprehensive Cancer Center ( Site 0050)
state: California
city: Miami
country: United States
facility: University of Miami Sylvester Comprehensive Cancer Center - Plantation ( Site 0026)
state: Florida
city: Newnan
country: United States
facility: Southeastern Regional Medical Center, Inc. ( Site 0058)
state: Georgia
city: Zion
country: United States
facility: Midwestern Regional Medical Center, Inc. ( Site 0059)
state: Illinois
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center ( Site 0070)
state: Massachusetts
city: Boston
country: United States
facility: Dana-Farber Cancer Institute [Boston, MA] ( Site 0010)
state: Massachusetts
city: Minneapolis
country: United States
facility: Minnesota Oncology Hematology, PA ( Site 8001)
state: Minnesota
city: Saint Louis
country: United States
facility: Washington University School of Medicine ( Site 0040)
state: Missouri
city: Middletown
country: United States
facility: Memorial Sloan Kettering Cancer Center- Monmouth ( Site 0071)
state: New Jersey
city: Harrison
country: United States
facility: Memorial Sloan-Kettering Cancer Center at West Harrison ( Site 0065)
state: New York
city: New York
country: United States
facility: Memorial Sloan-Kettering Cancer Center ( Site 0017)
state: New York
city: Rochester
country: United States
facility: University of Rochester ( Site 0041)
state: New York
city: Charlotte
country: United States
facility: Levine Cancer Institute ( Site 0015)
state: North Carolina
city: Durham
country: United States
facility: Duke Cancer Institute ( Site 0042)
state: North Carolina
city: Tulsa
country: United States
facility: CTCA Southwestern ( Site 0060)
state: Oklahoma
city: Philadelphia
country: United States
facility: Cancer Treatment Centers of America-Eastern Regional Medical Center ( Site 0025)
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Allegheny General Hospital ( Site 0053)
state: Pennsylvania
city: Sioux Falls
country: United States
facility: Sanford Hematology Oncology-Sioux Falls SD ( Site 0004)
state: South Dakota
city: Houston
country: United States
facility: University of Texas MD Anderson Cancer Center ( Site 0001)
state: Texas
city: Roanoke
country: United States
facility: Oncology & Hematology Assoc. SW Virginia, Inc., DBA Blue Ridge Cancer Care ( Site 8000)
state: Virginia
city: Seattle
country: United States
facility: Seattle Cancer Care Alliance ( Site 0038)
state: Washington
city: Liverpool
country: Australia
facility: Liverpool Hospital ( Site 2206)
state: New South Wales
city: Westmead
country: Australia
facility: Westmead Hospital ( Site 2200)
state: New South Wales
city: Wollongong
country: Australia
facility: Southern Medical Day Care Centre ( Site 2207)
state: New South Wales
city: Clayton
country: Australia
facility: Monash Health ( Site 2202)
state: Victoria
city: Salvador
country: Brazil
facility: Hospital Sao Rafael ( Site 0209)
state: Bahia
city: Fortaleza
country: Brazil
facility: Instituto do Cancer do Ceara ( Site 0208)
state: Ceara
city: Curitiba
country: Brazil
facility: CIONC - Centro Integrado de Oncologia de Curitiba ( Site 0205)
state: Parana
city: Ijui
country: Brazil
facility: Hospital de Caridade de Ijui ( Site 0202)
state: Rio Grande Do Sul
city: Porto Alegre
country: Brazil
facility: Hospital Nossa Senhora da Conceicao ( Site 0203)
state: Rio Grande Do Sul
city: Florianopolis
country: Brazil
facility: CEPON - Centro de Pesquisas Oncologicas ( Site 0200)
state: Santa Catarina
city: Rio de Janeiro
country: Brazil
facility: Instituto Nacional do Cancer Jose Alencar Gomes da Silva INCA ( Site 0201)
city: Sao Paulo
country: Brazil
facility: IBCC - Instituto Brasileiro de Controle do Cancer ( Site 0204)
city: Temuco
country: Chile
facility: Centro Investigación del Cáncer James Lind ( Site 0300)
state: Araucania
city: Talca
country: Chile
facility: Clinica Universidad Catolica del Maule ( Site 0305)
state: Maule
city: Santiago
country: Chile
facility: Fundacion Arturo Lopez Perez FALP ( Site 0302)
state: Region M. De Santiago
city: Santiago
country: Chile
facility: Pontificia Universidad Catolica de Chile ( Site 0301)
state: Region M. De Santiago
city: Santiago
country: Chile
facility: Instituto Nacional del Cancer ( Site 0303)
state: Region M. De Santiago
city: Shanghai
country: China
facility: Shanghai General Hospital ( Site 2404)
state: Anhui
city: Beijing
country: China
facility: Peking Union Medical College Hospital ( Site 2419)
state: Beijing
city: Beijing
country: China
facility: Fifth Medical Center of CPLA General Hospital ( Site 2415)
state: Beijing
city: Beijing
country: China
facility: Beijing Cancer Hospital ( Site 2413)
state: Beijing
city: Fuzhou
country: China
facility: Fujian Provincial Cancer Hospital ( Site 2418)
state: Fujian
city: Fuzhou
country: China
facility: 900 Hospital of the Joint ( Site 2420)
state: Fujian
city: Xiamen
country: China
facility: The First Affiliated Hospital of Xiamen University ( Site 2431)
state: Fujian
city: Guangzhou
country: China
facility: Guangdong General Hospital ( Site 2433)
state: Guangdong
city: Harbin
country: China
facility: Harbin Medical University Cancer Hospital ( Site 2407)
state: Heilongjiang
city: Zhengzhou
country: China
facility: Henan Cancer Hospital ( Site 2400)
state: Henan
city: Changsha
country: China
facility: Xiangya Hospital Central-South University ( Site 2426)
state: Hunan
city: Nanjing
country: China
facility: Jiangsu Cancer Hospital ( Site 2432)
state: Jiangsu
city: Chang chun
country: China
facility: The First Hospital Of Jilin University ( Site 2402)
state: Jilin
city: Shanghai
country: China
facility: Fudan University Shanghai Cancer Center ( Site 2424)
state: Shanghai
city: Shanghai
country: China
facility: Zhongshan Hospital affiliated to Fudan University ( Site 2401)
state: Shanghai
city: Urumqi
country: China
facility: Cancer Hospital Affiliated to Xinjiang Medical University ( Site 2430)
state: Xinjiang
city: Hangzhou
country: China
facility: The First Affiliated Hospital.Zhejiang University ( Site 2408)
state: Zhejiang
city: Hangzhou
country: China
facility: Sir Run Run Shaw Hospital ( Site 2412)
state: Zhejiang
city: Hangzhou
country: China
facility: Zhejiang Cancer Hospital ( Site 2409)
state: Zhejiang
city: Rouen
country: France
facility: CHU de Rouen ( Site 0912)
state: Ain
city: Strasbourg
country: France
facility: HUS Hopital Hautepierre ( Site 0910)
state: Bas-Rhin
city: Besancon
country: France
facility: Hopital Jean Minjoz Besancon ( Site 0901)
state: Doubs
city: Brest
country: France
facility: C.H.R.U. de Brest - Hopital Morvan ( Site 0913)
state: Finistere
city: Lille
country: France
facility: Centre Oscar Lambret ( Site 0911)
state: Nord
city: Lyon
country: France
facility: Centre Leon Berard ( Site 0904)
state: Rhone
city: Saint-Herblain
country: France
facility: Institut de Cancerologie de l Ouest Centre Rene Gauducheau ( Site 0902)
state: Val-de-Marne
city: Villejuif
country: France
facility: Institut Gustave Roussy ( Site 0900)
state: Val-de-Marne
city: Paris
country: France
facility: CHU Hopital Saint Antoine ( Site 0905)
city: Heilbronn
country: Germany
facility: SLK-Kliniken Heilbronn ( Site 1015)
state: Baden-Wurttemberg
city: Ludwigsburg
country: Germany
facility: Klinikum Ludwigsburg ( Site 1014)
state: Baden-Wurttemberg
city: Tuebingen
country: Germany
facility: Innere Medizin I, Universitaetsklinikum Tuebingen ( Site 1020)
state: Baden-Wurttemberg
city: Muenchen
country: Germany
facility: Klinikum rechts der Isar der Technischen Universitaet ( Site 1027)
state: Bayern
city: Hannover
country: Germany
facility: Medizinische Hochschule Hannover ( Site 1019)
state: Niedersachsen
city: Dresden
country: Germany
facility: Universitaetsklinikum Carl Gustav Carus der Technischen Univ ( Site 1001)
state: Sachsen
city: Leipzig
country: Germany
facility: Universitaetsklinikum Leipzig AOeR ( Site 1007)
state: Sachsen
city: Berlin
country: Germany
facility: Charite-Universitaetsmedizin Berlin Campus Virchow-Klinikum ( Site 1026)
city: Bremen
country: Germany
facility: Klinikum Bremen Nord ( Site 1017)
city: Hamburg
country: Germany
facility: Facharztzentrum Eppendorf ( Site 1025)
city: Hamburg
country: Germany
facility: Asklepios Klinik Altona ( Site 1000)
city: Guatemala
country: Guatemala
facility: Celan SA ( Site 0504)
city: Guatemala
country: Guatemala
facility: Oncomedica ( Site 0500)
city: Guatemala
country: Guatemala
facility: Grupo Angeles SA ( Site 0501)
city: Guatemala
country: Guatemala
facility: Nucare Center ( Site 0506)
city: Guatemala
country: Guatemala
facility: Medi-K Cayala ( Site 0505)
city: Quetzaltenango
country: Guatemala
facility: Centro Regional de Sub Especialidades Medicas SA ( Site 0502)
city: Dublin
country: Ireland
facility: Saint James's Hospital ( Site 1505)
city: Dublin
country: Ireland
facility: Beaumont Hospital ( Site 1506)
city: Dublin
country: Ireland
facility: Tallaght University Hospital ( Site 1513)
city: Beer Sheva
country: Israel
facility: Soroka University Medical Center ( Site 1603)
city: Haifa
country: Israel
facility: Rambam Health Care Campus ( Site 1606)
city: Holon
country: Israel
facility: Edith Wolfson Medical Center ( Site 1605)
city: Jerusalem
country: Israel
facility: Hadassah Ein Kerem Medical Center ( Site 1604)
city: Kfar-Saba
country: Israel
facility: Meir Medical Center ( Site 1609)
city: Petah Tikva
country: Israel
facility: Rabin Medical Center ( Site 1602)
city: Ramat Gan
country: Israel
facility: Chaim Sheba Medical Center. ( Site 1607)
city: Tel Aviv
country: Israel
facility: Sourasky Medical Center ( Site 1601)
city: Pisa
country: Italy
facility: AUOP Ospedale Santa Chiara ( Site 1100)
state: Toscana
city: Bergamo
country: Italy
facility: Humanitas Gavazzeni ( Site 1106)
city: Catanzaro
country: Italy
facility: Universita Magna Graecia di Catanzaro ( Site 1107)
city: Milano
country: Italy
facility: IEO Istituto Europeo di Oncologia ( Site 1105)
city: Modena
country: Italy
facility: Azienda Ospedaliero - Universitaria Policlinico di Modena ( Site 1102)
city: Napoli
country: Italy
facility: A.O.U. Universita degli Studi della Campania-Luigi Vanvitelli ( Site 1103)
city: Padova
country: Italy
facility: Istituto Oncologico Veneto ( Site 1101)
city: Pescara
country: Italy
facility: Ospedale Civile Spirito Santo ( Site 1104)
city: Nagoya
country: Japan
facility: Aichi Cancer Center Hospital ( Site 2617)
state: Aichi
city: Kashiwa
country: Japan
facility: National Cancer Center Hospital East ( Site 2605)
state: Chiba
city: Matsuyama
country: Japan
facility: National Hospital Organization Shikoku Cancer Center ( Site 2615)
state: Ehime
city: Ohta
country: Japan
facility: Gunma Prefectural Cancer Center ( Site 2602)
state: Gunma
city: Akashi
country: Japan
facility: Hyogo Cancer Center ( Site 2619)
state: Hyogo
city: Kobe
country: Japan
facility: Kobe City Medical Center General Hospital ( Site 2614)
state: Hyogo
city: Kasama
country: Japan
facility: Ibaraki Prefectural Central Hospital ( Site 2611)
state: Ibaraki
city: Kita-gun
country: Japan
facility: Kagawa University Hospital ( Site 2604)
state: Kagawa
city: Yokohama
country: Japan
facility: Kanagawa Cancer Center ( Site 2603)
state: Kanagawa
city: Osaki
country: Japan
facility: Osaki Citizen Hospital ( Site 2626)
state: Miyagi
city: Hirakata
country: Japan
facility: Kansai Medical University Hospital ( Site 2618)
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 2620)
state: Saitama
city: Sunto-gun
country: Japan
facility: Shizuoka Cancer Center Hospital and Research Institute ( Site 2607)
state: Shizuoka
city: Utsunomiya
country: Japan
facility: Tochigi Cancer Center ( Site 2627)
state: Tochigi
city: Mitaka
country: Japan
facility: Kyorin University Hospital ( Site 2608)
state: Tokyo
city: Chiba
country: Japan
facility: Chiba Cancer Center ( Site 2623)
city: Fukuoka
country: Japan
facility: National Hospital Organization Kyushu Cancer Center ( Site 2609)
city: Gifu
country: Japan
facility: Gifu University Hospital ( Site 2621)
city: Hiroshima
country: Japan
facility: Hiroshima City Hiroshima Citizens Hospital ( Site 2625)
city: Kumamoto
country: Japan
facility: Kumamoto University Hospital ( Site 2601)
city: Niigata
country: Japan
facility: Niigata Cancer Center Hospital ( Site 2622)
city: Osaka
country: Japan
facility: National Hospital Organization - Osaka National Hospital - Institute For Clinical Research ( Site 26
city: Osaka
country: Japan
facility: Osaka International Cancer Institute ( Site 2613)
city: Osaka
country: Japan
facility: Osaka General Medical Center ( Site 2624)
city: Tokyo
country: Japan
facility: National Cancer Center Hospital ( Site 2612)
city: Tokyo
country: Japan
facility: Toranomon Hospital ( Site 2628)
city: Tokyo
country: Japan
facility: Tokyo Metropolitan Komagome Hospital ( Site 2606)
city: Tokyo
country: Japan
facility: The Cancer Institute Hospital of JFCR ( Site 2610)
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital ( Site 2703)
city: Seoul
country: Korea, Republic of
facility: Severance Hospital Yonsei University Health System ( Site 2700)
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center ( Site 2702)
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center ( Site 2701)
city: Auckland
country: New Zealand
facility: Auckland City Hospital ( Site 2300)
city: Wroclaw
country: Poland
facility: Uniwersytecki Szpital Kliniczny im. J. M. Radeckiego we Wroclawiu ( Site 1705)
state: Dolnoslaskie
city: Wroclaw
country: Poland
facility: Dolnoslaskie Centrum Onkologii. ( Site 1712)
state: Dolnoslaskie
city: Lublin
country: Poland
facility: Samodzielny Publiczny Szpital Kliniczny Nr 1 w Lublinie ( Site 1709)
state: Lubelskie
city: Warszawa
country: Poland
facility: Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy w Warszawie (
state: Mazowieckie
city: Gdynia
country: Poland
facility: Szpital Morski im. PCK. Szpitale Pomorskie Sp. Z o.o ( Site 1715)
state: Pomorskie
city: Koscierzyna
country: Poland
facility: Szpital Specjalistyczny w Koscierzynie Sp. z o.o. ( Site 1708)
state: Pomorskie
city: Bielsko-Biala
country: Poland
facility: Beskidzkie Centrum Onkologii im. Jana Pawla II ( Site 1710)
state: Slaskie
city: Konin
country: Poland
facility: Przychodnia Lekarska Komed ( Site 1716)
state: Wielkopolskie
city: Ufa
country: Russian Federation
facility: Republican Clinical Oncology Dispensary of Republic of Bashkortostan ( Site 1807)
state: Baskortostan, Respublika
city: Chelyabinsk
country: Russian Federation
facility: Chelyabinsk Regional Clinical Oncological Dispensary ( Site 1815)
state: Chelyabinskaya Oblast
city: Podolsk
country: Russian Federation
facility: Podolsky City Clinical Hospital ( Site 1817)
state: Moskovskaya Oblast
city: Moscow
country: Russian Federation
facility: Blokhin National Medical Oncology ( Site 1805)
state: Moskva
city: Samara
country: Russian Federation
facility: Medical University REAVIZ ( Site 1816)
state: Samarskaya Oblast
city: Saint Petersburg
country: Russian Federation
facility: Scientific Research Oncology Institute n.a. N.N.Petrov ( Site 1801)
state: Sankt-Peterburg
city: Saint Petersburg
country: Russian Federation
facility: St Petersburg City Clinical Oncology Dispensary ( Site 1812)
state: Sankt-Peterburg
city: Saint-Petersburg
country: Russian Federation
facility: Leningrad Regional Oncology Center ( Site 1800)
state: Sankt-Peterburg
city: Elche
country: Spain
facility: Hospital General Universitario de Elche ( Site 1404)
state: Alicante
city: Oviedo
country: Spain
facility: Hospital Universitario Central de Asturias ( Site 1402)
state: Asturias
city: Badalona
country: Spain
facility: Hospital Germans Trias i Pujol. ICO de Badalona ( Site 1410)
state: Barcelona
city: Santander
country: Spain
facility: Hospital Universitario Marques de Valdecilla ( Site 1405)
state: Cantabria
city: Pozuelo de Alarcon
country: Spain
facility: Hospital Universitario Quiron Madrid ( Site 1407)
state: Madrid
city: Barcelona
country: Spain
facility: Hospital General Universitari Vall d Hebron ( Site 1401)
city: Madrid
country: Spain
facility: Hospital Universitario Ramon y Cajal ( Site 1400)
city: Adana
country: Turkey
facility: Adana Sehir Hastanesi ( Site 2002)
city: Ankara
country: Turkey
facility: Hacettepe Universitesi Tip Fakultesi Hastanesi ( 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 2102)
state: Dnipropetrovska Oblast
city: Kryviy Rih
country: Ukraine
facility: MI Kryviy Rih Center of Dnipropetrovsk Regional Council ( Site 2101)
state: Dnipropetrovska Oblast
city: Ivano-Frankivsk
country: Ukraine
facility: MI Precarpathian Clinical Oncology Center ( Site 2105)
state: Ivano-Frankivska Oblast
city: Kharkiv
country: Ukraine
facility: Communal non profit enterprise Regional Clinical Oncology Center ( Site 2112)
state: Kharkivska Oblast
city: Khodosivka
country: Ukraine
facility: Medical Center Asklepion LLC ( Site 2115)
state: Kyivska Oblast
city: Kyiv
country: Ukraine
facility: Clinic of National Cancer Institute ( Site 2104)
state: Kyivska Oblast
city: Kyiv
country: Ukraine
facility: Medical and Diagnostic Centre LLC Dobryi Prognoz ( Site 2114)
state: Kyivska Oblast
city: Lviv
country: Ukraine
facility: Lviv State Oncology Regional Treatment and Diagnostic Center ( Site 2106)
state: Lvivska Oblast
city: Odesa
country: Ukraine
facility: MI Odessa Regional Oncological Centre ( Site 2108)
state: Odeska Oblast
city: Zaporizhzhya
country: Ukraine
facility: Medical Centre LLC Oncolife ( Site 2103)
state: Zaporizka Oblast
city: Kyiv
country: Ukraine
facility: Kyiv City Clinical Oncology Centre ( Site 2110)
city: Derby
country: United Kingdom
facility: Royal Hospital in Derby ( Site 1514)
state: Derbyshire
city: Dundee
country: United Kingdom
facility: Ninewells Hospital and Medical School ( Site 1504)
state: Dundee City
city: Cottingham
country: United Kingdom
facility: Castle Hill Hospital ( Site 1501)
state: East Riding Of Yorkshire
city: London
country: United Kingdom
facility: University College London Hospital NHS Foundation Trust ( Site 1508)
state: London, City Of
city: London
country: United Kingdom
facility: St Georges University Hospitals NHS Foundation Trust. ( Site 1500)
state: London, City Of
city: Sutton
country: United Kingdom
facility: Royal Marsden Hospital ( Site 1510)
state: Surrey
city: London
country: United Kingdom
facility: Royal Marsden NHS Foundation Trust ( Site 1512)
city: Manchester
country: United Kingdom
facility: The Christie Hospital NHS Foundation Trust ( Site 1503)
city: Northwood
country: United Kingdom
facility: Mount Vernon Cancer Centre ( Site 1507)
city: Walsall
country: United Kingdom
facility: Manor Hospital Walsall England ( Site 1515)
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Director
role: STUDY_DIRECTOR
References:
citation: 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.
citation: Janjigian YY, Kawazoe A, Bai Y, Xu J, Lonardi S, Metges JP, Yanez P, Wyrwicz LS, Shen L, Ostapenko Y, Bilici M, Chung HC, Shitara K, Qin S, Van Cutsem E, Tabernero J, Luo S, Mahave M, Tang Y, Lowery M, Monteiro MMF, Xu L, Shih CS, Sharan KP, Bhagia P, Rha SY. Pembrolizumab in HER2-Positive Gastric Cancer. N Engl J Med. 2024 Oct 10;391(14):1360-1362. doi: 10.1056/NEJMc2408121. Epub 2024 Sep 14. No abstract available.
citation: Janjigian YY, Kawazoe A, Yanez P, Li N, Lonardi S, Kolesnik O, Barajas O, Bai Y, Shen L, Tang Y, Wyrwicz LS, Xu J, Shitara K, Qin S, Van Cutsem E, Tabernero J, Li L, Shah S, Bhagia P, Chung HC. The KEYNOTE-811 trial of dual PD-1 and HER2 blockade in HER2-positive gastric cancer. Nature. 2021 Dec;600(7890):727-730. doi: 10.1038/s41586-021-04161-3. Epub 2021 Dec 15.
citation: Chung HC, Bang YJ, S Fuchs C, Qin SK, Satoh T, Shitara K, Tabernero J, Van Cutsem E, Alsina M, Cao ZA, Lu J, Bhagia P, Shih CS, Janjigian YY. First-line pembrolizumab/placebo plus trastuzumab and chemotherapy in HER2-positive advanced gastric cancer: KEYNOTE-811. Future Oncol. 2021 Feb;17(5):491-501. doi: 10.2217/fon-2020-0737. Epub 2020 Nov 10.