Clinical trial NCT03221426: Study of Pembrolizumab (MK-3475) Plus Chemotherapy Versus Placebo Plus Chemotherapy in Participants With Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma (MK-3475-585/KEYNOTE-585)
Official title: A Phase III, Randomized, Double-Blind, Clinical Trial of Pembrolizumab (MK-3475) Plus Chemotherapy (XP or FP) Versus Placebo Plus Chemotherapy (XP or FP) as Neoadjuvant/Adjuvant Treatment for Subjects With Gastric and Gastroesophageal Junction (GEJ) Adenocarcinoma (KEYNOTE-585)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Gastric Cancer
Gastroesophageal Junction Cancer
Keywords: Programmed Cell Death-1 (PD1, PD-1)
Programmed Death-Ligand 1 (PDL1, PD-L1)
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2017-07-18
Enrollment: 1007
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 the neoadjuvant (prior to surgery) or adjuvant (after surgery) treatment of previously untreated adults with gastric and gastroesophageal junction (GEJ) adenocarcinoma.

The primary study hypotheses are that:

* Neoadjuvant and adjuvant pembrolizumab plus chemotherapy, followed by adjuvant pembrolizumab is superior to neoadjuvant and adjuvant placebo plus chemotherapy, followed by adjuvant placebo in terms of Event-free Survival (EFS) based on Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1), and
* Neoadjuvant pembrolizumab plus chemotherapy is superior to neoadjuvant placebo plus chemotherapy in terms of rate of Pathological Complete Response (pathCR) at the time of surgery.

With Amendment 10, upon study completion, participants will be discontinued and may be enrolled in an extension study.


Eligibility criteria: Inclusion Criteria:

* Has previously untreated localized gastric or GEJ adenocarcinoma as defined by T3 or greater primary lesion or the presence of any positive nodes - N+ (clinical nodes) without evidence of metastatic disease.
* Plans to proceed to surgery following pre-operative chemotherapy based on standard staging studies per local practice.
* Is willing to provide tissue from a tumor lesion at baseline and at time of surgery.
* Has an Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 1 within 3 days prior to the first dose of study treatment.
* Has adequate organ function.
* Male participants of childbearing potential must agree to use an adequate method of contraception for the course of the study through 180 days after the last dose of chemotherapy.
* Female participants of childbearing potential must be willing to use an adequate method of contraception for the course of the study through 180 days after the last dose of chemotherapy or through 120 days after the last dose of pembrolizumab, whichever is greater.
* Has life expectancy of greater than 6 months.

Exclusion Criteria:

* Has a history of (non-infectious) pneumonitis that required steroids or has current pneumonitis.
* Has an active infection requiring systemic therapy.
* Is currently participating in or has participated in a trial of an investigational agent or has used an investigational device within 4 weeks prior to the first dose of study treatment.
* Has received prior therapy with an anti-programmed cell death protein-1 (anti-PD-1), anti-programmed cell death-ligand 1 (anti-PD-L1), or anti-PD-L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (i.e., cytotoxic T-lymphocyte-associated protein 4 \[CTLA-4\], tumor necrosis factor receptor superfamily member 4 \[OX-40\], necrosis factor receptor superfamily member 9 \[CD137\]) or has previously participated in a Merck pembrolizumab (MK-3475) clinical trial.
* Has received prior systemic anti-cancer therapy including investigational agents for the current malignancy.
* Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 14 days prior the first dose of study treatment.
* Has a known additional malignancy that is progressing or has required active treatment within the past 5 years. Note: Participants with basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ that have undergone potentially curative therapy are not excluded.
* Has a known severe hypersensitivity (≥ Grade 3) to pembrolizumab, its active substance and/or any of its excipients, or to any of the study chemotherapy agents and/or to any of their excipients.
* Has an active autoimmune disease that has required systemic treatment in past 2 years.
* Has a known history of human immunodeficiency virus (HIV) infection.
* Has a known history of Hepatitis B or known active Hepatitis C virus infection.
* Has a known history of active tuberculosis (TB).
* Female participants who are pregnant or breastfeeding or expecting to conceive children within the projected duration of the study, starting with the screening visit through180 days after the last dose of chemotherapy or through 120 days after the last dose of pembrolizumab, whichever is greater.
* Male participants who are expecting to father children within the projected duration of the study, starting with the screening visit through 180 days after the last dose of chemotherapy.
* Has had an allogenic tissue/solid organ transplant.
* Has received a live vaccine within 30 days prior to the first dose of study treatment.

Primary outcomes:
measure: Event-free Survival (EFS) Per Response Criteria in Solid Tumors Version 1.1 (RECIST 1.1) - Pembrolizumab+XP/FP and Placebo+XP/FP Treatment Arms
timeFrame: Up to approximately 75 months
measure: Pathological Complete Response (pathCR) Rate - Pembrolizumab+XP/FP and Placebo+XP/FP Treatment Arms
timeFrame: Up to approximately 9 weeks following completion of neoadjuvant treatment (up to Study Week 18)
measure: Overall Survival (OS) - Pembrolizumab+XP/FP and Placebo+XP/FP Treatment Arms
timeFrame: Up to approximately 75 months
measure: Number of Participants Who Experience One or More Adverse Events (AEs) - Pembrolizumab+FLOT and Placebo+FLOT Cohorts
timeFrame: Up to approximately 70 months
measure: Number of Participants Who Discontinue Study Treatment Due to an AE - Pembrolizumab+FLOT and Placebo+FLOT Cohorts
timeFrame: Up to approximately 17 months
Secondary outcomes:
measure: Number of Participants Who Experience One or More Adverse Events (AEs) - Pembrolizumab+XP/FP and Placebo+XP/FP Treatment Arms Separately and in Combination With the Pembrolizumab+FLOT and Placebo+FLOT Cohorts
timeFrame: Up to approximately 75 months
measure: Number of Participants Who Discontinue Study Treatment Due to an AE - Pembrolizumab+XP/FP and Placebo+XP/FP Treatment Arms Separately and in Combination With the Pembrolizumab+FLOT and Placebo+FLOT Cohorts
timeFrame: Up to approximately 18 months
measure: Disease-free Survival (DFS) Per Response Criteria in Solid Tumors Version 1.1 (RECIST 1.1) - Pembrolizumab+XP/FP and Placebo+XP/FP Treatment Arms
timeFrame: Up to approximately 75 months
measure: Overall Survival (OS) - Pembrolizumab+XP/FP and Placebo+XP/FP Treatment Arms in Combination With the Pembrolizumab+FLOT and Placebo+FLOT Cohorts
timeFrame: Up to approximately 75 months
measure: Event-free Survival (EFS) Per Response Criteria in Solid Tumors Version 1.1 (RECIST 1.1) - Pembrolizumab+XP/FP and Placebo+XP/FP Treatment Arms in Combination With the Pembrolizumab+FLOT and Placebo+FLOT Cohorts
timeFrame: Up to approximately 75 months
Other outcomes:
Locations:
city: Duarte
country: United States
facility: City of Hope ( Site 0005)
state: California
city: New Haven
country: United States
facility: Yale Cancer Center ( Site 0016)
state: Connecticut
city: Washington
country: United States
facility: Georgetown University ( Site 0015)
state: District of Columbia
city: Chicago
country: United States
facility: Northwestern University - Robert H. Lurie Comprehensive Cancer Center ( Site 0018)
state: Illinois
city: Chicago
country: United States
facility: The University of Chicago Medical Center ( Site 0004)
state: Illinois
city: Buffalo
country: United States
facility: Roswell Park Cancer Institute ( Site 0001)
state: New York
city: New York
country: United States
facility: Laura and Isaac Perlmutter Cancer Center at NYU Langone Health ( Site 0019)
state: New York
city: New York
country: United States
facility: Memorial Sloan Kettering ( Site 0024)
state: New York
city: New York
country: United States
facility: Weill Cornell Medical Center ( Site 0023)
state: New York
city: Rochester
country: United States
facility: University of Rochester ( Site 0011)
state: New York
city: Philadelphia
country: United States
facility: Fox Chase Cancer Center ( Site 0006)
state: Pennsylvania
city: Philadelphia
country: United States
facility: Temple University Hospital ( Site 0026)
state: Pennsylvania
city: Salt Lake City
country: United States
facility: University of Utah, Huntsman Cancer Institute ( Site 0012)
state: Utah
city: Fairfax
country: United States
facility: Virginia Cancer Specialists, PC ( Site 0010)
state: Virginia
city: Brussels
country: Belgium
facility: Institut Jules Bordet ( Site 0480)
state: Bruxelles-Capitale, Region De
city: Brussels
country: Belgium
facility: Hopital Erasme ULB ( Site 0484)
state: Bruxelles-Capitale, Region De
city: Bruxelles
country: Belgium
facility: UCL Saint Luc ( Site 0479)
state: Bruxelles-Capitale, Region De
city: Charleroi
country: Belgium
facility: Grand Hopital de Charleroi ( Site 0478)
state: Hainaut
city: Liège
country: Belgium
facility: CHU de Liege ( Site 0482)
state: Liege
city: Yvoir
country: Belgium
facility: CHU UCL Namur Site de Godinne ( Site 0485)
state: Namur
city: Gent
country: Belgium
facility: UZ Gent ( Site 0486)
state: Oost-Vlaanderen
city: Leuven
country: Belgium
facility: UZ Leuven ( Site 0483)
state: Vlaams-Brabant
city: Kortrijk
country: Belgium
facility: AZ Groeninge ( Site 0481)
state: West-Vlaanderen
city: Fortaleza
country: Brazil
facility: Instituto do Cancer do Ceara ( Site 0311)
state: Ceara
city: Porto Alegre
country: Brazil
facility: Uniao Brasileira de Educacao e Assistencia Hospital Sao Lucas da Pucrs ( Site 0308)
state: Rio Grande Do Sul
city: Florianopolis
country: Brazil
facility: CEPON - Centro de Pesquisas Oncologicas ( Site 0302)
state: Santa Catarina
city: Barretos
country: Brazil
facility: Fundacao Pio XII - Hospital de Cancer de Barretos ( Site 0301)
state: Sao Paulo
city: Sao Jose Rio Preto
country: Brazil
facility: Hospital de Base de Sao Jose de Rio Preto ( Site 0304)
state: Sao Paulo
city: Rio de Janeiro
country: Brazil
facility: Instituto Nacional Do Cancer Jose Alencar Gomes Da Silva ( Site 0307)
city: Sao Paulo
country: Brazil
facility: Instituto do Cancer do Estado de Sao Paulo - ICESP ( Site 0305)
city: Sao Paulo
country: Brazil
facility: Hospital Israelita Albert Einstein ( Site 0309)
city: Edmonton
country: Canada
facility: Cross Cancer Institute ( Site 0033)
state: Alberta
city: Moncton
country: Canada
facility: Moncton Hospital - Horizon Health Network ( Site 0038)
state: New Brunswick
city: Toronto
country: Canada
facility: Sunnybrook Research Institute ( Site 0032)
state: Ontario
city: Greenfield Park
country: Canada
facility: CISSS de la Monteregie-Centre ( Site 0039)
state: Quebec
city: Montreal
country: Canada
facility: CIUSSS de l Est de L Ile de Montreal - Hopital Maisonneuve-Rosemont ( Site 0040)
state: Quebec
city: Montreal
country: Canada
facility: Jewish General Hospital ( Site 0034)
state: Quebec
city: Sherbrooke
country: Canada
facility: CIUSSS de l Estrie - CHUS - Centre Hosp. Univ. Sherbrooke ( Site 0035)
state: Quebec
city: Quebec
country: Canada
facility: CHU de Quebec - Hotel-Dieu de Quebec ( Site 0042)
city: Temuco
country: Chile
facility: Instituto Clinico del Sur. ICOS ( Site 0290)
state: Araucania
city: Rancagua
country: Chile
facility: Hospital Regional Rancagua Libertador Bernardo O Higgins ( Site 0299)
state: Lbtdr Gen Bernardo O Higgins
city: Santiago
country: Chile
facility: Fundacion Arturo Lopez Perez FALP ( Site 0286)
state: Region M. De Santiago
city: Santiago
country: Chile
facility: Pontificia Universidad Catolica de Chile ( Site 0285)
state: Region M. De Santiago
city: Santiago
country: Chile
facility: Hospital Clinico Universidad de Chile ( Site 0287)
state: Region M. De Santiago
city: Beijing
country: China
facility: Beijing Cancer Hospital ( Site 0221)
state: Beijing
city: Hangzhou
country: China
facility: Zhejiang Cancer Hospital ( Site 0231)
state: Zhejiang
city: Hangzhou
country: China
facility: Sir Run Run Shaw Hospital ( Site 0233)
state: Zhejiang
city: Tallinn
country: Estonia
facility: SA Pohja-Eesti Regionaalhaigla ( Site 0526)
state: Harjumaa
city: Lyon
country: France
facility: Hopital Prive Jean Mermoz ( Site 0462)
state: Auvergne
city: Marseille
country: France
facility: Institut Paoli Calmettes ( Site 0472)
state: Bouches-du-Rhone
city: Reims
country: France
facility: CHU Reims - Hopital Robert Debre ( Site 0465)
state: Champagne-Ardenne
city: Brest
country: France
facility: CHU Brest - Institut de Cancerologie et d Hematologie ( Site 0474)
state: Finistere
city: Toulouse
country: France
facility: CHU Toulouse - Hopital Rangueil ( Site 0470)
state: Haute-Garonne
city: Montpellier
country: France
facility: Institut du Cancer de Montpellier ( Site 0473)
state: Herault
city: Rennes
country: France
facility: Centre Eugene Marquis ( Site 0466)
state: Ille-et-Vilaine
city: Saint Herblain
country: France
facility: Institut de Cancerologie de l Ouest Centre Rene Gauducheau ( Site 0469)
state: Loire-Atlantique
city: Lille
country: France
facility: CHRU Lille - Hopital Claude Huriez ( Site 0461)
state: Nord
city: Poitiers
country: France
facility: CHU Poitiers - Pole Regional de Cancerologie ( Site 0467)
state: Vienne
city: Paris
country: France
facility: CHU Hopital Saint Antoine ( Site 0471)
city: Paris
country: France
facility: Institut Mutualiste Montsouris ( Site 0463)
city: Esslingen
country: Germany
facility: Klinikum Esslingen GmbH ( Site 0453)
state: Baden-Wurttemberg
city: Freiburg
country: Germany
facility: Universitaetsklinikum Freiburg ( Site 0450)
state: Baden-Wurttemberg
city: Muenchen
country: Germany
facility: Klinikum der Universitaet in Muenchen ( Site 0446)
state: Bayern
city: Hannover
country: Germany
facility: Medizinische Hochschule Hannover ( Site 0449)
state: Niedersachsen
city: Essen
country: Germany
facility: Kliniken Essen Mitte Gmbh Evang. Huyssens Stiftung ( Site 0445)
state: Nordrhein-Westfalen
city: Mainz
country: Germany
facility: Medizinische klinilk und Poliklinik Johannes Gutenberg Univ ( Site 0455)
state: Rheinland-Pfalz
city: Dresden
country: Germany
facility: Universitaetsklinikum Carl Gustav Carus der TU Dresden ( Site 0448)
state: Sachsen
city: Hamburg
country: Germany
facility: Haematologisch-Onkologische Praxis Eppendorf Facharztzentrum Eppendorf - Hope ( Site 0454)
city: Guatemala
country: Guatemala
facility: Integra Cancer Institute ( Site 0262)
city: Guatemala
country: Guatemala
facility: Grupo Medico Angeles ( Site 0261)
city: Quetzaltenango
country: Guatemala
facility: Centro Medico Integral De Cancerología (CEMIC) ( Site 0260)
city: Beer Sheva
country: Israel
facility: Soroka University M.C ( Site 0385)
state: HaDarom
city: Kfar Saba
country: Israel
facility: Meir medical center ( Site 0386)
state: HaMerkaz
city: Tel-Aviv
country: Israel
facility: Sourasky Medical Center. ( Site 0382)
state: Tell Abib
city: Haifa
country: Israel
facility: Rambam Health Care Campus ( Site 0381)
city: Jerusalem
country: Israel
facility: Hadassah Medical Center. Ein Kerem ( Site 0383)
city: Petah Tikva
country: Israel
facility: Rabin-Medical Center ( Site 0384)
city: Ramat Gan
country: Israel
facility: Sheba Medical center ( Site 0387)
city: Padova
country: Italy
facility: IRCCS Istituto Oncologico Veneto ( Site 0431)
state: Abruzzo
city: Milano
country: Italy
facility: Fondazione IRCCS Istituto Nazionale dei Tumori di Milano ( Site 0430)
state: Lombardia
city: Rozzano
country: Italy
facility: Istituto Clinico Humanitas Research Hospital ( Site 0432)
state: Milano
city: San Donato Milanese
country: Italy
facility: IRCCS Policlinico San Donato ( Site 0433)
state: Milano
city: Modena
country: Italy
facility: Azienda Ospedaliero Universitaria di Modena Policlinico ( Site 0429)
city: Napoli
country: Italy
facility: Seconda Universita Napoli ( Site 0436)
city: Udine
country: Italy
facility: A.O.U. Santa Maria della Misericordia di Udine ( Site 0434)
city: Nagoya
country: Japan
facility: Aichi Cancer Center Hospital ( Site 0165)
state: Aichi
city: Kashiwa
country: Japan
facility: National Cancer Center Hospital East ( Site 0178)
state: Chiba
city: Matsuyama
country: Japan
facility: National Hospital Organization Shikoku Cancer Center ( Site 0186)
state: Ehime
city: Sapporo
country: Japan
facility: Hokkaido University Hospital ( Site 0160)
state: Hokkaido
city: Akashi
country: Japan
facility: Hyogo Cancer Center ( Site 0182)
state: Hyogo
city: Kobe
country: Japan
facility: Kobe University Hospital ( Site 0188)
state: Hyogo
city: Kobe
country: Japan
facility: Kobe City Medical Center General Hospital ( Site 0181)
state: Hyogo
city: Kasama
country: Japan
facility: Ibaraki Prefectural Central Hospital ( Site 0177)
state: Ibaraki
city: Shiwa-gun
country: Japan
facility: Iwate Medical University Hospital ( Site 0184)
state: Iwate
city: Kawasaki
country: Japan
facility: St. Marianna University School of Medicine Hospital ( Site 0187)
state: Kanagawa
city: Yokohama
country: Japan
facility: Kanagawa Cancer Center ( Site 0167)
state: Kanagawa
city: Hirakata
country: Japan
facility: Kansai Medical University Hospital ( Site 0190)
state: Osaka
city: Suita
country: Japan
facility: Osaka University Hospital ( Site 0162)
state: Osaka
city: Takatsuki
country: Japan
facility: Osaka Medical College Hospital ( Site 0168)
state: Osaka
city: Kitaadachi-gun
country: Japan
facility: Saitama Cancer Center ( Site 0170)
state: Saitama
city: Sunto-gun
country: Japan
facility: Shizuoka Cancer Center Hospital and Research Institute ( Site 0176)
state: Shizuoka
city: Chiba
country: Japan
facility: Chiba Cancer Center ( Site 0180)
city: Fukuoka
country: Japan
facility: National Hospital Organization Kyushu Cancer Center ( Site 0172)
city: Fukuoka
country: Japan
facility: Kyushu University Hospital ( Site 0173)
city: Gifu
country: Japan
facility: Gifu University Hospital ( Site 0166)
city: Hiroshima
country: Japan
facility: Hiroshima City Hiroshima Citizens Hospital ( Site 0171)
city: Kochi
country: Japan
facility: Kochi Health Sciences Center ( Site 0189)
city: Kumamoto
country: Japan
facility: Kumamoto University Hospital ( Site 0164)
city: Niigata
country: Japan
facility: Niigata Cancer Center Hospital ( Site 0169)
city: Osaka
country: Japan
facility: Osaka International Cancer Institute ( Site 0161)
city: Osaka
country: Japan
facility: Osaka General Medical Center ( Site 0159)
city: Tokyo
country: Japan
facility: National Cancer Center Hospital ( Site 0179)
city: Tokyo
country: Japan
facility: Tokyo Metropolitan Komagome Hospital ( Site 0183)
city: Tokyo
country: Japan
facility: The Cancer Institute Hospital of JFCR ( Site 0185)
city: Toyama
country: Japan
facility: Toyama Prefectural Central Hospital ( Site 0163)
city: Hwasun Gun
country: Korea, Republic of
facility: Chonnam National University Hwasun Hospital ( Site 0083)
state: Jeonranamdo
city: Seongnam-si
country: Korea, Republic of
facility: Seoul National University Bundang Hospital ( Site 0085)
state: Kyonggi-do
city: Daegu
country: Korea, Republic of
facility: Kyungpook National University Chilgok Hospital ( Site 0089)
state: Taegu-Kwangyokshi
city: Incheon
country: Korea, Republic of
facility: Gachon University Gil Medical Center ( Site 0087)
city: Seoul
country: Korea, Republic of
facility: Korea University Anam Hospital ( Site 0084)
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital -SNUH- ( Site 0080)
city: Seoul
country: Korea, Republic of
facility: Severance Hospital Yonsei University Health System ( Site 0081)
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center ( Site 0082)
city: Seoul
country: Korea, Republic of
facility: Gangnam Severance Hospital ( Site 0088)
city: Seoul
country: Korea, Republic of
facility: SMG-SNU BORAMAE Medical Center ( Site 0086)
city: Riga
country: Latvia
facility: Riga East Clinical University Hospital ( Site 0550)
city: Kaunas
country: Lithuania
facility: LSMUL Kauno Klinikos ( Site 0570)
city: Vilnius
country: Lithuania
facility: Nacionalinis Vezio Institutas ( Site 0569)
city: Vilnius
country: Lithuania
facility: Vilniaus Universiteto Ligonine Santaros Klinikos ( Site 0568)
city: Kuala Lumpur
country: Malaysia
facility: Hospital Kuala Lumpur ( Site 0146)
city: Kuala Lumpur
country: Malaysia
facility: University Malaya Medical Centre ( Site 0143)
city: Quezon City
country: Philippines
facility: St. Luke s Medical Center ( Site 0622)
state: National Capital Region
city: Wroclaw
country: Poland
facility: Wojewodzki Szpital Specjalistyczny we Wroclawiu ( Site 0358)
state: Dolnoslaskie
city: Lublin
country: Poland
facility: Samodzielny Publiczny Szpital Kliniczny Nr 1 w Lublinie ( Site 0351)
state: Lubelskie
city: Krakow
country: Poland
facility: Szpital Uniwersytecki w Krakowie ( Site 0352)
state: Malopolskie
city: Warszawa
country: Poland
facility: Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie ( Site 0349)
state: Mazowieckie
city: Wieliszew
country: Poland
facility: Mazowiecki Szpital Onkologiczny ( Site 0363)
state: Mazowieckie
city: Koscierzyna
country: Poland
facility: Szpital Specjalistyczny w Koscierzynie Sp. z o.o. ( Site 0353)
state: Pomorskie
city: Bielsko-Biala
country: Poland
facility: Beskidzkie Centrum Onkologii im. Jana Pawla II ( Site 0354)
state: Slaskie
city: Gliwice
country: Poland
facility: Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie ( Site 0361)
state: Slaskie
city: Rybnik
country: Poland
facility: SPZOZ WSS nr 3 w Rybniku ( Site 0357)
state: Slaskie
city: Kaluga
country: Russian Federation
facility: Kaluga Regional Clinical Oncology Center ( Site 0345)
state: Kaluzskaja Oblast
city: Saint Petersburg
country: Russian Federation
facility: SBHI Leningrad Regional Clinical Hospital ( Site 0496)
state: Leningradskaya Oblast
city: Moscow
country: Russian Federation
facility: National Medical and Surgical Center n.a. N.I.Pirogov ( Site 0338)
state: Moskva
city: Moscow
country: Russian Federation
facility: Blokhin National Medical Oncology ( Site 0494)
state: Moskva
city: Saint Petersburg
country: Russian Federation
facility: Scientific Research Oncology Institute n.a. N.N.Petrov ( Site 0344)
state: Sankt-Peterburg
city: Saint-Petersburg
country: Russian Federation
facility: Leningrad Regional Oncology Center ( Site 0335)
state: Sankt-Peterburg
city: Sankt-Petersburg
country: Russian Federation
facility: City clinical oncological dispensary ( Site 0336)
state: Sankt-Peterburg
city: Tomsk
country: Russian Federation
facility: Tomsk Scientific Research Institute of Oncology ( Site 0337)
state: Tomskaya Oblast
city: Singapore
country: Singapore
facility: National University Hospital ( Site 0095)
state: Central Singapore
city: Singapore
country: Singapore
facility: National Cancer Centre Singapore ( Site 0097)
state: Central Singapore
city: Singapore
country: Singapore
facility: Oncocare Cancer Centre ( Site 0096)
state: Central Singapore
city: New Taipei
country: Taiwan
facility: Taipei Medical University Shuang Ho Hospital ( Site 0068)
city: Tainan
country: Taiwan
facility: National Cheng Kung University Hospital ( Site 0067)
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital ( Site 0063)
city: Taipei
country: Taiwan
facility: Mackay Memorial Hospital ( Site 0065)
city: Taipei
country: Taiwan
facility: Koo Foundation Sun Yat-Sen Cancer Center ( Site 0066)
city: Taoyuan
country: Taiwan
facility: Chang Gung Medical Foundation. Linkou ( Site 0064)
city: Dnipro
country: Ukraine
facility: City Clinical Hosp.4 of DCC ( Site 0325)
state: Dnipropetrovska Oblast
city: Kryviy Rih
country: Ukraine
facility: MI Kryvyi Rih Oncology Dispensary of Dnipropetrovsk Regional Council ( Site 0589)
state: Dnipropetrovska Oblast
city: Ivano-Frankivsk
country: Ukraine
facility: Ivano-Frankivsk Regional Oncology Clinical Dispensary ( Site 0321)
state: Ivano-Frankivska Oblast
city: Kharkiv
country: Ukraine
facility: Communal non profit enterprise Regional Clinical Oncology Center ( Site 0591)
state: Kharkivska Oblast
city: Kyiv
country: Ukraine
facility: National Cancer Institute of the MoH of Ukraine ( Site 0319)
state: Kyivska Oblast
city: Kyiv
country: Ukraine
facility: Kyiv City Clinical Oncology Center ( Site 0590)
state: Kyivska Oblast
city: Bristol
country: United Kingdom
facility: University Hospitals Bristol NHS Foundation Trust ( Site 0407)
state: Bristol, City Of
city: Dundee
country: United Kingdom
facility: Ninewells Hospital and Medical School ( Site 0406)
state: Dundee City
city: London
country: United Kingdom
facility: Royal Free London NHS Foundation Trust ( Site 0403)
state: London, City Of
city: London
country: United Kingdom
facility: The Royal Marsden Foundation Trust ( Site 0405)
state: London, City Of
city: London
country: United Kingdom
facility: Imperial College Healthcare NHS Trust ( Site 0402)
state: London, City Of
city: Sutton
country: United Kingdom
facility: Royal Marsden NHS Foundation Trust ( Site 0400)
state: Surrey
city: Manchester
country: United Kingdom
facility: The Christie NHS Foundation Trust ( Site 0397)
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Director
role: STUDY_DIRECTOR
References:
citation: Shitara K, Rha SY, Wyrwicz LS, Oshima T, Karaseva N, Osipov M, Yasui H, Yabusaki H, Afanasyev S, Park YK, Al-Batran SE, Yoshikawa T, Yanez P, Dib Bartolomeo M, Lonardi S, Tabernero J, Van Cutsem E, Janjigian YY, Oh DY, Xu J, Fang X, Shih CS, Bhagia P, Bang YJ; KEYNOTE-585 investigators. Neoadjuvant and adjuvant pembrolizumab plus chemotherapy in locally advanced gastric or gastro-oesophageal cancer (KEYNOTE-585): an interim analysis of the multicentre, double-blind, randomised phase 3 study. Lancet Oncol. 2024 Feb;25(2):212-224. doi: 10.1016/S1470-2045(23)00541-7. Epub 2023 Dec 19.
citation: Chang X, Ge X, Zhang Y, Xue X. The current management and biomarkers of immunotherapy in advanced gastric cancer. Medicine (Baltimore). 2022 May 27;101(21):e29304. doi: 10.1097/MD.0000000000029304.
citation: Bang YJ, Van Cutsem E, Fuchs CS, Ohtsu A, Tabernero J, Ilson DH, Hyung WJ, Strong VE, Goetze TO, Yoshikawa T, Tang LH, Hwang PMT, Webb N, Adelberg D, Shitara K. KEYNOTE-585: Phase III study of perioperative chemotherapy with or without pembrolizumab for gastric cancer. Future Oncol. 2019 Mar;15(9):943-952. doi: 10.2217/fon-2018-0581. Epub 2019 Feb 19.