Spots Global Cancer Trial Database for 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)
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Trial Identification
Brief Title: 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 ID: NCT03221426
Study Description
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.
Detailed Description:
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
City of Hope ( Site 0005), Duarte, California, United States
Yale Cancer Center ( Site 0016), New Haven, Connecticut, United States
Georgetown University ( Site 0015), Washington, District of Columbia, United States
Northwestern University - Robert H. Lurie Comprehensive Cancer Center ( Site 0018), Chicago, Illinois, United States
The University of Chicago Medical Center ( Site 0004), Chicago, Illinois, United States
Roswell Park Cancer Institute ( Site 0001), Buffalo, New York, United States
Laura and Isaac Perlmutter Cancer Center at NYU Langone Health ( Site 0019), New York, New York, United States
Memorial Sloan Kettering ( Site 0024), New York, New York, United States
Weill Cornell Medical Center ( Site 0023), New York, New York, United States
University of Rochester ( Site 0011), Rochester, New York, United States
Fox Chase Cancer Center ( Site 0006), Philadelphia, Pennsylvania, United States
Temple University Hospital ( Site 0026), Philadelphia, Pennsylvania, United States
University of Utah, Huntsman Cancer Institute ( Site 0012), Salt Lake City, Utah, United States
Virginia Cancer Specialists, PC ( Site 0010), Fairfax, Virginia, United States
Institut Jules Bordet ( Site 0480), Brussels, Bruxelles-Capitale, Region De, Belgium
Hopital Erasme ULB ( Site 0484), Brussels, Bruxelles-Capitale, Region De, Belgium
UCL Saint Luc ( Site 0479), Bruxelles, Bruxelles-Capitale, Region De, Belgium
Grand Hopital de Charleroi ( Site 0478), Charleroi, Hainaut, Belgium
CHU de Liege ( Site 0482), Liège, Liege, Belgium
CHU UCL Namur Site de Godinne ( Site 0485), Yvoir, Namur, Belgium
UZ Gent ( Site 0486), Gent, Oost-Vlaanderen, Belgium
UZ Leuven ( Site 0483), Leuven, Vlaams-Brabant, Belgium
AZ Groeninge ( Site 0481), Kortrijk, West-Vlaanderen, Belgium
Instituto do Cancer do Ceara ( Site 0311), Fortaleza, Ceara, Brazil
Uniao Brasileira de Educacao e Assistencia Hospital Sao Lucas da Pucrs ( Site 0308), Porto Alegre, Rio Grande Do Sul, Brazil
CEPON - Centro de Pesquisas Oncologicas ( Site 0302), Florianopolis, Santa Catarina, Brazil
Fundacao Pio XII - Hospital de Cancer de Barretos ( Site 0301), Barretos, Sao Paulo, Brazil
Hospital de Base de Sao Jose de Rio Preto ( Site 0304), Sao Jose Rio Preto, Sao Paulo, Brazil
Instituto Nacional Do Cancer Jose Alencar Gomes Da Silva ( Site 0307), Rio de Janeiro, , Brazil
Instituto do Cancer do Estado de Sao Paulo - ICESP ( Site 0305), Sao Paulo, , Brazil
Hospital Israelita Albert Einstein ( Site 0309), Sao Paulo, , Brazil
Cross Cancer Institute ( Site 0033), Edmonton, Alberta, Canada
Moncton Hospital - Horizon Health Network ( Site 0038), Moncton, New Brunswick, Canada
Sunnybrook Research Institute ( Site 0032), Toronto, Ontario, Canada
CISSS de la Monteregie-Centre ( Site 0039), Greenfield Park, Quebec, Canada
CIUSSS de l Est de L Ile de Montreal - Hopital Maisonneuve-Rosemont ( Site 0040), Montreal, Quebec, Canada
Jewish General Hospital ( Site 0034), Montreal, Quebec, Canada
CIUSSS de l Estrie - CHUS - Centre Hosp. Univ. Sherbrooke ( Site 0035), Sherbrooke, Quebec, Canada
CHU de Quebec - Hotel-Dieu de Quebec ( Site 0042), Quebec, , Canada
Instituto Clinico del Sur. ICOS ( Site 0290), Temuco, Araucania, Chile
Hospital Regional Rancagua Libertador Bernardo O Higgins ( Site 0299), Rancagua, Lbtdr Gen Bernardo O Higgins, Chile
Fundacion Arturo Lopez Perez FALP ( Site 0286), Santiago, Region M. De Santiago, Chile
Pontificia Universidad Catolica de Chile ( Site 0285), Santiago, Region M. De Santiago, Chile
Hospital Clinico Universidad de Chile ( Site 0287), Santiago, Region M. De Santiago, Chile
Beijing Cancer Hospital ( Site 0221), Beijing, Beijing, China
Zhejiang Cancer Hospital ( Site 0231), Hangzhou, Zhejiang, China
Sir Run Run Shaw Hospital ( Site 0233), Hangzhou, Zhejiang, China
SA Pohja-Eesti Regionaalhaigla ( Site 0526), Tallinn, Harjumaa, Estonia
Hopital Prive Jean Mermoz ( Site 0462), Lyon, Auvergne, France
Institut Paoli Calmettes ( Site 0472), Marseille, Bouches-du-Rhone, France
CHU Reims - Hopital Robert Debre ( Site 0465), Reims, Champagne-Ardenne, France
CHU Brest - Institut de Cancerologie et d Hematologie ( Site 0474), Brest, Finistere, France
CHU Toulouse - Hopital Rangueil ( Site 0470), Toulouse, Haute-Garonne, France
Institut du Cancer de Montpellier ( Site 0473), Montpellier, Herault, France
Centre Eugene Marquis ( Site 0466), Rennes, Ille-et-Vilaine, France
Institut de Cancerologie de l Ouest Centre Rene Gauducheau ( Site 0469), Saint Herblain, Loire-Atlantique, France
CHRU Lille - Hopital Claude Huriez ( Site 0461), Lille, Nord, France
CHU Poitiers - Pole Regional de Cancerologie ( Site 0467), Poitiers, Vienne, France
CHU Hopital Saint Antoine ( Site 0471), Paris, , France
Institut Mutualiste Montsouris ( Site 0463), Paris, , France
Klinikum Esslingen GmbH ( Site 0453), Esslingen, Baden-Wurttemberg, Germany
Universitaetsklinikum Freiburg ( Site 0450), Freiburg, Baden-Wurttemberg, Germany
Klinikum der Universitaet in Muenchen ( Site 0446), Muenchen, Bayern, Germany
Medizinische Hochschule Hannover ( Site 0449), Hannover, Niedersachsen, Germany
Kliniken Essen Mitte Gmbh Evang. Huyssens Stiftung ( Site 0445), Essen, Nordrhein-Westfalen, Germany
Medizinische klinilk und Poliklinik Johannes Gutenberg Univ ( Site 0455), Mainz, Rheinland-Pfalz, Germany
Universitaetsklinikum Carl Gustav Carus der TU Dresden ( Site 0448), Dresden, Sachsen, Germany
Haematologisch-Onkologische Praxis Eppendorf Facharztzentrum Eppendorf - Hope ( Site 0454), Hamburg, , Germany
Integra Cancer Institute ( Site 0262), Guatemala, , Guatemala
Grupo Medico Angeles ( Site 0261), Guatemala, , Guatemala
Centro Medico Integral De Cancerología (CEMIC) ( Site 0260), Quetzaltenango, , Guatemala
Soroka University M.C ( Site 0385), Beer Sheva, HaDarom, Israel
Meir medical center ( Site 0386), Kfar Saba, HaMerkaz, Israel
Sourasky Medical Center. ( Site 0382), Tel-Aviv, Tell Abib, Israel
Rambam Health Care Campus ( Site 0381), Haifa, , Israel
Hadassah Medical Center. Ein Kerem ( Site 0383), Jerusalem, , Israel
Rabin-Medical Center ( Site 0384), Petah Tikva, , Israel
Sheba Medical center ( Site 0387), Ramat Gan, , Israel
IRCCS Istituto Oncologico Veneto ( Site 0431), Padova, Abruzzo, Italy
Fondazione IRCCS Istituto Nazionale dei Tumori di Milano ( Site 0430), Milano, Lombardia, Italy
Istituto Clinico Humanitas Research Hospital ( Site 0432), Rozzano, Milano, Italy
IRCCS Policlinico San Donato ( Site 0433), San Donato Milanese, Milano, Italy
Azienda Ospedaliero Universitaria di Modena Policlinico ( Site 0429), Modena, , Italy
Seconda Universita Napoli ( Site 0436), Napoli, , Italy
A.O.U. Santa Maria della Misericordia di Udine ( Site 0434), Udine, , Italy
Aichi Cancer Center Hospital ( Site 0165), Nagoya, Aichi, Japan
National Cancer Center Hospital East ( Site 0178), Kashiwa, Chiba, Japan
National Hospital Organization Shikoku Cancer Center ( Site 0186), Matsuyama, Ehime, Japan
Hokkaido University Hospital ( Site 0160), Sapporo, Hokkaido, Japan
Hyogo Cancer Center ( Site 0182), Akashi, Hyogo, Japan
Kobe University Hospital ( Site 0188), Kobe, Hyogo, Japan
Kobe City Medical Center General Hospital ( Site 0181), Kobe, Hyogo, Japan
Ibaraki Prefectural Central Hospital ( Site 0177), Kasama, Ibaraki, Japan
Iwate Medical University Hospital ( Site 0184), Shiwa-gun, Iwate, Japan
St. Marianna University School of Medicine Hospital ( Site 0187), Kawasaki, Kanagawa, Japan
Kanagawa Cancer Center ( Site 0167), Yokohama, Kanagawa, Japan
Kansai Medical University Hospital ( Site 0190), Hirakata, Osaka, Japan
Osaka University Hospital ( Site 0162), Suita, Osaka, Japan
Osaka Medical College Hospital ( Site 0168), Takatsuki, Osaka, Japan
Saitama Cancer Center ( Site 0170), Kitaadachi-gun, Saitama, Japan
Shizuoka Cancer Center Hospital and Research Institute ( Site 0176), Sunto-gun, Shizuoka, Japan
Chiba Cancer Center ( Site 0180), Chiba, , Japan
National Hospital Organization Kyushu Cancer Center ( Site 0172), Fukuoka, , Japan
Kyushu University Hospital ( Site 0173), Fukuoka, , Japan
Gifu University Hospital ( Site 0166), Gifu, , Japan
Hiroshima City Hiroshima Citizens Hospital ( Site 0171), Hiroshima, , Japan
Kochi Health Sciences Center ( Site 0189), Kochi, , Japan
Kumamoto University Hospital ( Site 0164), Kumamoto, , Japan
Niigata Cancer Center Hospital ( Site 0169), Niigata, , Japan
Osaka International Cancer Institute ( Site 0161), Osaka, , Japan
Osaka General Medical Center ( Site 0159), Osaka, , Japan
National Cancer Center Hospital ( Site 0179), Tokyo, , Japan
Tokyo Metropolitan Komagome Hospital ( Site 0183), Tokyo, , Japan
The Cancer Institute Hospital of JFCR ( Site 0185), Tokyo, , Japan
Toyama Prefectural Central Hospital ( Site 0163), Toyama, , Japan
Chonnam National University Hwasun Hospital ( Site 0083), Hwasun Gun, Jeonranamdo, Korea, Republic of
Seoul National University Bundang Hospital ( Site 0085), Seongnam-si, Kyonggi-do, Korea, Republic of
Kyungpook National University Chilgok Hospital ( Site 0089), Daegu, Taegu-Kwangyokshi, Korea, Republic of
Gachon University Gil Medical Center ( Site 0087), Incheon, , Korea, Republic of
Korea University Anam Hospital ( Site 0084), Seoul, , Korea, Republic of
Seoul National University Hospital -SNUH- ( Site 0080), Seoul, , Korea, Republic of
Severance Hospital Yonsei University Health System ( Site 0081), Seoul, , Korea, Republic of
Asan Medical Center ( Site 0082), Seoul, , Korea, Republic of
Gangnam Severance Hospital ( Site 0088), Seoul, , Korea, Republic of
SMG-SNU BORAMAE Medical Center ( Site 0086), Seoul, , Korea, Republic of
Riga East Clinical University Hospital ( Site 0550), Riga, , Latvia
LSMUL Kauno Klinikos ( Site 0570), Kaunas, , Lithuania
Nacionalinis Vezio Institutas ( Site 0569), Vilnius, , Lithuania
Vilniaus Universiteto Ligonine Santaros Klinikos ( Site 0568), Vilnius, , Lithuania
Hospital Kuala Lumpur ( Site 0146), Kuala Lumpur, , Malaysia
University Malaya Medical Centre ( Site 0143), Kuala Lumpur, , Malaysia
St. Luke s Medical Center ( Site 0622), Quezon City, National Capital Region, Philippines
Wojewodzki Szpital Specjalistyczny we Wroclawiu ( Site 0358), Wroclaw, Dolnoslaskie, Poland
Samodzielny Publiczny Szpital Kliniczny Nr 1 w Lublinie ( Site 0351), Lublin, Lubelskie, Poland
Szpital Uniwersytecki w Krakowie ( Site 0352), Krakow, Malopolskie, Poland
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie ( Site 0349), Warszawa, Mazowieckie, Poland
Mazowiecki Szpital Onkologiczny ( Site 0363), Wieliszew, Mazowieckie, Poland
Szpital Specjalistyczny w Koscierzynie Sp. z o.o. ( Site 0353), Koscierzyna, Pomorskie, Poland
Beskidzkie Centrum Onkologii im. Jana Pawla II ( Site 0354), Bielsko-Biala, Slaskie, Poland
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie ( Site 0361), Gliwice, Slaskie, Poland
SPZOZ WSS nr 3 w Rybniku ( Site 0357), Rybnik, Slaskie, Poland
Kaluga Regional Clinical Oncology Center ( Site 0345), Kaluga, Kaluzskaja Oblast, Russian Federation
SBHI Leningrad Regional Clinical Hospital ( Site 0496), Saint Petersburg, Leningradskaya Oblast, Russian Federation
National Medical and Surgical Center n.a. N.I.Pirogov ( Site 0338), Moscow, Moskva, Russian Federation
Blokhin National Medical Oncology ( Site 0494), Moscow, Moskva, Russian Federation
Scientific Research Oncology Institute n.a. N.N.Petrov ( Site 0344), Saint Petersburg, Sankt-Peterburg, Russian Federation
Leningrad Regional Oncology Center ( Site 0335), Saint-Petersburg, Sankt-Peterburg, Russian Federation
City clinical oncological dispensary ( Site 0336), Sankt-Petersburg, Sankt-Peterburg, Russian Federation
Tomsk Scientific Research Institute of Oncology ( Site 0337), Tomsk, Tomskaya Oblast, Russian Federation
National University Hospital ( Site 0095), Singapore, Central Singapore, Singapore
National Cancer Centre Singapore ( Site 0097), Singapore, Central Singapore, Singapore
Oncocare Cancer Centre ( Site 0096), Singapore, Central Singapore, Singapore
Taipei Medical University Shuang Ho Hospital ( Site 0068), New Taipei, , Taiwan
National Cheng Kung University Hospital ( Site 0067), Tainan, , Taiwan
National Taiwan University Hospital ( Site 0063), Taipei, , Taiwan
Mackay Memorial Hospital ( Site 0065), Taipei, , Taiwan
Koo Foundation Sun Yat-Sen Cancer Center ( Site 0066), Taipei, , Taiwan
Chang Gung Medical Foundation. Linkou ( Site 0064), Taoyuan, , Taiwan
City Clinical Hosp.4 of DCC ( Site 0325), Dnipro, Dnipropetrovska Oblast, Ukraine
MI Kryvyi Rih Oncology Dispensary of Dnipropetrovsk Regional Council ( Site 0589), Kryviy Rih, Dnipropetrovska Oblast, Ukraine
Ivano-Frankivsk Regional Oncology Clinical Dispensary ( Site 0321), Ivano-Frankivsk, Ivano-Frankivska Oblast, Ukraine
Communal non profit enterprise Regional Clinical Oncology Center ( Site 0591), Kharkiv, Kharkivska Oblast, Ukraine
National Cancer Institute of the MoH of Ukraine ( Site 0319), Kyiv, Kyivska Oblast, Ukraine
Kyiv City Clinical Oncology Center ( Site 0590), Kyiv, Kyivska Oblast, Ukraine
University Hospitals Bristol NHS Foundation Trust ( Site 0407), Bristol, Bristol, City Of, United Kingdom
Ninewells Hospital and Medical School ( Site 0406), Dundee, Dundee City, United Kingdom
Royal Free London NHS Foundation Trust ( Site 0403), London, London, City Of, United Kingdom
The Royal Marsden Foundation Trust ( Site 0405), London, London, City Of, United Kingdom
Imperial College Healthcare NHS Trust ( Site 0402), London, London, City Of, United Kingdom
Royal Marsden NHS Foundation Trust ( Site 0400), Sutton, Surrey, United Kingdom
The Christie NHS Foundation Trust ( Site 0397), Manchester, , United Kingdom
Contact Details
Name: Medical Director
Affiliation: Merck Sharp & Dohme LLC
Role: STUDY_DIRECTOR
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