Spots Global Cancer Trial Database for Study of Pembrolizumab (MK-3475) Versus Placebo in Participants With Esophageal Carcinoma Who Are Receiving Chemotherapy and Radiation Therapy (MK-3475-975/KEYNOTE-975)
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Trial Identification
Brief Title: Study of Pembrolizumab (MK-3475) Versus Placebo in Participants With Esophageal Carcinoma Who Are Receiving Chemotherapy and Radiation Therapy (MK-3475-975/KEYNOTE-975)
Official Title: A Randomized, Double-blind, Placebo-controlled Phase 3 Trial of Pembrolizumab (MK-3475) Versus Placebo in Participants With Esophageal Carcinoma Receiving Concurrent Definitive Chemoradiotherapy (KEYNOTE 975)
Study ID: NCT04210115
Study Description
Brief Summary: The purpose of this study is to assess the efficacy and safety of treatment with definitive chemoradiotherapy (dCRT) + pembrolizumab (MK-3475) compared to treatment with dCRT + placebo with respect to Event-free Survival (EFS) and Overall Survival (OS) in: * participants whose tumors express Programmed Death-Ligand 1 (PD-L1) Combined Positive Score (CPS) ≥10 * participants whose tumors express PD-L1 CPS ≥1 * all participants The primary study hypotheses are that dCRT+ pembrolizumab is better than dCRT + placebo with respect to: * EFS in participants whose tumors express PD-L1 CPS ≥10 * EFS in participants whose tumors express PD-L1 CPS ≥1 * EFS in all participants * OS in participants whose tumors express PD-L1 CPS ≥10 * OS in participants whose tumors express PD-L1 CPS ≥1 * OS in all participants
Detailed Description: Participants receive pembrolizumab or placebo PLUS one of two chemotherapy regimens PLUS radiation therapy for up to approximately one year. The chemotherapy regimens are either: * FP (5-fluorouracil \[5-FU\] + cisplatin) or * FOLFOX (5-FU + oxaliplatin + leucovorin or levoleucovorin).
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
MemorialCare Health System - Long Beach Medical Center-Oncology ( Site 0691), Long Beach, California, United States
Columbus Regional Research Institute ( Site 0047), Columbus, Georgia, United States
University of Kansas Cancer Center ( Site 0023), Westwood, Kansas, United States
Cancer Center of Kansas ( Site 0058), Wichita, Kansas, United States
University Medical Center ( Site 0035), New Orleans, Louisiana, United States
Greater Baltimore Medical Center ( Site 0031), Baltimore, Maryland, United States
Dana Farber Cancer Center ( Site 0034), Boston, Massachusetts, United States
Henry Ford Hospital ( Site 0685), Detroit, Michigan, United States
University of Missouri ( Site 0688), Columbia, Missouri, United States
Renown Regional Medical Center ( Site 0706), Reno, Nevada, United States
Rutgers Cancer Institute of New Jersey ( Site 0695), New Brunswick, New Jersey, United States
Weill Cornell Medical College ( Site 0053), New York, New York, United States
Stephenson Cancer Center ( Site 0044), Oklahoma City, Oklahoma, United States
Oregon Health & Science University Center for Health & Healing 2- CHH2 ( Site 0060), Portland, Oregon, United States
Allegheny Health Network ( Site 0042), Pittsburgh, Pennsylvania, United States
Thompson Cancer Survival Center ( Site 0696), Knoxville, Tennessee, United States
Utah Cancer Specialists ( Site 0697), Salt Lake City, Utah, United States
Cancer Care Northwest - Spokane Valley ( Site 0036), Spokane Valley, Washington, United States
University of Wisconsin Hospital and Clinics ( Site 0033), Madison, Wisconsin, United States
Instituto Medico Alexander Fleming ( Site 0063), Buenos Aires, Caba, Argentina
Fundacion Favaloro ( Site 0061), Ciudad de Buenos Aires, Caba, Argentina
Hospital Municipal de Gastroenterologia Dr. Bonorino Udaondo ( Site 0066), Buenos Aires, , Argentina
CEMIC ( Site 0064), Buenos Aires, , Argentina
UCL Saint Luc ( Site 0162), Brussels, Bruxelles-Capitale, Region De, Belgium
UZ Gent ( Site 0163), Gent, Oost-Vlaanderen, Belgium
UZ Leuven ( Site 0161), Leuven, Vlaams-Brabant, Belgium
AZ Delta ( Site 0165), Roeselare, West-Vlaanderen, Belgium
ONCOSITE - Centro de Pesquisa Clinica em Oncologia ( Site 0088), Ijui, Rio Grande Do Sul, Brazil
Hospital Nossa Senhora da Conceicao ( Site 0087), Porto Alegre, Rio Grande Do Sul, Brazil
Clinica de Oncologia Reichow ( Site 0085), Blumenau, Santa Catarina, Brazil
Instituto do Cancer do Estado de Sao Paulo - ICESP ( Site 0081), Sao Paulo, , Brazil
Cross Cancer Institute ( Site 0010), Edmonton, Alberta, Canada
CancerCare Manitoba ( Site 0002), Winnipeg, Manitoba, Canada
The Ottawa Hospital - Cancer Care ( Site 0008), Ottawa, Ontario, Canada
Sunnybrook Research Institute ( Site 0012), Toronto, Ontario, Canada
Princess Margaret Cancer Centre ( Site 0011), Toronto, Ontario, Canada
Centre Hospitalier de l Universite de Montreal - CHUM ( Site 0005), Montreal, Quebec, Canada
Centro Investigación del Cáncer James Lind ( Site 0106), Temuco, Araucania, Chile
Centro de Investigacion y desarrollo Oncologico SpA - CIDO SpA ( Site 0103), Temuco, Araucania, Chile
Hospital Regional de Concepcion ( Site 0105), Concepcion, Biobio, Chile
Centro de Cancer Nuestra Senora de la Esperanza ( Site 0104), Santiago, Region M. De Santiago, Chile
Anhui Provincial Hospital-Oncology Radiotherapy Department ( Site 0531), Hefei, Anhui, China
The 900th Hospital of the Joint Logistics Support Force of the Chinese People's Liberation Army ( Si, Fuzhou, Fujian, China
The First Affiliated Hospital of Xiamen University ( Site 0538), Xiamen, Fujian, China
Hubei Cancer Hospital ( Site 0514), Wuhan, Hubei, China
Hunan Cancer Hospital ( Site 0515), Changsha, Hunan, China
Huai an First People s Hospital ( Site 0526), Huai An, Jiangsu, China
Jiangsu Cancer Hospital ( Site 0519), Nanjing, Jiangsu, China
The Affiliated Hospital of Xuzhou Medical University ( Site 0522), Xuzhou, Jiangsu, China
Affiliated Hospital of Jiangsu University ( Site 0524), Zhenjiang, Jiangsu, China
Jiangxi Cancer Hospital ( Site 0512), Nanchang, Jiangxi, China
Shanghai Chest Hospital ( Site 0503), Shangai, Shanghai, China
Shanghai Chest Hospital ( Site 0501), Shanghai, Shanghai, China
Zhongshan Hospital Fudan University ( Site 0502), Shanghai, Shanghai, China
Sichuan Cancer Hospital ( Site 0527), Chengdu, Sichuan, China
Tianjin Medical University Cancer Institute & Hospital ( Site 0505), Tianjin, Tianjin, China
Hangzhou First People's Hospital ( Site 0530), Hangzhou, Zhejiang, China
Sir Run Run Shaw Hospital ( Site 0523), Hangzhou, Zhejiang, China
Zhejiang Cancer Hospital ( Site 0529), Hangzhou, Zhejiang, China
Masarykuv onkologicky ustav-Klinika komplexni onkologicke pece ( Site 0721), Brno, Brno-mesto, Czechia
Fakultni nemocnice Ostrava-Klinika onkologicka ( Site 0719), Ostrava, Moravskoslezsky Kraj, Czechia
Fakultni nemocnice Olomouc-Onkologicka klinika ( Site 0720), Olomouc, Olomoucky Kraj, Czechia
Fakultni nemocnice v Motole-Onkologicka klinika 2. LF UK a FN Motol ( Site 0718), Praha, Praha 5, Czechia
Rigshospitalet ( Site 0199), Copenhagen, Hovedstaden, Denmark
Odense Universitetshospital ( Site 0200), Odense, Syddanmark, Denmark
SA Pohja-Eesti Regionaalhaigla ( Site 0201), Tallinn, Harjumaa, Estonia
SA Tartu Ulikooli Kliinikum ( Site 0202), Tartu, Tartumaa, Estonia
Institut De Cancerologie De Lorraine ( Site 0222), Vandoeuvre les Nancy, Ain, France
Centre Francois Baclesse ( Site 0236), Caen, Calvados, France
Centre Georges Francois Leclerc ( Site 0223), Dijon, Cote-d Or, France
CHU Limoges Hopital Dupuytren ( Site 0225), Limoges, Haute-Vienne, France
Institut Curie - Centre Rene Huguenin ( Site 0237), Saint-Cloud, Hauts-de-Seine, France
Institut Jean Godinot ( Site 0238), Reims, Marne, France
CHU Hotel Dieu Nantes ( Site 0230), Nantes, Pays-de-la-Loire, France
Institut Sainte Catherine ( Site 0228), Avignon, Provence-Alpes-Cote-d Azur, France
CHU Amiens Picardie Site Sud Amiens ( Site 0235), Amiens, Somme, France
CHD Vendee ( Site 0227), La Roche sur Yon, Vendee, France
Marienhospital Stuttgart Vincenz von Paul Kliniken gGmbH ( Site 0253), Stuttgart, Baden-Wurttemberg, Germany
Universitaetsklinikum Koeln ( Site 0251), Koeln, Nordrhein-Westfalen, Germany
Universitaetsklinikum Muenster ( Site 0248), Muenster, Nordrhein-Westfalen, Germany
Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz ( Site 0247), Mainz, Rheinland-Pfalz, Germany
Charite Campus Virchow Klinikum ( Site 0250), Berlin, , Germany
Facharztzentrum Eppendorf ( Site 0242), Hamburg, , Germany
Centro de Investigaciones Clinicas de Latinoamerica S.A. - CELAN ( Site 0122), Guatemala, , Guatemala
Gastrosoluciones ( Site 0126), Guatemala, , Guatemala
Oncomedica ( Site 0125), Guatemala, , Guatemala
Grupo Medico Angeles ( Site 0121), Guatemala, , Guatemala
Medi-K Cayala ( Site 0124), Guatemala, , Guatemala
Centro Medico Integral De Cancerología (CEMIC) ( Site 0123), Quetzaltenango, , Guatemala
Pamela Youde Nethersole Eastern Hospital ( Site 0543), Hong Kong, , Hong Kong
Princess Margaret Hospital. ( Site 0542), Hong Kong, , Hong Kong
Queen Mary Hospital ( Site 0541), Pokfulam, , Hong Kong
Pecsi Tudomanyegyetem AOK ( Site 0265), Pecs, Baranya, Hungary
Bekes Megyei Kozponti Korhaz - Pandy Kalman Tagkorhaza ( Site 0262), Gyula, Bekes, Hungary
Orszagos Onkologiai Intezet ( Site 0263), Budapest, , Hungary
Debreceni Egyetem Klinikai Kozpont ( Site 0261), Debrecen, , Hungary
Fondazione IRCCS Policlinico San Matteo-Oncology ( Site 0300), Pavia, Lombardia, Italy
IRCCS Policlinico San Donato ( Site 0295), San Donato Milanese, Milano, Italy
Azienda Ospedaliero Universitaria Pisana - Presidio Santa Chiara ( Site 0294), Pisa, Toscana, Italy
ASST Papa Giovanni XXIII ( Site 0296), Bergamo, , Italy
Azienda Socio Sanitaria Territoriale di Cremona ( Site 0299), Cremona, , Italy
Fondazione IRCCS Istituto Nazionale dei Tumori di Milano ( Site 0292), Milano, , Italy
Istituto Nazionale Tumori IRCCS Fondazione Pascale-SC Oncologia Clinica Sperimentale Addome ( Site 0, Napoli, , Italy
IRCCS Istituto Oncologico Veneto ( Site 0298), Padova, , Italy
Policlinico Universitario A. Gemelli ( Site 0297), Roma, , Italy
Aichi Cancer Center Hospital ( Site 0563), Nagoya, Aichi, Japan
National Cancer Center Hospital East ( Site 0562), Kashiwa, Chiba, Japan
Kanagawa Cancer Center ( Site 0565), Yokohama, Kanagawa, Japan
Saitama Cancer Center ( Site 0564), Kitaadachi-gun, Saitama, Japan
Shizuoka Cancer Center Hospital and Research Institute ( Site 0566), Sunto-gun, Shizuoka, Japan
National Cancer Center Hospital ( Site 0561), Tokyo, , Japan
Chonnam National University Hwasun Hospital ( Site 0625), Hwasun Gun, Jeonranamdo, Korea, Republic of
National Cancer Center ( Site 0626), Goyang-si, Kyonggi-do, Korea, Republic of
Asan Medical Center ( Site 0623), Songpagu, Seoul, Korea, Republic of
Severance Hospital Yonsei University Health System ( Site 0624), Seoul, , Korea, Republic of
Samsung Medical Center ( Site 0622), Seoul, , Korea, Republic of
Korea University Guro Hospital ( Site 0621), Seoul, , Korea, Republic of
Cryptex Investigación Clínica S.A. de C.V. ( Site 0729), Cuauhtémoc, Ciudad De México, Distrito Federal, Mexico
CENTRO HEMATO ONCOLOGICO PRIVADO-CHOP ( Site 0728), Toluca de Lerdo, , Mexico
Instituto Nacional de Enfermedades Neoplasicas ( Site 0141), Lima, Muni Metro De Lima, Peru
Detecta Clínica ( Site 0146), Surquillo, Muni Metro De Lima, Peru
Hospital Nacional Arzobispo Loayza ( Site 0143), Lima, , Peru
Clinica San Gabriel ( Site 0142), Lima, , Peru
Baguio General Hospital and Medical Center ( Site 0603), Baguio City, Benguet, Philippines
Cebu Doctors University Hospital ( Site 0604), Cebu City, Cebu, Philippines
The Medical City-Iloilo ( Site 0602), Iloilo City, Iloilo, Philippines
St. Luke s Medical Center ( Site 0601), Quezon, National Capital Region, Philippines
Hospital Beatriz Angelo ( Site 0374), Loures, Lisboa, Portugal
Inst. Portugues de Oncologia de Lisboa Francisco Gentil EPE ( Site 0372), Lisboa, , Portugal
Hospital da Luz ( Site 0373), Lisboa, , Portugal
CHLN Hospital Santa Maria ( Site 0376), Lisboa, , Portugal
Inst. Portugues de Oncologia de Porto Francisco Gentil EPE ( Site 0371), Porto, , Portugal
MedEuropa Bucuresti - Centru de Radioterapie-Oncology ( Site 0400), București, Bucuresti, Romania
Institutul Oncologic Prof.Dr. Ion Chiricuta Cluj-Napoca ( Site 0392), Cluj-Napoca, Cluj, Romania
S.C. Radiotherapy Center Cluj S.R.L ( Site 0391), Cluj-Napoca, Cluj, Romania
Ovidius Clinical Hospital OCH-Oncology and Hematology ( Site 0393), Ovidiu, Constanta, Romania
S.C. Centrul de Oncologie Sf. Nectarie SRL ( Site 0394), Craiova, Dolj, Romania
Centrul Medical Topmed ( Site 0398), Targu-Mures, Mures, Romania
S.C.Focus Lab Plus S.R.L ( Site 0395), Bucuresti, , Romania
GBUZ Republican Clinical Oncological Dispensary-Antitumor drug therapy department ( Site 0430), Ufa, Baskortostan, Respublika, Russian Federation
Kaluga Regional Clinical Oncology Center ( Site 0424), Kaluga, Kaluzskaja Oblast, Russian Federation
Main Military Clinical Hospital n.a. N.N.Burdenko ( Site 0421), Moscow, Moskva, Russian Federation
FSAI Treatment and Rehabilitation Centre of the MoH and SD of RF ( Site 0429), Moscow, Moskva, Russian Federation
SBHI Samara Regional Clinical Oncology Dispensary ( Site 0420), Samara, Samarskaya Oblast, Russian Federation
Pavlov First Saint Petersburg State Medical University ( Site 0426), St. Petersburg, Sankt-Peterburg, Russian Federation
Medical institute named after Berezin Sergey ( Site 0417), St. Petersburg, Sankt-Peterburg, Russian Federation
Sverdlovsk Regional Oncology Hospital ( Site 0411), Ekaterinburg, Sverdlovskaya Oblast, Russian Federation
Republican Clinical Oncology Dispensary of Tatarstan MoH ( Site 0412), Kazan, Tatarstan, Respublika, Russian Federation
Chang Gung Med Foundation. Kaohsiung Branch ( Site 0643), Kaohsiung, , Taiwan
China Medical University Hospital ( Site 0646), Taichung, , Taiwan
Taichung Veterans General Hospital-Radiation Oncology ( Site 0647), Taichung, , Taiwan
National Cheng Kung University Hospital ( Site 0645), Tainan, , Taiwan
National Taiwan University Hospital ( Site 0641), Taipei, , Taiwan
Koo Foundation Sun Yat-Sen Cancer Center ( Site 0644), Taipei, , Taiwan
Chang Gung Medical Foundation. Linkou ( Site 0642), Taoyuan, , Taiwan
Istanbul University Cerrahpasa Medical Faculty ( Site 0452), Istambul, Istanbul, Turkey
Memorial Ankara Hastanesi ( Site 0461), Ankara, , Turkey
Göztepe Prof. Dr. Süleyman Yalçın Şehir Hastanesi-oncology ( Site 0451), Istanbul, , Turkey
Ege Universitesi Tip Fakultesi ( Site 0457), Izmir, , Turkey
Izmir Katip Celebi Universitesi Ataturk Egitim ve Arastirma Hastanesi ( Site 0458), Izmir, , Turkey
Aberdeen Royal Infirmary ( Site 0474), Aberdeen, Aberdeen City, United Kingdom
Cambridge University Hospitals NHS Trust ( Site 0477), Cambridge, Cambridgeshire, United Kingdom
Royal Free Hospital ( Site 0702), London, England, United Kingdom
ROYAL MARSDEN HOSPITAL (CHELSEA) ( Site 0283), London, London, City Of, United Kingdom
Hammersmith Hospital-Medical Oncology ( Site 0471), London, London, City Of, United Kingdom
Nottingham University Hospitals NHS Trust ( Site 0476), Nottingham, Nottinghamshire, United Kingdom
Royal Marsden Hospital (Sutton) ( Site 0281), Sutton, Surrey, United Kingdom
University College Hospital NHS Foundation Trust ( Site 0701), London, Worcestershire, United Kingdom
The Christie NHS Foundation Trust ( Site 0282), Manchester, , United Kingdom
Mount Vernon Hospital ( Site 0478), Northwood, , United Kingdom
Contact Details
Name: Medical Director
Affiliation: Merck Sharp & Dohme LLC
Role: STUDY_DIRECTOR
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