Spots Global Cancer Trial Database for Study of Pembrolizumab (MK-3475) or Placebo With Chemoradiation in Participants With Locally Advanced Head and Neck Squamous Cell Carcinoma (MK-3475-412/KEYNOTE-412)
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Trial Identification
Brief Title: Study of Pembrolizumab (MK-3475) or Placebo With Chemoradiation in Participants With Locally Advanced Head and Neck Squamous Cell Carcinoma (MK-3475-412/KEYNOTE-412)
Official Title: A Randomized Phase III Study of Pembrolizumab Given Concomitantly With Chemoradiation and as Maintenance Therapy Versus Chemoradiation Alone in Subjects With Locally Advanced Head and Neck Squamous Cell Carcinoma (KEYNOTE-412)
Study ID: NCT03040999
Conditions
Study Description
Brief Summary: The purpose of this study is to determine the efficacy and safety of pembrolizumab given concomitantly with chemoradiation (CRT) and as maintenance therapy versus placebo plus CRT in participants with locally advanced head and neck squamous cell carcinoma (LA HNSCC). The primary hypothesis is that pembrolizumab in combination with CRT is superior to placebo in combination with CRT with respect to event-free survival (EFS).
Detailed Description:
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
UCLA Medical Center ( Site 0273), Los Angeles, California, United States
University of California San Francisco ( Site 0274), San Francisco, California, United States
St. Joseph Heritage Healthcare ( Site 0254), Santa Rosa, California, United States
Smilow Cancer Hospital at Yale New Haven ( Site 0256), New Haven, Connecticut, United States
Rush University Medical Center ( Site 0260), Chicago, Illinois, United States
Indiana University ( Site 0264), Indianapolis, Indiana, United States
Mary Bird Perkins Cancer Center at St. Tammany Parish Hospital ( Site 0281), Baton Rouge, Louisiana, United States
University of Massachusetts Memorial Medical Center ( Site 0285), Worcester, Massachusetts, United States
University of Michigan Hospital and Health Systems ( Site 0267), Ann Arbor, Michigan, United States
Barbara Ann Karmanos Cancer Institute ( Site 0272), Detroit, Michigan, United States
Mercy Clinic Cancer and Hematology - Chub O'Reilly Cancer Center ( Site 0290), Springfield, Missouri, United States
St. Vincent Healthcare Frontier Cancer Center ( Site 0286), Billings, Montana, United States
Comprehensive Cancer Centers of Nevada ( Site 8004), Las Vegas, Nevada, United States
University of Rochester - James P. Wilmot Cancer Center ( Site 0255), Rochester, New York, United States
Oncology Hematology Care, Inc. ( Site 8003), Cincinnati, Ohio, United States
Willamette Valley Cancer Institute and Research Center ( Site 8000), Eugene, Oregon, United States
St. Luke's Cancer Center - Anderson ( Site 0251), Easton, Pennsylvania, United States
St. Francis Hospital Cancer Center ( Site 1461), Greenville, South Carolina, United States
Texas Oncology-Arlington North ( Site 8005), Arlington, Texas, United States
Texas Oncology-Austin Central ( Site 8002), Austin, Texas, United States
Texas Oncology PA ( Site 8001), Longview, Texas, United States
University of Virginia Health System ( Site 0261), Charlottesville, Virginia, United States
Seattle Cancer Care Alliance/Univ of Washington Medical Center ( Site 0269), Seattle, Washington, United States
Medical Oncology Associates (Summit Cancer Centers) ( Site 0257), Spokane, Washington, United States
Liverpool Hospital ( Site 0301), Liverpool, New South Wales (Australia), Australia
Blacktown Hospital Western Sydney Local Health District ( Site 0304), Blacktown, New South Wales, Australia
Princess Alexandra Hospital ( Site 0305), Brisbane, Queensland, Australia
Royal Brisbane and Women s Hospital ( Site 0302), Herston, Queensland, Australia
Royal Adelaide Hospital ( Site 0303), Adelaide, South Australia, Australia
Peter MacCallum Cancer Centre ( Site 0300), Melbourne, Victoria, Australia
Landeskrankenhaus - Universitatsklinikum Graz ( Site 0601), Graz, , Austria
Krankenhaus der Barmherzigen Schwestern Linz ( Site 0603), Linz, , Austria
Landeskrankenhaus Salzburg ( Site 0600), Salzburg, , Austria
Allgemeines Krankenhaus der Stadt Wien ( Site 0602), Vienna/Wien, , Austria
Cliniques Universitaires Saint Luc - Bruxelles ( Site 0651), Brussels, , Belgium
UZ Gent ( Site 0650), Gent, , Belgium
UZ Leuven Campus Gasthuisberg ( Site 0652), Leuven, , Belgium
C.H.U. Sart Tilman-Service d'Oncologie Medicale ( Site 0654), Liege, , Belgium
Clinique et Maternite Sainte-Elisabeth ( Site 0653), Namur, , Belgium
Hospital Santa Izabel - Santa Casa de Misericordia da Bahia ( Site 0006), Salvador, Bahia, Brazil
Centro Regional Integrado de Oncologia ( Site 0002), Fortaleza, Ceara, Brazil
Liga Norte Riograndense Contra o Cancer ( Site 0005), Natal, Rio Grande Do Norte, Brazil
Hospital Nossa Senhora da Conceicao ( Site 0001), Porto Alegre, Rio Grande Do Sul, Brazil
Hospital de Clinicas de Porto Alegre ( Site 0011), Porto Alegre, RS, Brazil
Fundacao Pio XII - Hospital de Cancer de Barretos ( Site 0003), Barretos, Sao Paulo, Brazil
Instituto do Cancer de Sao Paulo - ICESP ( Site 0004), Sao Paulo, SP, Brazil
Hospital das Clinicas da FMUSP de Ribeirao Preto ( Site 0008), Ribeirao Preto, , Brazil
Instituto Nacional do Cancer Jose Alencar Gomes da Silva INCA ( Site 0010), Rio de Janeiro, , Brazil
Tom Baker Cancer Centre ( Site 0063), Calgary, Alberta, Canada
Cross Cancer Institute ( Site 0064), Edmonton, Alberta, Canada
Juravinski Cancer Centre ( Site 0062), Hamilton, Ontario, Canada
London Health Sciences Centre ( Site 0055), London, Ontario, Canada
The Ottawa Hospital - Cancer Care ( Site 0052), Ottawa, Ontario, Canada
Princess Margaret Cancer Centre ( Site 0051), Toronto, Ontario, Canada
McGill University Health Centre ( Site 0061), Montreal, Quebec, Canada
CIUSSS de l Estrie - CHUS - Centre Hosp. Univ. Sherbrooke ( Site 0057), Sherbrooke, Quebec, Canada
Hospital Pablo Tobon Uribe ( Site 0151), Medellin, Antioquia, Colombia
Fundacion Valle del Lili ( Site 0150), Cali, Valle Del Cauca, Colombia
Centro Medico Imbanaco de Cali S.A ( Site 0156), Cali, Valle Del Cauca, Colombia
Centro de Investigacion Clinica del Country ( Site 0155), Bogota, , Colombia
FN Brno. ( Site 0703), Brno, , Czechia
Fakultni Nemocnice Hradec Kralove ( Site 0705), Hradec Kralove, , Czechia
Fakultni nemocnice Olomouc ( Site 0701), Olomouc, , Czechia
Fakultni nemocnice Ostrava ( Site 0702), Ostrava, , Czechia
Nemocnice Na Bulovce ( Site 0700), Praha 8, , Czechia
2. LF UK a FN Motol ( Site 0704), Praha, , Czechia
Centre Jean Bernard Laboratoire Mahe Meziani ( Site 0760), Le Mans, , France
Clinique Francois Chenieux ( Site 0757), Limoges, , France
Institut Claudius Regaud ( Site 0754), Toulouse Cedex 09, , France
Institut De Cancerologie De Lorraine ( Site 0758), Vandoeuvre les Nancy, , France
Institut Gustave Roussy ( Site 0759), Villejuif, , France
Universitätsklinikum Erlangen ( Site 0801), Erlangen, , Germany
SRH Waldklinikum Gera GmbH ( Site 0802), Gera, , Germany
Universitares Cancer Center Hamburg - UCCH ( Site 0811), Hamburg, , Germany
Medizinische Hochschule Hannover ( Site 0807), Hannover, , Germany
Universitaetsklinikum Schleswig-Holstein-Campus Luebeck ( Site 0803), Luebeck, , Germany
Klinikum der Universitaet Munchen ( Site 0810), Munchen, , Germany
Universitaetsklinik Ulm ( Site 0804), Ulm, , Germany
Rambam MC ( Site 0903), Haifa, , Israel
Hadassah Ein Karem Jerusalem ( Site 0902), Jerusalem, , Israel
Rabin Medical Center ( Site 0904), Petah Tikva, , Israel
Sheba MC ( Site 0901), Ramat Gan, , Israel
Tel Aviv Sourasky Medical Center ( Site 0900), Tel Aviv, , Israel
Azienda Ospedaliero Universitaria di Modena Policlinico ( Site 0954), Modena, MO, Italy
Azienda Ospedaliero Universitaria Careggi ( Site 0955), Firenze, , Italy
Istituto Nazionale Tumori ( Site 0950), Milano, , Italy
Istituto Europeo di Oncologia ( Site 0953), Milano, , Italy
Azienda Ospedaliera San Paolo ( Site 0952), Milano, , Italy
Istituto Nazionale Tumori IRCCS Fondazione Pascale ( Site 0951), Napoli, , Italy
Istituto Oncologico Veneto ( Site 0957), Padova, , Italy
Fondazione IRCCS - Policlinico San Matteo ( Site 0960), Pavia, , Italy
National Cancer Center Hospital East ( Site 0350), Kashiwa, Chiba, Japan
Hokkaido University Hospital ( Site 0351), Sapporo, Hokkaido, Japan
Hyogo Cancer Center ( Site 0354), Akashi, Hyogo, Japan
Kagawa University Hospital ( Site 0359), Kita-gun, Kagawa, Japan
Miyagi Cancer Center ( Site 0353), Natori, Miyagi, Japan
Chiba Cancer Center ( Site 0358), Chiba, , Japan
Hiroshima University Hospital ( Site 0352), Hiroshima, , Japan
Osaka International Cancer Institute ( Site 0355), Osaka, , Japan
Medical Hospital, Tokyo Medical And Dental University ( Site 0356), Tokyo, , Japan
The Cancer Institute Hospital of JFCR ( Site 0357), Tokyo, , Japan
Chungbuk National University Hospital ( Site 0454), Cheongju si, Chungcheongbuk Do, Korea, Republic of
Seoul National University Bundang Hospital ( Site 0453), Seongnam-si, Gyeonggi-do, Korea, Republic of
Chungnam National University Hospital ( Site 0455), Daejeon, , Korea, Republic of
Severance Hospital Yonsei University Health System ( Site 0452), Seoul, , Korea, Republic of
Samsung Medical Center ( Site 0450), Seoul, , Korea, Republic of
Noordwest Ziekenhuisgroep NWZ ( Site 1350), Alkmaar, , Netherlands
VU Medisch Centrum ( Site 1352), Amsterdam, , Netherlands
UMCG ( Site 1351), Groningen, , Netherlands
UMC St. Radboud ( Site 1356), Nijmegen, , Netherlands
Erasmus University Medical Center ( Site 1354), Rotterdam, , Netherlands
Capital & Coast District Health Board - Wellington Hospital ( Site 0400), Wellington, Newtown, New Zealand
Dolnoslaskie Centrum Onkologii. ( Site 1001), Wroclaw, Dolnoslaskie, Poland
Mazowiecki Szpital Onkologiczny ( Site 1015), Wieliszew, Mazowieckie, Poland
Beskidzkie Centrum Onkologii im. Jana Pawla II ( Site 1005), Bielsko-Biala, , Poland
Szpital Morski im. PCK. Szpitale Pomorskie Sp. Z o.o ( Site 1007), Gdynia, , Poland
Centrum Onkologii. Instytut im. Marii Sklodowskiej-Curie ( Site 1010), Gliwice, , Poland
Szpital Specjalistyczny im. Ludwika Rydygiera w Krakowie ( Site 1008), Krakow, , Poland
Zachodniopomorskie Centrum Onkologii ( Site 1013), Szczecin, , Poland
Centrum Onkologii-Instytut im. Marii Sklodowskiej-Curie ( Site 1000), Warszawa, , Poland
H.U. Vall de Hebron ( Site 1052), Barcelona, , Spain
Hospital Duran i Reynals ( Site 1053), Hospitalet de Llobregat, , Spain
Hospital Doce de Octubre ( Site 1054), Madrid, , Spain
Hospital Universitario Ramon y Cajal ( Site 1055), Madrid, , Spain
Hospital Clinico San Carlos ( Site 1051), Madrid, , Spain
Hospital Universitario Virgen de la Victoria ( Site 1056), Malaga, , Spain
Hospital Gral Universitario de Valencia ( Site 1050), Valencia, , Spain
Chang Gung Medical Foundation - Kaohsiung ( Site 0501), Kaohsiung, , Taiwan
Taichung Veterans General Hospital ( Site 0506), Taichung, , Taiwan
National Cheng Kung University Hospital ( Site 0503), Tainan, , Taiwan
National Taiwan University Hospital ( Site 0500), Taipei, , Taiwan
MacKay Memorial Hospital ( Site 0505), Taipei, , Taiwan
Taipei Veterans General Hospital ( Site 0504), Taipei, , Taiwan
Linkou Chang Gung Memorial Hospital ( Site 0502), Taoyuan, , Taiwan
Basken Adana Dr.Turgut Noyan Uygulama ve Arastirma Merkezi ( Site 1103), Adana, , Turkey
Hacettepe Universitesi Tip Fakultesi Hastanesi ( Site 1102), Ankara, , Turkey
Ankara Sehir Hastanesi ( Site 1108), Ankara, , Turkey
Istanbul Universitesi Istanbul Tip Fakultesi ( Site 1100), Istanbul, , Turkey
Medipol Universite Hastanesi ( Site 1104), Istanbul, , Turkey
Medical Park Izmir Hastanesi ( Site 1109), Izmir, , Turkey
Kocaeli Universitesi Tip Fakultesi ( Site 1106), Kocaeli, , Turkey
Inonu Universitesi Tip Fakultesi ( Site 1101), Malatya, , Turkey
Norfolk & Norwich University Hospital NHS Foundation Trust ( Site 1206), Norwich, Norfolk, United Kingdom
University Hospital of North Staffordshire ( Site 1202), Stoke-On-Trent, Staffordshire, United Kingdom
Ipswich Hospital ( Site 1207), Ipswich, Suffolk, United Kingdom
St Bartholomew s Hospital ( Site 1205), London, , United Kingdom
The Royal Marsden Foundation Trust ( Site 1200), London, , United Kingdom
Imperial Healthcare NHS Trust Charing Cross Hospital ( Site 1204), London, , United Kingdom
Lancashire Teaching Hospitals NHS Foundation Trust ( Site 1208), Preston, , United Kingdom
University Hospital Southampton NHS Foundation Trust ( Site 1203), Southampton, , United Kingdom
Royal Marsden NHS Foundation Trust ( Site 1201), Sutton, , United Kingdom
Contact Details
Name: Medical Director
Affiliation: Merck Sharp & Dohme LLC
Role: STUDY_DIRECTOR
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