Spots Global Cancer Trial Database for Pembrolizumab Plus Epacadostat, Pembrolizumab Monotherapy, and the EXTREME Regimen in Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma (KEYNOTE-669/ECHO-304)
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Trial Identification
Brief Title: Pembrolizumab Plus Epacadostat, Pembrolizumab Monotherapy, and the EXTREME Regimen in Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma (KEYNOTE-669/ECHO-304)
Official Title: A Phase 3 Randomized, Open-Label Clinical Study to Evaluate the Efficacy and Safety of Pembrolizumab Plus Epacadostat, Pembrolizumab Monotherapy, and the EXTREME Regimen as First Line Treatment for Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma (KEYNOTE-669/ECHO-304)
Study ID: NCT03358472
Conditions
Study Description
Brief Summary: The purpose of this study was to evaluate the efficacy and safety of pembrolizumab plus epacadostat, pembrolizumab monotherapy, and the EXTREME regimen (cetuximab + cisplatin or carboplatin + 5-fluorouracil) as first-line treatment for recurrent or metastatic head and neck squamous cell carcinoma (HNSCC).
Detailed Description:
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Pacific Cancer Medical Center, Anaheim, California, United States
UC Davis Comprehensive Cancer Center, Sacramento, California, United States
St. Joseph Heritage Healthcare, Santa Rosa, California, United States
University of Colorado Cancer Center, Aurora, Colorado, United States
Yale Cancer Center, New Haven, Connecticut, United States
Northwest Georgia Oncology Centers PC, Douglasville, Georgia, United States
U of Kansas Cancer Center, Westwood, Kansas, United States
Baptist Health, Louisville, Kentucky, United States
St. Vincent Healthcare Cancer Ctr, Billings, Montana, United States
New Mexico Cancer Care Alliance, Albuquerque, New Mexico, United States
Oklahoma Cancer Specialists and Research, Tulsa, Oklahoma, United States
Providence Portland Med Center, Portland, Oregon, United States
Huntsman Cancer Institute Univ of Utah, Salt Lake City, Utah, United States
Viginia Mason Med Ctr, Seattle, Washington, United States
Chris OBrien Lifehouse, Camperdown, New South Wales, Australia
Macquarie University Hospital, North Ryde, New South Wales, Australia
Royal Brisbane & Women s Hospital, Herston, Queensland, Australia
Landeskrankenhaus Salzburg, Salzburg, , Austria
Allgemeines Krankenhaus der Stadt Wien, Wien, , Austria
Juravinski Cancer Center Hamilton Health Sciences, Hamilton, Ontario, Canada
Princess Margaret Cancer Centre, Toronto, Ontario, Canada
Jewish General Hospital, Montreal, Quebec, Canada
CHU de Quebec-Universite Laval-Hotel Dieu de Quebec, Quebec, , Canada
Borsod-Abauj-Zemplen Megyei Korhaz es Egyetemi Oktato Korhaz, Miskolc, , Hungary
Jasz Nagykun Szolnok Megyei Hetenyi Geza Korhaz Rendelointezet, Szolnok, , Hungary
Istituto Europeo di Oncologia, Milano, , Italy
IRRCS Instituto Clinico Humanitas, Rozzano, , Italy
National Cancer Center Hospital East, Kashiwa, Chiba, Japan
Kanazawa University Hospital, Kanazawa, Ishikawa, Japan
Kanagawa Cancer Center, Yokohama, Kanagawa, Japan
Miyagi Cancer Center, Natori, Miyagi, Japan
Tohoku University Hospital, Sendai, Miyagi, Japan
Hyogo Cancer Center, Akashi, , Japan
Kyushu University Hospital, Fukuoka, , Japan
Hiroshima University Hospital, Hiroshima, , Japan
Hokkaido University Hospital, Hokkaido, , Japan
Kobe City Medical Center General Hospital, Kobe, , Japan
Kindai University Hospital, Osakasayama City, , Japan
Saitama Cancer Center, Saitama, , Japan
Shizuoka Cancer Center Hospital and Research Institute, Shizuoka, , Japan
The Cancer Institute Hospital of JFCR, Tokyo, , Japan
Seoul National University Hospital, Seoul, , Korea, Republic of
Severance Hospital Yonsei University Health System, Seoul, , Korea, Republic of
Asan Medical Center, Seoul, , Korea, Republic of
Mazowiecki Szpital Onkologiczny, Wieliszew, Mazowieckie, Poland
Przychodnia Lekarska Komed, Konin, , Poland
Zachodniopomorskie Centrum Onkologii, Szczecin, , Poland
Inst. Portugues de Oncologia de Coimbra Frencisco Gentil EPE, Coimbra, , Portugal
Inst. Portugues de Oncologia de Lisboa Francisco Gentil EPE, Lisboa, , Portugal
Centro Hospitalar Lisboa Norte EPE - Hospital de Santa Maria, Lisboa, , Portugal
Inst. Portugues de Oncologia de Porto Francisco Gentil EPE, Porto, , Portugal
Hospital Germans Trias i Pujol. ICO de Badalona, Badalona, , Spain
Hospital General Universitari Vall d Hebron, Barcelona, , Spain
Hospital Ramon y Cajal, Madrid, , Spain
Hospital Universitario 12 de Octubre, Madrid, , Spain
Hospital Infanta Cristina, Madrid, , Spain
Hospital de Nuestra Senora de Valme, Sevilla, , Spain
Hospital Clinico Lozano Blesa, Zaragoza, , Spain
National Cheng Kung University Hospital, Tainan, , Taiwan
National Taiwan University Hospital, Taipei, , Taiwan
Chang Gung Medical Foundation. Linkou, Taoyuan, , Taiwan
Adana Sehir Hastanesi, Adana, , Turkey
Hacettepe Universitesi Tip Fakultesi Hastanesi, Ankara, , Turkey
Trakya Universitesi Tip Fakultesi, Edirne, , Turkey
Istanbul Universitesi Onkoloji Enstitusu, Istanbul, , Turkey
Medipol Hastanesi, Istanbul, , Turkey
Ege Universitesi Tip Fakultesi Hastanesi, Izmir, , Turkey
Inonu Universitesi Turgut Ozal Tip Merkezi, Malatya, , Turkey
North Middlesex Hospital, London, , United Kingdom
University College London Hospitals (UCLH), London, , United Kingdom
The Royal Marsden Foundation Trust, London, , United Kingdom
The Royal Marsden Nhs Foundation Trust - Chelsea, London, , United Kingdom
Musgrove Park Hospital, Taunton, , United Kingdom
Contact Details
Name: Mark Jones, MD
Affiliation: Incyte Corporation
Role: STUDY_DIRECTOR
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