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Pembrolizumab Plus Epacadostat, Pembrolizumab Monotherapy, and the EXTREME Regimen in Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma (KEYNOTE-669/ECHO-304)
Sponsor: Incyte Corporation
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).
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)
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
89
Start Date
2017-12-01
Completion Date
2025-10-30
Last Updated
2026-09-29
Healthy Volunteers
No
Conditions
Interventions
Pembrolizumab
Pembrolizumab administered intravenously every 3 weeks.
Epacadostat
Epacadostat administered orally twice daily.
Cetuximab
Cetuximab administered intravenously on Cycle 1 Day 1 followed by administration every week.
Cisplatin
Cisplatin administered intravenously every 3 weeks for \</= 6 cycles.
Carboplatin
Carboplatin administered intravenously every 3 weeks for \</= 6 cycles.
5-Fluorouracil
5-Fluorouracil administered intravenously every 3 weeks for \</= 6 cycles.
Locations (73)
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
Vienna, 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
Québec, 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
Milan, Italy
IRRCS Instituto Clinico Humanitas
Rozzano, Italy
National Cancer Center Hospital East
Kashiwa, Chiba, Japan
Kanazawa University Hospital
Kanazawa, Ishikawa-ken, Japan
Kanagawa Cancer Center
Yokohama, Kanagawa, Japan
Miyagi Cancer Center
Natori-shi, 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
Saitama Cancer Center
Saitama, Japan
Kindai University Hospital
Sayama, Japan
Shizuoka Cancer Center Hospital and Research Institute
Shizuoka, Japan
The Cancer Institute Hospital of JFCR
Tokyo, Japan
Mazowiecki Szpital Onkologiczny
Wieliszew, Masovian Voivodeship, 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
Lisbon, Portugal
Centro Hospitalar Lisboa Norte EPE - Hospital de Santa Maria
Lisbon, Portugal
Inst. Portugues de Oncologia de Porto Francisco Gentil EPE
Porto, Portugal
Seoul National University Hospital
Seoul, South Korea
Severance Hospital Yonsei University Health System
Seoul, South Korea
Asan Medical Center
Seoul, South Korea
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
Seville, 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 (Türkiye)
Hacettepe Universitesi Tip Fakultesi Hastanesi
Ankara, Turkey (Türkiye)
Trakya Universitesi Tip Fakultesi
Edirne, Turkey (Türkiye)
Istanbul Universitesi Onkoloji Enstitusu
Istanbul, Turkey (Türkiye)
Medipol Hastanesi
Istanbul, Turkey (Türkiye)
Ege Universitesi Tip Fakultesi Hastanesi
Izmir, Turkey (Türkiye)
Inonu Universitesi Turgut Ozal Tip Merkezi
Malatya, Turkey (Türkiye)
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