Pembrolizumab Plus Epacadostat, Pembrolizumab Monotherapy, and the EXTREME Regimen in Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma (KEYNOTE-669/ECHO-304)
NCT ID: NCT03358472
Last Updated: 2025-12-03
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
89 participants
INTERVENTIONAL
2017-12-01
2025-10-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Pembrolizumab + Epacadostat
Pembrolizumab
Pembrolizumab administered intravenously every 3 weeks.
Epacadostat
Epacadostat administered orally twice daily.
Pembrolizumab
Pembrolizumab
Pembrolizumab administered intravenously every 3 weeks.
EXTREME
EXTREME regimen includes cetuximab + cisplatin or carboplatin + 5-fluorouracil.
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.
Interventions
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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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
* Adequate organ function per protocol-defined criteria.
* Documentation of results from testing of human papilloma virus (HPV) status for oropharyngeal cancer.
* Baseline archival tumor specimen available or willing to undergo a prestudy treatment tumor core or excisional biopsy of a tumor lesion not previously irradiated, to obtain the specimen.
Exclusion Criteria
* Disease progression within 6 months of completion of curatively intended systemic treatment for locoregionally advanced HNSCC.
* Use of protocol-defined prior/concomitant therapy.
* Known additional malignancy that is progressing or has required active treatment within the past 3 years.
* Known active central nervous system (CNS) metastases and/or carcinomatous meningitis.
* Active autoimmune disease that has required systemic treatment in past 2 years.
* Known history of human immunodeficiency virus (HIV) infection. HIV testing is not required unless mandated by local health authority.
* Known history of or is positive for active hepatitis B (defined as hepatitis B surface antigen \[HBsAg\] reactive) or hepatitis C (defined as HCV RNA \[qualitative\] is detected).
18 Years
ALL
No
Sponsors
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Merck Sharp & Dohme LLC
INDUSTRY
Incyte Corporation
INDUSTRY
Responsible Party
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Principal Investigators
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Mark Jones, MD
Role: STUDY_DIRECTOR
Incyte Corporation
Locations
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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 District, , 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
Countries
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References
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Cho BC, Brana I, Cirauqui B, Aksoy S, Couture F, Hong RL, Miller WH Jr, Chaves-Conde M, Teixeira M, Leopold L, Munteanu M, Ge JY, Swaby RF, Hughes BGM. Pembrolizumab plus epacadostat in patients with recurrent/metastatic head and neck squamous cell carcinoma (KEYNOTE-669/ECHO-304): a phase 3, randomized, open-label study. BMC Cancer. 2024 Jul 25;23(Suppl 1):1254. doi: 10.1186/s12885-023-11316-0.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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2017-001338-24
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
KEYNOTE-669/ECHO 304
Identifier Type: -
Identifier Source: org_study_id
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