- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03358472
Pembrolizumab Plus Epacadostat, Pembrolizumab Monotherapy, and the EXTREME Regimen in Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma (KEYNOTE-669/ECHO-304)
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 Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
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New South Wales
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Camperdown, New South Wales, Australia, 2050
- Chris Obrien Lifehouse
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North Ryde, New South Wales, Australia, 2109
- Macquarie University Hospital
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Queensland
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Herston, Queensland, Australia, 4029
- Royal Brisbane & Women s Hospital
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Salzburg, Austria, 5020
- Landeskrankenhaus Salzburg
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Wien, Austria, 1090
- Allgemeines Krankenhaus der Stadt Wien
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Quebec, Canada, G1R 3S1
- CHU de Quebec-Universite Laval-Hotel Dieu de Quebec
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Ontario
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Hamilton, Ontario, Canada, L8V 5C2
- Juravinski Cancer Center Hamilton Health Sciences
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Toronto, Ontario, Canada, M5G 2M9
- Princess Margaret Cancer Centre
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Quebec
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Montreal, Quebec, Canada, H3T 1E2
- Jewish General Hospital
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Miskolc, Hungary, 3526
- Borsod-Abauj-Zemplen Megyei Korhaz es Egyetemi Oktato Korhaz
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Szolnok, Hungary, 5000
- Jasz Nagykun Szolnok Megyei Hetenyi Geza Korhaz Rendelointezet
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Milano, Italy, 20141
- Istituto Europeo Di Oncologia
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Rozzano, Italy, 20089
- Irrcs Instituto Clinico Humanitas
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Akashi, Japan, 673-8558
- Hyogo Cancer Center
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Fukuoka, Japan, 812-8582
- Kyushu University Hospital
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Hiroshima, Japan, 734-8551
- Hiroshima University Hospital
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Hokkaido, Japan, 060-8648
- Hokkaido University Hospital
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Kobe, Japan, 650-0047
- Kobe City Medical Center General Hospital
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Osakasayama City, Japan, 589-8511
- Kindai University Hospital
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Saitama, Japan, 362-0806
- Saitama Cancer Center
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Shizuoka, Japan, 411-8777
- Shizuoka Cancer Center Hospital and Research Institute
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Tokyo, Japan, 135-8550
- The Cancer Institute Hospital of JFCR
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Chiba
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Kashiwa, Chiba, Japan, 277-8577
- National Cancer Center Hospital East
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Ishikawa
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Kanazawa, Ishikawa, Japan, 920-8641
- Kanazawa University Hospital
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Kanagawa
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Yokohama, Kanagawa, Japan, 241-8515
- Kanagawa Cancer Center
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Miyagi
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Natori, Miyagi, Japan, 981-1293
- Miyagi Cancer Center
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Sendai, Miyagi, Japan, 980-8574
- Tohoku University Hospital
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Seoul, Korea, Republic of, 03080
- Seoul National University Hospital
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Seoul, Korea, Republic of, 05505
- Asan Medical Center
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Seoul, Korea, Republic of, 03722
- Severance Hospital Yonsei University Health System
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Konin, Poland, 62-500
- Przychodnia Lekarska KOMED
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Szczecin, Poland, 71-730
- Zachodniopomorskie Centrum Onkologii
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Mazowieckie
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Wieliszew, Mazowieckie, Poland, 05-135
- Mazowiecki Szpital Onkologiczny
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Coimbra, Portugal, 3000-075
- Inst. Portugues de Oncologia de Coimbra Frencisco Gentil EPE
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Lisboa, Portugal, 1649-035
- Centro Hospitalar Lisboa Norte EPE - Hospital de Santa Maria
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Lisboa, Portugal, 1099-023
- Inst. Portugues de Oncologia de Lisboa Francisco Gentil EPE
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Porto, Portugal, 4200-072
- Inst. Portugues de Oncologia de Porto Francisco Gentil EPE
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Badalona, Spain, 08916
- Hospital Germans Trias i Pujol. ICO de Badalona
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Barcelona, Spain, 08035
- Hospital General Universitari Vall D Hebron
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Madrid, Spain, 28041
- Hospital Universitario 12 De Octubre
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Madrid, Spain, 28034
- Hospital Ramón y Cajal
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Madrid, Spain, 28981
- Hospital Infanta Cristina
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Sevilla, Spain, 41014
- Hospital de Nuestra Senora de Valme
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Zaragoza, Spain, 50009
- Hospital Clinico Lozano Blesa
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Tainan, Taiwan, 70457
- National Cheng Kung University Hospital
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Taipei, Taiwan, 10048
- National Taiwan University Hospital
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Taoyuan, Taiwan, 33305
- Chang Gung Medical Foundation. Linkou
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Adana, Turkey, 01370
- Adana Sehir Hastanesi
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Ankara, Turkey, 06100
- Hacettepe Universitesi Tip Fakultesi Hastanesi
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Edirne, Turkey, 22030
- Trakya Universitesi Tip Fakultesi
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Istanbul, Turkey, 34093
- Istanbul Universitesi Onkoloji Enstitusu
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Istanbul, Turkey, 34214
- Medipol Hastanesi
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Izmir, Turkey, 35040
- Ege Universitesi Tip Fakultesi Hastanesi
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Malatya, Turkey, 44280
- Inonu Universitesi Turgut Ozal Tip Merkezi
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London, United Kingdom, N18 1QX
- North Middlesex Hospital
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London, United Kingdom, NW1 2PG
- University College London Hospitals (UCLH)
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London, United Kingdom, SW3 6JJ
- The Royal Marsden Foundation Trust
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London, United Kingdom, SW3 6JJ
- The Royal Marsden Nhs Foundation Trust - Chelsea
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Taunton, United Kingdom, TA1 5DA
- Musgrove Park Hospital
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California
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Anaheim, California, United States, 19026
- Pacific Cancer Medical Center
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Sacramento, California, United States, 95817
- UC Davis Comprehensive Cancer Center
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Santa Rosa, California, United States, 95403
- St. Joseph Heritage Healthcare
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Colorado
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Aurora, Colorado, United States, 80045
- University of Colorado Cancer Center
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Connecticut
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New Haven, Connecticut, United States, 06520
- Yale Cancer Center
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Georgia
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Douglasville, Georgia, United States, 30134
- Northwest Georgia Oncology Centers PC
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Kansas
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Westwood, Kansas, United States, 66205
- U of Kansas Cancer Center
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Kentucky
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Louisville, Kentucky, United States, 40223
- Baptist Health
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Montana
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Billings, Montana, United States, 59102
- St. Vincent Healthcare Cancer Ctr
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New Mexico
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Albuquerque, New Mexico, United States, 87106
- New Mexico Cancer Care Alliance
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Oklahoma
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Tulsa, Oklahoma, United States, 74146
- Oklahoma Cancer Specialists and Research
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Oregon
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Portland, Oregon, United States, 97213
- Providence Portland Med Center
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Utah
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Salt Lake City, Utah, United States, 19026
- Huntsman Cancer Institute Univ of Utah
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Washington
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Seattle, Washington, United States, 98101
- Viginia Mason Med Ctr
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Measurable disease based on RECIST v1.1.
- 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:
- Carcinoma of the nasopharynx, salivary gland, unknown primary origin, or nonsquamous histologies as primary tumors.
- 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).
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: Pembrolizumab
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Pembrolizumab administered intravenously every 3 weeks.
Other Names:
|
Experimental: Pembrolizumab + Epacadostat
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Pembrolizumab administered intravenously every 3 weeks.
Other Names:
Epacadostat administered orally twice daily.
Other Names:
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Active Comparator: EXTREME
EXTREME regimen includes cetuximab + cisplatin or carboplatin + 5-fluorouracil.
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Cetuximab administered intravenously on Cycle 1 Day 1 followed by administration every week.
Cisplatin administered intravenously every 3 weeks for
Carboplatin administered intravenously every 3 weeks for
5-Fluorouracil administered intravenously every 3 weeks for
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Objective Response Rate (ORR) of Pembrolizumab + Epacadostat, Pembrolizumab Monotherapy and the EXTREME Regimen
Time Frame: Minimum Week 9
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ORR was defined as the percentage of participants who had a complete response (CR), disappearance of all target lesions or partial response (PR), >=30% decrease in the sum of the longest diameter of target lesions per RECIST v1.1 by investigator determination. Responses are based on investigator assessments per RECIST 1.1 without confirmation using all available scans. |
Minimum Week 9
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Safety and Tolerability of Pembrolizumab + Epacadostat Versus Pembrolizumab Versus the EXTREME Regimen as Measured by Number of Participants Experiencing Adverse Events (AEs)
Time Frame: Up to 14 months
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AE is defined as any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. Data reported from start of study to data cutoff 17 Jan 2019, up to 14 months. |
Up to 14 months
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Safety and Tolerability of Pembrolizumab + Epacadostat Versus Pembrolizumab Versus the EXTREME Regimen as Measured by Number of Participants Discontinuing Study Treatment Due to AEs
Time Frame: Up to 14 months
|
AE is defined as any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. Data reported from start of study to data cutoff 17 Jan 2019, up to 14 months. |
Up to 14 months
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Director: Mark Jones, MD, Incyte Corporation
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Neoplasms by Histologic Type
- Neoplasms
- Neoplasms by Site
- Neoplasms, Glandular and Epithelial
- Head and Neck Neoplasms
- Neoplasms, Squamous Cell
- Carcinoma
- Carcinoma, Squamous Cell
- Squamous Cell Carcinoma of Head and Neck
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Antimetabolites, Antineoplastic
- Antimetabolites
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Antineoplastic Agents, Immunological
- Immune Checkpoint Inhibitors
- Carboplatin
- Fluorouracil
- Pembrolizumab
- Cetuximab
Other Study ID Numbers
- KEYNOTE-669/ECHO 304
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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