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)
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 type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Head and Neck Cancer
Keywords: Head and neck squamous cell carcinoma
programmed cell death 1 (PD-1) inhibitor
indoleamine 2,3-dioxygenase 1 (IDO1) inhibitor
Lead sponsor: Incyte Corporation
Sponsor class: INDUSTRY
Collaborators: name: Merck Sharp & Dohme LLC
First posted: 2017-11-30
Enrollment: 89
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


Eligibility criteria: 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).

Primary outcomes:
measure: Objective Response Rate (ORR) of Pembrolizumab + Epacadostat, Pembrolizumab Monotherapy and the EXTREME Regimen
timeFrame: Minimum Week 9
Secondary outcomes:
measure: Safety and Tolerability of Pembrolizumab + Epacadostat Versus Pembrolizumab Versus the EXTREME Regimen as Measured by Number of Participants Experiencing Adverse Events (AEs)
timeFrame: Up to 14 months
measure: Safety and Tolerability of Pembrolizumab + Epacadostat Versus Pembrolizumab Versus the EXTREME Regimen as Measured by Number of Participants Discontinuing Study Treatment Due to AEs
timeFrame: Up to 14 months
Other outcomes:
Locations:
city: Anaheim
country: United States
facility: Pacific Cancer Medical Center
state: California
city: Sacramento
country: United States
facility: UC Davis Comprehensive Cancer Center
state: California
city: Santa Rosa
country: United States
facility: St. Joseph Heritage Healthcare
state: California
city: Aurora
country: United States
facility: University of Colorado Cancer Center
state: Colorado
city: New Haven
country: United States
facility: Yale Cancer Center
state: Connecticut
city: Douglasville
country: United States
facility: Northwest Georgia Oncology Centers PC
state: Georgia
city: Westwood
country: United States
facility: U of Kansas Cancer Center
state: Kansas
city: Louisville
country: United States
facility: Baptist Health
state: Kentucky
city: Billings
country: United States
facility: St. Vincent Healthcare Cancer Ctr
state: Montana
city: Albuquerque
country: United States
facility: New Mexico Cancer Care Alliance
state: New Mexico
city: Tulsa
country: United States
facility: Oklahoma Cancer Specialists and Research
state: Oklahoma
city: Portland
country: United States
facility: Providence Portland Med Center
state: Oregon
city: Salt Lake City
country: United States
facility: Huntsman Cancer Institute Univ of Utah
state: Utah
city: Seattle
country: United States
facility: Viginia Mason Med Ctr
state: Washington
city: Camperdown
country: Australia
facility: Chris OBrien Lifehouse
state: New South Wales
city: North Ryde
country: Australia
facility: Macquarie University Hospital
state: New South Wales
city: Herston
country: Australia
facility: Royal Brisbane & Women s Hospital
state: Queensland
city: Salzburg
country: Austria
facility: Landeskrankenhaus Salzburg
city: Wien
country: Austria
facility: Allgemeines Krankenhaus der Stadt Wien
city: Hamilton
country: Canada
facility: Juravinski Cancer Center Hamilton Health Sciences
state: Ontario
city: Toronto
country: Canada
facility: Princess Margaret Cancer Centre
state: Ontario
city: Montreal
country: Canada
facility: Jewish General Hospital
state: Quebec
city: Quebec
country: Canada
facility: CHU de Quebec-Universite Laval-Hotel Dieu de Quebec
city: Miskolc
country: Hungary
facility: Borsod-Abauj-Zemplen Megyei Korhaz es Egyetemi Oktato Korhaz
city: Szolnok
country: Hungary
facility: Jasz Nagykun Szolnok Megyei Hetenyi Geza Korhaz Rendelointezet
city: Milano
country: Italy
facility: Istituto Europeo di Oncologia
city: Rozzano
country: Italy
facility: IRRCS Instituto Clinico Humanitas
city: Kashiwa
country: Japan
facility: National Cancer Center Hospital East
state: Chiba
city: Kanazawa
country: Japan
facility: Kanazawa University Hospital
state: Ishikawa
city: Yokohama
country: Japan
facility: Kanagawa Cancer Center
state: Kanagawa
city: Natori
country: Japan
facility: Miyagi Cancer Center
state: Miyagi
city: Sendai
country: Japan
facility: Tohoku University Hospital
state: Miyagi
city: Akashi
country: Japan
facility: Hyogo Cancer Center
city: Fukuoka
country: Japan
facility: Kyushu University Hospital
city: Hiroshima
country: Japan
facility: Hiroshima University Hospital
city: Hokkaido
country: Japan
facility: Hokkaido University Hospital
city: Kobe
country: Japan
facility: Kobe City Medical Center General Hospital
city: Osakasayama City
country: Japan
facility: Kindai University Hospital
city: Saitama
country: Japan
facility: Saitama Cancer Center
city: Shizuoka
country: Japan
facility: Shizuoka Cancer Center Hospital and Research Institute
city: Tokyo
country: Japan
facility: The Cancer Institute Hospital of JFCR
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
city: Seoul
country: Korea, Republic of
facility: Severance Hospital Yonsei University Health System
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
city: Wieliszew
country: Poland
facility: Mazowiecki Szpital Onkologiczny
state: Mazowieckie
city: Konin
country: Poland
facility: Przychodnia Lekarska Komed
city: Szczecin
country: Poland
facility: Zachodniopomorskie Centrum Onkologii
city: Coimbra
country: Portugal
facility: Inst. Portugues de Oncologia de Coimbra Frencisco Gentil EPE
city: Lisboa
country: Portugal
facility: Inst. Portugues de Oncologia de Lisboa Francisco Gentil EPE
city: Lisboa
country: Portugal
facility: Centro Hospitalar Lisboa Norte EPE - Hospital de Santa Maria
city: Porto
country: Portugal
facility: Inst. Portugues de Oncologia de Porto Francisco Gentil EPE
city: Badalona
country: Spain
facility: Hospital Germans Trias i Pujol. ICO de Badalona
city: Barcelona
country: Spain
facility: Hospital General Universitari Vall d Hebron
city: Madrid
country: Spain
facility: Hospital Ramon y Cajal
city: Madrid
country: Spain
facility: Hospital Universitario 12 de Octubre
city: Madrid
country: Spain
facility: Hospital Infanta Cristina
city: Sevilla
country: Spain
facility: Hospital de Nuestra Senora de Valme
city: Zaragoza
country: Spain
facility: Hospital Clinico Lozano Blesa
city: Tainan
country: Taiwan
facility: National Cheng Kung University Hospital
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
city: Taoyuan
country: Taiwan
facility: Chang Gung Medical Foundation. Linkou
city: Adana
country: Turkey
facility: Adana Sehir Hastanesi
city: Ankara
country: Turkey
facility: Hacettepe Universitesi Tip Fakultesi Hastanesi
city: Edirne
country: Turkey
facility: Trakya Universitesi Tip Fakultesi
city: Istanbul
country: Turkey
facility: Istanbul Universitesi Onkoloji Enstitusu
city: Istanbul
country: Turkey
facility: Medipol Hastanesi
city: Izmir
country: Turkey
facility: Ege Universitesi Tip Fakultesi Hastanesi
city: Malatya
country: Turkey
facility: Inonu Universitesi Turgut Ozal Tip Merkezi
city: London
country: United Kingdom
facility: North Middlesex Hospital
city: London
country: United Kingdom
facility: University College London Hospitals (UCLH)
city: London
country: United Kingdom
facility: The Royal Marsden Foundation Trust
city: London
country: United Kingdom
facility: The Royal Marsden Nhs Foundation Trust - Chelsea
city: Taunton
country: United Kingdom
facility: Musgrove Park Hospital
Study officials:
affiliation: Incyte Corporation
name: Mark Jones, MD
role: STUDY_DIRECTOR
References: