Pembrolizumab Plus Epacadostat, Pembrolizumab Monotherapy, and the EXTREME Regimen in Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma (KEYNOTE-669/ECHO-304)
- Conditions
- Head and Neck Cancer
- Interventions
- Registration Number
- NCT03358472
- Lead Sponsor
- Incyte Corporation
- 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
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 89
- 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.
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Pembrolizumab + Epacadostat Epacadostat - Pembrolizumab + Epacadostat Pembrolizumab - EXTREME Cetuximab EXTREME regimen includes cetuximab + cisplatin or carboplatin + 5-fluorouracil. Pembrolizumab Pembrolizumab - EXTREME Cisplatin EXTREME regimen includes cetuximab + cisplatin or carboplatin + 5-fluorouracil. EXTREME Carboplatin EXTREME regimen includes cetuximab + cisplatin or carboplatin + 5-fluorouracil. EXTREME 5-Fluorouracil EXTREME regimen includes cetuximab + cisplatin or carboplatin + 5-fluorouracil.
- Primary Outcome Measures
Name Time Method Objective Response Rate (ORR) of Pembrolizumab + Epacadostat, Pembrolizumab Monotherapy and the EXTREME Regimen Minimum Week 9 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.
- Secondary Outcome Measures
Name Time Method Safety and Tolerability of Pembrolizumab + Epacadostat Versus Pembrolizumab Versus the EXTREME Regimen as Measured by Number of Participants Experiencing Adverse Events (AEs) 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.Safety and Tolerability of Pembrolizumab + Epacadostat Versus Pembrolizumab Versus the EXTREME Regimen as Measured by Number of Participants Discontinuing Study Treatment Due to AEs 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.
Trial Locations
- Locations (73)
U of Kansas Cancer Center
🇺🇸Westwood, Kansas, United States
Royal Brisbane & Women s Hospital
🇦🇺Herston, Queensland, Australia
Princess Margaret Cancer Centre
🇨🇦Toronto, Ontario, Canada
Huntsman Cancer Institute Univ of Utah
🇺🇸Salt Lake City, Utah, United States
Northwest Georgia Oncology Centers PC
🇺🇸Douglasville, Georgia, United States
St. Vincent Healthcare Cancer Ctr
🇺🇸Billings, Montana, 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
Landeskrankenhaus Salzburg
🇦🇹Salzburg, Austria
Allgemeines Krankenhaus der Stadt Wien
🇦🇹Wien, Austria
Juravinski Cancer Center Hamilton Health Sciences
🇨🇦Hamilton, Ontario, Canada
CHU de Quebec-Universite Laval-Hotel Dieu de Quebec
🇨🇦Quebec, Canada
Borsod-Abauj-Zemplen Megyei Korhaz es Egyetemi Oktato Korhaz
🇭🇺Miskolc, Hungary
IRRCS Instituto Clinico Humanitas
🇮🇹Rozzano, Italy
National Cancer Center Hospital East
🇯🇵Kashiwa, Chiba, Japan
Kanazawa University Hospital
🇯🇵Kanazawa, Ishikawa, Japan
Miyagi Cancer Center
🇯🇵Natori, Miyagi, Japan
Kyushu University Hospital
🇯🇵Fukuoka, Japan
Hiroshima University Hospital
🇯🇵Hiroshima, Japan
Hokkaido University Hospital
🇯🇵Hokkaido, Japan
Mazowiecki Szpital Onkologiczny
🇵🇱Wieliszew, Mazowieckie, Poland
Asan Medical Center
🇰🇷Seoul, Korea, Republic of
Kobe City Medical Center General Hospital
🇯🇵Kobe, Japan
Saitama Cancer Center
🇯🇵Saitama, Japan
The Cancer Institute Hospital of JFCR
🇯🇵Tokyo, Japan
Severance Hospital Yonsei University Health System
🇰🇷Seoul, Korea, Republic of
Seoul National University Hospital
🇰🇷Seoul, Korea, Republic of
Kindai University Hospital
🇯🇵Osakasayama City, Japan
Shizuoka Cancer Center Hospital and Research Institute
🇯🇵Shizuoka, Japan
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
Inst. Portugues de Oncologia de Porto Francisco Gentil EPE
🇵🇹Porto, Portugal
Centro Hospitalar Lisboa Norte EPE - Hospital de Santa Maria
🇵🇹Lisboa, Portugal
Hospital Germans Trias i Pujol. ICO de Badalona
🇪🇸Badalona, Spain
Hospital Universitario 12 de Octubre
🇪🇸Madrid, Spain
Hospital General Universitari Vall d Hebron
🇪🇸Barcelona, 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
The Royal Marsden Foundation Trust
🇬🇧London, United Kingdom
The Royal Marsden Nhs Foundation Trust - Chelsea
🇬🇧London, United Kingdom
University College London Hospitals (UCLH)
🇬🇧London, United Kingdom
Musgrove Park Hospital
🇬🇧Taunton, United Kingdom
Pacific Cancer Medical Center
🇺🇸Anaheim, California, United States
Hospital Infanta Cristina
🇪🇸Madrid, Spain
Hospital Ramon y Cajal
🇪🇸Madrid, Spain
St. Joseph Heritage Healthcare
🇺🇸Santa Rosa, California, United States
Hospital de Nuestra Senora de Valme
🇪🇸Sevilla, Spain
Oklahoma Cancer Specialists and Research
🇺🇸Tulsa, Oklahoma, United States
New Mexico Cancer Care Alliance
🇺🇸Albuquerque, New Mexico, United States
Kanagawa Cancer Center
🇯🇵Yokohama, Kanagawa, Japan
Istituto Europeo di Oncologia
🇮🇹Milano, Italy
UC Davis Comprehensive Cancer Center
🇺🇸Sacramento, California, United States
University of Colorado Cancer Center
🇺🇸Aurora, Colorado, United States
Yale Cancer Center
🇺🇸New Haven, Connecticut, United States
Baptist Health
🇺🇸Louisville, Kentucky, United States
Providence Portland Med Center
🇺🇸Portland, Oregon, United States
Jewish General Hospital
🇨🇦Montreal, Quebec, Canada
Tohoku University Hospital
🇯🇵Sendai, Miyagi, Japan
Jasz Nagykun Szolnok Megyei Hetenyi Geza Korhaz Rendelointezet
🇭🇺Szolnok, Hungary
Hyogo Cancer Center
🇯🇵Akashi, Japan