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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03358472




Registration number
NCT03358472
Ethics application status
Date submitted
27/11/2017
Date registered
30/11/2017

Titles & IDs
Public title
Pembrolizumab Plus Epacadostat, Pembrolizumab Monotherapy, and the EXTREME Regimen in Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma (KEYNOTE-669/ECHO-304)
Scientific 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)
Secondary ID [1] 0 0
KEYNOTE-669/ECHO 304
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Head and Neck Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Non melanoma skin cancer
Cancer 0 0 0 0
Kidney
Cancer 0 0 0 0
Head and neck

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Pembrolizumab
Treatment: Drugs - Epacadostat
Treatment: Drugs - Cetuximab
Treatment: Drugs - Cisplatin
Treatment: Drugs - Carboplatin
Treatment: Drugs - 5-Fluorouracil

Experimental: Pembrolizumab + Epacadostat -

Experimental: Pembrolizumab -

Active comparator: EXTREME - EXTREME regimen includes cetuximab + cisplatin or carboplatin + 5-fluorouracil.


Treatment: Drugs: Pembrolizumab
Pembrolizumab administered intravenously every 3 weeks.

Treatment: Drugs: Epacadostat
Epacadostat administered orally twice daily.

Treatment: Drugs: Cetuximab
Cetuximab administered intravenously on Cycle 1 Day 1 followed by administration every week.

Treatment: Drugs: Cisplatin
Cisplatin administered intravenously every 3 weeks for \</= 6 cycles.

Treatment: Drugs: Carboplatin
Carboplatin administered intravenously every 3 weeks for \</= 6 cycles.

Treatment: Drugs: 5-Fluorouracil
5-Fluorouracil administered intravenously every 3 weeks for \</= 6 cycles.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Objective Response Rate (ORR) of Pembrolizumab + Epacadostat, Pembrolizumab Monotherapy and the EXTREME Regimen
Timepoint [1] 0 0
Minimum Week 9
Secondary outcome [1] 0 0
Safety and Tolerability of Pembrolizumab + Epacadostat Versus Pembrolizumab Versus the EXTREME Regimen as Measured by Number of Participants Experiencing Adverse Events (AEs)
Timepoint [1] 0 0
Up to 14 months
Secondary outcome [2] 0 0
Safety and Tolerability of Pembrolizumab + Epacadostat Versus Pembrolizumab Versus the EXTREME Regimen as Measured by Number of Participants Discontinuing Study Treatment Due to AEs
Timepoint [2] 0 0
Up to 14 months

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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 design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/12/2017
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
27/12/2024
Actual
Sample size
Target
Accrual to date
Final
89
Recruitment in Australia
Recruitment state(s)
NSW,QLD
Recruitment hospital [1] 0 0
Chris OBrien Lifehouse - Camperdown
Recruitment hospital [2] 0 0
Macquarie University Hospital - North Ryde
Recruitment hospital [3] 0 0
Royal Brisbane & Women s Hospital - Herston
Recruitment postcode(s) [1] 0 0
2050 - Camperdown
Recruitment postcode(s) [2] 0 0
2109 - North Ryde
Recruitment postcode(s) [3] 0 0
4029 - Herston
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Colorado
Country [3] 0 0
United States of America
State/province [3] 0 0
Connecticut
Country [4] 0 0
United States of America
State/province [4] 0 0
Georgia
Country [5] 0 0
United States of America
State/province [5] 0 0
Kansas
Country [6] 0 0
United States of America
State/province [6] 0 0
Kentucky
Country [7] 0 0
United States of America
State/province [7] 0 0
Montana
Country [8] 0 0
United States of America
State/province [8] 0 0
New Mexico
Country [9] 0 0
United States of America
State/province [9] 0 0
Oklahoma
Country [10] 0 0
United States of America
State/province [10] 0 0
Oregon
Country [11] 0 0
United States of America
State/province [11] 0 0
Utah
Country [12] 0 0
United States of America
State/province [12] 0 0
Washington
Country [13] 0 0
Austria
State/province [13] 0 0
Salzburg
Country [14] 0 0
Austria
State/province [14] 0 0
Wien
Country [15] 0 0
Canada
State/province [15] 0 0
Ontario
Country [16] 0 0
Canada
State/province [16] 0 0
Quebec
Country [17] 0 0
Hungary
State/province [17] 0 0
Miskolc
Country [18] 0 0
Hungary
State/province [18] 0 0
Szolnok
Country [19] 0 0
Italy
State/province [19] 0 0
Milano
Country [20] 0 0
Italy
State/province [20] 0 0
Rozzano
Country [21] 0 0
Japan
State/province [21] 0 0
Chiba
Country [22] 0 0
Japan
State/province [22] 0 0
Ishikawa
Country [23] 0 0
Japan
State/province [23] 0 0
Kanagawa
Country [24] 0 0
Japan
State/province [24] 0 0
Miyagi
Country [25] 0 0
Japan
State/province [25] 0 0
Akashi
Country [26] 0 0
Japan
State/province [26] 0 0
Fukuoka
Country [27] 0 0
Japan
State/province [27] 0 0
Hiroshima
Country [28] 0 0
Japan
State/province [28] 0 0
Hokkaido
Country [29] 0 0
Japan
State/province [29] 0 0
Kobe
Country [30] 0 0
Japan
State/province [30] 0 0
Osakasayama City
Country [31] 0 0
Japan
State/province [31] 0 0
Saitama
Country [32] 0 0
Japan
State/province [32] 0 0
Shizuoka
Country [33] 0 0
Japan
State/province [33] 0 0
Tokyo
Country [34] 0 0
Korea, Republic of
State/province [34] 0 0
Seoul
Country [35] 0 0
Poland
State/province [35] 0 0
Mazowieckie
Country [36] 0 0
Poland
State/province [36] 0 0
Konin
Country [37] 0 0
Poland
State/province [37] 0 0
Szczecin
Country [38] 0 0
Portugal
State/province [38] 0 0
Coimbra
Country [39] 0 0
Portugal
State/province [39] 0 0
Lisboa
Country [40] 0 0
Portugal
State/province [40] 0 0
Porto
Country [41] 0 0
Spain
State/province [41] 0 0
Badalona
Country [42] 0 0
Spain
State/province [42] 0 0
Barcelona
Country [43] 0 0
Spain
State/province [43] 0 0
Madrid
Country [44] 0 0
Spain
State/province [44] 0 0
Sevilla
Country [45] 0 0
Spain
State/province [45] 0 0
Zaragoza
Country [46] 0 0
Taiwan
State/province [46] 0 0
Tainan
Country [47] 0 0
Taiwan
State/province [47] 0 0
Taipei
Country [48] 0 0
Taiwan
State/province [48] 0 0
Taoyuan
Country [49] 0 0
Turkey
State/province [49] 0 0
Adana
Country [50] 0 0
Turkey
State/province [50] 0 0
Ankara
Country [51] 0 0
Turkey
State/province [51] 0 0
Edirne
Country [52] 0 0
Turkey
State/province [52] 0 0
Istanbul
Country [53] 0 0
Turkey
State/province [53] 0 0
Izmir
Country [54] 0 0
Turkey
State/province [54] 0 0
Malatya
Country [55] 0 0
United Kingdom
State/province [55] 0 0
London
Country [56] 0 0
United Kingdom
State/province [56] 0 0
Taunton

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Incyte Corporation
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
Merck Sharp & Dohme LLC
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Mark Jones, MD
Address 0 0
Incyte Corporation
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results are available at https://clinicaltrials.gov/study/NCT03358472