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Trial details imported from ClinicalTrials.gov

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




Registration number
NCT03358472
Ethics application status
Date submitted
27/11/2017
Date registered
30/11/2017
Date last updated
10/09/2019

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 - 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.
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) - 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.
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 - 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.
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
Gender
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
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC,WA
Recruitment hospital [1] 0 0
Blacktown Hospital Western Sydney Local Health District - Blacktown
Recruitment hospital [2] 0 0
Chris OBrien Lifehouse - Camperdown
Recruitment hospital [3] 0 0
Macquarie University Hospital - North Ryde
Recruitment hospital [4] 0 0
MNCCI Port Macquarie Base Hospital - Port Macquarie
Recruitment hospital [5] 0 0
Calvary Mater Newcastle - Waratah
Recruitment hospital [6] 0 0
Westmead Hospital - Westmead
Recruitment hospital [7] 0 0
Southern Medical Day Care Centre - Wollongong
Recruitment hospital [8] 0 0
Melanoma Institute Australia - Wollstonecraft
Recruitment hospital [9] 0 0
Cairns and Hinterland Hospital and Health Service - Cairns
Recruitment hospital [10] 0 0
Greenslopes Private Hospital - Greenslopes
Recruitment hospital [11] 0 0
Royal Brisbane & Women s Hospital - Herston
Recruitment hospital [12] 0 0
Ashford Cancer Centre Research - Kurralta Park
Recruitment hospital [13] 0 0
Austin Health-Austin Hospital - Heidelberg
Recruitment hospital [14] 0 0
Cabrini Health - Malvern
Recruitment hospital [15] 0 0
Peter MacCallum Cancer Centre - Melbourne
Recruitment hospital [16] 0 0
St John of God Murdoch Medical Clinic - Murdoch
Recruitment hospital [17] 0 0
Adelaide Cancer Centre - Kurralta Park
Recruitment hospital [18] 0 0
The Crown Princess Mary Cancer Centre Westmead - Westmead
Recruitment postcode(s) [1] 0 0
2148 - Blacktown
Recruitment postcode(s) [2] 0 0
2050 - Camperdown
Recruitment postcode(s) [3] 0 0
2109 - North Ryde
Recruitment postcode(s) [4] 0 0
2444 - Port Macquarie
Recruitment postcode(s) [5] 0 0
2298 - Waratah
Recruitment postcode(s) [6] 0 0
2145 - Westmead
Recruitment postcode(s) [7] 0 0
2500 - Wollongong
Recruitment postcode(s) [8] 0 0
2065 - Wollstonecraft
Recruitment postcode(s) [9] 0 0
4870 - Cairns
Recruitment postcode(s) [10] 0 0
4120 - Greenslopes
Recruitment postcode(s) [11] 0 0
4029 - Herston
Recruitment postcode(s) [12] 0 0
5037 - Kurralta Park
Recruitment postcode(s) [13] 0 0
3084 - Heidelberg
Recruitment postcode(s) [14] 0 0
3144 - Malvern
Recruitment postcode(s) [15] 0 0
3000 - Melbourne
Recruitment postcode(s) [16] 0 0
6150 - Murdoch
Recruitment outside Australia
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Manchester
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Newcastle upon Tyne

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 Corp.
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
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).
Trial website
https://clinicaltrials.gov/show/NCT03358472
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

Summary results
Other publications