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Pembrolizumab Plus Epacadostat, Pembrolizumab Monotherapy, and the EXTREME Regimen in Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma (KEYNOTE-669/ECHO-304)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03358472
Recruitment Status : Active, not recruiting
First Posted : November 30, 2017
Results First Posted : September 10, 2019
Last Update Posted : September 10, 2019
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
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).

Condition or disease Intervention/treatment Phase
Head and Neck Cancer Drug: Pembrolizumab Drug: Epacadostat Drug: Cetuximab Drug: Cisplatin Drug: Carboplatin Drug: 5-Fluorouracil Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 89 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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)
Actual Study Start Date : December 1, 2017
Actual Primary Completion Date : July 19, 2018
Estimated Study Completion Date : June 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Pembrolizumab + Epacadostat Drug: Pembrolizumab
Pembrolizumab administered intravenously every 3 weeks.
Other Name: MK-3475

Drug: Epacadostat
Epacadostat administered orally twice daily.
Other Name: INCB024360

Experimental: Pembrolizumab Drug: Pembrolizumab
Pembrolizumab administered intravenously every 3 weeks.
Other Name: MK-3475

Active Comparator: EXTREME
EXTREME regimen includes cetuximab + cisplatin or carboplatin + 5-fluorouracil.
Drug: Cetuximab
Cetuximab administered intravenously on Cycle 1 Day 1 followed by administration every week.

Drug: Cisplatin
Cisplatin administered intravenously every 3 weeks for </= 6 cycles.

Drug: Carboplatin
Carboplatin administered intravenously every 3 weeks for </= 6 cycles.

Drug: 5-Fluorouracil
5-Fluorouracil administered intravenously every 3 weeks for </= 6 cycles.




Primary Outcome Measures :
  1. Objective Response Rate (ORR) of Pembrolizumab + Epacadostat, Pembrolizumab Monotherapy and the EXTREME Regimen [ Time Frame: 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 :
  1. 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 ]

    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.


  2. 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.




Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03358472


Locations
Show Show 224 study locations
Sponsors and Collaborators
Incyte Corporation
Merck Sharp & Dohme Corp.
Investigators
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Study Director: Mark Jones, MD Incyte Corporation
  Study Documents (Full-Text)

Documents provided by Incyte Corporation:
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Responsible Party: Incyte Corporation
ClinicalTrials.gov Identifier: NCT03358472    
Other Study ID Numbers: KEYNOTE-669/ECHO 304
First Posted: November 30, 2017    Key Record Dates
Results First Posted: September 10, 2019
Last Update Posted: September 10, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Incyte Corporation:
Head and neck squamous cell carcinoma
programmed cell death 1 (PD-1) inhibitor
indoleamine 2,3-dioxygenase 1 (IDO1) inhibitor
Additional relevant MeSH terms:
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Carcinoma
Carcinoma, Squamous Cell
Squamous Cell Carcinoma of Head and Neck
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Squamous Cell
Head and Neck Neoplasms
Neoplasms by Site
Carboplatin
Fluorouracil
Pembrolizumab
Cetuximab
Antineoplastic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents, Immunological