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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)

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ClinicalTrials.gov Identifier: NCT03358472
Recruitment Status : Active, not recruiting
First Posted : November 30, 2017
Last Update Posted : August 15, 2018
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Incyte Corporation

Brief Summary:
The purpose of this study is 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

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: Group 1
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: Group 2
Pembrolizumab
Drug: Pembrolizumab
Pembrolizumab administered intravenously every 3 weeks.
Other Name: MK-3475

Active Comparator: Group 3
EXTREME regimen (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 with pembrolizumab + epacadostat versus the EXTREME regimen [ Time Frame: Up to 6 months ]
    Defined as the proportion of participants who have a confirmed complete response (CR) or partial response (PR) per RECIST v1.1.


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 2 years ]
    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.

  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 2 years ]
    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.



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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


  Show 151 Study Locations
Sponsors and Collaborators
Incyte Corporation
Merck Sharp & Dohme Corp.
Investigators
Study Director: Mark Jones, MD Incyte Corporation

Responsible Party: Incyte Corporation
ClinicalTrials.gov Identifier: NCT03358472     History of Changes
Other Study ID Numbers: 669-04/ECHO-304-04
First Posted: November 30, 2017    Key Record Dates
Last Update Posted: August 15, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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:
Carcinoma
Carcinoma, Squamous Cell
Head and Neck Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Squamous Cell
Neoplasms by Site
Pembrolizumab
Cisplatin
Carboplatin
Cetuximab
Fluorouracil
Antineoplastic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs