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OpenTrials
Completed

NCT Number: NCT03358472

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

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).

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Key information

Conditions

Head and Neck Cancer Carcinoma Carcinoma, Squamous Cell Head and Neck Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Parkinson Disease 4, Autosomal Dominant Lewy Body Squamous Cell Carcinoma of Head and Neck

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Chris OBrien Lifehouse, Camperdown, New South Wales, Australia

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Pembrolizumab

Drug

Pembrolizumab administered intravenously every 3 weeks.

Other names: MK-3475

Epacadostat

Drug

Epacadostat administered orally twice daily.

Other names: INCB024360

Cetuximab

Drug

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

Cisplatin

Drug

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

carboplatin

Drug

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

5-fluorouracil

Drug

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

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Incyte Corporation

Industry

Collaborators

  • Merck Sharp & Dohme LLC

Registry information

Official study 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)

Important dates

Study start
2017
Primary completion
2018
Study completion
2025
First posted
Nov 30, 2017
Registry last updated
Dec 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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