Clinical Trials /

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

NCT03358472

Description:

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).

Related Conditions:
  • Head and Neck Squamous Cell Carcinoma
Recruiting Status:

Active, not recruiting

Phase:

Phase 3

Trial Eligibility

Document

Title

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

Clinical Trial IDs

  • ORG STUDY ID: 669-01/ECHO-304-01
  • NCT ID: NCT03358472

Conditions

  • Recurrent Head and Neck Squamous Cell Carcinoma
  • Metastatic Head and Neck Squamous Cell Carcinoma

Interventions

DrugSynonymsArms
PembrolizumabMK-3475Group 1
EpacadostatINCB024360Group 1
CetuximabGroup 3
CisplatinGroup 3
CarboplatinGroup 3
5-FluorouracilGroup 3

Purpose

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).

Trial Arms

NameTypeDescriptionInterventions
Group 1ExperimentalPembrolizumab + Epacadostat
  • Pembrolizumab
  • Epacadostat
Group 2ExperimentalPembrolizumab
  • Pembrolizumab
Group 3Active ComparatorEXTREME regimen (cetuximab + cisplatin or carboplatin + 5-fluorouracil)
  • Cetuximab
  • Cisplatin
  • Carboplatin
  • 5-Fluorouracil

Eligibility 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).
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Overall survival (OS) with pembrolizumab + epacadostat versus EXTREME regimen
Time Frame:Approximately 37 months
Safety Issue:
Description:Defined as the time from randomization to death due to any cause.

Secondary Outcome Measures

Measure:Objective response rate with pembrolizumab + epacadostat versus the EXTREME regimen
Time Frame:Approximately 24 months
Safety Issue:
Description:Defined as the proportion of participants who have a confirmed complete response (CR) or partial response (PR) per RECIST v1.1.
Measure: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
Safety Issue:
Description: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.
Measure: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
Safety Issue:
Description: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.
Measure:Mean change from baseline in global health status/quality of life with pembrolizumab + epacadostat versus the EXTREME regimen.
Time Frame:Up to 2 years
Safety Issue:
Description:Global health status/quality of life scales of the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30).
Measure:Time to deterioration (TTD) in patient- reported outcomes (PROs) with pembrolizumab + epacadostat versus the EXTREME regimen.
Time Frame:Up to 2 years
Safety Issue:
Description:Defined as the time from baseline to first onset of PRO deterioration with confirmation.

Details

Phase:Phase 3
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Incyte Corporation

Trial Keywords

  • Head and neck squamous cell carcinoma
  • programmed cell death 1 (PD-1) inhibitor
  • indoleamine 2,3-dioxygenase 1 (IDO1) inhibitor

Last Updated

December 11, 2017