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

Part of paid clinical trials in Anaheim, California.

Sponsor
Incyte Corporation
Study ID
NCT03358472
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Pembrolizumab — DRUG
    Pembrolizumab administered intravenously every 3 weeks.
  • Epacadostat — DRUG
    Epacadostat administered orally twice daily.
  • 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.

Study Details

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).

Key Dates

First listed
Nov 30, 2017
Start date
Dec 1, 2017
Status verified
Nov 2025
Primary completion
Jul 19, 2018
Completion
Oct 30, 2025

Study Design

Enrollment
89 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Pembrolizumab + Epacadostat
  • Experimental: Pembrolizumab
  • Active Comparator: EXTREME
    EXTREME regimen includes cetuximab + cisplatin or carboplatin + 5-fluorouracil.

Primary Outcome Measure

Objective Response Rate (ORR) of Pembrolizumab + Epacadostat, Pembrolizumab Monotherapy and the EXTREME Regimen [ Time Frame: Minimum Week 9 ]

Locations (14)

FacilityCityStateZIPSite coordinators
Pacific Cancer Medical CenterAnaheimCalifornia19026-
UC Davis Comprehensive Cancer CenterSacramentoCalifornia95817-
St. Joseph Heritage HealthcareSanta RosaCalifornia95403-
University of Colorado Cancer CenterAuroraColorado80045-
Yale Cancer CenterNew HavenConnecticut06520-
Northwest Georgia Oncology Centers PCDouglasvilleGeorgia30134-
U of Kansas Cancer CenterWestwoodKansas66205-
Baptist HealthLouisvilleKentucky40223-
St. Vincent Healthcare Cancer CtrBillingsMontana59102-
New Mexico Cancer Care AllianceAlbuquerqueNew Mexico87106-
Oklahoma Cancer Specialists and ResearchTulsaOklahoma74146-
Providence Portland Med CenterPortlandOregon97213-
Huntsman Cancer Institute Univ of UtahSalt Lake CityUtah19026-
Viginia Mason Med CtrSeattleWashington98101-

Find similar trials in Anaheim, CA

Nationwide
Head and neck cancer trialsOncology trialsENT trials
By condition
Head and neck cancer
By specialty
OncologyENT
By research site
Pacific Cancer Medical Center· Anaheim, CAUC Davis Comprehensive Cancer Center· Sacramento, CASt. Joseph Heritage Healthcare· Santa Rosa, CAUniversity of Colorado Cancer Center· Aurora, COYale Cancer Center· New Haven, CTNorthwest Georgia Oncology Centers PC· Douglasville, GA

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