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

PHASE3Active, not recruitingINTERVENTIONAL
Enrollment

89

Participants

Timeline

Start Date

December 1, 2017

Primary Completion Date

July 19, 2018

Study Completion Date

December 19, 2025

Conditions
Head and Neck Cancer
Interventions
DRUG

Pembrolizumab

Pembrolizumab administered intravenously every 3 weeks.

DRUG

Epacadostat

Epacadostat administered orally twice daily.

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.

Trial Locations (73)

1090

Allgemeines Krankenhaus der Stadt Wien, Vienna

2050

Chris OBrien Lifehouse, Camperdown

2109

Macquarie University Hospital, North Ryde

3526

Borsod-Abauj-Zemplen Megyei Korhaz es Egyetemi Oktato Korhaz, Miskolc

4029

Royal Brisbane & Women s Hospital, Herston

5000

Jasz Nagykun Szolnok Megyei Hetenyi Geza Korhaz Rendelointezet, Szolnok

5020

Landeskrankenhaus Salzburg, Salzburg

10048

National Taiwan University Hospital, Taipei

19026

Pacific Cancer Medical Center, Anaheim

Huntsman Cancer Institute Univ of Utah, Salt Lake City

20089

IRRCS Instituto Clinico Humanitas, Rozzano

20141

Istituto Europeo di Oncologia, Milan

22030

Trakya Universitesi Tip Fakultesi, Edirne

28034

Hospital Ramon y Cajal, Madrid

28041

Hospital Universitario 12 de Octubre, Madrid

28981

Hospital Infanta Cristina, Madrid

30134

Northwest Georgia Oncology Centers PC, Douglasville

33305

Chang Gung Medical Foundation. Linkou, Taoyuan District

34093

Istanbul Universitesi Onkoloji Enstitusu, Istanbul

34214

Medipol Hastanesi, Istanbul

35040

Ege Universitesi Tip Fakultesi Hastanesi, Izmir

40223

Baptist Health, Louisville

41014

Hospital de Nuestra Senora de Valme, Seville

44280

Inonu Universitesi Turgut Ozal Tip Merkezi, Malatya

50009

Hospital Clinico Lozano Blesa, Zaragoza

59102

St. Vincent Healthcare Cancer Ctr, Billings

66205

U of Kansas Cancer Center, Westwood

70457

National Cheng Kung University Hospital, Tainan City

74146

Oklahoma Cancer Specialists and Research, Tulsa

80045

University of Colorado Cancer Center, Aurora

87106

New Mexico Cancer Care Alliance, Albuquerque

95403

St. Joseph Heritage Healthcare, Santa Rosa

95817

UC Davis Comprehensive Cancer Center, Sacramento

97213

Providence Portland Med Center, Portland

98101

Viginia Mason Med Ctr, Seattle

06520

Yale Cancer Center, New Haven

L8V 5C2

Juravinski Cancer Center Hamilton Health Sciences, Hamilton

M5G 2M9

Princess Margaret Cancer Centre, Toronto

H3T 1E2

Jewish General Hospital, Montreal

G1R 3S1

CHU de Quebec-Universite Laval-Hotel Dieu de Quebec, Québec

277-8577

National Cancer Center Hospital East, Kashiwa

920-8641

Kanazawa University Hospital, Kanazawa

241-8515

Kanagawa Cancer Center, Yokohama

981-1293

Miyagi Cancer Center, Natori-shi

980-8574

Tohoku University Hospital, Sendai

673-8558

Hyogo Cancer Center, Akashi

812-8582

Kyushu University Hospital, Fukuoka

734-8551

Hiroshima University Hospital, Hiroshima

060-8648

Hokkaido University Hospital, Hokkaido

650-0047

Kobe City Medical Center General Hospital, Kobe

362-0806

Saitama Cancer Center, Saitama

589-8511

Kindai University Hospital, Sayama

411-8777

Shizuoka Cancer Center Hospital and Research Institute, Shizuoka

135-8550

The Cancer Institute Hospital of JFCR, Tokyo

05-135

Mazowiecki Szpital Onkologiczny, Wieliszew

62-500

Przychodnia Lekarska Komed, Konin

71-730

Zachodniopomorskie Centrum Onkologii, Szczecin

3000-075

Inst. Portugues de Oncologia de Coimbra Frencisco Gentil EPE, Coimbra

1099-023

Inst. Portugues de Oncologia de Lisboa Francisco Gentil EPE, Lisbon

1649-035

Centro Hospitalar Lisboa Norte EPE - Hospital de Santa Maria, Lisbon

4200-072

Inst. Portugues de Oncologia de Porto Francisco Gentil EPE, Porto

03080

Seoul National University Hospital, Seoul

03722

Severance Hospital Yonsei University Health System, Seoul

05505

Asan Medical Center, Seoul

08916

Hospital Germans Trias i Pujol. ICO de Badalona, Badalona

08035

Hospital General Universitari Vall d Hebron, Barcelona

01370

Adana Sehir Hastanesi, Adana

06100

Hacettepe Universitesi Tip Fakultesi Hastanesi, Ankara

N18 1QX

North Middlesex Hospital, London

NW1 2PG

University College London Hospitals (UCLH), London

SW3 6JJ

The Royal Marsden Foundation Trust, London

The Royal Marsden Nhs Foundation Trust - Chelsea, London

TA1 5DA

Musgrove Park Hospital, Taunton

Sponsors

Lead Sponsor

All Listed Sponsors
collaborator

Merck Sharp & Dohme LLC

INDUSTRY

lead

Incyte Corporation

INDUSTRY