Pembrolizumab in Combination With Epacadostat or Placebo in Cisplatin-ineligible Urothelial Carcinoma (KEYNOTE-672/ECHO-307)

PHASE3CompletedINTERVENTIONAL
Enrollment

93

Participants

Timeline

Start Date

December 4, 2017

Primary Completion Date

August 9, 2018

Study Completion Date

August 4, 2020

Conditions
UC (Urothelial Cancer)
Interventions
DRUG

Pembrolizumab

Pembrolizumab administered intravenously every 3 weeks.

DRUG

Epacadostat

Epacadostat administered orally twice daily.

DRUG

Placebo

Matching placebo administered orally twice daily.

Trial Locations (143)

100

National Taiwan University Hospital, Taipei

112

Taipei Veterans General Hospital, Taipei

704

National Cheng Kung University Hospital, Tainan City

833

Chang Gung Medical Foundation - Kaohsiung, Kaohsiung City

1000

Institut Jules Bordet, Brussels

2109

Macquarie University Hospital, Macquarie Park

2298

Calvary Mater Newcastle, Waratah

2500

Southern Medical Day Care Centre, Wollongong

2610

GZA Sint Augustinus, Wilrijk

3084

Austin Health-Austin Hospital, Heidelberg

5037

Adelaide Cancer Centre, Kurralta Park

6000

Grand Hopital de Charleroi - Site Notre Dame - Oncology, Charleroi

7100

Hopital de Jolimont, Haine-Saint-Paul

9000

AZ Maria Middelares Gent, Ghent

Universitair Ziekenhuis Gent, Ghent

9100

AZ Nikolaas, Sint-Niklaas

10016

Laura and Isaac Perlmutter Cancer Center at NYU Langone, New York

13009

Institut Paoli Calmettes, Marseille

15006

Hospital Teresa Herrera - Chuac, A Coruña

19104

Abramson Cancer Center of the University of Pennsylvania, Philadelphia

19111

Fox Chase Cancer Center, Philadelphia

20133

Istituto Nazionale dei Tumori, Milan

20246

Universitatsklinikum Hamburg-Eppendorf, Hamburg

23538

Universitaetsklinikum Schleswig-Holstein. Campus Luebeck, Lübeck

25030

CHU de Besancon, Besançon

27003

Hospital Universitario Lucus Augusti, Lugo

28204

Levine Cancer Institute, Charlotte

29425

Medical University of South Carolina-Hollings Cancer Center, Charleston

31059

Institut Claudius Regaud, Toulouse

31096

Rambam Health Care Campus, Haifa

32503

Woodlands Medical Specialists, PA, Pensacola

33076

Institut Bergonie, Bordeaux

35015

Chungnam National University Hospital, Daejeon

35128

Istituto Oncologico Veneto, Padua

37044

C.H.U. de Tours - Hopital Bretonneau, Tours

37203

Sarah Cannon Research Institute, Nashville

Tennessee Oncology Nashville, Nashville

37232

Vanderbilt-Ingram Cancer Center, Nashville

37404

Tennessee Oncology, PLLC/The Sarah Cannon Research Institute, Chattanooga

37920

University of Tennessee Medical Center Knoxville, Knoxville

39120

Universitaetsklinikum Magdeburg A.o.R., Magdeburg

40022

RMI Sumy Regional Clinical Oncology Dispensary, Sumy

40225

Universitaetsklinikum Duesseldorf, Düsseldorf

40447

China Medical University Hospital, Taichung

41013

Hospital Virgen del Rocio, Seville

45136

Kliniken Essen Mitte, Essen

47014

Istituto Scientifico Romagnolo per Studio e Cura Tumori IRST, Meldola

49005

MI Dnipr Regional Clinical Hospital named after I.I. Mechnikov, Dnipropetrovsk

49055

Institut de Cancerologie de l Ouest Site Paul Papin, Angers

49100

Rabin Medical Center, Petah Tikva

49102

Dnipropetrovsk City Multidiscipline Clinical Hosp.4 of DRC, Dnipropetrovsk

51726

Institut Jean Godinot, Reims

52100

Medical Oncology Ospedale San Donato, Arezzo

52621

Chaim Sheba Medical Center, Ramat Gan

54100

Centre d Oncologie de Gentilly, Nancy

54292

Krankenhaus der Barmherzigen Brueder Trier, Trier

60612

Rush University Medical Center, Chicago

61000

Kharkiv Regional Clinical Oncology Center, Kharkiv

62301

Quincy Medical Group, Quincy

63011

Centre Jean Perrin, Clermont-Ferrand

65055

MI Odessa Regional Oncological Centre, Odesa

67091

CHU de Strasbourg - Nouvel Hopital Civil, Strasbourg

68130

GU Research Network-Urology Cancer Center, Omaha

69310

Centre Hospitalier Lyon Sud, Pierre-Bénite

70124

Istituto Tumori Giovanni Paolo II, Bari

70300

Assaf Harofeh Medical Center, Ẕerifin

72076

Universitaetsklinikum Tuebingen, Tübingen

75908

Hopital Europeen Georges Pompidou, Paris

77024

Texas Oncology-Memorial City, Houston

80131

Istituto Nazionale Tumori IRCCS Fondazione Pascale, Napoli

81675

Klinikum rechts der Isar der Technischen Universitat, München

85704

Arizona Oncology Associates PC- HOPE, Tucson

89169

Comprehensive Cancer Centers of Nevada, Las Vegas

92868

University of California Irvine Medical Center, Orange

94805

Institut Gustave Roussy, Villejuif

97401

Willamette Valley Cancer Institute and Research Center, Eugene

98195

University of Washington, Seattle

115478

N.N. Blokhin NMRCO, Moscow

117997

Russian Scientific Center of Roentgenoradiology, Moscow

125284

National Medical Research Radiological Centre, Moscow

153013

Ivanovo Regional Oncology Dispensary, Ivanovo

188663

Leningrad Regional Oncology Dispensary, Saint Petersburg

199106

Pokrovskaya City Hospital, Saint Petersburg

390046

Ryazan Regional Clinical Oncology Dispensary, Ryazan

450081

Clinic of Bashkortostan State Medical University, Ufa

4428164

Meir Medical Center, Kfar Saba

6423906

Sourasky Medical Center, Tel Aviv

8410101

Soroka Medical Center, Beersheba

06511

Yale Cancer Center, New Haven

02114

Massachusetts General Hospital, Boston

E1C 6Z8

Moncton Hospital - Horizon Health Network, Moncton

K7L 2V7

Cancer Centre of Southeastern Ontario at Kingston General Hospital, Kingston

K1H 8L6

The Ottawa Hospital Cancer Centre, Ottawa

M4N 3M5

Sunnybrook Health Science Centre, Toronto

H1T 2M4

CIUSSS de l Est de L Ile de Montreal - Hopital Maisonneuve-Rosemont, Montreal

G1R 2J6

CHU de Quebec - Hotel-Dieu de Quebec, Québec

07747

Universitaetsklinikum Jena, Jena

Unknown

Cork University Hospital, Cork

00024

Adelaide & Meath Hospital (Incl NCH), Dublin

H91YR71

University College Hospital Galway, Galway

V94 F858

University Hospital Limerick, Limerick

X91ER8E

University Hospital Waterford, Waterford

466-8560

Nagoya University Hospital, Nagoya

277-8577

National Cancer Center Hospital East, Kashiwa

305-8576

University of Tsukuba Hospital, Tsukuba

634-8522

Nara Medical University Hospital, Kashihara

589-8511

Kindai University Hospital, Sayama

755-8505

Yamaguchi University Hospital, Ube

770-8503

Tokushima University Hospital, Tokushima

113-8519

Medical Hospital, Tokyo Medical And Dental University, Tokyo

135-8550

The Cancer Institute Hospital of JFCR, Tokyo

4819EV

Amphia Ziekenhuis, Breda

1066 CX

Antoni van Leeuwenhoek Ziekenhuis, Amsterdam

1081 HV

VU University Medical Center, Amsterdam

5623 EJ

Catharina Ziekenhuis, Eindhoven

9713 GZ

University Medical Center Groningen, Groningen

3075 EA

Erasmus MC, Rotterdam

43-300

Beskidzkie Centrum Onkologii im. Jana Pawla II, Bielsko-Biala

58-506

Wojewodzkie Centrum Szpitalne Kotliny Jeleniogorskiej, Jelenia Góra

40-514

Uniwersyteckie Centrum Kliniczne Slaskiego Uniwersytetu Medycznego, Katowice

52-229

GLOBE Badania Kliniczne Oddzial we Wroclawiu, Komorowice

05-400

Europejskie Centrum Zdrowia Otwock, Otwock

08-110

Urologica Praktyka Lekarska Adam Marcheluk, Siedlce

70-111

Samodzielny Publiczny Szpital Kliniczny Nr 2 PUM w Szczecinie, Szczecin

01-748

Magodent Szpital Elblaska, Warsaw

02 616

Szpital Sw. Elzbiety Mokotowskie Centrum Medyczne, Warsaw

03080

Seoul National University Hospital, Seoul

03722

Severance Hospital Yonsei University Health System, Seoul

05505

Asan Medical Center, Seoul

06351

Samsung Medical Center, Seoul

06080

Hospital Infanta Cristina, Badajoz

08035

Hospital General Universitari Vall d Hebron, Barcelona

08908

ICO L Hospitalet, L'Hospitalet de Llobregat

08243

Xarxa Assistencial Universitaria Manresa, Manresa

08208

Consorci Hospitalari Parc Tauli de Sabadell, Sabadell

03115

Kyiv City Clinical Oncology Center, Kyiv

SM2 5PT

Royal Marsden NHS Trust, Sutton

G120YN

The Beatson West of Scotland Cancer Centre, Glasgow

EC1A 7BE

Barts Health NHS Trust - St Bartholomew's Hospital, London

NW3 2QG

Royal Free London NHS Foundation Trust, London

W6 8RF

Imperial College Healthcare NHS Trust, London

PL6 8DH

Plymouth Hospitals NHS Trust, Plymouth

SR4 7TP

Sunderland Royal Hospital, Sunderland

Sponsors

Lead Sponsor

All Listed Sponsors
collaborator

Merck Sharp & Dohme LLC

INDUSTRY

lead

Incyte Corporation

INDUSTRY