Pembrolizumab + Epacadostat vs Pembrolizumab + Placebo in Recurrent or Progressive Metastatic Urothelial Carcinoma

PHASE3CompletedINTERVENTIONAL
Enrollment

84

Participants

Timeline

Start Date

December 22, 2017

Primary Completion Date

July 27, 2018

Study Completion Date

July 23, 2020

Conditions
UC (Urothelial Cancer)
Interventions
DRUG

Pembrolizumab

Pembrolizumab administered intravenously Day 1 of each cycle every 3 weeks.

DRUG

Epacadostat

Epacadostat administered orally twice daily.

DRUG

Placebo

Matching placebo administered orally twice daily.

Trial Locations (135)

100

National Taiwan University Hospital, Taipei

704

National Cheng Kung University Hospital, Tainan City

833

Chang Gung Medical Foundation. Kaohsiung Branch, Kaohsiung City

1122

Orszagos Onkologiai Intezet, Budapest

1145

Uzsoki Utcai Korhaz, Budapest

2100

Rigshospitalet, Copenhagen

2109

Macquarie University Hospital, Macquarie Park

2500

Southern Medical Day Care Centre, Wollongong

2730

Herlev Hospital, Herlev

3084

Austin Health-Austin Hospital, Heidelberg

3526

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

4700

Sjaellands Universitetshospital Naestved, Næstved

5004

Jasz - Nagykun Szolnok megyei Hetenyi Geza Korhaz - Rendelointezet, Szolnok

5037

Adelaide Cancer Centre, Kurralta Park

7400

Somogy Megyei Kaposi Mor Oktato Korhaz, Kaposvár

7624

Pecsi Tudomanyegyetem AOK, Pécs

9000

Aalborg University Hospital, Aalborg

10016

NYU Clinical Cancer Center, New York

11217

Taipei Veterans General Hospital, Taipei

14000

Centre de Lutte Contre le Cancer Francois Baclesse, Caen

15706

Hospital Clinico Universitario de Santiago, Santiago de Compostela

19104

University of Pennsylvania, Philadelphia

19107

Thomas Jefferson University Hospital, Philadelphia

19111

Fox Chase Cancer Center, Philadelphia

20070

Pamukkale Unv. Tip Fak., Denizli

20133

Fondazione IRCCS Istituto Nazionale dei Tumori, Milan

20246

Universitatsklinikum Hamburg-Eppendorf, Hamburg

21287

Johns Hopkins University, Baltimore

22030

Trakya Universitesi Tip Fakultesi, Edirne

22031

Virginia Cancer Specialists, PC, Fairfax

23298

VCU Massey Cancer Center, Richmond

23502

Virginia Oncology Associates, Norfolk

23538

Universitaetsklinikum Schleswig-Holstein. Campus Luebeck, Lübeck

28007

Hospital General Universitario Gregorio Maranon, Madrid

28033

MD Anderson Cancer Center Madrid, Madrid

29010

Hospital Universitario Virgen de la Victoria, Málaga

29425

Medical University of South Carolina-Hollings Cancer Center, Charleston

30341

Northside Hospital, Inc. - GCS/Annex, Atlanta

31096

Rambam Medical Center, Haifa

34298

Institut du Cancer de Montpellier, Montpellier

34899

Marmara Universitesi Pendik Arastirma ve Uyg. Hastanesi, Istanbul

35128

Istituto Oncologico Veneto, Padua

35340

Dokuz Eylul University Faculty of Medicine, Izmir

37044

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

37203

Vanderbilt University Medical Center, Nashville

37920

University of Tennessee Medical Center Knoxville, Knoxville

39120

Universitaetsklinikum Magdeburg A.o.R., Magdeburg

40225

Universitaetsklinikum Duesseldorf, Düsseldorf

40447

China Medical University Hospital, Taichung

46009

Instituto Valenciano de Oncologia, Valencia

47014

Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori, Meldola

48109

University of Michigan Health System, Ann Arbor

49055

Institut de Cancerologie de l Ouest Site Paul Papin, Angers

49100

Rabin Medical Center, Petah Tikva

51726

Institut Jean Godinot, Reims

52100

Medical Oncology Ospedale San Donato, Arezzo

52621

Chaim Sheba Medical Center, Ramat Gan

55200

Samsun Medical Park Hastanesi, Samsun

59020

Centre Oscar Lambret, Lille

60637

University of Chicago, Chicago

62301

Quincy Medical Group, Quincy

69008

Centre Leon Berard, Lyon

70300

Assaf Harofeh Medical Center, Ẕerifin

72000

Clinique Victor Hugo, Le Mans

72076

Universitaetsklinikum Tuebingen, Tübingen

74146

Oklahoma Cancer Specialists & Research Institute, Tulsa

75014

Hopital Cochin, Paris

75475

Hopital Saint Louis, Paris

76177

US Oncology and Research, Fort Worth

80131

Istituto Nazionale Tumori Fondazione Pascale, Napoli

81675

Klinikum rechts der Isar der Technischen Universitat, München

84918

Clinique Sainte Catherine, Avignon

85224

Ironwood Cancer & Research Centers, Chandler

90404

UCLA Hematology Oncology Santa Monica, Santa Monica

92151

Centre Medico-Chirurgical Foch, Suresnes

92868

University of California Irvine Medical Center, Orange

94158

UCSF Helen Diller Family Comprehensive Cancer Center, San Francisco

94805

Institut Gustave Roussy, Villejuif

97210

Oregon Health & Science University, Portland

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

06510

Smilow Cancer Center at Yale-New Haven, New Haven

02114

Massachusetts General Hospital, Boston

N6A 4L6

London Health Sciences Centre, London

K1H 8L6

The Ottawa Hospital Cancer Centre, Ottawa

M4N 3M5

Sunnybrook Research Institute, Toronto

H1T 2M4

CIUSSS - Hopital Maisonneuve- Rosemont, Montreal

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

G1R 3S1

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

07747

Universitaetsklinikum Jena, Jena

Unknown

Cork University Hospital, Cork

00009

Beaumont Hospital, Dublin

00024

Adelaide & Meath Hospital (Incl NCH), Dublin

H91YR71

University College Hospital Galway, Galway

V94F858

University Hospital Limerick, Limerick

X91ER8E

Waterford Regional Hospital, 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

755-8505

Yamaguchi University Hospital, Ube

541-8567

Osaka International Cancer Institute, Osaka

113-8519

Medical Hospital, Tokyo Medical And Dental University, Tokyo

144-0042

Yusen Logistics Co Ltd,. Haneda Logistics Center (MSD DC), Tokyo

1066 CX

Antoni van Leeuwenhoek Ziekenhuis, Amsterdam

1081 HV

VU University Medical Center, Amsterdam

4819 EV

Amphia Ziekenhuis, Breda

5623 EJ

Catharina Ziekenhuis, Eindhoven

9713 GZ

University Medical Center Groningen, Groningen

03080

Seoul National University Hospital, Seoul

03722

Severance Hospital Yonsei University Health System, Seoul

05505

Asan Medical Center, Seoul

06351

Samsung Medical Center, Seoul

08003

Hospital del Mar, Barcelona

08035

Hospital Vall D Hebron, Barcelona

08041

Hospital de la Santa Creu i Sant Pau, Barcelona

01370

Adana Sehir Hastanesi, Adana

06200

Dr. Abdurrahman Yurtaslan Ankara Onkoloji EAH, Ankara

07059

Akdeniz Universitesi Tip Fakultesi, Antalya

SM2 5PT

Royal Marsden NHS Trust, Sutton

B15 2TH

Queen Elizabeth Hospital, Birmingham

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