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

Primary Purpose

UC (Urothelial Cancer)

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Pembrolizumab
Epacadostat
Placebo
Sponsored by
Incyte Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for UC (Urothelial Cancer) focused on measuring Urothelial carcinoma, programmed cell death protein 1 (PD-1) inhibitor, indoleamine 2,3-dioxygenase (IDO) inhibitor

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Histologically-confirmed diagnosis of urothelial carcinoma of the renal pelvis, ureter, bladder, or urethra, that is transitional cell, or mixed transitional/non-transitional (predominantly transitional) cell type.
  • Progression or recurrence of urothelial carcinoma following one prior platinum containing chemotherapy regimen for metastatic or unresectable locally advanced disease. A participant who receives a neoadjuvant or adjuvant platinum-containing regimen following cystectomy for localized muscle-invasive urothelial carcinoma is acceptable (without further systemic treatment), if recurrence/progression occurs ≤ 12 months following completion of therapy.
  • Measurable disease based on RECIST v1.1.
  • Have provided an archival tumor tissue sample or newly obtained core or excisional biopsy of a tumor lesion not previously irradiated for PD-L1 analysis.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
  • Adequate organ function per protocol-defined criteria.

Exclusion Criteria:

  • Urothelial carcinoma that is suitable for local therapy with curative intent.
  • History or presence of an abnormal electrocardiogram (ECG) that, in the investigator's opinion, is clinically meaningful.
  • 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. Participants with previously treated brain metastases may participate provided they are radiologically stable, ie, without evidence of progression for at least 4 weeks by repeat imaging.
  • 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 (HBsAg reactive) or has active hepatitis C (HCV RNA). Note: Testing must be performed to determine eligibility.
  • Use of protocol-defined prior/concomitant therapy.

Sites / Locations

  • Ironwood Cancer & Research Centers
  • University of California Irvine Medical Center
  • UCSF Helen Diller Family Comprehensive Cancer Center
  • UCLA Hematology Oncology Santa Monica
  • Smilow Cancer Center at Yale-New Haven
  • Northside Hospital, Inc. - GCS/Annex
  • University of Chicago
  • Quincy Medical Group
  • Johns Hopkins University
  • Massachusetts General Hospital
  • University of Michigan Health System
  • NYU Clinical Cancer Center
  • Oklahoma Cancer Specialists & Research Institute
  • Oregon Health & Science University
  • University of Pennsylvania
  • Thomas Jefferson University Hospital
  • Fox Chase Cancer Center
  • Medical University of South Carolina-Hollings Cancer Center
  • University of Tennessee Medical Center Knoxville
  • Vanderbilt University Medical Center
  • US Oncology and Research
  • Virginia Cancer Specialists, PC
  • Virginia Oncology Associates
  • VCU Massey Cancer Center
  • Southern Medical Day Care Centre
  • Austin Health-Austin Hospital
  • Adelaide Cancer Centre
  • Macquarie University Hospital
  • London Health Sciences Centre
  • The Ottawa Hospital Cancer Centre
  • Sunnybrook Research Institute
  • CIUSSS - Hopital Maisonneuve- Rosemont
  • CIUSSS de l Est de L Ile de Montreal - Hopital Maisonneuve-Rosemont
  • CHU de Quebec-Universite Laval-Hotel Dieu de Quebec
  • CHU de Quebec-Universite Laval-Hotel Dieu de Quebec
  • Aalborg University Hospital
  • Rigshospitalet
  • Herlev Hospital
  • Sjaellands Universitetshospital Naestved
  • Institut de Cancerologie de l Ouest Site Paul Papin
  • Clinique Sainte Catherine
  • Centre de Lutte Contre le Cancer Francois Baclesse
  • Clinique Victor Hugo
  • Centre Oscar Lambret
  • Centre Leon Berard
  • Institut du Cancer de Montpellier
  • Hopital Cochin
  • Hopital Saint Louis
  • Institut Jean Godinot
  • Centre Medico-Chirurgical Foch
  • C.H.U. de Tours - Hopital Bretonneau
  • Institut Gustave Roussy
  • Universitaetsklinikum Schleswig-Holstein. Campus Luebeck
  • Universitaetsklinikum Duesseldorf
  • Universitatsklinikum Hamburg-Eppendorf
  • Universitaetsklinikum Jena
  • Universitaetsklinikum Magdeburg A.o.R.
  • Klinikum rechts der Isar der Technischen Universitat
  • Universitaetsklinikum Tuebingen
  • Orszagos Onkologiai Intezet
  • Uzsoki Utcai Korhaz
  • Somogy Megyei Kaposi Mor Oktato Korhaz
  • Borsod-Abauj-Zemplen Megyei Korhaz es Egyetemi Oktato Korhaz
  • Pecsi Tudomanyegyetem AOK
  • Jasz - Nagykun Szolnok megyei Hetenyi Geza Korhaz - Rendelointezet
  • Cork University Hospital
  • Beaumont Hospital
  • Adelaide & Meath Hospital (Incl NCH)
  • University College Hospital Galway
  • University Hospital Limerick
  • Waterford Regional Hospital
  • Soroka Medical Center
  • Rambam Medical Center
  • Meir Medical Center
  • Rabin Medical Center
  • Chaim Sheba Medical Center
  • Sourasky Medical Center
  • Assaf Harofeh Medical Center
  • Medical Oncology Ospedale San Donato
  • Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori
  • Fondazione IRCCS Istituto Nazionale dei Tumori
  • Istituto Nazionale Tumori Fondazione Pascale
  • Istituto Oncologico Veneto
  • Nagoya University Hospital
  • National Cancer Center Hospital East
  • University of Tsukuba Hospital
  • Nara Medical University Hospital
  • Yamaguchi University Hospital
  • Osaka International Cancer Institute
  • Medical Hospital, Tokyo Medical And Dental University
  • Yusen Logistics Co Ltd,. Haneda Logistics Center (MSD DC)
  • Seoul National University Hospital
  • Severance Hospital Yonsei University Health System
  • Asan Medical Center
  • Samsung Medical Center
  • Antoni van Leeuwenhoek Ziekenhuis
  • VU University Medical Center
  • Amphia Ziekenhuis
  • Catharina Ziekenhuis
  • University Medical Center Groningen
  • Leningrad Regional Oncology Dispensary
  • Ivanovo Regional Oncology Dispensary
  • N.N. Blokhin NMRCO
  • Russian Scientific Center of Roentgenoradiology
  • National Medical Research Radiological Centre
  • Ryazan Regional Clinical Oncology Dispensary
  • Pokrovskaya City Hospital
  • Clinic of Bashkortostan State Medical University
  • Hospital del Mar
  • Hospital Vall D Hebron
  • Hospital de la Santa Creu i Sant Pau
  • Hospital General Universitario Gregorio Maranon
  • MD Anderson Cancer Center Madrid
  • Hospital Universitario Virgen de la Victoria
  • Hospital Clinico Universitario de Santiago
  • Instituto Valenciano de Oncologia
  • Chang Gung Medical Foundation. Kaohsiung Branch
  • China Medical University Hospital
  • National Cheng Kung University Hospital
  • National Taiwan University Hospital
  • Taipei Veterans General Hospital
  • Adana Sehir Hastanesi
  • Dr. Abdurrahman Yurtaslan Ankara Onkoloji EAH
  • Akdeniz Universitesi Tip Fakultesi
  • Pamukkale Unv. Tip Fak.
  • Trakya Universitesi Tip Fakultesi
  • Marmara Universitesi Pendik Arastirma ve Uyg. Hastanesi
  • Dokuz Eylul University Faculty of Medicine
  • Samsun Medical Park Hastanesi
  • Royal Marsden NHS Trust
  • Queen Elizabeth Hospital
  • Barts Health NHS Trust - St Bartholomew s Hospital
  • Royal Free London NHS Foundation Trust
  • Imperial College Healthcare NHS Trust
  • Plymouth Hospitals NHS Trust
  • Sunderland Royal Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Pembrolizumab 200 mg + Epacadostat 100 mg BID

Pembrolizumab 200 mg + placebo BID

Arm Description

Pembrolizumab + epacadostat

Pembrolizumab + placebo

Outcomes

Primary Outcome Measures

Objective Response Rate (ORR) With Pembrolizumab + Epacadostat Versus Pembrolizumab + Placebo
ORR was defined as the percentage of participants who had a complete response (CR), disappearance of all target lesions or partial response (PR), >=30% decrease in the sum of the longest diameter of target lesions per RECIST v1.1 by investigator determination.

Secondary Outcome Measures

Safety and Tolerability of Pembrolizumab + Epacadostat Versus Pembrolizumab + Placebo as Measured by Number of Participants Experiencing Adverse Events (AEs)
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.
Safety and Tolerability of Pembrolizumab + Epacadostat Versus Pembrolizumab + Placebo as Measured by Number of Participants Discontinuing Study Treatment Due to AE
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.

Full Information

First Posted
December 11, 2017
Last Updated
November 2, 2021
Sponsor
Incyte Corporation
Collaborators
Merck Sharp & Dohme LLC
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1. Study Identification

Unique Protocol Identification Number
NCT03374488
Brief Title
Pembrolizumab + Epacadostat vs Pembrolizumab + Placebo in Recurrent or Progressive Metastatic Urothelial Carcinoma
Official Title
A Phase 3 Randomized, Double-Blind Clinical Study of Pembrolizumab + Epacadostat vs Pembrolizumab + Placebo as a Treatment for Recurrent or Progressive Metastatic Urothelial Carcinoma in Patients Who Have Failed a First-Line Platinum-containing Chemotherapy Regimen for Advanced/Metastatic Disease (KEYNOTE-698/ECHO-303)
Study Type
Interventional

2. Study Status

Record Verification Date
November 2021
Overall Recruitment Status
Completed
Study Start Date
December 22, 2017 (Actual)
Primary Completion Date
July 27, 2018 (Actual)
Study Completion Date
July 23, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Incyte Corporation
Collaborators
Merck Sharp & Dohme LLC

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study was to evaluate the efficacy and safety of pembrolizumab + epacadostat vs pembrolizumab + placebo as a treatment for recurrent or progressive metastatic urothelial carcinoma in patients who have failed a first-line platinum-containing chemotherapy regimen for advanced/metastatic disease.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
UC (Urothelial Cancer)
Keywords
Urothelial carcinoma, programmed cell death protein 1 (PD-1) inhibitor, indoleamine 2,3-dioxygenase (IDO) inhibitor

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Masking Description
The study will be unblinded after the last participant completes Week 9 imaging assessment for efficacy analysis and after appropriate EC/IRB approvals have been received.
Allocation
Randomized
Enrollment
84 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Pembrolizumab 200 mg + Epacadostat 100 mg BID
Arm Type
Experimental
Arm Description
Pembrolizumab + epacadostat
Arm Title
Pembrolizumab 200 mg + placebo BID
Arm Type
Active Comparator
Arm Description
Pembrolizumab + placebo
Intervention Type
Drug
Intervention Name(s)
Pembrolizumab
Other Intervention Name(s)
MK-3475
Intervention Description
Pembrolizumab administered intravenously Day 1 of each cycle every 3 weeks.
Intervention Type
Drug
Intervention Name(s)
Epacadostat
Other Intervention Name(s)
INCB024360
Intervention Description
Epacadostat administered orally twice daily.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Matching placebo administered orally twice daily.
Primary Outcome Measure Information:
Title
Objective Response Rate (ORR) With Pembrolizumab + Epacadostat Versus Pembrolizumab + Placebo
Description
ORR was defined as the percentage of participants who had a complete response (CR), disappearance of all target lesions or partial response (PR), >=30% decrease in the sum of the longest diameter of target lesions per RECIST v1.1 by investigator determination.
Time Frame
up to 9 weeks +14 days
Secondary Outcome Measure Information:
Title
Safety and Tolerability of Pembrolizumab + Epacadostat Versus Pembrolizumab + Placebo as Measured by Number of Participants Experiencing Adverse Events (AEs)
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.
Time Frame
Up to 8 months
Title
Safety and Tolerability of Pembrolizumab + Epacadostat Versus Pembrolizumab + Placebo as Measured by Number of Participants Discontinuing Study Treatment Due to AE
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.
Time Frame
Up to 8 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Histologically-confirmed diagnosis of urothelial carcinoma of the renal pelvis, ureter, bladder, or urethra, that is transitional cell, or mixed transitional/non-transitional (predominantly transitional) cell type. Progression or recurrence of urothelial carcinoma following one prior platinum containing chemotherapy regimen for metastatic or unresectable locally advanced disease. A participant who receives a neoadjuvant or adjuvant platinum-containing regimen following cystectomy for localized muscle-invasive urothelial carcinoma is acceptable (without further systemic treatment), if recurrence/progression occurs ≤ 12 months following completion of therapy. Measurable disease based on RECIST v1.1. Have provided an archival tumor tissue sample or newly obtained core or excisional biopsy of a tumor lesion not previously irradiated for PD-L1 analysis. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. Adequate organ function per protocol-defined criteria. Exclusion Criteria: Urothelial carcinoma that is suitable for local therapy with curative intent. History or presence of an abnormal electrocardiogram (ECG) that, in the investigator's opinion, is clinically meaningful. 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. Participants with previously treated brain metastases may participate provided they are radiologically stable, ie, without evidence of progression for at least 4 weeks by repeat imaging. 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 (HBsAg reactive) or has active hepatitis C (HCV RNA). Note: Testing must be performed to determine eligibility. Use of protocol-defined prior/concomitant therapy.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mark Jones, MD
Organizational Affiliation
Incyte Corporation
Official's Role
Study Director
Facility Information:
Facility Name
Ironwood Cancer & Research Centers
City
Chandler
State/Province
Arizona
ZIP/Postal Code
85224
Country
United States
Facility Name
University of California Irvine Medical Center
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Facility Name
UCSF Helen Diller Family Comprehensive Cancer Center
City
San Francisco
State/Province
California
ZIP/Postal Code
94158
Country
United States
Facility Name
UCLA Hematology Oncology Santa Monica
City
Santa Monica
State/Province
California
ZIP/Postal Code
90404
Country
United States
Facility Name
Smilow Cancer Center at Yale-New Haven
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06510
Country
United States
Facility Name
Northside Hospital, Inc. - GCS/Annex
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30341
Country
United States
Facility Name
University of Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Facility Name
Quincy Medical Group
City
Quincy
State/Province
Illinois
ZIP/Postal Code
62301
Country
United States
Facility Name
Johns Hopkins University
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
University of Michigan Health System
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Facility Name
NYU Clinical Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
Oklahoma Cancer Specialists & Research Institute
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74146
Country
United States
Facility Name
Oregon Health & Science University
City
Portland
State/Province
Oregon
ZIP/Postal Code
97210
Country
United States
Facility Name
University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Thomas Jefferson University Hospital
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Facility Name
Fox Chase Cancer Center
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19111
Country
United States
Facility Name
Medical University of South Carolina-Hollings Cancer Center
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Facility Name
University of Tennessee Medical Center Knoxville
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37920
Country
United States
Facility Name
Vanderbilt University Medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Facility Name
US Oncology and Research
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76177
Country
United States
Facility Name
Virginia Cancer Specialists, PC
City
Fairfax
State/Province
Virginia
ZIP/Postal Code
22031
Country
United States
Facility Name
Virginia Oncology Associates
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23502
Country
United States
Facility Name
VCU Massey Cancer Center
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23298
Country
United States
Facility Name
Southern Medical Day Care Centre
City
Wollongong
State/Province
New South Wales
ZIP/Postal Code
2500
Country
Australia
Facility Name
Austin Health-Austin Hospital
City
Heidelberg
State/Province
Victoria
ZIP/Postal Code
3084
Country
Australia
Facility Name
Adelaide Cancer Centre
City
Kurralta Park
ZIP/Postal Code
5037
Country
Australia
Facility Name
Macquarie University Hospital
City
Macquarie Park
ZIP/Postal Code
2109
Country
Australia
Facility Name
London Health Sciences Centre
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 4L6
Country
Canada
Facility Name
The Ottawa Hospital Cancer Centre
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1H 8L6
Country
Canada
Facility Name
Sunnybrook Research Institute
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4N 3M5
Country
Canada
Facility Name
CIUSSS - Hopital Maisonneuve- Rosemont
City
Montréal
State/Province
Quebec
ZIP/Postal Code
H1T 2M4
Country
Canada
Facility Name
CIUSSS de l Est de L Ile de Montreal - Hopital Maisonneuve-Rosemont
City
Montréal
State/Province
Quebec
ZIP/Postal Code
H1T 2M4
Country
Canada
Facility Name
CHU de Quebec-Universite Laval-Hotel Dieu de Quebec
City
Québec
State/Province
Quebec
ZIP/Postal Code
G1R 3S1
Country
Canada
Facility Name
CHU de Quebec-Universite Laval-Hotel Dieu de Quebec
City
Quebec
ZIP/Postal Code
G1R 3S1
Country
Canada
Facility Name
Aalborg University Hospital
City
Aalborg
ZIP/Postal Code
9000
Country
Denmark
Facility Name
Rigshospitalet
City
Copenhagen
ZIP/Postal Code
2100
Country
Denmark
Facility Name
Herlev Hospital
City
Herlev
ZIP/Postal Code
2730
Country
Denmark
Facility Name
Sjaellands Universitetshospital Naestved
City
Næstved
ZIP/Postal Code
4700
Country
Denmark
Facility Name
Institut de Cancerologie de l Ouest Site Paul Papin
City
Angers
ZIP/Postal Code
49055
Country
France
Facility Name
Clinique Sainte Catherine
City
Avignon
ZIP/Postal Code
84918
Country
France
Facility Name
Centre de Lutte Contre le Cancer Francois Baclesse
City
Caen
ZIP/Postal Code
14000
Country
France
Facility Name
Clinique Victor Hugo
City
Le Mans
ZIP/Postal Code
72000
Country
France
Facility Name
Centre Oscar Lambret
City
Lille
ZIP/Postal Code
59020
Country
France
Facility Name
Centre Leon Berard
City
Lyon
ZIP/Postal Code
69008
Country
France
Facility Name
Institut du Cancer de Montpellier
City
Montpellier
ZIP/Postal Code
34298
Country
France
Facility Name
Hopital Cochin
City
Paris
ZIP/Postal Code
75014
Country
France
Facility Name
Hopital Saint Louis
City
Paris
ZIP/Postal Code
75475
Country
France
Facility Name
Institut Jean Godinot
City
Reims
ZIP/Postal Code
51726
Country
France
Facility Name
Centre Medico-Chirurgical Foch
City
Suresnes
ZIP/Postal Code
92151
Country
France
Facility Name
C.H.U. de Tours - Hopital Bretonneau
City
Tours
ZIP/Postal Code
37044
Country
France
Facility Name
Institut Gustave Roussy
City
Villejuif
ZIP/Postal Code
94805
Country
France
Facility Name
Universitaetsklinikum Schleswig-Holstein. Campus Luebeck
City
Luebeck
State/Province
Schleswig Holstein
ZIP/Postal Code
23538
Country
Germany
Facility Name
Universitaetsklinikum Duesseldorf
City
Duesseldorf
ZIP/Postal Code
40225
Country
Germany
Facility Name
Universitatsklinikum Hamburg-Eppendorf
City
Hamburg
ZIP/Postal Code
20246
Country
Germany
Facility Name
Universitaetsklinikum Jena
City
Jena
ZIP/Postal Code
07747
Country
Germany
Facility Name
Universitaetsklinikum Magdeburg A.o.R.
City
Magdeburg
ZIP/Postal Code
39120
Country
Germany
Facility Name
Klinikum rechts der Isar der Technischen Universitat
City
Muenchen
ZIP/Postal Code
81675
Country
Germany
Facility Name
Universitaetsklinikum Tuebingen
City
Tuebingen
ZIP/Postal Code
72076
Country
Germany
Facility Name
Orszagos Onkologiai Intezet
City
Budapest
ZIP/Postal Code
1122
Country
Hungary
Facility Name
Uzsoki Utcai Korhaz
City
Budapest
ZIP/Postal Code
1145
Country
Hungary
Facility Name
Somogy Megyei Kaposi Mor Oktato Korhaz
City
Kaposvár
ZIP/Postal Code
7400
Country
Hungary
Facility Name
Borsod-Abauj-Zemplen Megyei Korhaz es Egyetemi Oktato Korhaz
City
Miskolc
ZIP/Postal Code
3526
Country
Hungary
Facility Name
Pecsi Tudomanyegyetem AOK
City
Pécs
ZIP/Postal Code
7624
Country
Hungary
Facility Name
Jasz - Nagykun Szolnok megyei Hetenyi Geza Korhaz - Rendelointezet
City
Szolnok
ZIP/Postal Code
5004
Country
Hungary
Facility Name
Cork University Hospital
City
Cork
Country
Ireland
Facility Name
Beaumont Hospital
City
Dublin
ZIP/Postal Code
00009
Country
Ireland
Facility Name
Adelaide & Meath Hospital (Incl NCH)
City
Dublin
ZIP/Postal Code
00024
Country
Ireland
Facility Name
University College Hospital Galway
City
Galway
ZIP/Postal Code
H91YR71
Country
Ireland
Facility Name
University Hospital Limerick
City
Limerick
ZIP/Postal Code
V94F858
Country
Ireland
Facility Name
Waterford Regional Hospital
City
Waterford
ZIP/Postal Code
X91ER8E
Country
Ireland
Facility Name
Soroka Medical Center
City
Be'er Sheva
ZIP/Postal Code
8410101
Country
Israel
Facility Name
Rambam Medical Center
City
Haifa
ZIP/Postal Code
31096
Country
Israel
Facility Name
Meir Medical Center
City
Kfar Saba
ZIP/Postal Code
4428164
Country
Israel
Facility Name
Rabin Medical Center
City
Petach-Tikwa
ZIP/Postal Code
49100
Country
Israel
Facility Name
Chaim Sheba Medical Center
City
Ramat Gan
ZIP/Postal Code
52621
Country
Israel
Facility Name
Sourasky Medical Center
City
Tel Aviv
ZIP/Postal Code
6423906
Country
Israel
Facility Name
Assaf Harofeh Medical Center
City
Zerifin
ZIP/Postal Code
70300
Country
Israel
Facility Name
Medical Oncology Ospedale San Donato
City
Arezzo
ZIP/Postal Code
52100
Country
Italy
Facility Name
Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori
City
Meldola
ZIP/Postal Code
47014
Country
Italy
Facility Name
Fondazione IRCCS Istituto Nazionale dei Tumori
City
Milano
ZIP/Postal Code
20133
Country
Italy
Facility Name
Istituto Nazionale Tumori Fondazione Pascale
City
Napoli
ZIP/Postal Code
80131
Country
Italy
Facility Name
Istituto Oncologico Veneto
City
Padova
ZIP/Postal Code
35128
Country
Italy
Facility Name
Nagoya University Hospital
City
Nagoya
State/Province
Aichi
ZIP/Postal Code
466-8560
Country
Japan
Facility Name
National Cancer Center Hospital East
City
Kashiwa
State/Province
Chiba
ZIP/Postal Code
277-8577
Country
Japan
Facility Name
University of Tsukuba Hospital
City
Tsukuba
State/Province
Ibaraki
ZIP/Postal Code
305-8576
Country
Japan
Facility Name
Nara Medical University Hospital
City
Kashihara
State/Province
Nara
ZIP/Postal Code
634-8522
Country
Japan
Facility Name
Yamaguchi University Hospital
City
Ube
State/Province
Yamaguchi
ZIP/Postal Code
755-8505
Country
Japan
Facility Name
Osaka International Cancer Institute
City
Osaka
ZIP/Postal Code
541-8567
Country
Japan
Facility Name
Medical Hospital, Tokyo Medical And Dental University
City
Tokyo
ZIP/Postal Code
113-8519
Country
Japan
Facility Name
Yusen Logistics Co Ltd,. Haneda Logistics Center (MSD DC)
City
Tokyo
ZIP/Postal Code
144-0042
Country
Japan
Facility Name
Seoul National University Hospital
City
Seoul
ZIP/Postal Code
03080
Country
Korea, Republic of
Facility Name
Severance Hospital Yonsei University Health System
City
Seoul
ZIP/Postal Code
03722
Country
Korea, Republic of
Facility Name
Asan Medical Center
City
Seoul
ZIP/Postal Code
05505
Country
Korea, Republic of
Facility Name
Samsung Medical Center
City
Seoul
ZIP/Postal Code
06351
Country
Korea, Republic of
Facility Name
Antoni van Leeuwenhoek Ziekenhuis
City
Amsterdam
ZIP/Postal Code
1066 CX
Country
Netherlands
Facility Name
VU University Medical Center
City
Amsterdam
ZIP/Postal Code
1081 HV
Country
Netherlands
Facility Name
Amphia Ziekenhuis
City
Breda
ZIP/Postal Code
4819 EV
Country
Netherlands
Facility Name
Catharina Ziekenhuis
City
Eindhoven
ZIP/Postal Code
5623 EJ
Country
Netherlands
Facility Name
University Medical Center Groningen
City
Groningen
ZIP/Postal Code
9713 GZ
Country
Netherlands
Facility Name
Leningrad Regional Oncology Dispensary
City
Saint Petersburg
State/Province
Leningrad Region, Vsevolozhsky District
ZIP/Postal Code
188663
Country
Russian Federation
Facility Name
Ivanovo Regional Oncology Dispensary
City
Ivanovo
ZIP/Postal Code
153013
Country
Russian Federation
Facility Name
N.N. Blokhin NMRCO
City
Moscow
ZIP/Postal Code
115478
Country
Russian Federation
Facility Name
Russian Scientific Center of Roentgenoradiology
City
Moscow
ZIP/Postal Code
117997
Country
Russian Federation
Facility Name
National Medical Research Radiological Centre
City
Moscow
ZIP/Postal Code
125284
Country
Russian Federation
Facility Name
Ryazan Regional Clinical Oncology Dispensary
City
Ryazan'
ZIP/Postal Code
390046
Country
Russian Federation
Facility Name
Pokrovskaya City Hospital
City
Saint Petersburg
ZIP/Postal Code
199106
Country
Russian Federation
Facility Name
Clinic of Bashkortostan State Medical University
City
Ufa
ZIP/Postal Code
450081
Country
Russian Federation
Facility Name
Hospital del Mar
City
Barcelona
ZIP/Postal Code
08003
Country
Spain
Facility Name
Hospital Vall D Hebron
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
Hospital de la Santa Creu i Sant Pau
City
Barcelona
ZIP/Postal Code
08041
Country
Spain
Facility Name
Hospital General Universitario Gregorio Maranon
City
Madrid
ZIP/Postal Code
28007
Country
Spain
Facility Name
MD Anderson Cancer Center Madrid
City
Madrid
ZIP/Postal Code
28033
Country
Spain
Facility Name
Hospital Universitario Virgen de la Victoria
City
Málaga
ZIP/Postal Code
29010
Country
Spain
Facility Name
Hospital Clinico Universitario de Santiago
City
Santiago De Compostela
ZIP/Postal Code
15706
Country
Spain
Facility Name
Instituto Valenciano de Oncologia
City
Valencia
ZIP/Postal Code
46009
Country
Spain
Facility Name
Chang Gung Medical Foundation. Kaohsiung Branch
City
Kaohsiung
ZIP/Postal Code
833
Country
Taiwan
Facility Name
China Medical University Hospital
City
Taichung
ZIP/Postal Code
40447
Country
Taiwan
Facility Name
National Cheng Kung University Hospital
City
Tainan
ZIP/Postal Code
704
Country
Taiwan
Facility Name
National Taiwan University Hospital
City
Taipei
ZIP/Postal Code
100
Country
Taiwan
Facility Name
Taipei Veterans General Hospital
City
Taipei
ZIP/Postal Code
11217
Country
Taiwan
Facility Name
Adana Sehir Hastanesi
City
Adana
ZIP/Postal Code
01370
Country
Turkey
Facility Name
Dr. Abdurrahman Yurtaslan Ankara Onkoloji EAH
City
Ankara
ZIP/Postal Code
06200
Country
Turkey
Facility Name
Akdeniz Universitesi Tip Fakultesi
City
Antalya
ZIP/Postal Code
07059
Country
Turkey
Facility Name
Pamukkale Unv. Tip Fak.
City
Denizli
ZIP/Postal Code
20070
Country
Turkey
Facility Name
Trakya Universitesi Tip Fakultesi
City
Edirne
ZIP/Postal Code
22030
Country
Turkey
Facility Name
Marmara Universitesi Pendik Arastirma ve Uyg. Hastanesi
City
Istanbul
ZIP/Postal Code
34899
Country
Turkey
Facility Name
Dokuz Eylul University Faculty of Medicine
City
İzmir
ZIP/Postal Code
35340
Country
Turkey
Facility Name
Samsun Medical Park Hastanesi
City
Samsun
ZIP/Postal Code
55200
Country
Turkey
Facility Name
Royal Marsden NHS Trust
City
Sutton
State/Province
Surrey
ZIP/Postal Code
SM2 5PT
Country
United Kingdom
Facility Name
Queen Elizabeth Hospital
City
Birmingham
ZIP/Postal Code
B15 2TH
Country
United Kingdom
Facility Name
Barts Health NHS Trust - St Bartholomew s Hospital
City
London
ZIP/Postal Code
EC1A 7BE
Country
United Kingdom
Facility Name
Royal Free London NHS Foundation Trust
City
London
ZIP/Postal Code
NW3 2QG
Country
United Kingdom
Facility Name
Imperial College Healthcare NHS Trust
City
London
ZIP/Postal Code
W6 8RF
Country
United Kingdom
Facility Name
Plymouth Hospitals NHS Trust
City
Plymouth
ZIP/Postal Code
PL6 8DH
Country
United Kingdom
Facility Name
Sunderland Royal Hospital
City
Sunderland
ZIP/Postal Code
SR4 7TP
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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