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

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 cancer, programmed cell death 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 or cytologically-confirmed diagnosis of advanced/unresectable (inoperable) or metastatic urothelial cancer of the renal pelvis, ureter, bladder, or urethra.
  • Measurable disease based on RECIST v1.1.
  • Be considered ineligible to receive cisplatin-based combination therapy, based on protocol-defined criteria.
  • Have provided tissue for PD-L1 analysis from an archival tissue sample or newly obtained core or excisional biopsy of a tumor lesion not previously irradiated.
  • Have received no prior systemic chemotherapy for advanced/unresectable (inoperable) or metastatic urothelial cancer.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2 within 14 days prior to randomization.
  • Adequate organ function per protocol-defined criteria.

Exclusion Criteria:

  • Disease that is suitable for local therapy administered with curative intent.
  • 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, clinically stable and without requirement of steroid treatment for at least 14 days prior to first dose of study treatment.
  • 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 (hepatitis B surface antigen [HBsAg] reactive) or has active hepatitis C (HCV RNA). Note: Testing must be performed to determine eligibility.
  • History of a gastrointestinal condition that in the opinion of the Investigator may affect oral drug absorption.
  • History or presence of an abnormal electrocardiogram (ECG) that, in the investigator's opinion, is clinically meaningful.
  • Use of protocol-defined prior/concomitant therapy.

Sites / Locations

  • Arizona Oncology Associates PC- HOPE
  • University of California Irvine Medical Center
  • Yale Cancer Center
  • Woodlands Medical Specialists, PA
  • Rush University Medical Center
  • Quincy Medical Group
  • Massachusetts General Hospital
  • GU Research Network-Urology Cancer Center
  • Comprehensive Cancer Centers of Nevada
  • Laura and Isaac Perlmutter Cancer Center at NYU Langone
  • Levine Cancer Institute
  • Willamette Valley Cancer Institute and Research Center
  • Abramson Cancer Center of the University of Pennsylvania
  • Fox Chase Cancer Center
  • Medical University of South Carolina-Hollings Cancer Center
  • Tennessee Oncology, PLLC/The Sarah Cannon Research Institute
  • University of Tennessee Medical Center Knoxville
  • Sarah Cannon Research Institute
  • Tennessee Oncology Nashville
  • Vanderbilt-Ingram Cancer Center
  • Texas Oncology-Memorial City
  • University of Washington
  • Calvary Mater Newcastle
  • Southern Medical Day Care Centre
  • Austin Health-Austin Hospital
  • Adelaide Cancer Centre
  • Macquarie University Hospital
  • Institut Jules Bordet
  • Grand Hopital de Charleroi - Site Notre Dame - Oncology
  • AZ Maria Middelares Gent
  • Universitair Ziekenhuis Gent
  • Hopital de Jolimont
  • AZ Nikolaas
  • GZA Sint Augustinus
  • Moncton Hospital - Horizon Health Network
  • Cancer Centre of Southeastern Ontario at Kingston General Hospital
  • The Ottawa Hospital Cancer Centre
  • Sunnybrook Health Science Centre
  • CIUSSS de l Est de L Ile de Montreal - Hopital Maisonneuve-Rosemont
  • CHU de Quebec - Hotel-Dieu de Quebec
  • Institut de Cancerologie de l Ouest Site Paul Papin
  • CHU de Besancon
  • Institut Bergonie
  • Centre Jean Perrin
  • Institut Paoli Calmettes
  • Centre d Oncologie de Gentilly
  • Hopital Europeen Georges Pompidou
  • Centre Hospitalier Lyon Sud
  • Institut Jean Godinot
  • CHU de Strasbourg - Nouvel Hopital Civil
  • Institut Claudius Regaud
  • C.H.U. de Tours - Hopital Bretonneau
  • Institut Gustave Roussy
  • Universitaetsklinikum Schleswig-Holstein. Campus Luebeck
  • Universitaetsklinikum Duesseldorf
  • Kliniken Essen Mitte
  • Universitatsklinikum Hamburg-Eppendorf
  • Universitaetsklinikum Jena
  • Universitaetsklinikum Magdeburg A.o.R.
  • Klinikum rechts der Isar der Technischen Universitat
  • Krankenhaus der Barmherzigen Brueder Trier
  • Universitaetsklinikum Tuebingen
  • Cork University Hospital
  • Adelaide & Meath Hospital (Incl NCH)
  • University College Hospital Galway
  • University Hospital Limerick
  • University Hospital Waterford
  • Soroka Medical Center
  • Rambam Health Care Campus
  • Meir Medical Center
  • Rabin Medical Center
  • Chaim Sheba Medical Center
  • Sourasky Medical Center
  • Assaf Harofeh Medical Center
  • Medical Oncology Ospedale San Donato
  • Istituto Tumori Giovanni Paolo II
  • Istituto Scientifico Romagnolo per Studio e Cura Tumori IRST
  • Istituto Nazionale dei Tumori
  • Istituto Nazionale Tumori IRCCS Fondazione Pascale
  • Istituto Oncologico Veneto
  • Nagoya University Hospital
  • National Cancer Center Hospital East
  • University of Tsukuba Hospital
  • Nara Medical University Hospital
  • Kindai University Hospital
  • Yamaguchi University Hospital
  • Tokushima University Hospital
  • Medical Hospital, Tokyo Medical And Dental University
  • The Cancer Institute Hospital of JFCR
  • Chungnam National University Hospital
  • Seoul National University Hospital
  • Severance Hospital Yonsei University Health System
  • Asan Medical Center
  • Samsung Medical Center
  • Amphia Ziekenhuis
  • Antoni van Leeuwenhoek Ziekenhuis
  • VU University Medical Center
  • Catharina Ziekenhuis
  • University Medical Center Groningen
  • Erasmus MC
  • Beskidzkie Centrum Onkologii im. Jana Pawla II
  • Wojewodzkie Centrum Szpitalne Kotliny Jeleniogorskiej
  • Uniwersyteckie Centrum Kliniczne Slaskiego Uniwersytetu Medycznego
  • GLOBE Badania Kliniczne Oddzial we Wroclawiu
  • Europejskie Centrum Zdrowia Otwock
  • Urologica Praktyka Lekarska Adam Marcheluk
  • Samodzielny Publiczny Szpital Kliniczny Nr 2 PUM w Szczecinie
  • Magodent Szpital Elblaska
  • Szpital Sw. Elzbiety Mokotowskie Centrum Medyczne
  • 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 Teresa Herrera - Chuac
  • Hospital Infanta Cristina
  • Hospital General Universitari Vall d Hebron
  • ICO L Hospitalet
  • Hospital Universitario Lucus Augusti
  • Xarxa Assistencial Universitaria Manresa
  • Consorci Hospitalari Parc Tauli de Sabadell
  • Hospital Virgen del Rocio
  • Taipei Veterans General Hospital
  • Chang Gung Medical Foundation - Kaohsiung
  • China Medical University Hospital
  • National Cheng Kung University Hospital
  • National Taiwan University Hospital
  • MI Dnipr Regional Clinical Hospital named after I.I. Mechnikov
  • Dnipropetrovsk City Multidiscipline Clinical Hosp.4 of DRC
  • Kharkiv Regional Clinical Oncology Center
  • Kyiv City Clinical Oncology Center
  • MI Odessa Regional Oncological Centre
  • RMI Sumy Regional Clinical Oncology Dispensary
  • Royal Marsden NHS Trust
  • The Beatson West of Scotland Cancer Centre
  • 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 confirmed complete response (CR) or partial response (PR) per RECIST v1.1 by investigator determination. Responses are based on Investigator assessments per RECIST 1.1 without confirmation using all scans up to the cutoff date.

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
November 29, 2017
Last Updated
November 17, 2021
Sponsor
Incyte Corporation
Collaborators
Merck Sharp & Dohme LLC
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1. Study Identification

Unique Protocol Identification Number
NCT03361865
Brief Title
Pembrolizumab in Combination With Epacadostat or Placebo in Cisplatin-ineligible Urothelial Carcinoma (KEYNOTE-672/ECHO-307)
Official Title
A Phase 3 Randomized, Double-Blind Trial of Pembrolizumab (MK-3475) in Combination With Epacadostat (INCB024360) or Placebo in Participants With Cisplatin-ineligible Urothelial Carcinoma (KEYNOTE-672/ECHO-307)
Study Type
Interventional

2. Study Status

Record Verification Date
November 2021
Overall Recruitment Status
Completed
Study Start Date
December 4, 2017 (Actual)
Primary Completion Date
August 9, 2018 (Actual)
Study Completion Date
August 4, 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 in participants with cisplatin-ineligible urothelial carcinoma.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
UC (Urothelial Cancer)
Keywords
Urothelial cancer, programmed cell death 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
93 (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 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 confirmed complete response (CR) or partial response (PR) per RECIST v1.1 by investigator determination. Responses are based on Investigator assessments per RECIST 1.1 without confirmation using all scans up to the cutoff date.
Time Frame
Week 9
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 approximately 25 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 approximately 25 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Histologically or cytologically-confirmed diagnosis of advanced/unresectable (inoperable) or metastatic urothelial cancer of the renal pelvis, ureter, bladder, or urethra. Measurable disease based on RECIST v1.1. Be considered ineligible to receive cisplatin-based combination therapy, based on protocol-defined criteria. Have provided tissue for PD-L1 analysis from an archival tissue sample or newly obtained core or excisional biopsy of a tumor lesion not previously irradiated. Have received no prior systemic chemotherapy for advanced/unresectable (inoperable) or metastatic urothelial cancer. Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2 within 14 days prior to randomization. Adequate organ function per protocol-defined criteria. Exclusion Criteria: Disease that is suitable for local therapy administered with curative intent. 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, clinically stable and without requirement of steroid treatment for at least 14 days prior to first dose of study treatment. 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 (hepatitis B surface antigen [HBsAg] reactive) or has active hepatitis C (HCV RNA). Note: Testing must be performed to determine eligibility. History of a gastrointestinal condition that in the opinion of the Investigator may affect oral drug absorption. History or presence of an abnormal electrocardiogram (ECG) that, in the investigator's opinion, is clinically meaningful. 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
Arizona Oncology Associates PC- HOPE
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85704
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
Yale Cancer Center
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06511
Country
United States
Facility Name
Woodlands Medical Specialists, PA
City
Pensacola
State/Province
Florida
ZIP/Postal Code
32503
Country
United States
Facility Name
Rush University Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
Quincy Medical Group
City
Quincy
State/Province
Illinois
ZIP/Postal Code
62301
Country
United States
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
GU Research Network-Urology Cancer Center
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68130
Country
United States
Facility Name
Comprehensive Cancer Centers of Nevada
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89169
Country
United States
Facility Name
Laura and Isaac Perlmutter Cancer Center at NYU Langone
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
Levine Cancer Institute
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28204
Country
United States
Facility Name
Willamette Valley Cancer Institute and Research Center
City
Eugene
State/Province
Oregon
ZIP/Postal Code
97401
Country
United States
Facility Name
Abramson Cancer Center of the University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
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
Tennessee Oncology, PLLC/The Sarah Cannon Research Institute
City
Chattanooga
State/Province
Tennessee
ZIP/Postal Code
37404
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
Sarah Cannon Research Institute
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Facility Name
Tennessee Oncology Nashville
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Facility Name
Vanderbilt-Ingram Cancer Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
Facility Name
Texas Oncology-Memorial City
City
Houston
State/Province
Texas
ZIP/Postal Code
77024
Country
United States
Facility Name
University of Washington
City
Seattle
State/Province
Washington
ZIP/Postal Code
98195
Country
United States
Facility Name
Calvary Mater Newcastle
City
Waratah
State/Province
New South Wales
ZIP/Postal Code
2298
Country
Australia
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
Institut Jules Bordet
City
Bruxelles
ZIP/Postal Code
1000
Country
Belgium
Facility Name
Grand Hopital de Charleroi - Site Notre Dame - Oncology
City
Charleroi
ZIP/Postal Code
6000
Country
Belgium
Facility Name
AZ Maria Middelares Gent
City
Gent
ZIP/Postal Code
9000
Country
Belgium
Facility Name
Universitair Ziekenhuis Gent
City
Gent
ZIP/Postal Code
9000
Country
Belgium
Facility Name
Hopital de Jolimont
City
Haine-Saint-Paul
ZIP/Postal Code
7100
Country
Belgium
Facility Name
AZ Nikolaas
City
Sint-Niklaas
ZIP/Postal Code
9100
Country
Belgium
Facility Name
GZA Sint Augustinus
City
Wilrijk
ZIP/Postal Code
2610
Country
Belgium
Facility Name
Moncton Hospital - Horizon Health Network
City
Moncton
State/Province
New Brunswick
ZIP/Postal Code
E1C 6Z8
Country
Canada
Facility Name
Cancer Centre of Southeastern Ontario at Kingston General Hospital
City
Kingston
State/Province
Ontario
ZIP/Postal Code
K7L 2V7
Country
Canada
Facility Name
The Ottawa Hospital Cancer Centre
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1H 8L6
Country
Canada
Facility Name
Sunnybrook Health Science Centre
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4N 3M5
Country
Canada
Facility Name
CIUSSS de l Est de L Ile de Montreal - Hopital Maisonneuve-Rosemont
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H1T 2M4
Country
Canada
Facility Name
CHU de Quebec - Hotel-Dieu de Quebec
City
Québec
State/Province
Quebec
ZIP/Postal Code
G1R 2J6
Country
Canada
Facility Name
Institut de Cancerologie de l Ouest Site Paul Papin
City
Angers
ZIP/Postal Code
49055
Country
France
Facility Name
CHU de Besancon
City
Besançon
ZIP/Postal Code
25030
Country
France
Facility Name
Institut Bergonie
City
Bordeaux
ZIP/Postal Code
33076
Country
France
Facility Name
Centre Jean Perrin
City
Clermont-Ferrand
ZIP/Postal Code
63011
Country
France
Facility Name
Institut Paoli Calmettes
City
Marseille
ZIP/Postal Code
13009
Country
France
Facility Name
Centre d Oncologie de Gentilly
City
Nancy
ZIP/Postal Code
54100
Country
France
Facility Name
Hopital Europeen Georges Pompidou
City
Paris
ZIP/Postal Code
75908
Country
France
Facility Name
Centre Hospitalier Lyon Sud
City
Pierre-Bénite
ZIP/Postal Code
69310
Country
France
Facility Name
Institut Jean Godinot
City
Reims
ZIP/Postal Code
51726
Country
France
Facility Name
CHU de Strasbourg - Nouvel Hopital Civil
City
Strasbourg
ZIP/Postal Code
67091
Country
France
Facility Name
Institut Claudius Regaud
City
Toulouse
ZIP/Postal Code
31059
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
Kliniken Essen Mitte
City
Essen
ZIP/Postal Code
45136
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
Krankenhaus der Barmherzigen Brueder Trier
City
Trier
ZIP/Postal Code
54292
Country
Germany
Facility Name
Universitaetsklinikum Tuebingen
City
Tuebingen
ZIP/Postal Code
72076
Country
Germany
Facility Name
Cork University Hospital
City
Cork
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
V94 F858
Country
Ireland
Facility Name
University Hospital Waterford
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 Health Care Campus
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 Tumori Giovanni Paolo II
City
Bari
ZIP/Postal Code
70124
Country
Italy
Facility Name
Istituto Scientifico Romagnolo per Studio e Cura Tumori IRST
City
Meldola
ZIP/Postal Code
47014
Country
Italy
Facility Name
Istituto Nazionale dei Tumori
City
Milan
ZIP/Postal Code
20133
Country
Italy
Facility Name
Istituto Nazionale Tumori IRCCS 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
Kindai University Hospital
City
Osakasayama
State/Province
Osaka
ZIP/Postal Code
589-8511
Country
Japan
Facility Name
Yamaguchi University Hospital
City
Ube
State/Province
Yamaguchi
ZIP/Postal Code
755-8505
Country
Japan
Facility Name
Tokushima University Hospital
City
Tokushima
ZIP/Postal Code
770-8503
Country
Japan
Facility Name
Medical Hospital, Tokyo Medical And Dental University
City
Tokyo
ZIP/Postal Code
113-8519
Country
Japan
Facility Name
The Cancer Institute Hospital of JFCR
City
Tokyo
ZIP/Postal Code
135-8550
Country
Japan
Facility Name
Chungnam National University Hospital
City
Daejeon
ZIP/Postal Code
35015
Country
Korea, Republic of
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
Amphia Ziekenhuis
City
Breda
State/Province
Brabant
ZIP/Postal Code
4819EV
Country
Netherlands
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
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
Erasmus MC
City
Rotterdam
ZIP/Postal Code
3075 EA
Country
Netherlands
Facility Name
Beskidzkie Centrum Onkologii im. Jana Pawla II
City
Bielsko-Biala
ZIP/Postal Code
43-300
Country
Poland
Facility Name
Wojewodzkie Centrum Szpitalne Kotliny Jeleniogorskiej
City
Jelenia Góra
ZIP/Postal Code
58-506
Country
Poland
Facility Name
Uniwersyteckie Centrum Kliniczne Slaskiego Uniwersytetu Medycznego
City
Katowice
ZIP/Postal Code
40-514
Country
Poland
Facility Name
GLOBE Badania Kliniczne Oddzial we Wroclawiu
City
Komorowice
ZIP/Postal Code
52-229
Country
Poland
Facility Name
Europejskie Centrum Zdrowia Otwock
City
Otwock
ZIP/Postal Code
05-400
Country
Poland
Facility Name
Urologica Praktyka Lekarska Adam Marcheluk
City
Siedlce
ZIP/Postal Code
08-110
Country
Poland
Facility Name
Samodzielny Publiczny Szpital Kliniczny Nr 2 PUM w Szczecinie
City
Szczecin
ZIP/Postal Code
70-111
Country
Poland
Facility Name
Magodent Szpital Elblaska
City
Warszawa
ZIP/Postal Code
01-748
Country
Poland
Facility Name
Szpital Sw. Elzbiety Mokotowskie Centrum Medyczne
City
Warszawa
ZIP/Postal Code
02 616
Country
Poland
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 Teresa Herrera - Chuac
City
A Coruña
ZIP/Postal Code
15006
Country
Spain
Facility Name
Hospital Infanta Cristina
City
Badajoz
ZIP/Postal Code
06080
Country
Spain
Facility Name
Hospital General Universitari Vall d Hebron
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
ICO L Hospitalet
City
Hospitalet de Llobregat
ZIP/Postal Code
08908
Country
Spain
Facility Name
Hospital Universitario Lucus Augusti
City
Lugo
ZIP/Postal Code
27003
Country
Spain
Facility Name
Xarxa Assistencial Universitaria Manresa
City
Manresa
ZIP/Postal Code
08243
Country
Spain
Facility Name
Consorci Hospitalari Parc Tauli de Sabadell
City
Sabadell
ZIP/Postal Code
08208
Country
Spain
Facility Name
Hospital Virgen del Rocio
City
Sevilla
ZIP/Postal Code
41013
Country
Spain
Facility Name
Taipei Veterans General Hospital
City
Taipei
State/Province
Beitou
ZIP/Postal Code
112
Country
Taiwan
Facility Name
Chang Gung Medical Foundation - Kaohsiung
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
MI Dnipr Regional Clinical Hospital named after I.I. Mechnikov
City
Dnipropetrovsk
ZIP/Postal Code
49005
Country
Ukraine
Facility Name
Dnipropetrovsk City Multidiscipline Clinical Hosp.4 of DRC
City
Dnipropetrovsk
ZIP/Postal Code
49102
Country
Ukraine
Facility Name
Kharkiv Regional Clinical Oncology Center
City
Kharkiv
ZIP/Postal Code
61000
Country
Ukraine
Facility Name
Kyiv City Clinical Oncology Center
City
Kyiv
ZIP/Postal Code
03115
Country
Ukraine
Facility Name
MI Odessa Regional Oncological Centre
City
Odesa
ZIP/Postal Code
65055
Country
Ukraine
Facility Name
RMI Sumy Regional Clinical Oncology Dispensary
City
Sumy
ZIP/Postal Code
40022
Country
Ukraine
Facility Name
Royal Marsden NHS Trust
City
Sutton
State/Province
Surrey
ZIP/Postal Code
SM2 5PT
Country
United Kingdom
Facility Name
The Beatson West of Scotland Cancer Centre
City
Glasgow
ZIP/Postal Code
G120YN
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 in Combination With Epacadostat or Placebo in Cisplatin-ineligible Urothelial Carcinoma (KEYNOTE-672/ECHO-307)

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