search
Back to results

Pembrolizumab (MK-3475) Plus Epacadostat vs Standard of Care in mRCC (KEYNOTE-679/ECHO-302)

Primary Purpose

Renal Cell Carcinoma (RCC)

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

About this trial

This is an interventional treatment trial for Renal Cell Carcinoma (RCC) focused on measuring Renal cell carcinoma, programmed cell death 1 (PD-1) inhibitor, indoleamine 2, 3-dioxygenase 1 (IDO1) inhibitor

Eligibility Criteria

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

Inclusion Criteria:

  • Histologic confirmation of locally advanced or metastatic RCC with a clear-cell component with or without sarcomatoid features.
  • Must not have received any prior systemic therapy for their mRCC.
  • Measurable disease based on RECIST v1.1.
  • Archival tumor tissue sample or newly obtained core or excisional biopsy of a tumor lesion as required.
  • Karnofsky performance status ≥ 70%.
  • Adequate organ function per protocol-defined criteria.

Exclusion Criteria:

  • Use of protocol-defined prior/concomitant therapy.
  • Currently receiving or has received an investigational treatment as part of a study of an investigational agent or has used an investigational device within 4 weeks before randomization.
  • History of severe hypersensitivity reaction to study treatments or their excipients.
  • Active autoimmune disease that has required systemic treatment in past 2 years.
  • Known additional malignancy that has progressed or has required active treatment in the last 3 years.
  • Known active central nervous system metastases and/or carcinomatous meningitis.
  • History of (noninfectious) pneumonitis that required steroids or current pneumonitis.
  • History or presence of an abnormal electrocardiogram that, in the investigator's opinion, is clinically meaningful.
  • Significant cardiac event within 12 months before Cycle 1 Day 1.

Sites / Locations

  • Pinnacle Oncology Hematology
  • Scottsdale Healthcare
  • Arizona Oncology Associates PC- HOPE
  • Cedars-Sinai Medical Center
  • UC Irvine Comprehensive Cancer Center/Chao Family Comprehensive Cancer Center
  • UC Davis Comprehensive Cancer Center
  • Woodlands Medical Specialists, PA
  • Northside Hospital
  • Atlanta Cancer Care - Conyers
  • Northwest Georgia Oncology Centers Pc
  • Rush University Medical Center
  • Massachusetts General Hospital
  • Dana Farber Cancer Institute
  • Southeast Nebraska Hematology & Oncology Consultants, P.C.
  • New York Oncology Hematology P.C
  • Memorial Sloan Kettering Cancer Center
  • Levine Cancer Institute
  • Willamette Valley Cancer Institute and Research Center
  • University of Tennessee Erlanger Oncology & Hematology
  • The West Clinic, P.C.
  • US Oncology and Research
  • Utah Cancer Specialists
  • Huntsman Cancer Institute
  • Oncology & Hematology Associates of Southwest Virginia, Inc., DBA Blue Ridge Cancer Care
  • Shenandoah Oncology, P.C.
  • Canberra Hospital
  • Calvary Mater Newcastle
  • Westmead Hospital
  • Cabrini Health
  • Fiona Stanley Hospital
  • Centro de pesquisa Porto Alegre
  • Fundacao Pio XII - Hospital de Cancer de Barretos
  • Instituto do Cancer de Sao Paulo - ICESP
  • Hospital Sao Jose
  • Centro Avancado de Tratamento Oncologico - CENANTRON -
  • Hospital de Clinicas de Porto Alegre
  • Tom Baker Cancer Centre
  • Kingston Health Sciences Centre - KGH Site
  • Sunnybrook Health Sciences, Odette Cancer Centre
  • Jewish General Hospital
  • CIUSSS de la Mauricie-et-du-Centre-du-Quebec
  • CHU de Quebec-Universite Laval-Hotel Dieu de Quebec
  • Clinica Alemana de Osorno
  • Fundacion Arturo Lopez Perez FALP
  • Pontificia Universidad Catolica de Chile
  • Hospital Clinico Vina del Mar
  • Centre Antoine Lacassagne
  • CHU Besancon - Hopital Jean Minjoz
  • Hopital Saint Andre
  • Centre Francois Baclesse
  • Hopital Prive Toulon Hyeres Sainte Marguerite
  • Hopital Europeen Georges Pompidou
  • Hospices Civils de Lyon Centre Hospitalier Lyon Sud
  • Clinique Sainte Anne
  • CHU de Strasbourg - Nouvel Hopital Civil
  • Institut Gustave Roussy
  • Helios Klinikum Berlin Buch
  • Universitaetsklinikum der Technischen Universitaet Dresden
  • Universitaetsklinikum Essen
  • Universitaetsklinikum Frankfurt
  • Medizinische Hochschule Hannover
  • Universitaetsklinikum Jena
  • Universitaetsklinikum Magdeburg. Klinik fuer Urologie
  • Universitaetsklinikum Tuebingen
  • Orszagos Onkologiai Intezet
  • Zala Megyei Szent Rafael Korhaz
  • Somogy Megyei Kaposi Mor Oktato Korhaz
  • Borsod-Abauj-Zemplen Megyei Korhaz es Egyetemi Oktato Korhaz
  • Jasz Nagykun Szolnok Megyei Hetenyi Geza Korhaz Rendelointezet
  • Markusovszky Egyetemi Oktatokorhaz
  • Adelaide & Meath Hospital
  • University Hospital Waterford
  • Medical Oncology Ospedale San Donato
  • Azienda Ospedaliera-Spedali Civili
  • Fondazione IRCCS Istituto Nazionale dei Tumori
  • A.O. Cardarelli
  • Policlinico San Matteo
  • Azienda Ospedaliera San Camillo Forlanini
  • Nagoya University Hospital
  • National Cancer Center Hospital East
  • Sapporo Medical University Hospital
  • Hokkaido University Hospital
  • Nara Medical University Hospital
  • Kindai University Hospital
  • Saitama Medical University International Medical Center
  • Yamaguchi University Hospital
  • Akita University Hospital
  • Kyushu University Hospital
  • Niigata University Medical & Dental Hospital
  • Toranomon Hospital
  • Nippon Medical School Hospital
  • Keio University Hospital
  • Chonnam National University Hwasun Hospital
  • Severance Hospital Yonsei University Health System
  • Asan Medical Center
  • Samsung Medical Center
  • Auckland City Hospital
  • Helse Bergen HF Haukeland sykehus
  • Sykehuset Oestfold
  • Sorlandet sykehus HF
  • Akershus University Hospital
  • Oslo universitetssykehus
  • Universitetssykehuset i Nord Norge. Kreftavdelingen
  • St Olavs Hospital
  • Leningrad Regional Oncology Dispensary
  • Ivanovo regional oncology dispensary
  • Russian Scientific Center of Roentgenoradiology
  • Central Clinical Hospital with outpatient Clinic
  • National Medical Research Radiology Centre
  • Republican Clinical Oncology Dispensary of Republic of Bashkortostan
  • Hospital Parc Tauli
  • Hospital del Mar
  • Hospital Germans Trias i Pujol
  • Hospital General Universitario Gregorio Maranon
  • Hospital Universitario HM Sanchinarro
  • Hospital Clinico Universitario de Santiago
  • Instituto Valenciano de Oncologia
  • Chang Gung Med Foundation. Kaohsiung Branch
  • China Medical University Hospital
  • National Cheng Kung University Hospital
  • National Taiwan University Hospital
  • Taipei Veterans General Hospital
  • Baskent Universitesi Adana Dr. Turgut Noyan Uygulama ve Arastirma Merkezi
  • Ankara Numune Education and Research Hospital
  • Hacettepe University Medical Faculty
  • Istanbul Universitesi Onkoloji Enstitusu
  • Istanbul Medeniyet Universitesi Goztepe EAH
  • Ege Universitesi Tıp Fakultesi
  • Namik Kemal Universitesi Tip Fakultesi
  • MI Kryviy Rih Center of Dnipropetrovsk Regional Council
  • Dnipropetrovsk Regional Hospital n.a. I.I. Mechnikov
  • Dnipropetrovsk City Multidiscipline Clinical Hosp. 4 of DRC
  • MI Precarpathian Clinical Oncology Center
  • RMI Sumy Regional Clinical Oncology Dispensary
  • The Royal Marsden NHS Foundation Trust.
  • Western General Hospital
  • Beatson Institute of Cancer Research
  • Barts Health NHS Trust - St Bartholomew s Hospital
  • The Royal Marsden Foundation Trust
  • The Christie NHS Foundation Trust

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Pembrolizumab + Epacadostat

SoC (Sunitinib or Pazopanib)

Arm Description

Standard of care (SoC) (sunitinib or pazopanib monotherapy).

Outcomes

Primary Outcome Measures

Objective Response Rate (ORR) of Pembrolizumab + Epacadostat Versus Standard of Care (SOC)
ORR was defined as the percentage of participants who had complete response (CR) or partial response (PR) per RECIST v1.1 by investigator determination.

Secondary Outcome Measures

Safety and Tolerability of Pembrolizumab + Epacadostat Versus SOC as Measured by the 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 SOC as Measured by the Number of Participants Discontinuing Study Drug Due to 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.

Full Information

First Posted
August 22, 2017
Last Updated
May 15, 2023
Sponsor
Incyte Corporation
Collaborators
Merck Sharp & Dohme LLC
search

1. Study Identification

Unique Protocol Identification Number
NCT03260894
Brief Title
Pembrolizumab (MK-3475) Plus Epacadostat vs Standard of Care in mRCC (KEYNOTE-679/ECHO-302)
Official Title
A Randomized, Open-Label, Phase 3 Study to Evaluate Efficacy and Safety of Pembrolizumab (MK-3475) Plus Epacadostat vs Standard of Care (Sunitinib or Pazopanib) as First-Line Treatment for Locally Advanced or Metastatic Renal Cell Carcinoma (mRCC) (KEYNOTE-679/ECHO-302)
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
December 7, 2017 (Actual)
Primary Completion Date
August 22, 2018 (Actual)
Study Completion Date
December 31, 2024 (Anticipated)

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 plus epacadostat compared to sunitinib or pazopanib in participants with locally advanced/metastatic renal cell carcinoma (mRCC) with a clear cell component who have not received prior systemic therapy for their mRCC.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Renal Cell Carcinoma (RCC)
Keywords
Renal cell carcinoma, programmed cell death 1 (PD-1) inhibitor, indoleamine 2, 3-dioxygenase 1 (IDO1) inhibitor

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
129 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Pembrolizumab + Epacadostat
Arm Type
Experimental
Arm Title
SoC (Sunitinib or Pazopanib)
Arm Type
Active Comparator
Arm Description
Standard of care (SoC) (sunitinib or pazopanib monotherapy).
Intervention Type
Drug
Intervention Name(s)
Pembrolizumab
Other Intervention Name(s)
MK-3475
Intervention Description
Pembrolizumab 200 mg administered intravenously every 3 weeks.
Intervention Type
Drug
Intervention Name(s)
Epacadostat
Other Intervention Name(s)
INCB024360
Intervention Description
Epacadostat 100 mg administered orally twice daily.
Intervention Type
Drug
Intervention Name(s)
Sunitinib
Other Intervention Name(s)
Sutent, SU11248
Intervention Description
Sunitinib 50 mg administered orally once daily; 4 weeks on, 2 weeks off for 6-wk cycle.
Intervention Type
Drug
Intervention Name(s)
Pazopanib
Other Intervention Name(s)
Votrient
Intervention Description
Pazopanib 800 mg administered orally once daily.
Primary Outcome Measure Information:
Title
Objective Response Rate (ORR) of Pembrolizumab + Epacadostat Versus Standard of Care (SOC)
Description
ORR was defined as the percentage of participants who had complete response (CR) or partial response (PR) per RECIST v1.1 by investigator determination.
Time Frame
Minimum up to 6 months
Secondary Outcome Measure Information:
Title
Safety and Tolerability of Pembrolizumab + Epacadostat Versus SOC as Measured by the 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
Data reported from start of study to data cutoff 28-Feb-2019, up to 15 months.
Title
Safety and Tolerability of Pembrolizumab + Epacadostat Versus SOC as Measured by the Number of Participants Discontinuing Study Drug Due to 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
Data reported from start of study to data cutoff 28-Feb-2019, up to 15 months.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Histologic confirmation of locally advanced or metastatic RCC with a clear-cell component with or without sarcomatoid features. Must not have received any prior systemic therapy for their mRCC. Measurable disease based on RECIST v1.1. Archival tumor tissue sample or newly obtained core or excisional biopsy of a tumor lesion as required. Karnofsky performance status ≥ 70%. Adequate organ function per protocol-defined criteria. Exclusion Criteria: Use of protocol-defined prior/concomitant therapy. Currently receiving or has received an investigational treatment as part of a study of an investigational agent or has used an investigational device within 4 weeks before randomization. History of severe hypersensitivity reaction to study treatments or their excipients. Active autoimmune disease that has required systemic treatment in past 2 years. Known additional malignancy that has progressed or has required active treatment in the last 3 years. Known active central nervous system metastases and/or carcinomatous meningitis. History of (noninfectious) pneumonitis that required steroids or current pneumonitis. History or presence of an abnormal electrocardiogram that, in the investigator's opinion, is clinically meaningful. Significant cardiac event within 12 months before Cycle 1 Day 1.
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
Pinnacle Oncology Hematology
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85258
Country
United States
Facility Name
Scottsdale Healthcare
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85258
Country
United States
Facility Name
Arizona Oncology Associates PC- HOPE
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85711
Country
United States
Facility Name
Cedars-Sinai Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
Facility Name
UC Irvine Comprehensive Cancer Center/Chao Family Comprehensive Cancer Center
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Facility Name
UC Davis Comprehensive Cancer Center
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States
Facility Name
Woodlands Medical Specialists, PA
City
Pensacola
State/Province
Florida
ZIP/Postal Code
32503
Country
United States
Facility Name
Northside Hospital
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30342
Country
United States
Facility Name
Atlanta Cancer Care - Conyers
City
Conyers
State/Province
Georgia
ZIP/Postal Code
30094
Country
United States
Facility Name
Northwest Georgia Oncology Centers Pc
City
Marietta
State/Province
Georgia
ZIP/Postal Code
30060
Country
United States
Facility Name
Rush University Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Dana Farber Cancer Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
Southeast Nebraska Hematology & Oncology Consultants, P.C.
City
Lincoln
State/Province
Nebraska
ZIP/Postal Code
68510
Country
United States
Facility Name
New York Oncology Hematology P.C
City
Albany
State/Province
New York
ZIP/Postal Code
12208
Country
United States
Facility Name
Memorial Sloan Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10065
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
University of Tennessee Erlanger Oncology & Hematology
City
Chattanooga
State/Province
Tennessee
ZIP/Postal Code
37403
Country
United States
Facility Name
The West Clinic, P.C.
City
Germantown
State/Province
Tennessee
ZIP/Postal Code
38138
Country
United States
Facility Name
US Oncology and Research
City
The Woodlands
State/Province
Texas
ZIP/Postal Code
77380
Country
United States
Facility Name
Utah Cancer Specialists
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84106
Country
United States
Facility Name
Huntsman Cancer Institute
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84112
Country
United States
Facility Name
Oncology & Hematology Associates of Southwest Virginia, Inc., DBA Blue Ridge Cancer Care
City
Roanoke
State/Province
Virginia
ZIP/Postal Code
24014
Country
United States
Facility Name
Shenandoah Oncology, P.C.
City
Winchester
State/Province
Virginia
ZIP/Postal Code
22601
Country
United States
Facility Name
Canberra Hospital
City
Garran
State/Province
Australian Capital Territory
ZIP/Postal Code
2605
Country
Australia
Facility Name
Calvary Mater Newcastle
City
Waratah
State/Province
New South Wales
ZIP/Postal Code
2298
Country
Australia
Facility Name
Westmead Hospital
City
Westmead
State/Province
New South Wales
ZIP/Postal Code
2145
Country
Australia
Facility Name
Cabrini Health
City
Malvern
State/Province
Victoria
ZIP/Postal Code
3144
Country
Australia
Facility Name
Fiona Stanley Hospital
City
Murdoch
ZIP/Postal Code
6150
Country
Australia
Facility Name
Centro de pesquisa Porto Alegre
City
Porto Alegre
State/Province
Florianopolis
ZIP/Postal Code
90610-000
Country
Brazil
Facility Name
Fundacao Pio XII - Hospital de Cancer de Barretos
City
Barretos
State/Province
Sao Paulo
ZIP/Postal Code
14784-400
Country
Brazil
Facility Name
Instituto do Cancer de Sao Paulo - ICESP
City
São Paulo
State/Province
Sao Paulo
ZIP/Postal Code
01246-000
Country
Brazil
Facility Name
Hospital Sao Jose
City
São Paulo
State/Province
Sao Paulo
ZIP/Postal Code
01321-001
Country
Brazil
Facility Name
Centro Avancado de Tratamento Oncologico - CENANTRON -
City
Belo Horizonte
ZIP/Postal Code
30130090
Country
Brazil
Facility Name
Hospital de Clinicas de Porto Alegre
City
Porto Alegre
ZIP/Postal Code
90035-903
Country
Brazil
Facility Name
Tom Baker Cancer Centre
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N 4N2
Country
Canada
Facility Name
Kingston Health Sciences Centre - KGH Site
City
Kingston
State/Province
Ontario
ZIP/Postal Code
K7L 2V7
Country
Canada
Facility Name
Sunnybrook Health Sciences, Odette Cancer Centre
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4N 3M5
Country
Canada
Facility Name
Jewish General Hospital
City
Montréal
State/Province
Quebec
ZIP/Postal Code
H3T 1E2
Country
Canada
Facility Name
CIUSSS de la Mauricie-et-du-Centre-du-Quebec
City
Trois-Rivières
State/Province
Quebec
ZIP/Postal Code
G8Z 3R9
Country
Canada
Facility Name
CHU de Quebec-Universite Laval-Hotel Dieu de Quebec
City
Quebec
ZIP/Postal Code
G1R 2J6
Country
Canada
Facility Name
Clinica Alemana de Osorno
City
Osorno
State/Province
Region De Los Lagos
ZIP/Postal Code
5311089
Country
Chile
Facility Name
Fundacion Arturo Lopez Perez FALP
City
Santiago
ZIP/Postal Code
7500921
Country
Chile
Facility Name
Pontificia Universidad Catolica de Chile
City
Santiago
ZIP/Postal Code
8320000
Country
Chile
Facility Name
Hospital Clinico Vina del Mar
City
Vina del Mar
ZIP/Postal Code
2520000
Country
Chile
Facility Name
Centre Antoine Lacassagne
City
Nice
State/Province
Cedex 2
ZIP/Postal Code
06189
Country
France
Facility Name
CHU Besancon - Hopital Jean Minjoz
City
Besançon
ZIP/Postal Code
25030
Country
France
Facility Name
Hopital Saint Andre
City
Bordeaux
ZIP/Postal Code
33075
Country
France
Facility Name
Centre Francois Baclesse
City
Caen
ZIP/Postal Code
14076
Country
France
Facility Name
Hopital Prive Toulon Hyeres Sainte Marguerite
City
Hyeres
ZIP/Postal Code
83400
Country
France
Facility Name
Hopital Europeen Georges Pompidou
City
Paris
ZIP/Postal Code
75015
Country
France
Facility Name
Hospices Civils de Lyon Centre Hospitalier Lyon Sud
City
Pierre Benite
ZIP/Postal Code
69310
Country
France
Facility Name
Clinique Sainte Anne
City
Strasbourg
ZIP/Postal Code
67000
Country
France
Facility Name
CHU de Strasbourg - Nouvel Hopital Civil
City
Strasbourg
ZIP/Postal Code
67091
Country
France
Facility Name
Institut Gustave Roussy
City
Villejuif
ZIP/Postal Code
94805
Country
France
Facility Name
Helios Klinikum Berlin Buch
City
Berlin
ZIP/Postal Code
13125
Country
Germany
Facility Name
Universitaetsklinikum der Technischen Universitaet Dresden
City
Dresden
ZIP/Postal Code
01307
Country
Germany
Facility Name
Universitaetsklinikum Essen
City
Essen
ZIP/Postal Code
45147
Country
Germany
Facility Name
Universitaetsklinikum Frankfurt
City
Frankfurt am Main
ZIP/Postal Code
60590
Country
Germany
Facility Name
Medizinische Hochschule Hannover
City
Hannover
ZIP/Postal Code
30625
Country
Germany
Facility Name
Universitaetsklinikum Jena
City
Jena
ZIP/Postal Code
07747
Country
Germany
Facility Name
Universitaetsklinikum Magdeburg. Klinik fuer Urologie
City
Magdeburg
ZIP/Postal Code
39120
Country
Germany
Facility Name
Universitaetsklinikum Tuebingen
City
Tuebingen
ZIP/Postal Code
72076
Country
Germany
Facility Name
Orszagos Onkologiai Intezet
City
Budapest
State/Province
Pest
ZIP/Postal Code
1122
Country
Hungary
Facility Name
Zala Megyei Szent Rafael Korhaz
City
Zalaegerszeg
State/Province
Pozva
ZIP/Postal Code
8900
Country
Hungary
Facility Name
Somogy Megyei Kaposi Mor Oktato Korhaz
City
Kaposvar
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
Jasz Nagykun Szolnok Megyei Hetenyi Geza Korhaz Rendelointezet
City
Szolnok
ZIP/Postal Code
5000
Country
Hungary
Facility Name
Markusovszky Egyetemi Oktatokorhaz
City
Szombathely
ZIP/Postal Code
9700
Country
Hungary
Facility Name
Adelaide & Meath Hospital
City
Dublin
ZIP/Postal Code
00024
Country
Ireland
Facility Name
University Hospital Waterford
City
Waterford
ZIP/Postal Code
X91ER8E
Country
Ireland
Facility Name
Medical Oncology Ospedale San Donato
City
Arezzo
ZIP/Postal Code
52100
Country
Italy
Facility Name
Azienda Ospedaliera-Spedali Civili
City
Brescia
ZIP/Postal Code
25123
Country
Italy
Facility Name
Fondazione IRCCS Istituto Nazionale dei Tumori
City
Milano
ZIP/Postal Code
20133
Country
Italy
Facility Name
A.O. Cardarelli
City
Napoli
ZIP/Postal Code
80131
Country
Italy
Facility Name
Policlinico San Matteo
City
Pavia
ZIP/Postal Code
27100
Country
Italy
Facility Name
Azienda Ospedaliera San Camillo Forlanini
City
Roma
ZIP/Postal Code
00152
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
Sapporo Medical University Hospital
City
Sapporo
State/Province
Hokkaido
ZIP/Postal Code
060-8543
Country
Japan
Facility Name
Hokkaido University Hospital
City
Sapporo
State/Province
Hokkaido
ZIP/Postal Code
060-8648
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
Saitama Medical University International Medical Center
City
Hidaka
State/Province
Saitama
ZIP/Postal Code
350-1298
Country
Japan
Facility Name
Yamaguchi University Hospital
City
Ube
State/Province
Yamaguchi
ZIP/Postal Code
755-8505
Country
Japan
Facility Name
Akita University Hospital
City
Akita
ZIP/Postal Code
010-8543
Country
Japan
Facility Name
Kyushu University Hospital
City
Fukuoka
ZIP/Postal Code
812-8582
Country
Japan
Facility Name
Niigata University Medical & Dental Hospital
City
Niigata
ZIP/Postal Code
951-8520
Country
Japan
Facility Name
Toranomon Hospital
City
Tokyo
ZIP/Postal Code
105-8470
Country
Japan
Facility Name
Nippon Medical School Hospital
City
Tokyo
ZIP/Postal Code
113-8603
Country
Japan
Facility Name
Keio University Hospital
City
Tokyo
ZIP/Postal Code
160-8582
Country
Japan
Facility Name
Chonnam National University Hwasun Hospital
City
Hwasun
State/Province
Jeollanam Do
ZIP/Postal Code
58128
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
Auckland City Hospital
City
Auckland
State/Province
Grafton
ZIP/Postal Code
1023
Country
New Zealand
Facility Name
Helse Bergen HF Haukeland sykehus
City
Bergen
ZIP/Postal Code
5053
Country
Norway
Facility Name
Sykehuset Oestfold
City
Gralum
ZIP/Postal Code
1714
Country
Norway
Facility Name
Sorlandet sykehus HF
City
Kristiansand
ZIP/Postal Code
4615
Country
Norway
Facility Name
Akershus University Hospital
City
Lørenskog
ZIP/Postal Code
1478
Country
Norway
Facility Name
Oslo universitetssykehus
City
Oslo
ZIP/Postal Code
0450
Country
Norway
Facility Name
Universitetssykehuset i Nord Norge. Kreftavdelingen
City
Tromsø
ZIP/Postal Code
9019
Country
Norway
Facility Name
St Olavs Hospital
City
Trondheim
ZIP/Postal Code
7030
Country
Norway
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
153040
Country
Russian Federation
Facility Name
Russian Scientific Center of Roentgenoradiology
City
Moscow
ZIP/Postal Code
117997
Country
Russian Federation
Facility Name
Central Clinical Hospital with outpatient Clinic
City
Moscow
ZIP/Postal Code
121359
Country
Russian Federation
Facility Name
National Medical Research Radiology Centre
City
Moscow
ZIP/Postal Code
125284
Country
Russian Federation
Facility Name
Republican Clinical Oncology Dispensary of Republic of Bashkortostan
City
Ufa
ZIP/Postal Code
450054
Country
Russian Federation
Facility Name
Hospital Parc Tauli
City
Sabadell
State/Province
Barcelona
ZIP/Postal Code
08208
Country
Spain
Facility Name
Hospital del Mar
City
Barcelona
ZIP/Postal Code
08003
Country
Spain
Facility Name
Hospital Germans Trias i Pujol
City
Barcelona
ZIP/Postal Code
08916
Country
Spain
Facility Name
Hospital General Universitario Gregorio Maranon
City
Madrid
ZIP/Postal Code
28007
Country
Spain
Facility Name
Hospital Universitario HM Sanchinarro
City
Madrid
ZIP/Postal Code
28050
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 Med 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
70457
Country
Taiwan
Facility Name
National Taiwan University Hospital
City
Taipei
ZIP/Postal Code
10048
Country
Taiwan
Facility Name
Taipei Veterans General Hospital
City
Taipei
ZIP/Postal Code
112
Country
Taiwan
Facility Name
Baskent Universitesi Adana Dr. Turgut Noyan Uygulama ve Arastirma Merkezi
City
Adana
ZIP/Postal Code
01250
Country
Turkey
Facility Name
Ankara Numune Education and Research Hospital
City
Ankara
ZIP/Postal Code
06100
Country
Turkey
Facility Name
Hacettepe University Medical Faculty
City
Ankara
ZIP/Postal Code
06100
Country
Turkey
Facility Name
Istanbul Universitesi Onkoloji Enstitusu
City
Istanbul
ZIP/Postal Code
34093
Country
Turkey
Facility Name
Istanbul Medeniyet Universitesi Goztepe EAH
City
Istanbul
ZIP/Postal Code
34732
Country
Turkey
Facility Name
Ege Universitesi Tıp Fakultesi
City
Izmir
ZIP/Postal Code
35040
Country
Turkey
Facility Name
Namik Kemal Universitesi Tip Fakultesi
City
Tekirdag
ZIP/Postal Code
59100
Country
Turkey
Facility Name
MI Kryviy Rih Center of Dnipropetrovsk Regional Council
City
Kryvyi Rih
State/Province
Dnipropetrovsk Region
ZIP/Postal Code
50048
Country
Ukraine
Facility Name
Dnipropetrovsk Regional Hospital n.a. I.I. Mechnikov
City
Dnipropetrovs'k
ZIP/Postal Code
49005
Country
Ukraine
Facility Name
Dnipropetrovsk City Multidiscipline Clinical Hosp. 4 of DRC
City
Dnipropetrovs'k
ZIP/Postal Code
49102
Country
Ukraine
Facility Name
MI Precarpathian Clinical Oncology Center
City
Ivano-Frankivs'k
ZIP/Postal Code
76018
Country
Ukraine
Facility Name
RMI Sumy Regional Clinical Oncology Dispensary
City
Sumy
ZIP/Postal Code
40022
Country
Ukraine
Facility Name
The Royal Marsden NHS Foundation Trust.
City
Sutton
State/Province
Surrey
ZIP/Postal Code
SM2 5PT
Country
United Kingdom
Facility Name
Western General Hospital
City
Edinburgh
ZIP/Postal Code
EH4 2XU
Country
United Kingdom
Facility Name
Beatson Institute of Cancer Research
City
Glasgow
ZIP/Postal Code
G12 0YN
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
The Royal Marsden Foundation Trust
City
London
ZIP/Postal Code
SW3 6JJ
Country
United Kingdom
Facility Name
The Christie NHS Foundation Trust
City
Manchester
ZIP/Postal Code
MB204BX
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Pembrolizumab (MK-3475) Plus Epacadostat vs Standard of Care in mRCC (KEYNOTE-679/ECHO-302)

We'll reach out to this number within 24 hrs