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

May 19, 2026 updated by: Incyte Corporation

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)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

129

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
      • Murdoch, Australia, 6150
        • Fiona Stanley Hospital
    • Australian Capital Territory
      • Garran, Australian Capital Territory, Australia, 2605
        • Canberra Hospital
    • New South Wales
      • Waratah, New South Wales, Australia, 2298
        • Calvary Mater Newcastle
      • Westmead, New South Wales, Australia, 2145
        • Westmead Hospital
    • Victoria
      • Malvern, Victoria, Australia, 3144
        • Cabrini Health
  • Brazil
      • Belo Horizonte, Brazil, 30130090
        • Centro Avancado de Tratamento Oncologico - CENANTRON -
      • Porto Alegre, Brazil, 90035-903
        • Hospital de Clinicas de Porto Alegre
    • Florianopolis
      • Porto Alegre, Florianopolis, Brazil, 90610-000
        • Centro de pesquisa Porto Alegre
    • São Paulo
      • Barretos, São Paulo, Brazil, 14784-400
        • Fundação Pio XII - Hospital de Câncer de Barretos
      • São Paulo, São Paulo, Brazil, 01246-000
        • Instituto do Cancer de Sao Paulo - ICESP
      • São Paulo, São Paulo, Brazil, 01321-001
        • Hospital São José
  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2N 4N2
        • Tom Baker Cancer Centre
    • Ontario
      • Kingston, Ontario, Canada, K7L 2V7
        • Kingston Health Sciences Centre - KGH Site
      • Toronto, Ontario, Canada, M4N 3M5
        • Sunnybrook Health Sciences, Odette Cancer Centre
    • Quebec
      • Montreal, Quebec, Canada, H3T 1E2
        • Jewish General Hospital
      • Québec, Quebec, Canada, G1R 2J6
        • CHU de Quebec-Universite Laval-Hotel Dieu de Quebec
      • Trois-Rivières, Quebec, Canada, G8Z 3R9
        • CIUSSS de la Mauricie-et-du-Centre-du-Quebec
  • Chile
      • Santiago, Chile, 7500921
        • Fundacion Arturo Lopez Perez FALP
      • Santiago, Chile, 8320000
        • Pontificia Universidad Catolica de Chile
      • Viña del Mar, Chile, 2520000
        • Hospital Clinico Vina del Mar
    • Los Lagos Region
      • Osorno, Los Lagos Region, Chile, 5311089
        • Clinica Alemana de Osorno
  • France
      • Besançon, France, 25030
        • CHU Besancon - Hôpital Jean Minjoz
      • Bordeaux, France, 33075
        • Hopital Saint André
      • Caen, France, 14076
        • Centre Francois Baclesse
      • Hyères, France, 83400
        • Hopital Prive Toulon Hyeres Sainte Marguerite
      • Paris, France, 75015
        • Hôpital Européen Georges Pompidou
      • Pierre-Bénite, France, 69310
        • Hospices Civils de Lyon Centre Hospitalier Lyon Sud
      • Strasbourg, France, 67000
        • Clinique Sainte Anne
      • Strasbourg, France, 67091
        • CHU de Strasbourg - Nouvel Hôpital Civil
      • Villejuif, France, 94805
        • Institut Gustave Roussy
    • Cedex 2
      • Nice, Cedex 2, France, 06189
        • Centre Antoine Lacassagne
  • Germany
      • Berlin, Germany, 13125
        • HELIOS Klinikum Berlin Buch
      • Dresden, Germany, 01307
        • Universitaetsklinikum der Technischen Universitaet Dresden
      • Essen, Germany, 45147
        • Universitaetsklinikum Essen
      • Frankfurt am Main, Germany, 60590
        • Universitaetsklinikum Frankfurt
      • Hanover, Germany, 30625
        • Medizinische Hochschule Hannover
      • Jena, Germany, 07747
        • Universitaetsklinikum Jena
      • Magdeburg, Germany, 39120
        • Universitaetsklinikum Magdeburg. Klinik fuer Urologie
      • Tübingen, Germany, 72076
        • Universitaetsklinikum Tuebingen
  • Hungary
      • Kaposvár, Hungary, 7400
        • Somogy Megyei Kaposi Mor Oktato Korhaz
      • Miskolc, Hungary, 3526
        • Borsod-Abauj-Zemplen Megyei Korhaz es Egyetemi Oktato Korhaz
      • Szolnok, Hungary, 5000
        • Jasz Nagykun Szolnok Megyei Hetenyi Geza Korhaz Rendelointezet
      • Szombathely, Hungary, 9700
        • Markusovszky Egyetemi Oktatókórház
    • Pest County
      • Budapest, Pest County, Hungary, 1122
        • Orszagos Onkologiai Intezet
    • Pozva
      • Zalaegerszeg, Pozva, Hungary, 8900
        • Zala Megyei Szent Rafael Korhaz
  • Ireland
      • Dublin, Ireland, 00024
        • Adelaide & Meath Hospital
      • Waterford, Ireland, X91ER8E
        • University Hospital Waterford
  • Italy
      • Arezzo, Italy, 52100
        • Medical Oncology Ospedale San Donato
      • Brescia, Italy, 25123
        • Azienda Ospedaliera-Spedali Civili
      • Milan, Italy, 20133
        • Fondazione IRCCS Istituto Nazionale dei Tumori
      • Naples, Italy, 80131
        • A.O. Cardarelli
      • Pavia, Italy, 27100
        • Policlinico San Matteo
      • Roma, Italy, 00152
        • Azienda Ospedaliera San Camillo Forlanini
  • Japan
      • Akita, Japan, 010-8543
        • Akita University Hospital
      • Fukuoka, Japan, 812-8582
        • Kyushu University Hospital
      • Niigata, Japan, 951-8520
        • Niigata University Medical & Dental Hospital
      • Tokyo, Japan, 160-8582
        • Keio University Hospital
      • Tokyo, Japan, 105-8470
        • Toranomon Hospital
      • Tokyo, Japan, 113-8603
        • Nippon Medical School Hospital
    • Aichi-ken
      • Nagoya, Aichi-ken, Japan, 466-8560
        • Nagoya University Hospital
    • Chiba
      • Kashiwa, Chiba, Japan, 277-8577
        • National Cancer Center Hospital East
    • Hokkaido
      • Sapporo, Hokkaido, Japan, 060-8543
        • Sapporo Medical University Hospital
      • Sapporo, Hokkaido, Japan, 060-8648
        • Hokkaido University Hospital
    • Nara
      • Kashihara, Nara, Japan, 634-8522
        • Nara Medical University Hospital
    • Osaka
      • Sayama, Osaka, Japan, 589-8511
        • Kindai University Hospital
    • Saitama
      • Hidaka, Saitama, Japan, 350-1298
        • Saitama Medical University International Medical Center
    • Yamaguchi
      • Ube, Yamaguchi, Japan, 755-8505
        • Yamaguchi University Hospital
  • New Zealand
    • Grafton
      • Auckland, Grafton, New Zealand, 1023
        • Auckland City Hospital
  • Norway
      • Bergen, Norway, 5053
        • Helse Bergen HF Haukeland sykehus
      • Grålum, Norway, 1714
        • Sykehuset Oestfold
      • Kristiansand, Norway, 4615
        • Sorlandet sykehus HF
      • Lørenskog, Norway, 1478
        • Akershus University Hospital
      • Oslo, Norway, 0450
        • Oslo Universitetssykehus
      • Tromsø, Norway, 9019
        • Universitetssykehuset i Nord Norge. Kreftavdelingen
      • Trondheim, Norway, 7030
        • St Olavs hospital
  • Russia
      • Ivanovo, Russia, 153040
        • Ivanovo regional oncology dispensary
      • Moscow, Russia, 117997
        • Russian Scientific Center of Roentgenoradiology
      • Moscow, Russia, 121359
        • Central Clinical Hospital with outpatient Clinic
      • Moscow, Russia, 125284
        • National Medical Research Radiology Centre
      • Ufa, Russia, 450054
        • Republican Clinical Oncology Dispensary of Republic of Bashkortostan
    • Leningrad Region, Vsevolozhsky District
      • Saint Petersburg, Leningrad Region, Vsevolozhsky District, Russia, 188663
        • Leningrad Regional Oncology Dispensary
  • South Korea
      • Seoul, South Korea, 05505
        • Asan Medical Center
      • Seoul, South Korea, 03722
        • Severance Hospital Yonsei University Health System
      • Seoul, South Korea, 06351
        • Samsung Medical Center
    • Jeollanam-do
      • Hwasun, Jeollanam-do, South Korea, 58128
        • Chonnam National University Hwasun Hospital
  • Spain
      • Barcelona, Spain, 08003
        • Hospital del Mar
      • Barcelona, Spain, 08916
        • Hospital Germans Trias i Pujol
      • Madrid, Spain, 28007
        • Hospital General Universitario Gregorio Maranon
      • Madrid, Spain, 28050
        • Hospital Universitario HM Sanchinarro
      • Santiago de Compostela, Spain, 15706
        • Hospital Clínico Universitario de Santiago
      • Valencia, Spain, 46009
        • Instituto Valenciano de Oncologia
    • Barcelona
      • Sabadell, Barcelona, Spain, 08208
        • Hospital Parc Tauli
  • Taiwan
      • Kaohsiung City, Taiwan, 833
        • Chang Gung Med Foundation. Kaohsiung Branch
      • Taichung, Taiwan, 40447
        • China Medical University Hospital
      • Tainan, Taiwan, 70457
        • National Cheng Kung University Hospital
      • Taipei, Taiwan, 112
        • Taipei Veterans General Hospital
      • Taipei, Taiwan, 10048
        • National Taiwan University Hospital
  • Turkey (Türkiye)
      • Adana, Turkey (Türkiye), 01250
        • Baskent Universitesi Adana Dr. Turgut Noyan Uygulama ve Arastirma Merkezi
      • Ankara, Turkey (Türkiye), 06100
        • Hacettepe University Medical Faculty
      • Ankara, Turkey (Türkiye), 06100
        • Ankara Numune Education and Research Hospital
      • Istanbul, Turkey (Türkiye), 34093
        • Istanbul Universitesi Onkoloji Enstitusu
      • Istanbul, Turkey (Türkiye), 34732
        • Istanbul Medeniyet Universitesi Goztepe EAH
      • Izmir, Turkey (Türkiye), 35040
        • Ege Universitesi Tıp Fakultesi
      • Tekirdağ, Turkey (Türkiye), 59100
        • Namik Kemal Universitesi Tip Fakultesi
  • Ukraine
      • Dnipro, Ukraine, 49005
        • Dnipropetrovsk Regional Hospital n.a. I.I. Mechnikov
      • Dnipro, Ukraine, 49102
        • Dnipropetrovsk City Multidiscipline Clinical Hosp. 4 of DRC
      • Ivano-Frankivsk, Ukraine, 76018
        • MI Precarpathian Clinical Oncology Center
      • Sumy, Ukraine, 40022
        • RMI Sumy Regional Clinical Oncology Dispensary
    • Dnipropetrovsk Oblast
      • Kryvyi Rih, Dnipropetrovsk Oblast, Ukraine, 50048
        • MI Kryviy Rih Center of Dnipropetrovsk Regional Council
  • United Kingdom
      • Edinburgh, United Kingdom, EH4 2XU
        • Western General Hospital
      • Glasgow, United Kingdom, G12 0YN
        • Beatson Institute of Cancer Research
      • London, United Kingdom, EC1A 7BE
        • Barts Health NHS Trust - St Bartholomew s Hospital
      • London, United Kingdom, SW3 6JJ
        • The Royal Marsden Foundation Trust
      • Manchester, United Kingdom, MB204BX
        • The Christie NHS Foundation Trust
    • Surrey
      • Sutton, Surrey, United Kingdom, SM2 5PT
        • The Royal Marsden NHS Foundation Trust.
  • United States
    • Arizona
      • Scottsdale, Arizona, United States, 85258
        • Pinnacle Oncology Hematology
      • Scottsdale, Arizona, United States, 85258
        • Scottsdale Healthcare
      • Tucson, Arizona, United States, 85711
        • Arizona Oncology Associates PC- HOPE
    • California
      • Los Angeles, California, United States, 90048
        • Cedars-Sinai Medical Center
      • Orange, California, United States, 92868
        • UC Irvine Comprehensive Cancer Center/Chao Family Comprehensive Cancer Center
      • Sacramento, California, United States, 95817
        • UC Davis Comprehensive Cancer Center
    • Florida
      • Pensacola, Florida, United States, 32503
        • Woodlands Medical Specialists, PA
    • Georgia
      • Atlanta, Georgia, United States, 30342
        • Northside Hospital
      • Conyers, Georgia, United States, 30094
        • Atlanta Cancer Care - Conyers
      • Marietta, Georgia, United States, 30060
        • Northwest Georgia Oncology Centers Pc
    • Illinois
      • Chicago, Illinois, United States, 60612
        • Rush University Medical Center
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Massachusetts General Hospital
      • Boston, Massachusetts, United States, 02215
        • Dana Farber Cancer Institute
    • Nebraska
      • Lincoln, Nebraska, United States, 68510
        • Southeast Nebraska Hematology & Oncology Consultants, P.C.
    • New York
      • Albany, New York, United States, 12208
        • New York Oncology Hematology P.C
      • New York, New York, United States, 10065
        • Memorial Sloan Kettering Cancer Center
    • North Carolina
      • Charlotte, North Carolina, United States, 28204
        • Levine Cancer Institute
    • Oregon
      • Eugene, Oregon, United States, 97401
        • Willamette Valley Cancer Institute and Research Center
    • Tennessee
      • Chattanooga, Tennessee, United States, 37403
        • University of Tennessee Erlanger Oncology & Hematology
      • Germantown, Tennessee, United States, 38138
        • The West Clinic, P.C.
    • Texas
      • The Woodlands, Texas, United States, 77380
        • US Oncology and Research
    • Utah
      • Salt Lake City, Utah, United States, 84106
        • Utah Cancer Specialists
      • Salt Lake City, Utah, United States, 84112
        • Huntsman Cancer Institute
    • Virginia
      • Roanoke, Virginia, United States, 24014
        • Oncology & Hematology Associates of Southwest Virginia, Inc., DBA Blue Ridge Cancer Care
      • Winchester, Virginia, United States, 22601
        • Shenandoah Oncology, P.C.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Pembrolizumab + Epacadostat
Drug: Pembrolizumab
Pembrolizumab 200 mg administered intravenously every 3 weeks.
Other Names:
  • MK-3475
Drug: Epacadostat
Epacadostat 100 mg administered orally twice daily.
Other Names:
  • INCB024360
Active Comparator: SoC (Sunitinib or Pazopanib)
Standard of care (SoC) (sunitinib or pazopanib monotherapy).
Drug: Sunitinib
Sunitinib 50 mg administered orally once daily; 4 weeks on, 2 weeks off for 6-wk cycle.
Other Names:
  • Sutent
  • SU11248
Drug: Pazopanib
Pazopanib 800 mg administered orally once daily.
Other Names:
  • Votrient

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Objective Response Rate (ORR) of Pembrolizumab + Epacadostat Versus Standard of Care (SOC)
Time Frame: up to approximately 8 months
ORR was defined as the percentage of participants who had complete response (CR) or partial response (PR) per RECIST v1.1 by investigator determination.
up to approximately 8 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety and Tolerability of Pembrolizumab + Epacadostat Versus SOC as Measured by the Number of Participants Experiencing Adverse Events (AEs)
Time Frame: Data reported from start of study to data cutoff 28-Feb-2019, up to 15 months.
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.
Data reported from start of study to data cutoff 28-Feb-2019, up to 15 months.
Safety and Tolerability of Pembrolizumab + Epacadostat Versus SOC as Measured by the Number of Participants Discontinuing Study Drug Due to AEs
Time Frame: Data reported from start of study to data cutoff 28-Feb-2019, up to 15 months.
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.
Data reported from start of study to data cutoff 28-Feb-2019, up to 15 months.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Incyte Corporation

Collaborators

Merck Sharp & Dohme LLC

Investigators

  • Study Director: Mark Jones, MD, Incyte Corporation

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 7, 2017

Primary Completion (Actual)

August 22, 2018

Study Completion (Actual)

June 4, 2025

Study Registration Dates

First Submitted

August 22, 2017

First Submitted That Met QC Criteria

August 22, 2017

First Posted (Actual)

August 24, 2017

Study Record Updates

Last Update Posted (Actual)

May 22, 2026

Last Update Submitted That Met QC Criteria

May 19, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KEYNOTE-679/ECHO-302
  • 2017-002259-26 (EudraCT Number)
  • 2024-512016-22-00 (Registry Identifier: EU CT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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