Pembrolizumab (MK-3475) Plus Epacadostat vs Standard of Care in mRCC (KEYNOTE-679/ECHO-302)
NCT ID: NCT03260894
Last Updated: 2025-07-29
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
129 participants
INTERVENTIONAL
2017-12-07
2025-06-04
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Pembrolizumab + Epacadostat
Pembrolizumab
Pembrolizumab 200 mg administered intravenously every 3 weeks.
Epacadostat
Epacadostat 100 mg administered orally twice daily.
SoC (Sunitinib or Pazopanib)
Standard of care (SoC) (sunitinib or pazopanib monotherapy).
Sunitinib
Sunitinib 50 mg administered orally once daily; 4 weeks on, 2 weeks off for 6-wk cycle.
Pazopanib
Pazopanib 800 mg administered orally once daily.
Interventions
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Pembrolizumab
Pembrolizumab 200 mg administered intravenously every 3 weeks.
Epacadostat
Epacadostat 100 mg administered orally twice daily.
Sunitinib
Sunitinib 50 mg administered orally once daily; 4 weeks on, 2 weeks off for 6-wk cycle.
Pazopanib
Pazopanib 800 mg administered orally once daily.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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Merck Sharp & Dohme LLC
INDUSTRY
Incyte Corporation
INDUSTRY
Responsible Party
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Principal Investigators
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Mark Jones, MD
Role: STUDY_DIRECTOR
Incyte Corporation
Locations
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Pinnacle Oncology Hematology
Scottsdale, Arizona, United States
Scottsdale Healthcare
Scottsdale, Arizona, United States
Arizona Oncology Associates PC- HOPE
Tucson, Arizona, United States
Cedars-Sinai Medical Center
Los Angeles, California, United States
UC Irvine Comprehensive Cancer Center/Chao Family Comprehensive Cancer Center
Orange, California, United States
UC Davis Comprehensive Cancer Center
Sacramento, California, United States
Woodlands Medical Specialists, PA
Pensacola, Florida, United States
Northside Hospital
Atlanta, Georgia, United States
Atlanta Cancer Care - Conyers
Conyers, Georgia, United States
Northwest Georgia Oncology Centers Pc
Marietta, Georgia, United States
Rush University Medical Center
Chicago, Illinois, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Dana Farber Cancer Institute
Boston, Massachusetts, United States
Southeast Nebraska Hematology & Oncology Consultants, P.C.
Lincoln, Nebraska, United States
New York Oncology Hematology P.C
Albany, New York, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
Levine Cancer Institute
Charlotte, North Carolina, United States
Willamette Valley Cancer Institute and Research Center
Eugene, Oregon, United States
University of Tennessee Erlanger Oncology & Hematology
Chattanooga, Tennessee, United States
The West Clinic, P.C.
Germantown, Tennessee, United States
US Oncology and Research
The Woodlands, Texas, United States
Utah Cancer Specialists
Salt Lake City, Utah, United States
Huntsman Cancer Institute
Salt Lake City, Utah, United States
Oncology & Hematology Associates of Southwest Virginia, Inc., DBA Blue Ridge Cancer Care
Roanoke, Virginia, United States
Shenandoah Oncology, P.C.
Winchester, Virginia, United States
Canberra Hospital
Garran, Australian Capital Territory, Australia
Calvary Mater Newcastle
Waratah, New South Wales, Australia
Westmead Hospital
Westmead, New South Wales, Australia
Cabrini Health
Malvern, Victoria, Australia
Fiona Stanley Hospital
Murdoch, , Australia
Centro de pesquisa Porto Alegre
Porto Alegre, Florianopolis, Brazil
Fundacao Pio XII - Hospital de Cancer de Barretos
Barretos, São Paulo, Brazil
Instituto do Cancer de Sao Paulo - ICESP
São Paulo, São Paulo, Brazil
Hospital Sao Jose
São Paulo, São Paulo, Brazil
Centro Avancado de Tratamento Oncologico - CENANTRON -
Belo Horizonte, , Brazil
Hospital de Clinicas de Porto Alegre
Porto Alegre, , Brazil
Tom Baker Cancer Centre
Calgary, Alberta, Canada
Kingston Health Sciences Centre - KGH Site
Kingston, Ontario, Canada
Sunnybrook Health Sciences, Odette Cancer Centre
Toronto, Ontario, Canada
Jewish General Hospital
Montreal, Quebec, Canada
CHU de Quebec-Universite Laval-Hotel Dieu de Quebec
Québec, Quebec, Canada
CIUSSS de la Mauricie-et-du-Centre-du-Quebec
Trois-Rivières, Quebec, Canada
Clinica Alemana de Osorno
Osorno, Los Lagos Region, Chile
Fundacion Arturo Lopez Perez FALP
Santiago, , Chile
Pontificia Universidad Catolica de Chile
Santiago, , Chile
Hospital Clinico Vina del Mar
Viña del Mar, , Chile
Centre Antoine Lacassagne
Nice, Cedex 2, France
CHU Besancon - Hopital Jean Minjoz
Besançon, , France
Hopital Saint Andre
Bordeaux, , France
Centre Francois Baclesse
Caen, , France
Hopital Prive Toulon Hyeres Sainte Marguerite
Hyères, , France
Hopital Europeen Georges Pompidou
Paris, , France
Hospices Civils de Lyon Centre Hospitalier Lyon Sud
Pierre-Bénite, , France
Clinique Sainte Anne
Strasbourg, , France
CHU de Strasbourg - Nouvel Hopital Civil
Strasbourg, , France
Institut Gustave Roussy
Villejuif, , France
Helios Klinikum Berlin Buch
Berlin, , Germany
Universitaetsklinikum der Technischen Universitaet Dresden
Dresden, , Germany
Universitaetsklinikum Essen
Essen, , Germany
Universitaetsklinikum Frankfurt
Frankfurt am Main, , Germany
Medizinische Hochschule Hannover
Hanover, , Germany
Universitaetsklinikum Jena
Jena, , Germany
Universitaetsklinikum Magdeburg. Klinik fuer Urologie
Magdeburg, , Germany
Universitaetsklinikum Tuebingen
Tübingen, , Germany
Orszagos Onkologiai Intezet
Budapest, Pest County, Hungary
Zala Megyei Szent Rafael Korhaz
Zalaegerszeg, Pozva, Hungary
Somogy Megyei Kaposi Mor Oktato Korhaz
Kaposvár, , Hungary
Borsod-Abauj-Zemplen Megyei Korhaz es Egyetemi Oktato Korhaz
Miskolc, , Hungary
Jasz Nagykun Szolnok Megyei Hetenyi Geza Korhaz Rendelointezet
Szolnok, , Hungary
Markusovszky Egyetemi Oktatokorhaz
Szombathely, , Hungary
Adelaide & Meath Hospital
Dublin, , Ireland
University Hospital Waterford
Waterford, , Ireland
Medical Oncology Ospedale San Donato
Arezzo, , Italy
Azienda Ospedaliera-Spedali Civili
Brescia, , Italy
Fondazione IRCCS Istituto Nazionale dei Tumori
Milan, , Italy
A.O. Cardarelli
Napoli, , Italy
Policlinico San Matteo
Pavia, , Italy
Azienda Ospedaliera San Camillo Forlanini
Roma, , Italy
Nagoya University Hospital
Nagoya, Aichi-ken, Japan
National Cancer Center Hospital East
Kashiwa, Chiba, Japan
Sapporo Medical University Hospital
Sapporo, Hokkaido, Japan
Hokkaido University Hospital
Sapporo, Hokkaido, Japan
Nara Medical University Hospital
Kashihara, Nara, Japan
Kindai University Hospital
Sayama, Osaka, Japan
Saitama Medical University International Medical Center
Hidaka, Saitama, Japan
Yamaguchi University Hospital
Ube, Yamaguchi, Japan
Akita University Hospital
Akita, , Japan
Kyushu University Hospital
Fukuoka, , Japan
Niigata University Medical & Dental Hospital
Niigata, , Japan
Toranomon Hospital
Tokyo, , Japan
Nippon Medical School Hospital
Tokyo, , Japan
Keio University Hospital
Tokyo, , Japan
Auckland City Hospital
Auckland, Grafton, New Zealand
Helse Bergen HF Haukeland sykehus
Bergen, , Norway
Sykehuset Oestfold
Grålum, , Norway
Sorlandet sykehus HF
Kristiansand, , Norway
Akershus University Hospital
Lørenskog, , Norway
Oslo universitetssykehus
Oslo, , Norway
Universitetssykehuset i Nord Norge. Kreftavdelingen
Tromsø, , Norway
St Olavs Hospital
Trondheim, , Norway
Leningrad Regional Oncology Dispensary
Saint Petersburg, Leningrad Region, Vsevolozhsky District, Russia
Ivanovo regional oncology dispensary
Ivanovo, , Russia
Russian Scientific Center of Roentgenoradiology
Moscow, , Russia
Central Clinical Hospital with outpatient Clinic
Moscow, , Russia
National Medical Research Radiology Centre
Moscow, , Russia
Republican Clinical Oncology Dispensary of Republic of Bashkortostan
Ufa, , Russia
Chonnam National University Hwasun Hospital
Hwasun, Jeollanam-do, South Korea
Severance Hospital Yonsei University Health System
Seoul, , South Korea
Asan Medical Center
Seoul, , South Korea
Samsung Medical Center
Seoul, , South Korea
Hospital Parc Tauli
Sabadell, Barcelona, Spain
Hospital del Mar
Barcelona, , Spain
Hospital Germans Trias i Pujol
Barcelona, , Spain
Hospital General Universitario Gregorio Maranon
Madrid, , Spain
Hospital Universitario HM Sanchinarro
Madrid, , Spain
Hospital Clinico Universitario de Santiago
Santiago de Compostela, , Spain
Instituto Valenciano de Oncologia
Valencia, , Spain
Chang Gung Med Foundation. Kaohsiung Branch
Kaohsiung City, , Taiwan
China Medical University Hospital
Taichung, , Taiwan
National Cheng Kung University Hospital
Tainan City, , Taiwan
National Taiwan University Hospital
Taipei, , Taiwan
Taipei Veterans General Hospital
Taipei, , Taiwan
Baskent Universitesi Adana Dr. Turgut Noyan Uygulama ve Arastirma Merkezi
Adana, , Turkey (Türkiye)
Ankara Numune Education and Research Hospital
Ankara, , Turkey (Türkiye)
Hacettepe University Medical Faculty
Ankara, , Turkey (Türkiye)
Istanbul Universitesi Onkoloji Enstitusu
Istanbul, , Turkey (Türkiye)
Istanbul Medeniyet Universitesi Goztepe EAH
Istanbul, , Turkey (Türkiye)
Ege Universitesi Tıp Fakultesi
Izmir, , Turkey (Türkiye)
Namik Kemal Universitesi Tip Fakultesi
Tekirdağ, , Turkey (Türkiye)
MI Kryviy Rih Center of Dnipropetrovsk Regional Council
Kryvyi Rih, Dnipropetrovsk Oblast, Ukraine
Dnipropetrovsk Regional Hospital n.a. I.I. Mechnikov
Dnipro, , Ukraine
Dnipropetrovsk City Multidiscipline Clinical Hosp. 4 of DRC
Dnipro, , Ukraine
MI Precarpathian Clinical Oncology Center
Ivano-Frankivsk, , Ukraine
RMI Sumy Regional Clinical Oncology Dispensary
Sumy, , Ukraine
The Royal Marsden NHS Foundation Trust.
Sutton, Surrey, United Kingdom
Western General Hospital
Edinburgh, , United Kingdom
Beatson Institute of Cancer Research
Glasgow, , United Kingdom
Barts Health NHS Trust - St Bartholomew s Hospital
London, , United Kingdom
The Royal Marsden Foundation Trust
London, , United Kingdom
The Christie NHS Foundation Trust
Manchester, , United Kingdom
Countries
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References
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Lara PN Jr, Villanueva L, Ibanez C, Erman M, Lee JL, Heinrich D, Lipatov ON, Gedye C, Gokmen E, Acevedo A, Semenov A, Park SH, Gafanov RA, Kose F, Jones M, Du X, Munteanu M, Perini R, Choueiri TK, Motzer RJ. A randomized, open-label, phase 3 trial of pembrolizumab plus epacadostat versus sunitinib or pazopanib as first-line treatment for metastatic renal cell carcinoma (KEYNOTE-679/ECHO-302). BMC Cancer. 2024 Jul 25;23(Suppl 1):1253. doi: 10.1186/s12885-023-10971-7.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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2024-512016-22-00
Identifier Type: REGISTRY
Identifier Source: secondary_id
2017-002259-26
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
KEYNOTE-679/ECHO-302
Identifier Type: -
Identifier Source: org_study_id
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