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COMPLETED
NCT03260894
PHASE3

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

Sponsor: Incyte Corporation

View on ClinicalTrials.gov

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.

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)

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

129

Start Date

2017-12-07

Completion Date

2025-06-04

Last Updated

2026-05-22

Healthy Volunteers

No

Interventions

DRUG

Pembrolizumab

Pembrolizumab 200 mg administered intravenously every 3 weeks.

DRUG

Epacadostat

Epacadostat 100 mg administered orally twice daily.

DRUG

Sunitinib

Sunitinib 50 mg administered orally once daily; 4 weeks on, 2 weeks off for 6-wk cycle.

DRUG

Pazopanib

Pazopanib 800 mg administered orally once daily.

Locations (140)

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

Naples, 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

And 40 more locations on ClinicalTrials.gov