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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 ID: NCT03260894
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.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
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, Sao Paulo, Brazil
Instituto do Cancer de Sao Paulo - ICESP, São Paulo, Sao Paulo, Brazil
Hospital Sao Jose, São Paulo, Sao 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, Montréal, Quebec, Canada
CIUSSS de la Mauricie-et-du-Centre-du-Quebec, Trois-Rivières, Quebec, Canada
CHU de Quebec-Universite Laval-Hotel Dieu de Quebec, Quebec, , Canada
Clinica Alemana de Osorno, Osorno, Region De Los Lagos, Chile
Fundacion Arturo Lopez Perez FALP, Santiago, , Chile
Pontificia Universidad Catolica de Chile, Santiago, , Chile
Hospital Clinico Vina del Mar, Vina 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, Hyeres, , France
Hopital Europeen Georges Pompidou, Paris, , France
Hospices Civils de Lyon Centre Hospitalier Lyon Sud, Pierre Benite, , 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, Hannover, , Germany
Universitaetsklinikum Jena, Jena, , Germany
Universitaetsklinikum Magdeburg. Klinik fuer Urologie, Magdeburg, , Germany
Universitaetsklinikum Tuebingen, Tuebingen, , Germany
Orszagos Onkologiai Intezet, Budapest, Pest, Hungary
Zala Megyei Szent Rafael Korhaz, Zalaegerszeg, Pozva, Hungary
Somogy Megyei Kaposi Mor Oktato Korhaz, Kaposvar, , 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, Milano, , Italy
A.O. Cardarelli, Napoli, , Italy
Policlinico San Matteo, Pavia, , Italy
Azienda Ospedaliera San Camillo Forlanini, Roma, , Italy
Nagoya University Hospital, Nagoya, Aichi, 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, Osakasayama, 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
Chonnam National University Hwasun Hospital, Hwasun, Jeollanam Do, Korea, Republic of
Severance Hospital Yonsei University Health System, Seoul, , Korea, Republic of
Asan Medical Center, Seoul, , Korea, Republic of
Samsung Medical Center, Seoul, , Korea, Republic of
Auckland City Hospital, Auckland, Grafton, New Zealand
Helse Bergen HF Haukeland sykehus, Bergen, , Norway
Sykehuset Oestfold, Gralum, , 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, Russian Federation
Ivanovo regional oncology dispensary, Ivanovo, , Russian Federation
Russian Scientific Center of Roentgenoradiology, Moscow, , Russian Federation
Central Clinical Hospital with outpatient Clinic, Moscow, , Russian Federation
National Medical Research Radiology Centre, Moscow, , Russian Federation
Republican Clinical Oncology Dispensary of Republic of Bashkortostan, Ufa, , Russian Federation
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, , Taiwan
China Medical University Hospital, Taichung, , Taiwan
National Cheng Kung University Hospital, Tainan, , 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
Ankara Numune Education and Research Hospital, Ankara, , Turkey
Hacettepe University Medical Faculty, Ankara, , Turkey
Istanbul Universitesi Onkoloji Enstitusu, Istanbul, , Turkey
Istanbul Medeniyet Universitesi Goztepe EAH, Istanbul, , Turkey
Ege Universitesi Tıp Fakultesi, Izmir, , Turkey
Namik Kemal Universitesi Tip Fakultesi, Tekirdag, , Turkey
MI Kryviy Rih Center of Dnipropetrovsk Regional Council, Kryvyi Rih, Dnipropetrovsk Region, Ukraine
Dnipropetrovsk Regional Hospital n.a. I.I. Mechnikov, Dnipropetrovs'k, , Ukraine
Dnipropetrovsk City Multidiscipline Clinical Hosp. 4 of DRC, Dnipropetrovs'k, , Ukraine
MI Precarpathian Clinical Oncology Center, Ivano-Frankivs'k, , 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
Name: Mark Jones, MD
Affiliation: Incyte Corporation
Role: STUDY_DIRECTOR