Kidney Cancer Clinical Trial

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

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.

View Eligibility Criteria

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.

Study is for people with:

Kidney Cancer

Phase:

Phase 3

Estimated Enrollment:

129

Study ID:

NCT03260894

Recruitment Status:

Active, not recruiting

Sponsor:

Incyte Corporation

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There are 137 Locations for this study

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Pinnacle Oncology Hematology
Scottsdale Arizona, 85258, United States
Scottsdale Healthcare
Scottsdale Arizona, 85258, United States
Arizona Oncology Associates PC- HOPE
Tucson Arizona, 85711, United States
Cedars-Sinai Medical Center
Los Angeles California, 90048, United States
UC Irvine Comprehensive Cancer Center/Chao Family Comprehensive Cancer Center
Orange California, 92868, United States
UC Davis Comprehensive Cancer Center
Sacramento California, 95817, United States
Woodlands Medical Specialists, PA
Pensacola Florida, 32503, United States
Northside Hospital
Atlanta Georgia, 30342, United States
Atlanta Cancer Care - Conyers
Conyers Georgia, 30094, United States
Northwest Georgia Oncology Centers Pc
Marietta Georgia, 30060, United States
Rush University Medical Center
Chicago Illinois, 60612, United States
Massachusetts General Hospital
Boston Massachusetts, 02114, United States
Dana Farber Cancer Institute
Boston Massachusetts, 02215, United States
Southeast Nebraska Hematology & Oncology Consultants, P.C.
Lincoln Nebraska, 68510, United States
New York Oncology Hematology P.C
Albany New York, 12208, United States
Memorial Sloan Kettering Cancer Center
New York New York, 10065, United States
Levine Cancer Institute
Charlotte North Carolina, 28204, United States
Willamette Valley Cancer Institute and Research Center
Eugene Oregon, 97401, United States
University of Tennessee Erlanger Oncology & Hematology
Chattanooga Tennessee, 37403, United States
The West Clinic, P.C.
Germantown Tennessee, 38138, United States
US Oncology and Research
The Woodlands Texas, 77380, United States
Utah Cancer Specialists
Salt Lake City Utah, 84106, United States
Huntsman Cancer Institute
Salt Lake City Utah, 84112, United States
Oncology & Hematology Associates of Southwest Virginia, Inc., DBA Blue Ridge Cancer Care
Roanoke Virginia, 24014, United States
Shenandoah Oncology, P.C.
Winchester Virginia, 22601, United States
Canberra Hospital
Garran Australian Capital Territory, 2605, Australia
Calvary Mater Newcastle
Waratah New South Wales, 2298, Australia
Westmead Hospital
Westmead New South Wales, 2145, Australia
Cabrini Health
Malvern Victoria, 3144, Australia
Fiona Stanley Hospital
Murdoch , 6150, Australia
Centro de pesquisa Porto Alegre
Porto Alegre Florianopolis, 90610, Brazil
Fundacao Pio XII - Hospital de Cancer de Barretos
Barretos Sao Paulo, 14784, Brazil
Instituto do Cancer de Sao Paulo - ICESP
São Paulo Sao Paulo, 01246, Brazil
Hospital Sao Jose
São Paulo Sao Paulo, 01321, Brazil
Centro Avancado de Tratamento Oncologico - CENANTRON -
Belo Horizonte , 30130, Brazil
Hospital de Clinicas de Porto Alegre
Porto Alegre , 90035, Brazil
Tom Baker Cancer Centre
Calgary Alberta, T2N 4, Canada
Kingston Health Sciences Centre - KGH Site
Kingston Ontario, K7L 2, Canada
Sunnybrook Health Sciences, Odette Cancer Centre
Toronto Ontario, M4N 3, Canada
Jewish General Hospital
Montréal Quebec, H3T 1, Canada
CIUSSS de la Mauricie-et-du-Centre-du-Quebec
Trois-Rivières Quebec, G8Z 3, Canada
CHU de Quebec-Universite Laval-Hotel Dieu de Quebec
Quebec , G1R 2, Canada
Clinica Alemana de Osorno
Osorno Region De Los Lagos, 53110, Chile
Fundacion Arturo Lopez Perez FALP
Santiago , 75009, Chile
Pontificia Universidad Catolica de Chile
Santiago , 83200, Chile
Hospital Clinico Vina del Mar
Vina del Mar , 25200, Chile
Centre Antoine Lacassagne
Nice Cedex 2, 06189, France
CHU Besancon - Hopital Jean Minjoz
Besançon , 25030, France
Hopital Saint Andre
Bordeaux , 33075, France
Centre Francois Baclesse
Caen , 14076, France
Hopital Prive Toulon Hyeres Sainte Marguerite
Hyeres , 83400, France
Hopital Europeen Georges Pompidou
Paris , 75015, France
Hospices Civils de Lyon Centre Hospitalier Lyon Sud
Pierre Benite , 69310, France
Clinique Sainte Anne
Strasbourg , 67000, France
CHU de Strasbourg - Nouvel Hopital Civil
Strasbourg , 67091, France
Institut Gustave Roussy
Villejuif , 94805, France
Helios Klinikum Berlin Buch
Berlin , 13125, Germany
Universitaetsklinikum der Technischen Universitaet Dresden
Dresden , 01307, Germany
Universitaetsklinikum Essen
Essen , 45147, Germany
Universitaetsklinikum Frankfurt
Frankfurt am Main , 60590, Germany
Medizinische Hochschule Hannover
Hannover , 30625, Germany
Universitaetsklinikum Jena
Jena , 07747, Germany
Universitaetsklinikum Magdeburg. Klinik fuer Urologie
Magdeburg , 39120, Germany
Universitaetsklinikum Tuebingen
Tuebingen , 72076, Germany
Orszagos Onkologiai Intezet
Budapest Pest, 1122, Hungary
Zala Megyei Szent Rafael Korhaz
Zalaegerszeg Pozva, 8900, Hungary
Somogy Megyei Kaposi Mor Oktato Korhaz
Kaposvar , 7400, Hungary
Borsod-Abauj-Zemplen Megyei Korhaz es Egyetemi Oktato Korhaz
Miskolc , 3526, Hungary
Jasz Nagykun Szolnok Megyei Hetenyi Geza Korhaz Rendelointezet
Szolnok , 5000, Hungary
Markusovszky Egyetemi Oktatokorhaz
Szombathely , 9700, Hungary
Adelaide & Meath Hospital
Dublin , 00024, Ireland
University Hospital Waterford
Waterford , X91ER, Ireland
Medical Oncology Ospedale San Donato
Arezzo , 52100, Italy
Azienda Ospedaliera-Spedali Civili
Brescia , 25123, Italy
Fondazione IRCCS Istituto Nazionale dei Tumori
Milano , 20133, Italy
A.O. Cardarelli
Napoli , 80131, Italy
Policlinico San Matteo
Pavia , 27100, Italy
Azienda Ospedaliera San Camillo Forlanini
Roma , 00152, Italy
Nagoya University Hospital
Nagoya Aichi, 466-8, Japan
National Cancer Center Hospital East
Kashiwa Chiba, 277-8, Japan
Sapporo Medical University Hospital
Sapporo Hokkaido, 060-8, Japan
Hokkaido University Hospital
Sapporo Hokkaido, 060-8, Japan
Nara Medical University Hospital
Kashihara Nara, 634-8, Japan
Kindai University Hospital
Osakasayama Osaka, 589-8, Japan
Saitama Medical University International Medical Center
Hidaka Saitama, 350-1, Japan
Yamaguchi University Hospital
Ube Yamaguchi, 755-8, Japan
Akita University Hospital
Akita , 010-8, Japan
Kyushu University Hospital
Fukuoka , 812-8, Japan
Niigata University Medical & Dental Hospital
Niigata , 951-8, Japan
Toranomon Hospital
Tokyo , 105-8, Japan
Nippon Medical School Hospital
Tokyo , 113-8, Japan
Keio University Hospital
Tokyo , 160-8, Japan
Chonnam National University Hwasun Hospital
Hwasun Jeollanam Do, 58128, Korea, Republic of
Severance Hospital Yonsei University Health System
Seoul , 03722, Korea, Republic of
Asan Medical Center
Seoul , 05505, Korea, Republic of
Samsung Medical Center
Seoul , 06351, Korea, Republic of
Auckland City Hospital
Auckland Grafton, 1023, New Zealand
Helse Bergen HF Haukeland sykehus
Bergen , 5053, Norway
Sykehuset Oestfold
Gralum , 1714, Norway
Sorlandet sykehus HF
Kristiansand , 4615, Norway
Akershus University Hospital
Lørenskog , 1478, Norway
Oslo universitetssykehus
Oslo , 0450, Norway
Universitetssykehuset i Nord Norge. Kreftavdelingen
Tromsø , 9019, Norway
St Olavs Hospital
Trondheim , 7030, Norway
Leningrad Regional Oncology Dispensary
Saint Petersburg Leningrad Region, Vsevolozhsky District, 18866, Russian Federation
Ivanovo regional oncology dispensary
Ivanovo , 15304, Russian Federation
Russian Scientific Center of Roentgenoradiology
Moscow , 11799, Russian Federation
Central Clinical Hospital with outpatient Clinic
Moscow , 12135, Russian Federation
National Medical Research Radiology Centre
Moscow , 12528, Russian Federation
Republican Clinical Oncology Dispensary of Republic of Bashkortostan
Ufa , 45005, Russian Federation
Hospital Parc Tauli
Sabadell Barcelona, 08208, Spain
Hospital del Mar
Barcelona , 08003, Spain
Hospital Germans Trias i Pujol
Barcelona , 08916, Spain
Hospital General Universitario Gregorio Maranon
Madrid , 28007, Spain
Hospital Universitario HM Sanchinarro
Madrid , 28050, Spain
Hospital Clinico Universitario de Santiago
Santiago de Compostela , 15706, Spain
Instituto Valenciano de Oncologia
Valencia , 46009, Spain
Chang Gung Med Foundation. Kaohsiung Branch
Kaohsiung , 833, Taiwan
China Medical University Hospital
Taichung , 40447, Taiwan
National Cheng Kung University Hospital
Tainan , 70457, Taiwan
National Taiwan University Hospital
Taipei , 10048, Taiwan
Taipei Veterans General Hospital
Taipei , 112, Taiwan
Baskent Universitesi Adana Dr. Turgut Noyan Uygulama ve Arastirma Merkezi
Adana , 01250, Turkey
Ankara Numune Education and Research Hospital
Ankara , 06100, Turkey
Hacettepe University Medical Faculty
Ankara , 06100, Turkey
Istanbul Universitesi Onkoloji Enstitusu
Istanbul , 34093, Turkey
Istanbul Medeniyet Universitesi Goztepe EAH
Istanbul , 34732, Turkey
Ege Universitesi Tıp Fakultesi
Izmir , 35040, Turkey
Namik Kemal Universitesi Tip Fakultesi
Tekirdag , 59100, Turkey
MI Kryviy Rih Center of Dnipropetrovsk Regional Council
Kryvyi Rih Dnipropetrovsk Region, 50048, Ukraine
Dnipropetrovsk Regional Hospital n.a. I.I. Mechnikov
Dnipropetrovs'k , 49005, Ukraine
Dnipropetrovsk City Multidiscipline Clinical Hosp. 4 of DRC
Dnipropetrovs'k , 49102, Ukraine
MI Precarpathian Clinical Oncology Center
Ivano-Frankivs'k , 76018, Ukraine
RMI Sumy Regional Clinical Oncology Dispensary
Sumy , 40022, Ukraine
The Royal Marsden NHS Foundation Trust.
Sutton Surrey, SM2 5, United Kingdom
Western General Hospital
Edinburgh , EH4 2, United Kingdom
Beatson Institute of Cancer Research
Glasgow , G12 0, United Kingdom
Barts Health NHS Trust - St Bartholomew s Hospital
London , EC1A , United Kingdom
The Royal Marsden Foundation Trust
London , SW3 6, United Kingdom
The Christie NHS Foundation Trust
Manchester , MB204, United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Kidney Cancer

Phase:

Phase 3

Estimated Enrollment:

129

Study ID:

NCT03260894

Recruitment Status:

Active, not recruiting

Sponsor:


Incyte Corporation

How clear is this clinincal trial information?

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