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Trial record 1 of 1 for:    NCT03260894
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Pembrolizumab (MK-3475) Plus Epacadostat vs Standard of Care in mRCC

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ClinicalTrials.gov Identifier: NCT03260894
Recruitment Status : Active, not recruiting
First Posted : August 24, 2017
Last Update Posted : August 15, 2018
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Incyte Corporation

Brief Summary:
The purpose of this study is 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 clear cell component who have not received prior systemic therapy for their mRCC.

Condition or disease Intervention/treatment Phase
Renal Cell Carcinoma (RCC) Drug: Pembrolizumab Drug: Epacadostat Drug: Sunitinib Drug: Pazopanib Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 129 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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)
Actual Study Start Date : December 7, 2017
Estimated Primary Completion Date : August 2018
Estimated Study Completion Date : June 2020


Arm Intervention/treatment
Experimental: Group 1
Pembrolizumab + epacadostat
Drug: Pembrolizumab
Pembrolizumab administered intravenously every 3 weeks.
Other Name: MK-3475

Drug: Epacadostat
Epacadostat administered orally twice daily.
Other Name: INCB024360

Active Comparator: Group 2
Sunitinib or pazopanib
Drug: Sunitinib
Sunitinib administered orally once daily.
Other Names:
  • Sutent
  • SU11248

Drug: Pazopanib
Pazopanib administered orally once daily.
Other Name: Votrient




Primary Outcome Measures :
  1. Objective response rate of pembrolizumab + epacadostat versus standard of care (SOC) [ Time Frame: Up to 6 months ]
    Defined as proportion of participants who have a best response of complete response (CR) or partial response (PR) as measured per RECIST v1.1.


Secondary Outcome Measures :
  1. Safety and tolerability of pembrolizumab + epacadostat and SOC as measured by number of participants experiencing adverse events (AEs) [ Time Frame: Up to 30 months ]
    AEs 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.

  2. Safety and tolerability of pembrolizumab + epacadostat and SOC as measured by number of participants discontinuing study drug due to AEs [ Time Frame: Up to 30 months ]
    AEs 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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03260894


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Locations
United States, Arizona
Pinnacle Oncology Hematology
Scottsdale, Arizona, United States, 85258
Scottsdale Healthcare
Scottsdale, Arizona, United States, 85258
Arizona Oncology Associates PC- HOPE
Tucson, Arizona, United States, 85711
United States, California
Cedars-Sinai Medical Center
Los Angeles, California, United States, 90048
UC Irvine Comprehensive Cancer Center/Chao Family Comprehensive Cancer Center
Orange, California, United States, 92868
UC Davis Comprehensive Cancer Center
Sacramento, California, United States, 95817
United States, Florida
Woodlands Medical Specialists, PA
Pensacola, Florida, United States, 32503
United States, Georgia
Northside Hospital
Atlanta, Georgia, United States, 30342
Atlanta Cancer Care - Conyers
Conyers, Georgia, United States, 30094
Northwest Georgia Oncology Centers Pc
Marietta, Georgia, United States, 30060
United States, Illinois
Rush University Medical Center
Chicago, Illinois, United States, 60612
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02215
United States, Nebraska
Southeast Nebraska Hematology & Oncology Consultants, P.C.
Lincoln, Nebraska, United States, 68510
United States, New York
New York Oncology Hematology P.C
Albany, New York, United States, 12208
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
United States, North Carolina
Levine Cancer Institute
Charlotte, North Carolina, United States, 28204
United States, Oregon
Willamette Valley Cancer Institute and Research Center
Eugene, Oregon, United States, 97401
United States, Tennessee
University of Tennessee Erlanger Oncology & Hematology
Chattanooga, Tennessee, United States, 37403
The West Clinic, P.C.
Germantown, Tennessee, United States, 38138
United States, Texas
US Oncology and Research
The Woodlands, Texas, United States, 77380
United States, Utah
Utah Cancer Specialists
Salt Lake City, Utah, United States, 84106
Huntsman Cancer Institute
Salt Lake City, Utah, United States, 84112
United States, Virginia
Oncology & Hematology Associates of Southwest Virginia, Inc., DBA Blue Ridge Cancer Care
Roanoke, Virginia, United States, 24014
Shenandoah Oncology, P.C.
Winchester, Virginia, United States, 22601
United States, Washington
Seattle Cancer Care Alliance
Seattle, Washington, United States, 98019
Australia, Australian Capital Territory
Canberra Hospital
Garran, Australian Capital Territory, Australia, 2605
Australia, New South Wales
Calvary Mater Newcastle
Waratah, New South Wales, Australia, 2298
Westmead Hospital
Westmead, New South Wales, Australia, 2145
Australia, Victoria
Cabrini Health
Malvern, Victoria, Australia, 3144
Australia
Fiona Stanley Hospital
Murdoch, Australia, 6150
Brazil
Centro de pesquisa Porto Alegre
Porto Alegre, Florianopolis, Brazil, 90610-000
Fundacao Pio XII - Hospital de Cancer de Barretos
Barretos, Sao Paulo, Brazil, 14784-400
Instituto do Cancer de Sao Paulo - ICESP
São Paulo, Sao Paulo, Brazil, 01246-000
Hospital Sao Jose
São Paulo, Sao Paulo, Brazil, 01321-001
Centro Avancado de Tratamento Oncologico - CENANTRON -
Belo Horizonte, Brazil, 30130090
Hospital de Clinicas de Porto Alegre
Porto Alegre, Brazil, 90035-903
Canada, Alberta
Tom Baker Cancer Centre
Calgary, Alberta, Canada, T2N 4N2
Canada, Ontario
Kingston Health Sciences Centre - KGH Site
Kingston, Ontario, Canada, K7L 2V7
Sunnybrook Health Sciences, Odette Cancer Centre
Toronto, Ontario, Canada, M4N 3M5
Canada, Quebec
Jewish General Hospital
Montréal, Quebec, Canada, H3T 1E2
CIUSSS de la Mauricie-et-du-Centre-du-Quebec
Trois-Rivières, Quebec, Canada, G8Z 3R9
Canada
CHU de Quebec-Universite Laval-Hotel Dieu de Quebec
Quebec, Canada, G1R 2J6
Chile
Clinica Alemana de Osorno
Osorno, Region De Los Lagos, Chile, 5311089
Fundacion Arturo Lopez Perez FALP
Santiago, Chile, 7500921
Pontificia Universidad Catolica de Chile
Santiago, Chile, 8320000
Hospital Clinico Vina del Mar
Vina del Mar, Chile, 2520000
France
Centre Antoine Lacassagne
Nice, Cedex 2, France, 06189
CHU Besancon - Hopital Jean Minjoz
Besançon, France, 25030
Hopital Saint Andre
Bordeaux, France, 33075
Centre Francois Baclesse
Caen, France, 14076
Hopital Prive Toulon Hyeres Sainte Marguerite
Hyeres, France, 83400
Hopital Europeen Georges Pompidou
Paris, France, 75015
Hospices Civils de Lyon Centre Hospitalier Lyon Sud
Pierre Benite, France, 69310
Clinique Sainte Anne
Strasbourg, France, 67000
CHU de Strasbourg - Nouvel Hopital Civil
Strasbourg, France, 67091
Institut Gustave Roussy
Villejuif, France, 94805
Germany
Helios Klinikum Berlin Buch
Berlin, Germany, 13125
Universitaetsklinikum der Technischen Universitaet Dresden
Dresden, Germany, 01307
Universitaetsklinikum Essen. Klinik und Poliklinik fuer Urologie
Essen, Germany, 45147
Universitaetsklinikum Essen
Essen, Germany, 45147
Universitaetsklinikum Frankfurt
Frankfurt am Main, Germany, 60590
Medizinische Hochschule Hannover
Hannover, Germany, 30625
Universitaetsklinikum Jena
Jena, Germany, 07747
Universitaetsklinikum Magdeburg. Klinik fuer Urologie
Magdeburg, Germany, 39120
Universitaetsklinikum Tuebingen
Tuebingen, Germany, 72076
Hungary
Orszagos Onkologiai Intezet
Budapest, Pest, Hungary, 1122
Zala Megyei Szent Rafael Korhaz
Zalaegerszeg, Pozva, Hungary, 8900
Somogy Megyei Kaposi Mor Oktato Korhaz
Kaposvar, Hungary, 7400
Borsod-Abauj-Zemplen Megyei Korhaz es Egyetemi Oktato Korhaz
Miskolc, Hungary, 3526
Jasz Nagykun Szolnok Megyei Hetenyi Geza Korhaz Rendelointezet
Szolnok, Hungary, 5000
Markusovszky Egyetemi Oktatokorhaz
Szombathely, Hungary, 9700
Ireland
Adelaide & Meath Hospital
Dublin, Ireland, 00024
University Hospital Waterford
Waterford, Ireland, X91ER8E
Italy
Medical Oncology Ospedale San Donato
Arezzo, Italy, 52100
Azienda Ospedaliera-Spedali Civili
Brescia, Italy, 25123
Fondazione IRCCS Istituto Nazionale dei Tumori
Milano, Italy, 20133
A.O. Cardarelli
Napoli, Italy, 80131
Policlinico San Matteo
Pavia, Italy, 27100
Azienda Ospedaliera San Camillo Forlanini
Roma, Italy, 00152
Japan
Nagoya University Hospital
Nagoya, Aichi, Japan, 466-8560
National Cancer Center Hospital East
Kashiwa, Chiba, Japan, 277-8577
Sapporo Medical University Hospital
Sapporo, Hokkaido, Japan, 060-8543
Hokkaido University Hospital
Sapporo, Hokkaido, Japan, 060-8648
Nara Medical University Hospital
Kashihara, Nara, Japan, 634-8522
Kindai University Hospital
Osakasayama, Osaka, Japan, 589-8511
Saitama Medical University International Medical Center
Hidaka, Saitama, Japan, 350-1298
Yamaguchi University Hospital
Ube, Yamaguchi, Japan, 755-8505
Akita University Hospital
Akita, Japan, 010-8543
Kyushu University Hospital
Fukuoka, Japan, 812-8582
Niigata University Medical & Dental Hospital
Niigata, Japan, 951-8520
Toranomon Hospital
Tokyo, Japan, 105-8470
Nippon Medical School Hospital
Tokyo, Japan, 113-8603
Keio University Hospital
Tokyo, Japan, 160-8582
Korea, Republic of
Chonnam National University Hwasun Hospital
Hwasun, Jeollanam Do, Korea, Republic of, 58128
Severance Hospital Yonsei University Health System
Seoul, Korea, Republic of, 03722
Asan Medical Center
Seoul, Korea, Republic of, 05505
Samsung Medical Center
Seoul, Korea, Republic of, 06351
New Zealand
Auckland City Hospital
Auckland, Grafton, New Zealand, 1023
Norway
Helse Bergen HF Haukeland sykehus
Bergen, Norway, 5053
Sykehuset Oestfold
Gralum, Norway, 1714
Sorlandet sykehus HF
Kristiansand, Norway, 4615
Akershus University Hospital
Lørenskog, Norway, 1478
Oslo universitetssykehus
Oslo, Norway, 0450
Universitetssykehuset i Nord Norge. Kreftavdelingen
Tromsø, Norway, 9019
St Olavs Hospital
Trondheim, Norway, 7030
Russian Federation
Leningrad Regional Oncology Dispensary
Saint Petersburg, Leningrad Region, Vsevolozhsky District, Russian Federation, 188663
Ivanovo regional oncology dispensary
Ivanovo, Russian Federation, 153040
Russian Scientific Center of Roentgenoradiology
Moscow, Russian Federation, 117997
Central Clinical Hospital with outpatient Clinic
Moscow, Russian Federation, 121359
National Medical Research Radiology Centre
Moscow, Russian Federation, 125284
Republican Clinical Oncology Dispensary of Republic of Bashkortostan
Ufa, Russian Federation, 450054
Spain
Hospital Parc Tauli
Sabadell, Barcelona, Spain, 08208
Hospital del Mar
Barcelona, Spain, 08003
Hospital Germans Trias i Pujol
Barcelona, Spain, 08916
Hospital General Universitario Gregorio Maranon
Madrid, Spain, 28007
Hospital Universitario HM Sanchinarro
Madrid, Spain, 28050
Hospital Clinico Universitario de Santiago
Santiago de Compostela, Spain, 15706
Instituto Valenciano de Oncologia
Valencia, Spain, 46009
Taiwan
Chang Gung Med Foundation. Kaohsiung Branch
Kaohsiung, Taiwan, 833
China Medical University Hospital
Taichung, Taiwan, 40447
National Cheng Kung University Hospital
Tainan, Taiwan, 70457
National Taiwan University Hospital
Taipei, Taiwan, 10048
Taipei Veterans General Hospital
Taipei, Taiwan, 112
Turkey
Baskent Universitesi Adana Dr. Turgut Noyan Uygulama ve Arastirma Merkezi
Adana, Turkey, 01250
Ankara Numune Education and Research Hospital
Ankara, Turkey, 06100
Hacettepe University Medical Faculty
Ankara, Turkey, 06100
Istanbul Universitesi Onkoloji Enstitusu
Istanbul, Turkey, 34093
Istanbul Medeniyet Universitesi Goztepe EAH
Istanbul, Turkey, 34732
Ege Universitesi Tıp Fakultesi
Izmir, Turkey, 35040
Namik Kemal Universitesi Tip Fakultesi
Tekirdag, Turkey, 59100
Ukraine
MI Kryviy Rih Center of Dnipropetrovsk Regional Council
Kryvyi Rih, Dnipropetrovsk Region, Ukraine, 50048
Dnipropetrovsk Regional Hospital n.a. I.I. Mechnikov
Dnipropetrovs'k, Ukraine, 49005
Dnipropetrovsk City Multidiscipline Clinical Hosp. 4 of DRC
Dnipropetrovs'k, Ukraine, 49102
MI Precarpathian Clinical Oncology Center
Ivano-Frankivs'k, Ukraine, 76018
RMI Sumy Regional Clinical Oncology Dispensary
Sumy, Ukraine, 40022
United Kingdom
The Royal Marsden NHS Foundation Trust.
Sutton, Surrey, United Kingdom, SM2 5PT
Western General Hospital
Edinburgh, United Kingdom, EH4 2XU
Beatson Institute of Cancer Research
Glasgow, United Kingdom, G12 0YN
Barts Health NHS Trust - St Bartholomew s Hospital
London, United Kingdom, EC1A 7BE
The Royal Marsden Foundation Trust
London, United Kingdom, SW3 6JJ
The Christie NHS Foundation Trust
Manchester, United Kingdom, MB204BX
Sponsors and Collaborators
Incyte Corporation
Merck Sharp & Dohme Corp.
Investigators
Study Director: Mark Jones, MD Incyte Corporation

Responsible Party: Incyte Corporation
ClinicalTrials.gov Identifier: NCT03260894     History of Changes
Other Study ID Numbers: 679-06/ECHO-302-06
2017-002259-26 ( EudraCT Number )
First Posted: August 24, 2017    Key Record Dates
Last Update Posted: August 15, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Incyte Corporation:
Renal cell carcinoma
programmed cell death 1 (PD-1) inhibitor
indoleamine 2
3-dioxygenase 1 (IDO1) inhibitor

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Renal Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Kidney Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases
Pembrolizumab
Sunitinib
Antineoplastic Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors