Pembrolizumab (MK-3475) Plus Epacadostat vs Standard of Care in mRCC (KEYNOTE-679/ECHO-302)
- Conditions
- Renal Cell Carcinoma (RCC)
- Interventions
- Registration Number
- NCT03260894
- Lead Sponsor
- Incyte Corporation
- 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
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 129
- 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.
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Pembrolizumab + Epacadostat Epacadostat - SoC (Sunitinib or Pazopanib) Sunitinib Standard of care (SoC) (sunitinib or pazopanib monotherapy). SoC (Sunitinib or Pazopanib) Pazopanib Standard of care (SoC) (sunitinib or pazopanib monotherapy). Pembrolizumab + Epacadostat Pembrolizumab -
- Primary Outcome Measures
Name Time Method Objective Response Rate (ORR) of Pembrolizumab + Epacadostat Versus Standard of Care (SOC) Minimum up to 6 months ORR was defined as the percentage of participants who had complete response (CR) or partial response (PR) per RECIST v1.1 by investigator determination.
- Secondary Outcome Measures
Name Time Method Safety and Tolerability of Pembrolizumab + Epacadostat Versus SOC as Measured by the Number of Participants Experiencing Adverse Events (AEs) Data reported from start of study to data cutoff 28-Feb-2019, up to 15 months. AE is 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.
Safety and Tolerability of Pembrolizumab + Epacadostat Versus SOC as Measured by the Number of Participants Discontinuing Study Drug Due to AEs Data reported from start of study to data cutoff 28-Feb-2019, up to 15 months. AE is 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.
Related Research Topics
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Trial Locations
- Locations (140)
Cedars-Sinai Medical Center
🇺🇸Los Angeles, California, United States
Rush University Medical Center
🇺🇸Chicago, Illinois, United States
Sunnybrook Health Sciences, Odette Cancer Centre
🇨🇦Toronto, Ontario, Canada
Massachusetts General Hospital
🇺🇸Boston, Massachusetts, United States
Dana Farber Cancer Institute
🇺🇸Boston, Massachusetts, United States
Hokkaido University Hospital
🇯🇵Sapporo, Hokkaido, Japan
Ivanovo regional oncology dispensary
🇷🇺Ivanovo, Russian Federation
Utah Cancer Specialists
🇺🇸Salt Lake City, Utah, United States
Huntsman Cancer Institute
🇺🇸Salt Lake City, Utah, United States
Jewish General Hospital
🇨🇦Montréal, Quebec, Canada
Yamaguchi University Hospital
🇯🇵Ube, Yamaguchi, Japan
Nippon Medical School Hospital
🇯🇵Tokyo, Japan
Russian Scientific Center of Roentgenoradiology
🇷🇺Moscow, Russian Federation
Fundacion Arturo Lopez Perez FALP
🇨🇱Santiago, Chile
Southeast Nebraska Hematology & Oncology Consultants, P.C.
🇺🇸Lincoln, Nebraska, United States
The West Clinic, P.C.
🇺🇸Germantown, Tennessee, United States
University of Tennessee Erlanger Oncology & Hematology
🇺🇸Chattanooga, Tennessee, United States
Pinnacle Oncology Hematology
🇺🇸Scottsdale, Arizona, United States
Sapporo Medical University Hospital
🇯🇵Sapporo, Hokkaido, Japan
Kyushu University Hospital
🇯🇵Fukuoka, Japan
Sorlandet sykehus HF
🇳🇴Kristiansand, Norway
Republican Clinical Oncology Dispensary of Republic of Bashkortostan
🇷🇺Ufa, Russian Federation
National Cheng Kung University Hospital
🇨🇳Tainan, Taiwan
Ege Universitesi Tıp Fakultesi
🇹🇷Izmir, Turkey
MI Kryviy Rih Center of Dnipropetrovsk Regional Council
🇺🇦Kryvyi Rih, Dnipropetrovsk Region, Ukraine
Clinica Alemana de Osorno
🇨🇱Osorno, Region De Los Lagos, Chile
Pontificia Universidad Catolica de Chile
🇨🇱Santiago, Chile
Hospital Clinico Vina del Mar
🇨🇱Vina del Mar, Chile
Keio University Hospital
🇯🇵Tokyo, Japan
St Olavs Hospital
🇳🇴Trondheim, Norway
China Medical University Hospital
🇨🇳Taichung, Taiwan
Ankara Numune Education and Research Hospital
🇹🇷Ankara, Turkey
Tom Baker Cancer Centre
🇨🇦Calgary, Alberta, Canada
Cabrini Health
🇦🇺Malvern, Victoria, Australia
Saitama Medical University International Medical Center
🇯🇵Hidaka, Saitama, Japan
CIUSSS de la Mauricie-et-du-Centre-du-Quebec
🇨🇦Trois-Rivières, Quebec, Canada
National Cancer Center Hospital East
🇯🇵Kashiwa, Chiba, Japan
Sykehuset Oestfold
🇳🇴Gralum, Norway
Chang Gung Med Foundation. Kaohsiung Branch
🇨🇳Kaohsiung, Taiwan
Hacettepe University Medical Faculty
🇹🇷Ankara, Turkey
The Royal Marsden NHS Foundation Trust.
🇬🇧Sutton, Surrey, United Kingdom
National Taiwan University Hospital
🇨🇳Taipei, Taiwan
Leningrad Regional Oncology Dispensary
🇷🇺Saint Petersburg, Leningrad Region, Vsevolozhsky District, Russian Federation
Baskent Universitesi Adana Dr. Turgut Noyan Uygulama ve Arastirma Merkezi
🇹🇷Adana, Turkey
Istanbul Universitesi Onkoloji Enstitusu
🇹🇷Istanbul, Turkey
Dnipropetrovsk Regional Hospital n.a. I.I. Mechnikov
🇺🇦Dnipropetrovs'k, Ukraine
MI Precarpathian Clinical Oncology Center
🇺🇦Ivano-Frankivs'k, Ukraine
National Medical Research Radiology Centre
🇷🇺Moscow, Russian Federation
Hospital Parc Tauli
🇪🇸Sabadell, Barcelona, Spain
UC Davis Comprehensive Cancer Center
🇺🇸Sacramento, California, United States
A.O. Cardarelli
🇮🇹Napoli, Italy
Scottsdale Healthcare
🇺🇸Scottsdale, Arizona, United States
Arizona Oncology Associates PC- HOPE
🇺🇸Tucson, Arizona, United States
UC Irvine Comprehensive Cancer Center/Chao Family Comprehensive Cancer Center
🇺🇸Orange, California, United States
Fiona Stanley Hospital
🇦🇺Murdoch, Australia
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
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
Shenandoah Oncology, P.C.
🇺🇸Winchester, Virginia, United States
Oncology & Hematology Associates of Southwest Virginia, Inc., DBA Blue Ridge Cancer Care
🇺🇸Roanoke, Virginia, United States
Calvary Mater Newcastle
🇦🇺Waratah, New South Wales, Australia
Canberra Hospital
🇦🇺Garran, Australian Capital Territory, Australia
Westmead Hospital
🇦🇺Westmead, New South Wales, Australia
Centro de pesquisa Porto Alegre
🇧🇷Porto Alegre, Florianopolis, Brazil
Centro Avancado de Tratamento Oncologico - CENANTRON -
🇧🇷Belo Horizonte, 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 de Clinicas de Porto Alegre
🇧🇷Porto Alegre, Brazil
CHU de Quebec-Universite Laval-Hotel Dieu de Quebec
🇨🇦Quebec, Canada
Hopital Saint Andre
🇫🇷Bordeaux, France
Centre Antoine Lacassagne
🇫🇷Nice, Cedex 2, France
CHU Besancon - Hopital Jean Minjoz
🇫🇷Besançon, France
Centre Francois Baclesse
🇫🇷Caen, France
Hopital Prive Toulon Hyeres Sainte Marguerite
🇫🇷Hyeres, France
Hopital Europeen Georges Pompidou
🇫🇷Paris, France
CHU de Strasbourg - Nouvel Hopital Civil
🇫🇷Strasbourg, France
Institut Gustave Roussy
🇫🇷Villejuif, France
Clinique Sainte Anne
🇫🇷Strasbourg, France
Hospices Civils de Lyon Centre Hospitalier Lyon Sud
🇫🇷Pierre Benite, France
Helios Klinikum Berlin Buch
🇩🇪Berlin, Germany
Universitaetsklinikum der Technischen Universitaet Dresden
🇩🇪Dresden, Germany
Universitaetsklinikum Frankfurt
🇩🇪Frankfurt am Main, Germany
Universitaetsklinikum Essen
🇩🇪Essen, Germany
Medizinische Hochschule Hannover
🇩🇪Hannover, Germany
Universitaetsklinikum Magdeburg. Klinik fuer Urologie
🇩🇪Magdeburg, Germany
Universitaetsklinikum Jena
🇩🇪Jena, Germany
Orszagos Onkologiai Intezet
🇭🇺Budapest, Pest, Hungary
Universitaetsklinikum Tuebingen
🇩🇪Tuebingen, Germany
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
University Hospital Waterford
🇮🇪Waterford, Ireland
Markusovszky Egyetemi Oktatokorhaz
🇭🇺Szombathely, Hungary
Adelaide & Meath Hospital
🇮🇪Dublin, Ireland
Medical Oncology Ospedale San Donato
🇮🇹Arezzo, Italy
Fondazione IRCCS Istituto Nazionale dei Tumori
🇮🇹Milano, Italy
Azienda Ospedaliera San Camillo Forlanini
🇮🇹Roma, Italy
Azienda Ospedaliera-Spedali Civili
🇮🇹Brescia, Italy
Policlinico San Matteo
🇮🇹Pavia, Italy
Nagoya University Hospital
🇯🇵Nagoya, Aichi, Japan
Nara Medical University Hospital
🇯🇵Kashihara, Nara, Japan
Kindai University Hospital
🇯🇵Osakasayama, Osaka, Japan
Niigata University Medical & Dental Hospital
🇯🇵Niigata, Japan
Akita University Hospital
🇯🇵Akita, Japan
Toranomon Hospital
🇯🇵Tokyo, Japan
Chonnam National University Hwasun Hospital
🇰🇷Hwasun, Jeollanam Do, Korea, Republic of
Severance Hospital Yonsei University Health System
🇰🇷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
Akershus University Hospital
🇳🇴Lørenskog, Norway
Oslo universitetssykehus
🇳🇴Oslo, Norway
Universitetssykehuset i Nord Norge. Kreftavdelingen
🇳🇴Tromsø, Norway
Central Clinical Hospital with outpatient Clinic
🇷🇺Moscow, Russian Federation
Hospital General Universitario Gregorio Maranon
🇪🇸Madrid, Spain
Hospital del Mar
🇪🇸Barcelona, Spain
Hospital Germans Trias i Pujol
🇪🇸Barcelona, Spain
Hospital Universitario HM Sanchinarro
🇪🇸Madrid, Spain
Instituto Valenciano de Oncologia
🇪🇸Valencia, Spain
Hospital Clinico Universitario de Santiago
🇪🇸Santiago de Compostela, Spain
Taipei Veterans General Hospital
🇨🇳Taipei, Taiwan
Istanbul Medeniyet Universitesi Goztepe EAH
🇹🇷Istanbul, Turkey
Namik Kemal Universitesi Tip Fakultesi
🇹🇷Tekirdag, Turkey
RMI Sumy Regional Clinical Oncology Dispensary
🇺🇦Sumy, Ukraine
Dnipropetrovsk City Multidiscipline Clinical Hosp. 4 of DRC
🇺🇦Dnipropetrovs'k, Ukraine
Beatson Institute of Cancer Research
🇬🇧Glasgow, United Kingdom
Western General Hospital
🇬🇧Edinburgh, 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
Kingston Health Sciences Centre - KGH Site
🇨🇦Kingston, Ontario, Canada
US Oncology and Research
🇺🇸The Woodlands, Texas, United States
New York Oncology Hematology P.C
🇺🇸Albany, New York, United States
Asan Medical Center
🇰🇷Seoul, Korea, Republic of
Hospital Sao Jose
🇧🇷São Paulo, Sao Paulo, Brazil