Clinical trial NCT03260894: 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 type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Renal Cell Carcinoma (RCC)
Keywords: Renal cell carcinoma
programmed cell death 1 (PD-1) inhibitor
indoleamine 2
3-dioxygenase 1 (IDO1) inhibitor
Lead sponsor: Incyte Corporation
Sponsor class: INDUSTRY
Collaborators: name: Merck Sharp & Dohme LLC
First posted: 2017-08-24
Enrollment: 129
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Objective Response Rate (ORR) of Pembrolizumab + Epacadostat Versus Standard of Care (SOC)
timeFrame: Minimum up to 6 months
Secondary outcomes:
measure: Safety and Tolerability of Pembrolizumab + Epacadostat Versus SOC as Measured by the Number of Participants Experiencing Adverse Events (AEs)
timeFrame: Data reported from start of study to data cutoff 28-Feb-2019, up to 15 months.
measure: Safety and Tolerability of Pembrolizumab + Epacadostat Versus SOC as Measured by the Number of Participants Discontinuing Study Drug Due to AEs
timeFrame: Data reported from start of study to data cutoff 28-Feb-2019, up to 15 months.
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: Pinnacle Oncology Hematology
state: Arizona
city: Scottsdale
country: United States
facility: Scottsdale Healthcare
state: Arizona
city: Tucson
country: United States
facility: Arizona Oncology Associates PC- HOPE
state: Arizona
city: Los Angeles
country: United States
facility: Cedars-Sinai Medical Center
state: California
city: Orange
country: United States
facility: UC Irvine Comprehensive Cancer Center/Chao Family Comprehensive Cancer Center
state: California
city: Sacramento
country: United States
facility: UC Davis Comprehensive Cancer Center
state: California
city: Pensacola
country: United States
facility: Woodlands Medical Specialists, PA
state: Florida
city: Atlanta
country: United States
facility: Northside Hospital
state: Georgia
city: Conyers
country: United States
facility: Atlanta Cancer Care - Conyers
state: Georgia
city: Marietta
country: United States
facility: Northwest Georgia Oncology Centers Pc
state: Georgia
city: Chicago
country: United States
facility: Rush University Medical Center
state: Illinois
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Boston
country: United States
facility: Dana Farber Cancer Institute
state: Massachusetts
city: Lincoln
country: United States
facility: Southeast Nebraska Hematology & Oncology Consultants, P.C.
state: Nebraska
city: Albany
country: United States
facility: New York Oncology Hematology P.C
state: New York
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
city: Charlotte
country: United States
facility: Levine Cancer Institute
state: North Carolina
city: Eugene
country: United States
facility: Willamette Valley Cancer Institute and Research Center
state: Oregon
city: Chattanooga
country: United States
facility: University of Tennessee Erlanger Oncology & Hematology
state: Tennessee
city: Germantown
country: United States
facility: The West Clinic, P.C.
state: Tennessee
city: The Woodlands
country: United States
facility: US Oncology and Research
state: Texas
city: Salt Lake City
country: United States
facility: Utah Cancer Specialists
state: Utah
city: Salt Lake City
country: United States
facility: Huntsman Cancer Institute
state: Utah
city: Roanoke
country: United States
facility: Oncology & Hematology Associates of Southwest Virginia, Inc., DBA Blue Ridge Cancer Care
state: Virginia
city: Winchester
country: United States
facility: Shenandoah Oncology, P.C.
state: Virginia
city: Garran
country: Australia
facility: Canberra Hospital
state: Australian Capital Territory
city: Waratah
country: Australia
facility: Calvary Mater Newcastle
state: New South Wales
city: Westmead
country: Australia
facility: Westmead Hospital
state: New South Wales
city: Malvern
country: Australia
facility: Cabrini Health
state: Victoria
city: Murdoch
country: Australia
facility: Fiona Stanley Hospital
city: Porto Alegre
country: Brazil
facility: Centro de pesquisa Porto Alegre
state: Florianopolis
city: Barretos
country: Brazil
facility: Fundacao Pio XII - Hospital de Cancer de Barretos
state: Sao Paulo
city: São Paulo
country: Brazil
facility: Instituto do Cancer de Sao Paulo - ICESP
state: Sao Paulo
city: São Paulo
country: Brazil
facility: Hospital Sao Jose
state: Sao Paulo
city: Belo Horizonte
country: Brazil
facility: Centro Avancado de Tratamento Oncologico - CENANTRON -
city: Porto Alegre
country: Brazil
facility: Hospital de Clinicas de Porto Alegre
city: Calgary
country: Canada
facility: Tom Baker Cancer Centre
state: Alberta
city: Kingston
country: Canada
facility: Kingston Health Sciences Centre - KGH Site
state: Ontario
city: Toronto
country: Canada
facility: Sunnybrook Health Sciences, Odette Cancer Centre
state: Ontario
city: Montréal
country: Canada
facility: Jewish General Hospital
state: Quebec
city: Trois-Rivières
country: Canada
facility: CIUSSS de la Mauricie-et-du-Centre-du-Quebec
state: Quebec
city: Quebec
country: Canada
facility: CHU de Quebec-Universite Laval-Hotel Dieu de Quebec
city: Osorno
country: Chile
facility: Clinica Alemana de Osorno
state: Region De Los Lagos
city: Santiago
country: Chile
facility: Fundacion Arturo Lopez Perez FALP
city: Santiago
country: Chile
facility: Pontificia Universidad Catolica de Chile
city: Vina del Mar
country: Chile
facility: Hospital Clinico Vina del Mar
city: Nice
country: France
facility: Centre Antoine Lacassagne
state: Cedex 2
city: Besançon
country: France
facility: CHU Besancon - Hopital Jean Minjoz
city: Bordeaux
country: France
facility: Hopital Saint Andre
city: Caen
country: France
facility: Centre Francois Baclesse
city: Hyeres
country: France
facility: Hopital Prive Toulon Hyeres Sainte Marguerite
city: Paris
country: France
facility: Hopital Europeen Georges Pompidou
city: Pierre Benite
country: France
facility: Hospices Civils de Lyon Centre Hospitalier Lyon Sud
city: Strasbourg
country: France
facility: Clinique Sainte Anne
city: Strasbourg
country: France
facility: CHU de Strasbourg - Nouvel Hopital Civil
city: Villejuif
country: France
facility: Institut Gustave Roussy
city: Berlin
country: Germany
facility: Helios Klinikum Berlin Buch
city: Dresden
country: Germany
facility: Universitaetsklinikum der Technischen Universitaet Dresden
city: Essen
country: Germany
facility: Universitaetsklinikum Essen
city: Frankfurt am Main
country: Germany
facility: Universitaetsklinikum Frankfurt
city: Hannover
country: Germany
facility: Medizinische Hochschule Hannover
city: Jena
country: Germany
facility: Universitaetsklinikum Jena
city: Magdeburg
country: Germany
facility: Universitaetsklinikum Magdeburg. Klinik fuer Urologie
city: Tuebingen
country: Germany
facility: Universitaetsklinikum Tuebingen
city: Budapest
country: Hungary
facility: Orszagos Onkologiai Intezet
state: Pest
city: Zalaegerszeg
country: Hungary
facility: Zala Megyei Szent Rafael Korhaz
state: Pozva
city: Kaposvar
country: Hungary
facility: Somogy Megyei Kaposi Mor Oktato Korhaz
city: Miskolc
country: Hungary
facility: Borsod-Abauj-Zemplen Megyei Korhaz es Egyetemi Oktato Korhaz
city: Szolnok
country: Hungary
facility: Jasz Nagykun Szolnok Megyei Hetenyi Geza Korhaz Rendelointezet
city: Szombathely
country: Hungary
facility: Markusovszky Egyetemi Oktatokorhaz
city: Dublin
country: Ireland
facility: Adelaide & Meath Hospital
city: Waterford
country: Ireland
facility: University Hospital Waterford
city: Arezzo
country: Italy
facility: Medical Oncology Ospedale San Donato
city: Brescia
country: Italy
facility: Azienda Ospedaliera-Spedali Civili
city: Milano
country: Italy
facility: Fondazione IRCCS Istituto Nazionale dei Tumori
city: Napoli
country: Italy
facility: A.O. Cardarelli
city: Pavia
country: Italy
facility: Policlinico San Matteo
city: Roma
country: Italy
facility: Azienda Ospedaliera San Camillo Forlanini
city: Nagoya
country: Japan
facility: Nagoya University Hospital
state: Aichi
city: Kashiwa
country: Japan
facility: National Cancer Center Hospital East
state: Chiba
city: Sapporo
country: Japan
facility: Sapporo Medical University Hospital
state: Hokkaido
city: Sapporo
country: Japan
facility: Hokkaido University Hospital
state: Hokkaido
city: Kashihara
country: Japan
facility: Nara Medical University Hospital
state: Nara
city: Osakasayama
country: Japan
facility: Kindai University Hospital
state: Osaka
city: Hidaka
country: Japan
facility: Saitama Medical University International Medical Center
state: Saitama
city: Ube
country: Japan
facility: Yamaguchi University Hospital
state: Yamaguchi
city: Akita
country: Japan
facility: Akita University Hospital
city: Fukuoka
country: Japan
facility: Kyushu University Hospital
city: Niigata
country: Japan
facility: Niigata University Medical & Dental Hospital
city: Tokyo
country: Japan
facility: Toranomon Hospital
city: Tokyo
country: Japan
facility: Nippon Medical School Hospital
city: Tokyo
country: Japan
facility: Keio University Hospital
city: Hwasun
country: Korea, Republic of
facility: Chonnam National University Hwasun Hospital
state: Jeollanam Do
city: Seoul
country: Korea, Republic of
facility: Severance Hospital Yonsei University Health System
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
city: Auckland
country: New Zealand
facility: Auckland City Hospital
state: Grafton
city: Bergen
country: Norway
facility: Helse Bergen HF Haukeland sykehus
city: Gralum
country: Norway
facility: Sykehuset Oestfold
city: Kristiansand
country: Norway
facility: Sorlandet sykehus HF
city: Lørenskog
country: Norway
facility: Akershus University Hospital
city: Oslo
country: Norway
facility: Oslo universitetssykehus
city: Tromsø
country: Norway
facility: Universitetssykehuset i Nord Norge. Kreftavdelingen
city: Trondheim
country: Norway
facility: St Olavs Hospital
city: Saint Petersburg
country: Russian Federation
facility: Leningrad Regional Oncology Dispensary
state: Leningrad Region, Vsevolozhsky District
city: Ivanovo
country: Russian Federation
facility: Ivanovo regional oncology dispensary
city: Moscow
country: Russian Federation
facility: Russian Scientific Center of Roentgenoradiology
city: Moscow
country: Russian Federation
facility: Central Clinical Hospital with outpatient Clinic
city: Moscow
country: Russian Federation
facility: National Medical Research Radiology Centre
city: Ufa
country: Russian Federation
facility: Republican Clinical Oncology Dispensary of Republic of Bashkortostan
city: Sabadell
country: Spain
facility: Hospital Parc Tauli
state: Barcelona
city: Barcelona
country: Spain
facility: Hospital del Mar
city: Barcelona
country: Spain
facility: Hospital Germans Trias i Pujol
city: Madrid
country: Spain
facility: Hospital General Universitario Gregorio Maranon
city: Madrid
country: Spain
facility: Hospital Universitario HM Sanchinarro
city: Santiago de Compostela
country: Spain
facility: Hospital Clinico Universitario de Santiago
city: Valencia
country: Spain
facility: Instituto Valenciano de Oncologia
city: Kaohsiung
country: Taiwan
facility: Chang Gung Med Foundation. Kaohsiung Branch
city: Taichung
country: Taiwan
facility: China Medical University Hospital
city: Tainan
country: Taiwan
facility: National Cheng Kung University Hospital
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
city: Taipei
country: Taiwan
facility: Taipei Veterans General Hospital
city: Adana
country: Turkey
facility: Baskent Universitesi Adana Dr. Turgut Noyan Uygulama ve Arastirma Merkezi
city: Ankara
country: Turkey
facility: Ankara Numune Education and Research Hospital
city: Ankara
country: Turkey
facility: Hacettepe University Medical Faculty
city: Istanbul
country: Turkey
facility: Istanbul Universitesi Onkoloji Enstitusu
city: Istanbul
country: Turkey
facility: Istanbul Medeniyet Universitesi Goztepe EAH
city: Izmir
country: Turkey
facility: Ege Universitesi Tıp Fakultesi
city: Tekirdag
country: Turkey
facility: Namik Kemal Universitesi Tip Fakultesi
city: Kryvyi Rih
country: Ukraine
facility: MI Kryviy Rih Center of Dnipropetrovsk Regional Council
state: Dnipropetrovsk Region
city: Dnipropetrovs'k
country: Ukraine
facility: Dnipropetrovsk Regional Hospital n.a. I.I. Mechnikov
city: Dnipropetrovs'k
country: Ukraine
facility: Dnipropetrovsk City Multidiscipline Clinical Hosp. 4 of DRC
city: Ivano-Frankivs'k
country: Ukraine
facility: MI Precarpathian Clinical Oncology Center
city: Sumy
country: Ukraine
facility: RMI Sumy Regional Clinical Oncology Dispensary
city: Sutton
country: United Kingdom
facility: The Royal Marsden NHS Foundation Trust.
state: Surrey
city: Edinburgh
country: United Kingdom
facility: Western General Hospital
city: Glasgow
country: United Kingdom
facility: Beatson Institute of Cancer Research
city: London
country: United Kingdom
facility: Barts Health NHS Trust - St Bartholomew s Hospital
city: London
country: United Kingdom
facility: The Royal Marsden Foundation Trust
city: Manchester
country: United Kingdom
facility: The Christie NHS Foundation Trust
Study officials:
affiliation: Incyte Corporation
name: Mark Jones, MD
role: STUDY_DIRECTOR
References: