Pembrolizumab (MK-3475) Plus Epacadostat vs Standard of Care in mRCC (KEYNOTE-679/ECHO-302)
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 Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
Study Type
Study Type
Enrollment (Actual)
Enrollment
Phase
Phase
- Phase 3
Contacts and Locations
Study Locations
-
-
-
Murdoch, Australia, 6150
- Fiona Stanley Hospital
-
-
Australian Capital Territory
-
Garran, Australian Capital Territory, Australia, 2605
- Canberra Hospital
-
-
New South Wales
-
Waratah, New South Wales, Australia, 2298
- Calvary Mater Newcastle
-
Westmead, New South Wales, Australia, 2145
- Westmead Hospital
-
-
Victoria
-
Malvern, Victoria, Australia, 3144
- Cabrini Health
-
-
-
-
-
Belo Horizonte, Brazil, 30130090
- Centro Avancado de Tratamento Oncologico - CENANTRON -
-
Porto Alegre, Brazil, 90035-903
- Hospital de Clinicas de Porto Alegre
-
-
Florianopolis
-
Porto Alegre, Florianopolis, Brazil, 90610-000
- Centro de pesquisa Porto Alegre
-
-
São Paulo
-
Barretos, São Paulo, Brazil, 14784-400
- Fundação Pio XII - Hospital de Câncer de Barretos
-
São Paulo, São Paulo, Brazil, 01246-000
- Instituto do Cancer de Sao Paulo - ICESP
-
São Paulo, São Paulo, Brazil, 01321-001
- Hospital São José
-
-
-
-
Alberta
-
Calgary, Alberta, Canada, T2N 4N2
- Tom Baker Cancer Centre
-
-
Ontario
-
Kingston, Ontario, Canada, K7L 2V7
- Kingston Health Sciences Centre - KGH Site
-
Toronto, Ontario, Canada, M4N 3M5
- Sunnybrook Health Sciences, Odette Cancer Centre
-
-
Quebec
-
Montreal, Quebec, Canada, H3T 1E2
- Jewish General Hospital
-
Québec, Quebec, Canada, G1R 2J6
- CHU de Quebec-Universite Laval-Hotel Dieu de Quebec
-
Trois-Rivières, Quebec, Canada, G8Z 3R9
- CIUSSS de la Mauricie-et-du-Centre-du-Quebec
-
-
-
-
-
Santiago, Chile, 7500921
- Fundacion Arturo Lopez Perez FALP
-
Santiago, Chile, 8320000
- Pontificia Universidad Catolica de Chile
-
Viña del Mar, Chile, 2520000
- Hospital Clinico Viña del Mar
-
-
Los Lagos Region
-
Osorno, Los Lagos Region, Chile, 5311089
- Clinica Alemana de Osorno
-
-
-
-
-
Besançon, France, 25030
- CHU Besancon - Hôpital Jean Minjoz
-
Bordeaux, France, 33075
- Hopital Saint André
-
Caen, France, 14076
- Centre Francois Baclesse
-
Hyères, France, 83400
- Hopital Prive Toulon Hyeres Sainte Marguerite
-
Paris, France, 75015
- Hôpital Européen Georges Pompidou
-
Pierre-Bénite, France, 69310
- Hospices Civils de Lyon Centre Hospitalier Lyon Sud
-
Strasbourg, France, 67000
- Clinique Sainte Anne
-
Strasbourg, France, 67091
- CHU de Strasbourg - Nouvel Hôpital Civil
-
Villejuif, France, 94805
- Institut Gustave Roussy
-
-
Cedex 2
-
Nice, Cedex 2, France, 06189
- Centre Antoine Lacassagne
-
-
-
-
-
Berlin, Germany, 13125
- HELIOS Klinikum Berlin Buch
-
Dresden, Germany, 01307
- Universitaetsklinikum der Technischen Universitaet Dresden
-
Essen, Germany, 45147
- Universitaetsklinikum Essen
-
Frankfurt am Main, Germany, 60590
- Universitaetsklinikum Frankfurt
-
Hanover, Germany, 30625
- Medizinische Hochschule Hannover
-
Jena, Germany, 07747
- Universitaetsklinikum Jena
-
Magdeburg, Germany, 39120
- Universitaetsklinikum Magdeburg. Klinik fuer Urologie
-
Tübingen, Germany, 72076
- Universitaetsklinikum Tuebingen
-
-
-
-
-
Kaposvár, Hungary, 7400
- Somogy Megyei Kaposi Mor Oktato Korhaz
-
Miskolc, Hungary, 3526
- Borsod-Abauj-Zemplen Megyei Korhaz es Egyetemi Oktato Korhaz
-
Szolnok, Hungary, 5000
- Jasz Nagykun Szolnok Megyei Hetenyi Geza Korhaz Rendelointezet
-
Szombathely, Hungary, 9700
- Markusovszky Egyetemi Oktatókórház
-
-
Pest County
-
Budapest, Pest County, Hungary, 1122
- Országos Onkológiai Intézet
-
-
Pozva
-
Zalaegerszeg, Pozva, Hungary, 8900
- Zala Megyei Szent Rafael Korhaz
-
-
-
-
-
Dublin, Ireland, 00024
- Adelaide & Meath Hospital
-
Waterford, Ireland, X91ER8E
- University Hospital Waterford
-
-
-
-
-
Arezzo, Italy, 52100
- Medical Oncology Ospedale San Donato
-
Brescia, Italy, 25123
- Azienda Ospedaliera-Spedali Civili
-
Milan, Italy, 20133
- Fondazione IRCCS Istituto Nazionale dei Tumori
-
Naples, Italy, 80131
- A.O. Cardarelli
-
Pavia, Italy, 27100
- Policlinico San Matteo
-
Roma, Italy, 00152
- Azienda Ospedaliera San Camillo Forlanini
-
-
-
-
-
Akita, Japan, 010-8543
- Akita University Hospital
-
Fukuoka, Japan, 812-8582
- Kyushu University Hospital
-
Niigata, Japan, 951-8520
- Niigata University Medical & Dental Hospital
-
Tokyo, Japan, 160-8582
- Keio University Hospital
-
Tokyo, Japan, 105-8470
- Toranomon Hospital
-
Tokyo, Japan, 113-8603
- Nippon Medical School Hospital
-
-
Aichi-ken
-
Nagoya, Aichi-ken, Japan, 466-8560
- Nagoya University Hospital
-
-
Chiba
-
Kashiwa, Chiba, Japan, 277-8577
- National Cancer Center Hospital East
-
-
Hokkaido
-
Sapporo, Hokkaido, Japan, 060-8543
- Sapporo Medical University Hospital
-
Sapporo, Hokkaido, Japan, 060-8648
- Hokkaido University Hospital
-
-
Nara
-
Kashihara, Nara, Japan, 634-8522
- Nara Medical University Hospital
-
-
Osaka
-
Sayama, Osaka, Japan, 589-8511
- Kindai University Hospital
-
-
Saitama
-
Hidaka, Saitama, Japan, 350-1298
- Saitama Medical University International Medical Center
-
-
Yamaguchi
-
Ube, Yamaguchi, Japan, 755-8505
- Yamaguchi University Hospital
-
-
-
-
Grafton
-
Auckland, Grafton, New Zealand, 1023
- Auckland City Hospital
-
-
-
-
-
Bergen, Norway, 5053
- Helse Bergen HF Haukeland sykehus
-
Grålum, Norway, 1714
- Sykehuset Oestfold
-
Kristiansand, Norway, 4615
- Sorlandet sykehus HF
-
Lørenskog, Norway, 1478
- Akershus University Hospital
-
Oslo, Norway, 0450
- Oslo Universitetssykehus
-
Tromsø, Norway, 9019
- Universitetssykehuset i Nord Norge. Kreftavdelingen
-
Trondheim, Norway, 7030
- St Olavs hospital
-
-
-
-
-
Ivanovo, Russia, 153040
- Ivanovo regional oncology dispensary
-
Moscow, Russia, 117997
- Russian Scientific Center of Roentgenoradiology
-
Moscow, Russia, 121359
- Central Clinical Hospital with outpatient Clinic
-
Moscow, Russia, 125284
- National Medical Research Radiology Centre
-
Ufa, Russia, 450054
- Republican Clinical Oncology Dispensary of Republic of Bashkortostan
-
-
Leningrad Region, Vsevolozhsky District
-
Saint Petersburg, Leningrad Region, Vsevolozhsky District, Russia, 188663
- Leningrad Regional Oncology Dispensary
-
-
-
-
-
Seoul, South Korea, 05505
- Asan Medical Center
-
Seoul, South Korea, 03722
- Severance Hospital Yonsei University Health System
-
Seoul, South Korea, 06351
- Samsung Medical Center
-
-
Jeollanam-do
-
Hwasun, Jeollanam-do, South Korea, 58128
- Chonnam National University Hwasun Hospital
-
-
-
-
-
Barcelona, Spain, 08003
- Hospital del Mar
-
Barcelona, Spain, 08916
- Hospital Germans Trias i Pujol
-
Madrid, Spain, 28007
- Hospital General Universitario Gregorio Marañon
-
Madrid, Spain, 28050
- Hospital Universitario HM Sanchinarro
-
Santiago de Compostela, Spain, 15706
- Hospital Clinico Universitario de Santiago
-
Valencia, Spain, 46009
- Instituto Valenciano de Oncologia
-
-
Barcelona
-
Sabadell, Barcelona, Spain, 08208
- Hospital Parc Tauli
-
-
-
-
-
Kaohsiung City, Taiwan, 833
- Chang Gung Med Foundation. Kaohsiung Branch
-
Taichung, Taiwan, 40447
- China Medical University Hospital
-
Tainan, Taiwan, 70457
- National Cheng Kung University Hospital
-
Taipei, Taiwan, 112
- Taipei Veterans General Hospital
-
Taipei, Taiwan, 10048
- National Taiwan University Hospital
-
-
-
-
-
Adana, Turkey (Türkiye), 01250
- Baskent Universitesi Adana Dr. Turgut Noyan Uygulama ve Arastirma Merkezi
-
Ankara, Turkey (Türkiye), 06100
- Hacettepe University Medical Faculty
-
Ankara, Turkey (Türkiye), 06100
- Ankara Numune Education and Research Hospital
-
Istanbul, Turkey (Türkiye), 34093
- Istanbul Universitesi Onkoloji Enstitusu
-
Istanbul, Turkey (Türkiye), 34732
- Istanbul Medeniyet Universitesi Goztepe EAH
-
Izmir, Turkey (Türkiye), 35040
- Ege Universitesi Tıp Fakultesi
-
Tekirdağ, Turkey (Türkiye), 59100
- Namik Kemal Universitesi Tip Fakultesi
-
-
-
-
-
Dnipro, Ukraine, 49005
- Dnipropetrovsk Regional Hospital n.a. I.I. Mechnikov
-
Dnipro, Ukraine, 49102
- Dnipropetrovsk City Multidiscipline Clinical Hosp. 4 of DRC
-
Ivano-Frankivsk, Ukraine, 76018
- MI Precarpathian Clinical Oncology Center
-
Sumy, Ukraine, 40022
- RMI Sumy Regional Clinical Oncology Dispensary
-
-
Dnipropetrovsk Oblast
-
Kryvyi Rih, Dnipropetrovsk Oblast, Ukraine, 50048
- MI Kryviy Rih Center of Dnipropetrovsk Regional Council
-
-
-
-
-
Edinburgh, United Kingdom, EH4 2XU
- Western General Hospital
-
Glasgow, United Kingdom, G12 0YN
- Beatson Institute of Cancer Research
-
London, United Kingdom, EC1A 7BE
- Barts Health NHS Trust - St Bartholomew s Hospital
-
London, United Kingdom, SW3 6JJ
- The Royal Marsden Foundation Trust
-
Manchester, United Kingdom, MB204BX
- The Christie NHS Foundation Trust
-
-
Surrey
-
Sutton, Surrey, United Kingdom, SM2 5PT
- The Royal Marsden NHS Foundation Trust.
-
-
-
-
Arizona
-
Scottsdale, Arizona, United States, 85258
- Pinnacle Oncology Hematology
-
Scottsdale, Arizona, United States, 85258
- Scottsdale Healthcare
-
Tucson, Arizona, United States, 85711
- Arizona Oncology Associates PC- HOPE
-
-
California
-
Los Angeles, California, United States, 90048
- Cedars-Sinai Medical Center
-
Orange, California, United States, 92868
- UC Irvine Comprehensive Cancer Center/Chao Family Comprehensive Cancer Center
-
Sacramento, California, United States, 95817
- UC Davis Comprehensive Cancer Center
-
-
Florida
-
Pensacola, Florida, United States, 32503
- Woodlands Medical Specialists, PA
-
-
Georgia
-
Atlanta, Georgia, United States, 30342
- Northside Hospital
-
Conyers, Georgia, United States, 30094
- Atlanta Cancer Care - Conyers
-
Marietta, Georgia, United States, 30060
- Northwest Georgia Oncology Centers Pc
-
-
Illinois
-
Chicago, Illinois, United States, 60612
- Rush University Medical Center
-
-
Massachusetts
-
Boston, Massachusetts, United States, 02114
- Massachusetts General Hospital
-
Boston, Massachusetts, United States, 02215
- Dana Farber Cancer Institute
-
-
Nebraska
-
Lincoln, Nebraska, United States, 68510
- Southeast Nebraska Hematology & Oncology Consultants, P.C.
-
-
New York
-
Albany, New York, United States, 12208
- New York Oncology Hematology P.C
-
New York, New York, United States, 10065
- Memorial Sloan Kettering Cancer Center
-
-
North Carolina
-
Charlotte, North Carolina, United States, 28204
- Levine Cancer Institute
-
-
Oregon
-
Eugene, Oregon, United States, 97401
- Willamette Valley Cancer Institute and Research Center
-
-
Tennessee
-
Chattanooga, Tennessee, United States, 37403
- University of Tennessee Erlanger Oncology & Hematology
-
Germantown, Tennessee, United States, 38138
- The West Clinic, P.C.
-
-
Texas
-
The Woodlands, Texas, United States, 77380
- US Oncology and Research
-
-
Utah
-
Salt Lake City, Utah, United States, 84106
- Utah Cancer Specialists
-
Salt Lake City, Utah, United States, 84112
- Huntsman Cancer Institute
-
-
Virginia
-
Roanoke, Virginia, United States, 24014
- Oncology & Hematology Associates of Southwest Virginia, Inc., DBA Blue Ridge Cancer Care
-
Winchester, Virginia, United States, 22601
- Shenandoah Oncology, P.C.
-
-
Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Number of Arms
Arms and Interventions
Participant Group / ArmParticipant Group / Arm |
Intervention / TreatmentIntervention / Treatment |
|---|---|
|
Experimental: Pembrolizumab + Epacadostat
|
Pembrolizumab 200 mg administered intravenously every 3 weeks.
Other Names:
Epacadostat 100 mg administered orally twice daily.
Other Names:
|
|
Active Comparator: SoC (Sunitinib or Pazopanib)
Standard of care (SoC) (sunitinib or pazopanib monotherapy).
|
Sunitinib 50 mg administered orally once daily; 4 weeks on, 2 weeks off for 6-wk cycle.
Other Names:
Pazopanib 800 mg administered orally once daily.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Objective Response Rate (ORR) of Pembrolizumab + Epacadostat Versus Standard of Care (SOC)
Time Frame: up to approximately 8 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.
|
up to approximately 8 months
|
Secondary Outcome Measures
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Safety and Tolerability of Pembrolizumab + Epacadostat Versus SOC as Measured by the Number of Participants Experiencing Adverse Events (AEs)
Time Frame: 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.
|
Data reported from start of study to data cutoff 28-Feb-2019, up to 15 months.
|
|
Safety and Tolerability of Pembrolizumab + Epacadostat Versus SOC as Measured by the Number of Participants Discontinuing Study Drug Due to AEs
Time Frame: 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.
|
Data reported from start of study to data cutoff 28-Feb-2019, up to 15 months.
|
Collaborators and Investigators
Sponsor
Sponsor
Collaborators
Collaborators
Investigators
Investigators
- Study Director: Mark Jones, MD, Incyte Corporation
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Study Start
Primary Completion (Actual)
Primary Completion
Study Completion (Actual)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (Actual)
First Posted
Study Record Updates
Last Update Posted (Actual)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Urogenital Diseases
- Urogenital Neoplasms
- Neoplasms by Site
- Neoplasms
- Male Urogenital Diseases
- Kidney Diseases
- Urologic Diseases
- Female Urogenital Diseases
- Female Urogenital Diseases and Pregnancy Complications
- Neoplasms by Histologic Type
- Neoplasms, Glandular and Epithelial
- Adenocarcinoma
- Urologic Neoplasms
- Carcinoma
- Kidney Neoplasms
- Carcinoma, Renal Cell
- Parkinson Disease 4, Autosomal Dominant Lewy Body
- Heterocyclic Compounds, 1-Ring
- Heterocyclic Compounds
- Heterocyclic Compounds, 2-Ring
- Heterocyclic Compounds, Fused-Ring
- Azoles
- Indoles
- Pyrroles
- Sunitinib
- pembrolizumab
- pazopanib
- epacadostat
Other Study ID Numbers
Other Study ID Numbers
- KEYNOTE-679/ECHO-302
- 2017-002259-26 (EudraCT Number)
- 2024-512016-22-00 (Registry Identifier: EU CT Number)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Renal Cell Carcinoma (RCC)
-
NCT03035630WithdrawnKidney Cancer | Clear-cell Renal Cell Carcinoma | RCC | Clear-cell Kidney Carcinoma
-
NCT00520533TerminatedRenal Cell Carcinoma (RCC)
-
NCT00199888CompletedKidney Cancer | Clear Cell Renal Cell Carcinoma | Renal Cancer | Renal Cell Carcinoma (RCC) | Renal Neoplasms | Cancer of Kidney | Neoplasms, Kidney
-
NCT07488572Enrolling by invitationMetastatic Clear Cell Renal Cell Carcinoma | Renal Cell Carcinoma (RCC)
-
NCT02837991TerminatedKidney Neoplasms | Metastatic Renal Cell Carcinoma | Ovarian Clear Cell Carcinoma | Papillary Renal Cell Carcinoma | Renal Cell Carcinoma (RCC) | Clear-cell Renal Cell Carcinoma
-
NCT01235962CompletedCancer | Renal Cell Carcinoma (RCC)
-
NCT07300241RecruitingRenal Cell Carcinoma | Clear Cell Renal Cell Carcinoma | Kidney Cancer Metastatic | ccRCC | RCC | VHL-Associated Renal Cell Carcinoma | VHL-Associated Clear Cell Renal Cell Carcinoma | Clear Cell Renal Cell Carcinoma Metastatic | Kidney Cancers
-
NCT02447887TerminatedMetastatic Renal Cell Carcinoma | RCC
-
NCT02974738Active, not recruitingA Trial of Belzutifan (PT2977, MK-6482) Tablets In Patients With Advanced Solid Tumors (MK-6482-001)Kidney Cancer | Clear Cell Renal Cell Carcinoma | Glioblastoma | Solid Tumor | Glioblastoma Multiforme | Advanced Solid Tumors | GBM | Solid Tumor, Adult | Solid Carcinoma | Glioblastoma, Adult
-
NCT07175480RecruitingRenal Cell Carcinoma (RCC) | Metastatic Renal Cell Carcinoma (mRCC)
Clinical Trials on Pembrolizumab
-
NCT07448831Recruiting
-
NCT07484139Not yet recruitingHead and Neck Cancer | Oral Cavity Squamous Cell Carcinoma
-
NCT07409844Not yet recruitingImmunotherapy | Pembrolizumab | DMMR Colorectal Cancer | Colon Cancer Stage I | Colon Cancer Stage II/III
-
NCT07269158Not yet recruitingAdvanced Cancer | Biliary Tract Neoplasms | Immunotherapy
-
NCT05929235RecruitingAdvanced Urothelial Carcinoma | Open Label | Oral Drug Administration
-
NCT07283822RecruitingNon-Hodgkin Lymphoma | Peripheral T-cell Lymphoma | Hodgkin Disease Recurrent | Gray Zone Lymphoma | Primary Mediastinal B Cell Lymphoma | Cutaneous T-Cell Lymphomas | Hodgkin Disease Lymphoma | Non-Hodgkin Lymphoma Refractory/ Relapsed
-
NCT07231458Recruiting
-
NCT07227168RecruitingCervical Cancer | Gastric Cancer | Colorectal Cancer | Esophageal Cancer | Endometrial Cancer | Urothelial Cancer | Pancreatic Ductal Adenocarcinoma (PDAC) | Non-Small Cell Lung Cancer NSCLC | Head and Neck Squamous Cell Carcinoma HNSCC
-
NCT06877650RecruitingAdvanced Malignant Tumors
-
NCT06137144RecruitingLymphoma | Hodgkin Lymphoma | Non-Hodgkin Lymphoma | PTCL-NOS | AITL | ALCL | Peripheral T-cell Lymphoma (PTCL)