AzTrials
AzTrials

Renal Cell Carcinoma (RCC)Phase 3NCT03260894

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

A Phase 3 study testing Pembrolizumab, Epacadostat and Sunitinib in people with Renal Cell Carcinoma (RCC), run by Incyte Corporation at 140 sites in 20 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Renal Cell Carcinoma (RCC)
What is being tested?
Pembrolizumab, Epacadostat and Sunitinib
Could I receive a placebo?
No, everyone receives an active treatment
How many people
129 participants
Where
140 sitesin 20 countries
Study dates
7 Dec 2017to 4 Jun 2025
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 9Show fewer
  • 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.

Trial locations and contacts

140 sites in 20 countries.

140 sites in 20 countries

United States25 sites

  • New York Oncology Hematology P.C

    Albany, New York, 12208

  • Northside Hospital

    Atlanta, Georgia, 30342

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

  • Dana Farber Cancer Institute

    Boston, Massachusetts, 02215

  • Levine Cancer Institute

    Charlotte, North Carolina, 28204

  • University of Tennessee Erlanger Oncology & Hematology

    Chattanooga, Tennessee, 37403

  • Rush University Medical Center

    Chicago, Illinois, 60612

  • Atlanta Cancer Care - Conyers

    Conyers, Georgia, 30094

  • Willamette Valley Cancer Institute and Research Center

    Eugene, Oregon, 97401

  • The West Clinic, P.C.

    Germantown, Tennessee, 38138

  • Southeast Nebraska Hematology & Oncology Consultants, P.C.

    Lincoln, Nebraska, 68510

  • Cedars-Sinai Medical Center

    Los Angeles, California, 90048

  • Northwest Georgia Oncology Centers Pc

    Marietta, Georgia, 30060

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10065

  • UC Irvine Comprehensive Cancer Center/Chao Family Comprehensive Cancer Center

    Orange, California, 92868

  • Woodlands Medical Specialists, PA

    Pensacola, Florida, 32503

  • Oncology & Hematology Associates of Southwest Virginia, Inc., DBA Blue Ridge Cancer Care

    Roanoke, Virginia, 24014

  • UC Davis Comprehensive Cancer Center

    Sacramento, California, 95817

  • Utah Cancer Specialists

    Salt Lake City, Utah, 84106

  • Huntsman Cancer Institute

    Salt Lake City, Utah, 84112

  • Pinnacle Oncology Hematology

    Scottsdale, Arizona, 85258

  • Scottsdale Healthcare

    Scottsdale, Arizona, 85258

  • US Oncology and Research

    The Woodlands, Texas, 77380

  • Arizona Oncology Associates PC- HOPE

    Tucson, Arizona, 85711

  • Shenandoah Oncology, P.C.

    Winchester, Virginia, 22601

Other trials in United States

Japan14 sites

  • Akita University Hospital

    Akita, 010-8543

  • Kyushu University Hospital

    Fukuoka, 812-8582

  • Saitama Medical University International Medical Center

    Hidaka, Saitama, 350-1298

  • Nara Medical University Hospital

    Kashihara, Nara, 634-8522

  • National Cancer Center Hospital East

    Kashiwa, Chiba, 277-8577

  • Nagoya University Hospital

    Nagoya, Aichi-ken, 466-8560

  • Niigata University Medical & Dental Hospital

    Niigata, 951-8520

  • Sapporo Medical University Hospital

    Sapporo, Hokkaido, 060-8543

  • Hokkaido University Hospital

    Sapporo, Hokkaido, 060-8648

  • Kindai University Hospital

    Sayama, Osaka, 589-8511

  • Toranomon Hospital

    Tokyo, 105-8470

  • Nippon Medical School Hospital

    Tokyo, 113-8603

  • Keio University Hospital

    Tokyo, 160-8582

  • Yamaguchi University Hospital

    Ube, Yamaguchi, 755-8505

Other trials in Japan

France10 sites

  • CHU Besancon - Hopital Jean Minjoz

    Besançon, 25030

  • Hopital Saint Andre

    Bordeaux, 33075

  • Centre Francois Baclesse

    Caen, 14076

  • Hopital Prive Toulon Hyeres Sainte Marguerite

    Hyères, 83400

  • Centre Antoine Lacassagne

    Nice, Cedex 2, 06189

  • Hopital Europeen Georges Pompidou

    Paris, 75015

  • Hospices Civils de Lyon Centre Hospitalier Lyon Sud

    Pierre-Bénite, 69310

  • Clinique Sainte Anne

    Strasbourg, 67000

  • CHU de Strasbourg - Nouvel Hopital Civil

    Strasbourg, 67091

  • Institut Gustave Roussy

    Villejuif, 94805

Other trials in France

Germany8 sites

  • Helios Klinikum Berlin Buch

    Berlin, 13125

  • Universitaetsklinikum der Technischen Universitaet Dresden

    Dresden, 01307

  • Universitaetsklinikum Essen

    Essen, 45147

  • Universitaetsklinikum Frankfurt

    Frankfurt am Main, 60590

  • Medizinische Hochschule Hannover

    Hanover, 30625

  • Universitaetsklinikum Jena

    Jena, 07747

  • Universitaetsklinikum Magdeburg. Klinik fuer Urologie

    Magdeburg, 39120

  • Universitaetsklinikum Tuebingen

    Tübingen, 72076

Other trials in Germany

Norway7 sites

  • Helse Bergen HF Haukeland sykehus

    Bergen, 5053

  • Sykehuset Oestfold

    Grålum, 1714

  • Sorlandet sykehus HF

    Kristiansand, 4615

  • Akershus University Hospital

    Lørenskog, 1478

  • Oslo universitetssykehus

    Oslo, 0450

  • Universitetssykehuset i Nord Norge. Kreftavdelingen

    Tromsø, 9019

  • St Olavs Hospital

    Trondheim, 7030

Other trials in Norway

Spain7 sites

  • Hospital del Mar

    Barcelona, 08003

  • Hospital Germans Trias i Pujol

    Barcelona, 08916

  • Hospital General Universitario Gregorio Maranon

    Madrid, 28007

  • Hospital Universitario HM Sanchinarro

    Madrid, 28050

  • Hospital Parc Tauli

    Sabadell, Barcelona, 08208

  • Hospital Clinico Universitario de Santiago

    Santiago de Compostela, 15706

  • Instituto Valenciano de Oncologia

    Valencia, 46009

Other trials in Spain

Turkey (Türkiye)7 sites

  • Baskent Universitesi Adana Dr. Turgut Noyan Uygulama ve Arastirma Merkezi

    Adana, 01250

  • Ankara Numune Education and Research Hospital

    Ankara, 06100

  • Hacettepe University Medical Faculty

    Ankara, 06100

  • Istanbul Universitesi Onkoloji Enstitusu

    Istanbul, 34093

  • Istanbul Medeniyet Universitesi Goztepe EAH

    Istanbul, 34732

  • Ege Universitesi Tıp Fakultesi

    Izmir, 35040

  • Namik Kemal Universitesi Tip Fakultesi

    Tekirdağ, 59100

Other trials in Turkey (Türkiye)

Brazil6 sites

  • Fundacao Pio XII - Hospital de Cancer de Barretos

    Barretos, São Paulo, 14784-400

  • Centro Avancado de Tratamento Oncologico - CENANTRON -

    Belo Horizonte, 30130090

  • Centro de pesquisa Porto Alegre

    Porto Alegre, Florianopolis, 90610-000

  • Hospital de Clinicas de Porto Alegre

    Porto Alegre, 90035-903

  • Instituto do Cancer de Sao Paulo - ICESP

    São Paulo, São Paulo, 01246-000

  • Hospital Sao Jose

    São Paulo, São Paulo, 01321-001

Other trials in Brazil

Canada6 sites

  • Tom Baker Cancer Centre

    Calgary, Alberta, T2N 4N2

  • Kingston Health Sciences Centre - KGH Site

    Kingston, Ontario, K7L 2V7

  • Jewish General Hospital

    Montreal, Quebec, H3T 1E2

  • CHU de Quebec-Universite Laval-Hotel Dieu de Quebec

    Québec, Quebec, G1R 2J6

  • Sunnybrook Health Sciences, Odette Cancer Centre

    Toronto, Ontario, M4N 3M5

  • CIUSSS de la Mauricie-et-du-Centre-du-Quebec

    Trois-Rivières, Quebec, G8Z 3R9

Other trials in Canada

Hungary6 sites

  • Orszagos Onkologiai Intezet

    Budapest, Pest County, 1122

  • Somogy Megyei Kaposi Mor Oktato Korhaz

    Kaposvár, 7400

  • Borsod-Abauj-Zemplen Megyei Korhaz es Egyetemi Oktato Korhaz

    Miskolc, 3526

  • Jasz Nagykun Szolnok Megyei Hetenyi Geza Korhaz Rendelointezet

    Szolnok, 5000

  • Markusovszky Egyetemi Oktatokorhaz

    Szombathely, 9700

  • Zala Megyei Szent Rafael Korhaz

    Zalaegerszeg, Pozva, 8900

Other trials in Hungary

Italy6 sites

  • Medical Oncology Ospedale San Donato

    Arezzo, 52100

  • Azienda Ospedaliera-Spedali Civili

    Brescia, 25123

  • Fondazione IRCCS Istituto Nazionale dei Tumori

    Milan, 20133

  • A.O. Cardarelli

    Naples, 80131

  • Policlinico San Matteo

    Pavia, 27100

  • Azienda Ospedaliera San Camillo Forlanini

    Roma, 00152

Other trials in Italy

Russia6 sites

  • Ivanovo regional oncology dispensary

    Ivanovo, 153040

  • Russian Scientific Center of Roentgenoradiology

    Moscow, 117997

  • Central Clinical Hospital with outpatient Clinic

    Moscow, 121359

  • National Medical Research Radiology Centre

    Moscow, 125284

  • Leningrad Regional Oncology Dispensary

    Saint Petersburg, Leningrad Region, Vsevolozhsky District, 188663

  • Republican Clinical Oncology Dispensary of Republic of Bashkortostan

    Ufa, 450054

Other trials in Russia

United Kingdom6 sites

  • Western General Hospital

    Edinburgh, EH4 2XU

  • Beatson Institute of Cancer Research

    Glasgow, G12 0YN

  • Barts Health NHS Trust - St Bartholomew s Hospital

    London, EC1A 7BE

  • The Royal Marsden Foundation Trust

    London, SW3 6JJ

  • The Christie NHS Foundation Trust

    Manchester, MB204BX

  • The Royal Marsden NHS Foundation Trust.

    Sutton, Surrey, SM2 5PT

Other trials in United Kingdom

Australia5 sites

  • Canberra Hospital

    Garran, Australian Capital Territory, 2605

  • Cabrini Health

    Malvern, Victoria, 3144

  • Fiona Stanley Hospital

    Murdoch, 6150

  • Calvary Mater Newcastle

    Waratah, New South Wales, 2298

  • Westmead Hospital

    Westmead, New South Wales, 2145

Other trials in Australia

Taiwan5 sites

  • Chang Gung Med Foundation. Kaohsiung Branch

    Kaohsiung City, 833

  • China Medical University Hospital

    Taichung, 40447

  • National Cheng Kung University Hospital

    Tainan, 70457

  • National Taiwan University Hospital

    Taipei, 10048

  • Taipei Veterans General Hospital

    Taipei, 112

Other trials in Taiwan

Ukraine5 sites

  • Dnipropetrovsk Regional Hospital n.a. I.I. Mechnikov

    Dnipro, 49005

  • Dnipropetrovsk City Multidiscipline Clinical Hosp. 4 of DRC

    Dnipro, 49102

  • MI Precarpathian Clinical Oncology Center

    Ivano-Frankivsk, 76018

  • MI Kryviy Rih Center of Dnipropetrovsk Regional Council

    Kryvyi Rih, Dnipropetrovsk Oblast, 50048

  • RMI Sumy Regional Clinical Oncology Dispensary

    Sumy, 40022

Other trials in Ukraine

Chile4 sites

  • Clinica Alemana de Osorno

    Osorno, Los Lagos Region, 5311089

  • Fundacion Arturo Lopez Perez FALP

    Santiago, 7500921

  • Pontificia Universidad Catolica de Chile

    Santiago, 8320000

  • Hospital Clinico Vina del Mar

    Viña del Mar, 2520000

Other trials in Chile

South Korea4 sites

  • Chonnam National University Hwasun Hospital

    Hwasun, Jeollanam-do, 58128

  • Severance Hospital Yonsei University Health System

    Seoul, 03722

  • Asan Medical Center

    Seoul, 05505

  • Samsung Medical Center

    Seoul, 06351

Other trials in South Korea

Ireland2 sites

  • Adelaide & Meath Hospital

    Dublin, 00024

  • University Hospital Waterford

    Waterford, X91ER8E

Other trials in Ireland

New Zealand1 site

  • Auckland City Hospital

    Auckland, Grafton, 1023

Other trials in New Zealand

About this study

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)

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.

Being tested
Pembrolizumab, Epacadostat, Sunitinib, Pazopanib
Keywords
Renal cell carcinoma, programmed cell death 1 (PD-1) inhibitor, indoleamine 2, 3-dioxygenase 1 (IDO1) inhibitor
Medical subject headings
Carcinoma, Renal Cell, Parkinson Disease 4, Autosomal Dominant Lewy Body

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PembrolizumabDrug

    Also called MK-3475

    Pembrolizumab 200 mg administered intravenously every 3 weeks.

  • EpacadostatDrug

    Also called INCB024360

    Epacadostat 100 mg administered orally twice daily.

  • SunitinibDrug

    Also called Sutent, SU11248

    Sunitinib 50 mg administered orally once daily; 4 weeks on, 2 weeks off for 6-wk cycle.

  • PazopanibDrug

    Also called Votrient

    Pazopanib 800 mg administered orally once daily.

Study groups in NCT03260894
Study groupRoleWhat they receive
Pembrolizumab + EpacadostatExperimentalNot described
Receives: Drug: Pembrolizumab; Drug: Epacadostat
SoC (Sunitinib or Pazopanib)Active comparatorStandard of care (SoC) (sunitinib or pazopanib monotherapy).
Receives: Drug: Sunitinib; Drug: Pazopanib

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Objective Response Rate (ORR) of Pembrolizumab + Epacadostat Versus Standard of Care (SOC)

    ORR was defined as the percentage of participants who had complete response (CR) or partial response (PR) per RECIST v1.1 by investigator determination.

    Measured: up to approximately 8 months

Secondary outcomes (2)

  1. Safety and Tolerability of Pembrolizumab + Epacadostat Versus SOC as Measured by the Number of Participants Experiencing Adverse Events (AEs)

    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.

    Measured: Data reported from start of study to data cutoff 28-Feb-2019, up to 15 months.

  2. Safety and Tolerability of Pembrolizumab + Epacadostat Versus SOC as Measured by the Number of Participants Discontinuing Study Drug Due to AEs

    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.

    Measured: Data reported from start of study to data cutoff 28-Feb-2019, up to 15 months.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Aug 2017
  2. Study start7 Dec 2017
  3. Primary completion22 Aug 2018
  4. Study completion4 Jun 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
129 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03260894
Sponsor's protocol ID
KEYNOTE-679/ECHO-302
Other IDs
2024-512016-22-00, 2017-002259-26, 2017
Status last verified
Apr 2026
First submitted
22 Aug 2017
Last updated
22 May 2026
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Lara PN Jr, Villanueva L, Ibanez C, Erman M, Lee JL, Heinrich D, Lipatov ON, Gedye C, Gokmen E, Acevedo A, Semenov A, Park SH, Gafanov RA, Kose F, Jones M, Du X, Munteanu M, Perini R, Choueiri TK, Motzer RJ. A randomized, open-label, phase 3 trial of pembrolizumab plus epacadostat versus sunitinib or pazopanib as first-line treatment for metastatic renal cell carcinoma (KEYNOTE-679/ECHO-302). BMC Cancer. 2024 Jul 25;23(Suppl 1):1253. doi: 10.1186/s12885-023-10971-7.

    PubMed 39054430

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Pembrolizumab, Epacadostat and Sunitinib in people with Renal Cell Carcinoma (RCC), run by Incyte Corporation at 140 sites in 20 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 140 sites in United States, Japan, France, Germany, Norway and 15 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 10 Sep 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective Response Rate (ORR) of Pembrolizumab + Epacadostat Versus Standard of Care (SOC) (time frame: up to approximately 8 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03260894, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in