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

NCT03260894 | Completed Phase 3 Results DMC FDA Drug

• 3 other identifiers: KEYNOTE-679/ECHO-3022024-512016-22-002017-002259-26
• Study Type: interventional
• Target: 129
• Locations: 20 countries
• Sites: 140

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.

Conditions

Renal Cell Carcinoma (RCC)

Keywords

Renal cell carcinoma; programmed cell death 1 (PD-1) inhibitor; indoleamine 2; 3-dioxygenase 1 (IDO1) inhibitor

Outcome Measures

Primary Outcomes (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.

  Minimum up to 6 months

Secondary Outcomes (2)

• 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.

• 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.

Study Arms (2)

Pembrolizumab + Epacadostat

EXPERIMENTAL

Drug: Pembrolizumab; Drug: Epacadostat

SoC (Sunitinib or Pazopanib)

ACTIVE COMPARATOR

Standard of care (SoC) (sunitinib or pazopanib monotherapy).

Drug: Sunitinib; Drug: Pazopanib

Interventions

Pembrolizumab DRUG

Pembrolizumab 200 mg administered intravenously every 3 weeks.

Also known as: MK-3475

Pembrolizumab + Epacadostat

Epacadostat DRUG

Epacadostat 100 mg administered orally twice daily.

Also known as: INCB024360

Pembrolizumab + Epacadostat

Sunitinib DRUG

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

Also known as: Sutent, SU11248

SoC (Sunitinib or Pazopanib)

Pazopanib DRUG

Pazopanib 800 mg administered orally once daily.

Also known as: Votrient

SoC (Sunitinib or Pazopanib)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Incyte Corporation: lead
• Merck Sharp & Dohme LLC: collaborator

Study Sites (140)

Pinnacle Oncology Hematology

Scottsdale, Arizona, 85258, United States

Location

Scottsdale Healthcare

Scottsdale, Arizona, 85258, United States

Location

Arizona Oncology Associates PC- HOPE

Tucson, Arizona, 85711, United States

Location

Cedars-Sinai Medical Center

Los Angeles, California, 90048, United States

Location

UC Irvine Comprehensive Cancer Center/Chao Family Comprehensive Cancer Center

Orange, California, 92868, United States

Location

UC Davis Comprehensive Cancer Center

Sacramento, California, 95817, United States

Location

Woodlands Medical Specialists, PA

Pensacola, Florida, 32503, United States

Location

Northside Hospital

Atlanta, Georgia, 30342, United States

Location

Atlanta Cancer Care - Conyers

Conyers, Georgia, 30094, United States

Location

Northwest Georgia Oncology Centers Pc

Marietta, Georgia, 30060, United States

Location

Rush University Medical Center

Chicago, Illinois, 60612, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Dana Farber Cancer Institute

Boston, Massachusetts, 02215, United States

Location

Southeast Nebraska Hematology & Oncology Consultants, P.C.

Lincoln, Nebraska, 68510, United States

Location

New York Oncology Hematology P.C

Albany, New York, 12208, United States

Location

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

Levine Cancer Institute

Charlotte, North Carolina, 28204, United States

Location

Willamette Valley Cancer Institute and Research Center

Eugene, Oregon, 97401, United States

Location

University of Tennessee Erlanger Oncology & Hematology

Chattanooga, Tennessee, 37403, United States

Location

The West Clinic, P.C.

Germantown, Tennessee, 38138, United States

Location

US Oncology and Research

The Woodlands, Texas, 77380, United States

Location

Utah Cancer Specialists

Salt Lake City, Utah, 84106, United States

Location

Huntsman Cancer Institute

Salt Lake City, Utah, 84112, United States

Location

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

Roanoke, Virginia, 24014, United States

Location

Shenandoah Oncology, P.C.

Winchester, Virginia, 22601, United States

Location

Canberra Hospital

Garran, Australian Capital Territory, 2605, Australia

Location

Calvary Mater Newcastle

Waratah, New South Wales, 2298, Australia

Location

Westmead Hospital

Westmead, New South Wales, 2145, Australia

Location

Cabrini Health

Malvern, Victoria, 3144, Australia

Location

Fiona Stanley Hospital

Murdoch, 6150, Australia

Location

Centro de pesquisa Porto Alegre

Porto Alegre, Florianopolis, 90610-000, Brazil

Location

Fundacao Pio XII - Hospital de Cancer de Barretos

Barretos, São Paulo, 14784-400, Brazil

Location

Instituto do Cancer de Sao Paulo - ICESP

São Paulo, São Paulo, 01246-000, Brazil

Location

Hospital Sao Jose

São Paulo, São Paulo, 01321-001, Brazil

Location

Centro Avancado de Tratamento Oncologico - CENANTRON -

Belo Horizonte, 30130090, Brazil

Location

Hospital de Clinicas de Porto Alegre

Porto Alegre, 90035-903, Brazil

Location

Tom Baker Cancer Centre

Calgary, Alberta, T2N 4N2, Canada

Location

Kingston Health Sciences Centre - KGH Site

Kingston, Ontario, K7L 2V7, Canada

Location

Sunnybrook Health Sciences, Odette Cancer Centre

Toronto, Ontario, M4N 3M5, Canada

Location

Jewish General Hospital

Montreal, Quebec, H3T 1E2, Canada

Location

CHU de Quebec-Universite Laval-Hotel Dieu de Quebec

Québec, Quebec, G1R 2J6, Canada

Location

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

Trois-Rivières, Quebec, G8Z 3R9, Canada

Location

Clinica Alemana de Osorno

Osorno, Los Lagos Region, 5311089, Chile

Location

Fundacion Arturo Lopez Perez FALP

Santiago, 7500921, Chile

Location

Pontificia Universidad Catolica de Chile

Santiago, 8320000, Chile

Location

Hospital Clinico Vina del Mar

Viña del Mar, 2520000, Chile

Location

Centre Antoine Lacassagne

Nice, Cedex 2, 06189, France

Location

CHU Besancon - Hopital Jean Minjoz

Besançon, 25030, France

Location

Hopital Saint Andre

Bordeaux, 33075, France

Location

Centre Francois Baclesse

Caen, 14076, France

Location

Hopital Prive Toulon Hyeres Sainte Marguerite

Hyères, 83400, France

Location

Hopital Europeen Georges Pompidou

Paris, 75015, France

Location

Hospices Civils de Lyon Centre Hospitalier Lyon Sud

Pierre-Bénite, 69310, France

Location

Clinique Sainte Anne

Strasbourg, 67000, France

Location

CHU de Strasbourg - Nouvel Hopital Civil

Strasbourg, 67091, France

Location

Institut Gustave Roussy

Villejuif, 94805, France

Location

Helios Klinikum Berlin Buch

Berlin, 13125, Germany

Location

Universitaetsklinikum der Technischen Universitaet Dresden

Dresden, 01307, Germany

Location

Universitaetsklinikum Essen

Essen, 45147, Germany

Location

Universitaetsklinikum Frankfurt

Frankfurt am Main, 60590, Germany

Location

Medizinische Hochschule Hannover

Hanover, 30625, Germany

Location

Universitaetsklinikum Jena

Jena, 07747, Germany

Location

Universitaetsklinikum Magdeburg. Klinik fuer Urologie

Magdeburg, 39120, Germany

Location

Universitaetsklinikum Tuebingen

Tübingen, 72076, Germany

Location

Orszagos Onkologiai Intezet

Budapest, Pest County, 1122, Hungary

Location

Zala Megyei Szent Rafael Korhaz

Zalaegerszeg, Pozva, 8900, Hungary

Location

Somogy Megyei Kaposi Mor Oktato Korhaz

Kaposvár, 7400, Hungary

Location

Borsod-Abauj-Zemplen Megyei Korhaz es Egyetemi Oktato Korhaz

Miskolc, 3526, Hungary

Location

Jasz Nagykun Szolnok Megyei Hetenyi Geza Korhaz Rendelointezet

Szolnok, 5000, Hungary

Location

Markusovszky Egyetemi Oktatokorhaz

Szombathely, 9700, Hungary

Location

Adelaide & Meath Hospital

Dublin, 00024, Ireland

Location

University Hospital Waterford

Waterford, X91ER8E, Ireland

Location

Medical Oncology Ospedale San Donato

Arezzo, 52100, Italy

Location

Azienda Ospedaliera-Spedali Civili

Brescia, 25123, Italy

Location

Fondazione IRCCS Istituto Nazionale dei Tumori

Milan, 20133, Italy

Location

A.O. Cardarelli

Napoli, 80131, Italy

Location

Policlinico San Matteo

Pavia, 27100, Italy

Location

Azienda Ospedaliera San Camillo Forlanini

Roma, 00152, Italy

Location

Nagoya University Hospital

Nagoya, Aichi-ken, 466-8560, Japan

Location

National Cancer Center Hospital East

Kashiwa, Chiba, 277-8577, Japan

Location

Sapporo Medical University Hospital

Sapporo, Hokkaido, 060-8543, Japan

Location

Hokkaido University Hospital

Sapporo, Hokkaido, 060-8648, Japan

Location

Nara Medical University Hospital

Kashihara, Nara, 634-8522, Japan

Location

Kindai University Hospital

Sayama, Osaka, 589-8511, Japan

Location

Saitama Medical University International Medical Center

Hidaka, Saitama, 350-1298, Japan

Location

Yamaguchi University Hospital

Ube, Yamaguchi, 755-8505, Japan

Location

Akita University Hospital

Akita, 010-8543, Japan

Location

Kyushu University Hospital

Fukuoka, 812-8582, Japan

Location

Niigata University Medical & Dental Hospital

Niigata, 951-8520, Japan

Location

Toranomon Hospital

Tokyo, 105-8470, Japan

Location

Nippon Medical School Hospital

Tokyo, 113-8603, Japan

Location

Keio University Hospital

Tokyo, 160-8582, Japan

Location

Auckland City Hospital

Auckland, Grafton, 1023, New Zealand

Location

Helse Bergen HF Haukeland sykehus

Bergen, 5053, Norway

Location

Sykehuset Oestfold

Grålum, 1714, Norway

Location

Sorlandet sykehus HF

Kristiansand, 4615, Norway

Location

Akershus University Hospital

Lørenskog, 1478, Norway

Location

Oslo universitetssykehus

Oslo, 0450, Norway

Location

Universitetssykehuset i Nord Norge. Kreftavdelingen

Tromsø, 9019, Norway

Location

St Olavs Hospital

Trondheim, 7030, Norway

Location

Leningrad Regional Oncology Dispensary

Saint Petersburg, Leningrad Region, Vsevolozhsky District, 188663, Russia

Location

Ivanovo regional oncology dispensary

Ivanovo, 153040, Russia

Location

Russian Scientific Center of Roentgenoradiology

Moscow, 117997, Russia

Location

Central Clinical Hospital with outpatient Clinic

Moscow, 121359, Russia

Location

National Medical Research Radiology Centre

Moscow, 125284, Russia

Location

Republican Clinical Oncology Dispensary of Republic of Bashkortostan

Ufa, 450054, Russia

Location

Chonnam National University Hwasun Hospital

Hwasun, Jeollanam-do, 58128, South Korea

Location

Severance Hospital Yonsei University Health System

Seoul, 03722, South Korea

Location

Asan Medical Center

Seoul, 05505, South Korea

Location

Samsung Medical Center

Seoul, 06351, South Korea

Location

Hospital Parc Tauli

Sabadell, Barcelona, 08208, Spain

Location

Hospital del Mar

Barcelona, 08003, Spain

Location

Hospital Germans Trias i Pujol

Barcelona, 08916, Spain

Location

Hospital General Universitario Gregorio Maranon

Madrid, 28007, Spain

Location

Hospital Universitario HM Sanchinarro

Madrid, 28050, Spain

Location

Hospital Clinico Universitario de Santiago

Santiago de Compostela, 15706, Spain

Location

Instituto Valenciano de Oncologia

Valencia, 46009, Spain

Location

Chang Gung Med Foundation. Kaohsiung Branch

Kaohsiung City, 833, Taiwan

Location

China Medical University Hospital

Taichung, 40447, Taiwan

Location

National Cheng Kung University Hospital

Tainan, 70457, Taiwan

Location

National Taiwan University Hospital

Taipei, 10048, Taiwan

Location

Taipei Veterans General Hospital

Taipei, 112, Taiwan

Location

Baskent Universitesi Adana Dr. Turgut Noyan Uygulama ve Arastirma Merkezi

Adana, 01250, Turkey (Türkiye)

Location

Ankara Numune Education and Research Hospital

Ankara, 06100, Turkey (Türkiye)

Location

Hacettepe University Medical Faculty

Ankara, 06100, Turkey (Türkiye)

Location

Istanbul Universitesi Onkoloji Enstitusu

Istanbul, 34093, Turkey (Türkiye)

Location

Istanbul Medeniyet Universitesi Goztepe EAH

Istanbul, 34732, Turkey (Türkiye)

Location

Ege Universitesi Tıp Fakultesi

Izmir, 35040, Turkey (Türkiye)

Location

Namik Kemal Universitesi Tip Fakultesi

Tekirdağ, 59100, Turkey (Türkiye)

Location

MI Kryviy Rih Center of Dnipropetrovsk Regional Council

Kryvyi Rih, Dnipropetrovsk Oblast, 50048, Ukraine

Location

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

Dnipro, 49005, Ukraine

Location

Dnipropetrovsk City Multidiscipline Clinical Hosp. 4 of DRC

Dnipro, 49102, Ukraine

Location

MI Precarpathian Clinical Oncology Center

Ivano-Frankivsk, 76018, Ukraine

Location

RMI Sumy Regional Clinical Oncology Dispensary

Sumy, 40022, Ukraine

Location

The Royal Marsden NHS Foundation Trust.

Sutton, Surrey, SM2 5PT, United Kingdom

Location

Western General Hospital

Edinburgh, EH4 2XU, United Kingdom

Location

Beatson Institute of Cancer Research

Glasgow, G12 0YN, United Kingdom

Location

Barts Health NHS Trust - St Bartholomew s Hospital

London, EC1A 7BE, United Kingdom

Location

The Royal Marsden Foundation Trust

London, SW3 6JJ, United Kingdom

Location

The Christie NHS Foundation Trust

Manchester, MB204BX, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 39054430 DERIVED

MeSH Terms

Conditions

Carcinoma, Renal Cell; Parkinson Disease 4, Autosomal Dominant Lewy Body

Interventions

pembrolizumab; epacadostat; Sunitinib; pazopanib

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Kidney Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Results Point of Contact

• Title: Study Director
• Organization: Incyte Corporation

medinfo@incyte.com

855-463-3463

Study Officials

• Mark Jones, MD

  Incyte Corporation

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 22, 2017
• First Posted: August 24, 2017
• Study Start: December 7, 2017
• Primary Completion: August 22, 2018
• Study Completion: June 4, 2025
• Last Updated: July 29, 2025
• Results First Posted: September 10, 2019

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

DE (8); IE (2); JP (14); FR (10); RU (6); UA (5); GB (6); BR (6); ES (7); NZ (1); TU (7); CL (4); TW (5); US (25); AU (5); CA (6); HU (6); IT (6); NO (7); KR (4)