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New drug duo takes on kidney cancer in major trial

NCT ID NCT03260894

Disease control Sponsor: Incyte Corporation Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This Phase 3 trial tested whether combining pembrolizumab (an immunotherapy) with epacadostat (a drug that boosts the immune response) works better than standard drugs (sunitinib or pazopanib) for people with advanced kidney cancer that hasn't been treated before. The study enrolled 129 participants and measured how many saw their tumors shrink. The goal is to find a more effective first-line treatment for this type of cancer.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
pembrolizumab plus epacadostat
What this could lead to
If it works, this combination could offer a new first-line treatment option for advanced kidney cancer, potentially improving tumor shrinkage rates.
What could go wrong
This is a completed Phase 3 trial with only 129 participants, so results may not be definitive. The combination may cause side effects and might not outperform existing standard therapies.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

129 people

The number who actually took part.

Started

Dec 2017

Finished

Jun 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

autosomal dominant Parkinson disease 4 clear cell renal carcinoma renal cell carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Renal cell carcinoma (RCC)

Contacts and locations

Locations

  • A.O. Cardarelli

    Naples, 80131, Italy

  • Adelaide & Meath Hospital

    Dublin, 00024, Ireland

  • Akershus University Hospital

    Lørenskog, 1478, Norway

  • Akita University Hospital

    Akita, 010-8543, Japan

  • Ankara Numune Education and Research Hospital

    Ankara, 06100, Turkey (Türkiye)

  • Arizona Oncology Associates PC- HOPE

    Tucson, Arizona, 85711, United States

  • Asan Medical Center

    Seoul, 05505, South Korea

  • Atlanta Cancer Care - Conyers

    Conyers, Georgia, 30094, United States

  • Auckland City Hospital

    Auckland, Grafton, 1023, New Zealand

  • Azienda Ospedaliera San Camillo Forlanini

    Roma, 00152, Italy

  • Azienda Ospedaliera-Spedali Civili

    Brescia, 25123, Italy

  • Barts Health NHS Trust - St Bartholomew s Hospital

    London, EC1A 7BE, United Kingdom

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

    Adana, 01250, Turkey (Türkiye)

  • Beatson Institute of Cancer Research

    Glasgow, G12 0YN, United Kingdom

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

    Miskolc, 3526, Hungary

  • CHU Besancon - Hopital Jean Minjoz

    Besançon, 25030, France

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

    Québec, Quebec, G1R 2J6, Canada

  • CHU de Strasbourg - Nouvel Hopital Civil

    Strasbourg, 67091, France

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

    Trois-Rivières, Quebec, G8Z 3R9, Canada

  • Cabrini Health

    Malvern, Victoria, 3144, Australia

  • Calvary Mater Newcastle

    Waratah, New South Wales, 2298, Australia

  • Canberra Hospital

    Garran, Australian Capital Territory, 2605, Australia

  • Cedars-Sinai Medical Center

    Los Angeles, California, 90048, United States

  • Central Clinical Hospital with outpatient Clinic

    Moscow, 121359, Russia

  • Centre Antoine Lacassagne

    Nice, Cedex 2, 06189, France

  • Centre Francois Baclesse

    Caen, 14076, France

  • Centro Avancado de Tratamento Oncologico - CENANTRON -

    Belo Horizonte, 30130090, Brazil

  • Centro de pesquisa Porto Alegre

    Porto Alegre, Florianopolis, 90610-000, Brazil

  • Chang Gung Med Foundation. Kaohsiung Branch

    Kaohsiung City, 833, Taiwan

  • China Medical University Hospital

    Taichung, 40447, Taiwan

  • Chonnam National University Hwasun Hospital

    Hwasun, Jeollanam-do, 58128, South Korea

  • Clinica Alemana de Osorno

    Osorno, Los Lagos Region, 5311089, Chile

  • Clinique Sainte Anne

    Strasbourg, 67000, France

  • Dana Farber Cancer Institute

    Boston, Massachusetts, 02215, United States

  • Dnipropetrovsk City Multidiscipline Clinical Hosp. 4 of DRC

    Dnipro, 49102, Ukraine

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

    Dnipro, 49005, Ukraine

  • Ege Universitesi Tıp Fakultesi

    Izmir, 35040, Turkey (Türkiye)

  • Fiona Stanley Hospital

    Murdoch, 6150, Australia

  • Fondazione IRCCS Istituto Nazionale dei Tumori

    Milan, 20133, Italy

  • Fundacao Pio XII - Hospital de Cancer de Barretos

    Barretos, São Paulo, 14784-400, Brazil

  • Fundacion Arturo Lopez Perez FALP

    Santiago, 7500921, Chile

  • Hacettepe University Medical Faculty

    Ankara, 06100, Turkey (Türkiye)

  • Helios Klinikum Berlin Buch

    Berlin, 13125, Germany

  • Helse Bergen HF Haukeland sykehus

    Bergen, 5053, Norway

  • Hokkaido University Hospital

    Sapporo, Hokkaido, 060-8648, Japan

  • Hopital Europeen Georges Pompidou

    Paris, 75015, France

  • Hopital Prive Toulon Hyeres Sainte Marguerite

    Hyères, 83400, France

  • Hopital Saint Andre

    Bordeaux, 33075, France

  • Hospices Civils de Lyon Centre Hospitalier Lyon Sud

    Pierre-Bénite, 69310, France

  • Hospital Clinico Universitario de Santiago

    Santiago de Compostela, 15706, Spain

  • Hospital Clinico Vina del Mar

    Viña del Mar, 2520000, Chile

  • Hospital General Universitario Gregorio Maranon

    Madrid, 28007, Spain

  • Hospital Germans Trias i Pujol

    Barcelona, 08916, Spain

  • Hospital Parc Tauli

    Sabadell, Barcelona, 08208, Spain

  • Hospital Sao Jose

    São Paulo, São Paulo, 01321-001, Brazil

  • Hospital Universitario HM Sanchinarro

    Madrid, 28050, Spain

  • Hospital de Clinicas de Porto Alegre

    Porto Alegre, 90035-903, Brazil

  • Hospital del Mar

    Barcelona, 08003, Spain

  • Huntsman Cancer Institute

    Salt Lake City, Utah, 84112, United States

  • Institut Gustave Roussy

    Villejuif, 94805, France

  • Instituto Valenciano de Oncologia

    Valencia, 46009, Spain

  • Instituto do Cancer de Sao Paulo - ICESP

    São Paulo, São Paulo, 01246-000, Brazil

  • Istanbul Medeniyet Universitesi Goztepe EAH

    Istanbul, 34732, Turkey (Türkiye)

  • Istanbul Universitesi Onkoloji Enstitusu

    Istanbul, 34093, Turkey (Türkiye)

  • Ivanovo regional oncology dispensary

    Ivanovo, 153040, Russia

  • Jasz Nagykun Szolnok Megyei Hetenyi Geza Korhaz Rendelointezet

    Szolnok, 5000, Hungary

  • Jewish General Hospital

    Montreal, Quebec, H3T 1E2, Canada

  • Keio University Hospital

    Tokyo, 160-8582, Japan

  • Kindai University Hospital

    Sayama, Osaka, 589-8511, Japan

  • Kingston Health Sciences Centre - KGH Site

    Kingston, Ontario, K7L 2V7, Canada

  • Kyushu University Hospital

    Fukuoka, 812-8582, Japan

  • Leningrad Regional Oncology Dispensary

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

  • Levine Cancer Institute

    Charlotte, North Carolina, 28204, United States

  • MI Kryviy Rih Center of Dnipropetrovsk Regional Council

    Kryvyi Rih, Dnipropetrovsk Oblast, 50048, Ukraine

  • MI Precarpathian Clinical Oncology Center

    Ivano-Frankivsk, 76018, Ukraine

  • Markusovszky Egyetemi Oktatokorhaz

    Szombathely, 9700, Hungary

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114, United States

  • Medical Oncology Ospedale San Donato

    Arezzo, 52100, Italy

  • Medizinische Hochschule Hannover

    Hanover, 30625, Germany

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10065, United States

  • Nagoya University Hospital

    Nagoya, Aichi-ken, 466-8560, Japan

  • Namik Kemal Universitesi Tip Fakultesi

    Tekirdağ, 59100, Turkey (Türkiye)

  • Nara Medical University Hospital

    Kashihara, Nara, 634-8522, Japan

  • National Cancer Center Hospital East

    Kashiwa, Chiba, 277-8577, Japan

  • National Cheng Kung University Hospital

    Tainan, 70457, Taiwan

  • National Medical Research Radiology Centre

    Moscow, 125284, Russia

  • National Taiwan University Hospital

    Taipei, 10048, Taiwan

  • New York Oncology Hematology P.C

    Albany, New York, 12208, United States

  • Niigata University Medical & Dental Hospital

    Niigata, 951-8520, Japan

  • Nippon Medical School Hospital

    Tokyo, 113-8603, Japan

  • Northside Hospital

    Atlanta, Georgia, 30342, United States

  • Northwest Georgia Oncology Centers Pc

    Marietta, Georgia, 30060, United States

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

    Roanoke, Virginia, 24014, United States

  • Orszagos Onkologiai Intezet

    Budapest, Pest County, 1122, Hungary

  • Oslo universitetssykehus

    Oslo, 0450, Norway

  • Pinnacle Oncology Hematology

    Scottsdale, Arizona, 85258, United States

  • Policlinico San Matteo

    Pavia, 27100, Italy

  • Pontificia Universidad Catolica de Chile

    Santiago, 8320000, Chile

  • RMI Sumy Regional Clinical Oncology Dispensary

    Sumy, 40022, Ukraine

  • Republican Clinical Oncology Dispensary of Republic of Bashkortostan

    Ufa, 450054, Russia

  • Rush University Medical Center

    Chicago, Illinois, 60612, United States

  • Russian Scientific Center of Roentgenoradiology

    Moscow, 117997, Russia

  • Saitama Medical University International Medical Center

    Hidaka, Saitama, 350-1298, Japan

  • Samsung Medical Center

    Seoul, 06351, South Korea

  • Sapporo Medical University Hospital

    Sapporo, Hokkaido, 060-8543, Japan

  • Scottsdale Healthcare

    Scottsdale, Arizona, 85258, United States

  • Severance Hospital Yonsei University Health System

    Seoul, 03722, South Korea

  • Shenandoah Oncology, P.C.

    Winchester, Virginia, 22601, United States

  • Somogy Megyei Kaposi Mor Oktato Korhaz

    Kaposvár, 7400, Hungary

  • Sorlandet sykehus HF

    Kristiansand, 4615, Norway

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

    Lincoln, Nebraska, 68510, United States

  • St Olavs Hospital

    Trondheim, 7030, Norway

  • Sunnybrook Health Sciences, Odette Cancer Centre

    Toronto, Ontario, M4N 3M5, Canada

  • Sykehuset Oestfold

    Grålum, 1714, Norway

  • Taipei Veterans General Hospital

    Taipei, 112, Taiwan

  • The Christie NHS Foundation Trust

    Manchester, MB204BX, United Kingdom

  • The Royal Marsden Foundation Trust

    London, SW3 6JJ, United Kingdom

  • The Royal Marsden NHS Foundation Trust.

    Sutton, Surrey, SM2 5PT, United Kingdom

  • The West Clinic, P.C.

    Germantown, Tennessee, 38138, United States

  • Tom Baker Cancer Centre

    Calgary, Alberta, T2N 4N2, Canada

  • Toranomon Hospital

    Tokyo, 105-8470, Japan

  • UC Davis Comprehensive Cancer Center

    Sacramento, California, 95817, United States

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

    Orange, California, 92868, United States

  • US Oncology and Research

    The Woodlands, Texas, 77380, United States

  • Universitaetsklinikum Essen

    Essen, 45147, Germany

  • Universitaetsklinikum Frankfurt

    Frankfurt am Main, 60590, Germany

  • Universitaetsklinikum Jena

    Jena, 07747, Germany

  • Universitaetsklinikum Magdeburg. Klinik fuer Urologie

    Magdeburg, 39120, Germany

  • Universitaetsklinikum Tuebingen

    Tübingen, 72076, Germany

  • Universitaetsklinikum der Technischen Universitaet Dresden

    Dresden, 01307, Germany

  • Universitetssykehuset i Nord Norge. Kreftavdelingen

    Tromsø, 9019, Norway

  • University Hospital Waterford

    Waterford, X91ER8E, Ireland

  • University of Tennessee Erlanger Oncology & Hematology

    Chattanooga, Tennessee, 37403, United States

  • Utah Cancer Specialists

    Salt Lake City, Utah, 84106, United States

  • Western General Hospital

    Edinburgh, EH4 2XU, United Kingdom

  • Westmead Hospital

    Westmead, New South Wales, 2145, Australia

  • Willamette Valley Cancer Institute and Research Center

    Eugene, Oregon, 97401, United States

  • Woodlands Medical Specialists, PA

    Pensacola, Florida, 32503, United States

  • Yamaguchi University Hospital

    Ube, Yamaguchi, 755-8505, Japan

  • Zala Megyei Szent Rafael Korhaz

    Zalaegerszeg, Pozva, 8900, Hungary

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