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UC (Urothelial Cancer)Phase 3NCT03361865

Pembrolizumab in Combination With Epacadostat or Placebo in Cisplatin-ineligible Urothelial Carcinoma (KEYNOTE-672/ECHO-307)

A Phase 3 study testing Pembrolizumab and Epacadostat in people with UC (Urothelial Cancer), run by Incyte Corporation at 143 sites in 18 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 + epacadostat vs pembrolizumab + placebo in participants with cisplatin-ineligible urothelial carcinoma. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
UC (Urothelial Cancer)
What is being tested?
Pembrolizumab and Epacadostat
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
93 participants
Where
143 sitesin 18 countries
Study dates
4 Dec 2017to 4 Aug 2020
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

  • Histologically or cytologically-confirmed diagnosis of advanced/unresectable (inoperable) or metastatic urothelial cancer of the renal pelvis, ureter, bladder, or urethra.
  • Measurable disease based on RECIST v1.1.
  • Be considered ineligible to receive cisplatin-based combination therapy, based on protocol-defined criteria.
  • Have provided tissue for PD-L1 analysis from an archival tissue sample or newly obtained core or excisional biopsy of a tumor lesion not previously irradiated.
  • Have received no prior systemic chemotherapy for advanced/unresectable (inoperable) or metastatic urothelial cancer.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2 within 14 days prior to randomization.
  • Adequate organ function per protocol-defined criteria.

Who cannot join

  • Disease that is suitable for local therapy administered with curative intent.
  • Known additional malignancy that is progressing or has required active treatment within the past 3 years.
  • Known active central nervous system (CNS) metastases and/or carcinomatous meningitis. Participants with previously treated brain metastases may participate provided they are radiologically stable, ie, without evidence of progression for at least 4 weeks by repeat imaging, clinically stable and without requirement of steroid treatment for at least 14 days prior to first dose of study treatment.
  • Active autoimmune disease that has required systemic treatment in past 2 years.
  • Known history of human immunodeficiency virus (HIV) infection. HIV testing is not required unless mandated by local health authority.
  • Known history of or is positive for active hepatitis B (hepatitis B surface antigen [HBsAg] reactive) or has active hepatitis C (HCV RNA). Note: Testing must be performed to determine eligibility.
Show all 9Show fewer
  • History of a gastrointestinal condition that in the opinion of the Investigator may affect oral drug absorption.
  • History or presence of an abnormal electrocardiogram (ECG) that, in the investigator's opinion, is clinically meaningful.
  • Use of protocol-defined prior/concomitant therapy.

Trial locations and contacts

143 sites in 18 countries.

143 sites in 18 countries

United States22 sites

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

  • Medical University of South Carolina-Hollings Cancer Center

    Charleston, South Carolina, 29425

  • Levine Cancer Institute

    Charlotte, North Carolina, 28204

  • Tennessee Oncology, PLLC/The Sarah Cannon Research Institute

    Chattanooga, Tennessee, 37404

  • Rush University Medical Center

    Chicago, Illinois, 60612

  • Willamette Valley Cancer Institute and Research Center

    Eugene, Oregon, 97401

  • Texas Oncology-Memorial City

    Houston, Texas, 77024

  • University of Tennessee Medical Center Knoxville

    Knoxville, Tennessee, 37920

  • Comprehensive Cancer Centers of Nevada

    Las Vegas, Nevada, 89169

  • Sarah Cannon Research Institute

    Nashville, Tennessee, 37203

  • Tennessee Oncology Nashville

    Nashville, Tennessee, 37203

  • Vanderbilt-Ingram Cancer Center

    Nashville, Tennessee, 37232

  • Yale Cancer Center

    New Haven, Connecticut, 06511

  • Laura and Isaac Perlmutter Cancer Center at NYU Langone

    New York, New York, 10016

  • GU Research Network-Urology Cancer Center

    Omaha, Nebraska, 68130

  • University of California Irvine Medical Center

    Orange, California, 92868

  • Woodlands Medical Specialists, PA

    Pensacola, Florida, 32503

  • Abramson Cancer Center of the University of Pennsylvania

    Philadelphia, Pennsylvania, 19104

  • Fox Chase Cancer Center

    Philadelphia, Pennsylvania, 19111

  • Quincy Medical Group

    Quincy, Illinois, 62301

  • University of Washington

    Seattle, Washington, 98195

  • Arizona Oncology Associates PC- HOPE

    Tucson, Arizona, 85704

Other trials in United States

France13 sites

  • Institut de Cancerologie de l Ouest Site Paul Papin

    Angers, 49055

  • CHU de Besancon

    Besançon, 25030

  • Institut Bergonie

    Bordeaux, 33076

  • Centre Jean Perrin

    Clermont-Ferrand, 63011

  • Institut Paoli Calmettes

    Marseille, 13009

  • Centre d Oncologie de Gentilly

    Nancy, 54100

  • Hopital Europeen Georges Pompidou

    Paris, 75908

  • Centre Hospitalier Lyon Sud

    Pierre-Bénite, 69310

  • Institut Jean Godinot

    Reims, 51726

  • CHU de Strasbourg - Nouvel Hopital Civil

    Strasbourg, 67091

  • Institut Claudius Regaud

    Toulouse, 31059

  • C.H.U. de Tours - Hopital Bretonneau

    Tours, 37044

  • Institut Gustave Roussy

    Villejuif, 94805

Other trials in France

Germany9 sites

  • Universitaetsklinikum Duesseldorf

    Düsseldorf, 40225

  • Kliniken Essen Mitte

    Essen, 45136

  • Universitatsklinikum Hamburg-Eppendorf

    Hamburg, 20246

  • Universitaetsklinikum Jena

    Jena, 07747

  • Universitaetsklinikum Schleswig-Holstein. Campus Luebeck

    Lübeck, Schleswig-Holstein, 23538

  • Universitaetsklinikum Magdeburg A.o.R.

    Magdeburg, 39120

  • Klinikum rechts der Isar der Technischen Universitat

    München, 81675

  • Krankenhaus der Barmherzigen Brueder Trier

    Trier, 54292

  • Universitaetsklinikum Tuebingen

    Tübingen, 72076

Other trials in Germany

Japan9 sites

  • 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

  • Kindai University Hospital

    Sayama, Osaka, 589-8511

  • Tokushima University Hospital

    Tokushima, 770-8503

  • Medical Hospital, Tokyo Medical And Dental University

    Tokyo, 113-8519

  • The Cancer Institute Hospital of JFCR

    Tokyo, 135-8550

  • University of Tsukuba Hospital

    Tsukuba, Ibaraki, 305-8576

  • Yamaguchi University Hospital

    Ube, Yamaguchi, 755-8505

Other trials in Japan

Poland9 sites

  • Beskidzkie Centrum Onkologii im. Jana Pawla II

    Bielsko-Biala, 43-300

  • Wojewodzkie Centrum Szpitalne Kotliny Jeleniogorskiej

    Jelenia Góra, 58-506

  • Uniwersyteckie Centrum Kliniczne Slaskiego Uniwersytetu Medycznego

    Katowice, 40-514

  • GLOBE Badania Kliniczne Oddzial we Wroclawiu

    Komorowice, 52-229

  • Europejskie Centrum Zdrowia Otwock

    Otwock, 05-400

  • Urologica Praktyka Lekarska Adam Marcheluk

    Siedlce, 08-110

  • Samodzielny Publiczny Szpital Kliniczny Nr 2 PUM w Szczecinie

    Szczecin, 70-111

  • Magodent Szpital Elblaska

    Warsaw, 01-748

  • Szpital Sw. Elzbiety Mokotowskie Centrum Medyczne

    Warsaw, 02 616

Other trials in Poland

Russia8 sites

  • Ivanovo Regional Oncology Dispensary

    Ivanovo, 153013

  • N.N. Blokhin NMRCO

    Moscow, 115478

  • Russian Scientific Center of Roentgenoradiology

    Moscow, 117997

  • National Medical Research Radiological Centre

    Moscow, 125284

  • Ryazan Regional Clinical Oncology Dispensary

    Ryazan, 390046

  • Leningrad Regional Oncology Dispensary

    Saint Petersburg, Leningrad Region, Vsevolozhsky District, 188663

  • Pokrovskaya City Hospital

    Saint Petersburg, 199106

  • Clinic of Bashkortostan State Medical University

    Ufa, 450081

Other trials in Russia

Spain8 sites

  • Hospital Teresa Herrera - Chuac

    A Coruña, 15006

  • Hospital Infanta Cristina

    Badajoz, 06080

  • Hospital General Universitari Vall d Hebron

    Barcelona, 08035

  • ICO L Hospitalet

    L'Hospitalet de Llobregat, 08908

  • Hospital Universitario Lucus Augusti

    Lugo, 27003

  • Xarxa Assistencial Universitaria Manresa

    Manresa, 08243

  • Consorci Hospitalari Parc Tauli de Sabadell

    Sabadell, 08208

  • Hospital Virgen del Rocio

    Seville, 41013

Other trials in Spain

Belgium7 sites

  • Institut Jules Bordet

    Brussels, 1000

  • Grand Hopital de Charleroi - Site Notre Dame - Oncology

    Charleroi, 6000

  • AZ Maria Middelares Gent

    Ghent, 9000

  • Universitair Ziekenhuis Gent

    Ghent, 9000

  • Hopital de Jolimont

    Haine-Saint-Paul, 7100

  • AZ Nikolaas

    Sint-Niklaas, 9100

  • GZA Sint Augustinus

    Wilrijk, 2610

Other trials in Belgium

Israel7 sites

  • Soroka Medical Center

    Beersheba, 8410101

  • Rambam Health Care Campus

    Haifa, 31096

  • Meir Medical Center

    Kfar Saba, 4428164

  • Rabin Medical Center

    Petah Tikva, 49100

  • Chaim Sheba Medical Center

    Ramat Gan, 52621

  • Sourasky Medical Center

    Tel Aviv, 6423906

  • Assaf Harofeh Medical Center

    Tsrifin, 70300

Other trials in Israel

United Kingdom7 sites

  • The Beatson West of Scotland Cancer Centre

    Glasgow, G120YN

  • Barts Health NHS Trust - St Bartholomew's Hospital

    London, EC1A 7BE

  • Royal Free London NHS Foundation Trust

    London, NW3 2QG

  • Imperial College Healthcare NHS Trust

    London, W6 8RF

  • Plymouth Hospitals NHS Trust

    Plymouth, PL6 8DH

  • Sunderland Royal Hospital

    Sunderland, SR4 7TP

  • Royal Marsden NHS Trust

    Sutton, Surrey, SM2 5PT

Other trials in United Kingdom

Canada6 sites

  • Cancer Centre of Southeastern Ontario at Kingston General Hospital

    Kingston, Ontario, K7L 2V7

  • Moncton Hospital - Horizon Health Network

    Moncton, New Brunswick, E1C 6Z8

  • CIUSSS de l Est de L Ile de Montreal - Hopital Maisonneuve-Rosemont

    Montreal, Quebec, H1T 2M4

  • The Ottawa Hospital Cancer Centre

    Ottawa, Ontario, K1H 8L6

  • CHU de Quebec - Hotel-Dieu de Quebec

    Québec, Quebec, G1R 2J6

  • Sunnybrook Health Science Centre

    Toronto, Ontario, M4N 3M5

Other trials in Canada

Italy6 sites

  • Medical Oncology Ospedale San Donato

    Arezzo, 52100

  • Istituto Tumori Giovanni Paolo II

    Bari, 70124

  • Istituto Scientifico Romagnolo per Studio e Cura Tumori IRST

    Meldola, 47014

  • Istituto Nazionale dei Tumori

    Milan, 20133

  • Istituto Nazionale Tumori IRCCS Fondazione Pascale

    Naples, 80131

  • Istituto Oncologico Veneto

    Padova, 35128

Other trials in Italy

Netherlands6 sites

  • Antoni van Leeuwenhoek Ziekenhuis

    Amsterdam, 1066 CX

  • VU University Medical Center

    Amsterdam, 1081 HV

  • Amphia Ziekenhuis

    Breda, North Brabant, 4819EV

  • Catharina Ziekenhuis

    Eindhoven, 5623 EJ

  • University Medical Center Groningen

    Groningen, 9713 GZ

  • Erasmus MC

    Rotterdam, 3075 EA

Other trials in Netherlands

Ukraine6 sites

  • MI Dnipr Regional Clinical Hospital named after I.I. Mechnikov

    Dnipropetrovsk, 49005

  • Dnipropetrovsk City Multidiscipline Clinical Hosp.4 of DRC

    Dnipropetrovsk, 49102

  • Kharkiv Regional Clinical Oncology Center

    Kharkiv, 61000

  • Kyiv City Clinical Oncology Center

    Kyiv, 03115

  • MI Odessa Regional Oncological Centre

    Odesa, 65055

  • RMI Sumy Regional Clinical Oncology Dispensary

    Sumy, 40022

Other trials in Ukraine

Australia5 sites

  • Austin Health-Austin Hospital

    Heidelberg, Victoria, 3084

  • Adelaide Cancer Centre

    Kurralta Park, 5037

  • Macquarie University Hospital

    Macquarie Park, 2109

  • Calvary Mater Newcastle

    Waratah, New South Wales, 2298

  • Southern Medical Day Care Centre

    Wollongong, New South Wales, 2500

Other trials in Australia

Ireland5 sites

  • Cork University Hospital

    Cork

  • Adelaide & Meath Hospital (Incl NCH)

    Dublin, 00024

  • University College Hospital Galway

    Galway, H91YR71

  • University Hospital Limerick

    Limerick, V94 F858

  • University Hospital Waterford

    Waterford, X91ER8E

Other trials in Ireland

South Korea5 sites

  • Chungnam National University Hospital

    Daejeon, 35015

  • Seoul National University Hospital

    Seoul, 03080

  • Severance Hospital Yonsei University Health System

    Seoul, 03722

  • Asan Medical Center

    Seoul, 05505

  • Samsung Medical Center

    Seoul, 06351

Other trials in South Korea

Taiwan5 sites

  • Chang Gung Medical Foundation - Kaohsiung

    Kaohsiung City, 833

  • China Medical University Hospital

    Taichung, 40447

  • National Cheng Kung University Hospital

    Tainan, 704

  • Taipei Veterans General Hospital

    Taipei, Beitou, 112

  • National Taiwan University Hospital

    Taipei, 100

Other trials in Taiwan

About this study

Official title: A Phase 3 Randomized, Double-Blind Trial of Pembrolizumab (MK-3475) in Combination With Epacadostat (INCB024360) or Placebo in Participants With Cisplatin-ineligible Urothelial Carcinoma (KEYNOTE-672/ECHO-307)

The purpose of this study was to evaluate the efficacy and safety of pembrolizumab + epacadostat vs pembrolizumab + placebo in participants with cisplatin-ineligible urothelial carcinoma.

Being tested
Pembrolizumab, Epacadostat, Placebo
Keywords
Urothelial cancer, programmed cell death 1 (PD-1) inhibitor, indoleamine 2,3-dioxygenase (IDO) inhibitor
Medical subject headings
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 administered intravenously every 3 weeks.

  • EpacadostatDrug

    Also called INCB024360

    Epacadostat administered orally twice daily.

  • PlaceboDrug

    Matching placebo administered orally twice daily.

Study groups in NCT03361865
Study groupRoleWhat they receive
Pembrolizumab 200 mg + epacadostat 100 mg BIDExperimentalPembrolizumab + epacadostat
Receives: Drug: Pembrolizumab; Drug: Epacadostat
Pembrolizumab 200 mg + placebo BIDActive comparatorPembrolizumab + placebo
Receives: Drug: Pembrolizumab; Drug: Placebo

What is being measured

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

  1. Objective Response Rate (ORR) With Pembrolizumab + Epacadostat Versus Pembrolizumab + Placebo

    ORR was defined as the percentage of participants who had a confirmed complete response (CR) or partial response (PR) per RECIST v1.1 by investigator determination. Responses are based on Investigator assessments per RECIST 1.1 without confirmation using all scans up to the cutoff date.

    Measured: Week 9

Secondary outcomes (2)

  1. Safety and Tolerability of Pembrolizumab + Epacadostat Versus Pembrolizumab + Placebo as Measured by 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: Up to approximately 25 months

  2. Safety and Tolerability of Pembrolizumab + Epacadostat Versus Pembrolizumab + Placebo as Measured by Number of Participants Discontinuing Study Treatment Due to AE

    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: Up to approximately 25 months

Timeline

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

  1. First posted5 Dec 2017
  2. Study start4 Dec 2017
  3. Primary completion9 Aug 2018
  4. Study completion4 Aug 2020

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
93 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03361865
Sponsor's protocol ID
KEYNOTE-672/ECHO-307
Other IDs
2017-002311-34, 2017
Status last verified
Aug 2025
First submitted
29 Nov 2017
Last updated
22 Aug 2025
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Necchi A, Van der Heijden MS, Trukhin D, Peer A, Gurney H, Alekseev BY, Parnis FX, Leibowitz R, De Santis M, Grivas P, Clark J, Munteanu M, Kataria R, Jia C, Balar AV, de Wit R. Pembrolizumab plus either epacadostat or placebo for cisplatin-ineligible urothelial carcinoma: results from the ECHO-307/KEYNOTE-672 study. BMC Cancer. 2024 Jul 25;23(Suppl 1):1252. doi: 10.1186/s12885-023-10727-3.

    PubMed 39054491

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Pembrolizumab and Epacadostat in people with UC (Urothelial Cancer), run by Incyte Corporation at 143 sites in 18 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 7 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 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 143 sites in United States, France, Germany, Japan, Poland and 13 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 29 Aug 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) With Pembrolizumab + Epacadostat Versus Pembrolizumab + Placebo (time frame: Week 9). 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 NCT03361865, 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 Aug 2025.

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