Pembrolizumab + Epacadostat vs Pembrolizumab + Placebo in Recurrent or Progressive Metastatic Urothelial Carcinoma
NCT ID: NCT03374488
Last Updated: 2025-08-22
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
84 participants
INTERVENTIONAL
2017-12-22
2020-07-23
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Pembrolizumab 200 mg + Epacadostat 100 mg BID
Pembrolizumab + epacadostat
Pembrolizumab
Pembrolizumab administered intravenously Day 1 of each cycle every 3 weeks.
Epacadostat
Epacadostat administered orally twice daily.
Pembrolizumab 200 mg + placebo BID
Pembrolizumab + placebo
Pembrolizumab
Pembrolizumab administered intravenously Day 1 of each cycle every 3 weeks.
Placebo
Matching placebo administered orally twice daily.
Interventions
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Pembrolizumab
Pembrolizumab administered intravenously Day 1 of each cycle every 3 weeks.
Epacadostat
Epacadostat administered orally twice daily.
Placebo
Matching placebo administered orally twice daily.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Progression or recurrence of urothelial carcinoma following one prior platinum containing chemotherapy regimen for metastatic or unresectable locally advanced disease. A participant who receives a neoadjuvant or adjuvant platinum-containing regimen following cystectomy for localized muscle-invasive urothelial carcinoma is acceptable (without further systemic treatment), if recurrence/progression occurs ≤ 12 months following completion of therapy.
* Measurable disease based on RECIST v1.1.
* Have provided an archival tumor tissue sample or newly obtained core or excisional biopsy of a tumor lesion not previously irradiated for PD-L1 analysis.
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
* Adequate organ function per protocol-defined criteria.
Exclusion Criteria
* History or presence of an abnormal electrocardiogram (ECG) that, in the investigator's opinion, is clinically meaningful.
* 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.
* 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 (HBsAg reactive) or has active hepatitis C (HCV RNA). Note: Testing must be performed to determine eligibility.
* Use of protocol-defined prior/concomitant therapy.
18 Years
ALL
No
Sponsors
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Merck Sharp & Dohme LLC
INDUSTRY
Incyte Corporation
INDUSTRY
Responsible Party
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Principal Investigators
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Mark Jones, MD
Role: STUDY_DIRECTOR
Incyte Corporation
Locations
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Ironwood Cancer & Research Centers
Chandler, Arizona, United States
University of California Irvine Medical Center
Orange, California, United States
UCSF Helen Diller Family Comprehensive Cancer Center
San Francisco, California, United States
UCLA Hematology Oncology Santa Monica
Santa Monica, California, United States
Smilow Cancer Center at Yale-New Haven
New Haven, Connecticut, United States
Northside Hospital, Inc. - GCS/Annex
Atlanta, Georgia, United States
University of Chicago
Chicago, Illinois, United States
Quincy Medical Group
Quincy, Illinois, United States
Johns Hopkins University
Baltimore, Maryland, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
University of Michigan Health System
Ann Arbor, Michigan, United States
NYU Clinical Cancer Center
New York, New York, United States
Oklahoma Cancer Specialists & Research Institute
Tulsa, Oklahoma, United States
Oregon Health & Science University
Portland, Oregon, United States
University of Pennsylvania
Philadelphia, Pennsylvania, United States
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, United States
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States
Medical University of South Carolina-Hollings Cancer Center
Charleston, South Carolina, United States
University of Tennessee Medical Center Knoxville
Knoxville, Tennessee, United States
Vanderbilt University Medical Center
Nashville, Tennessee, United States
US Oncology and Research
Fort Worth, Texas, United States
Virginia Cancer Specialists, PC
Fairfax, Virginia, United States
Virginia Oncology Associates
Norfolk, Virginia, United States
VCU Massey Cancer Center
Richmond, Virginia, United States
Southern Medical Day Care Centre
Wollongong, New South Wales, Australia
Austin Health-Austin Hospital
Heidelberg, Victoria, Australia
Adelaide Cancer Centre
Kurralta Park, , Australia
Macquarie University Hospital
Macquarie Park, , Australia
London Health Sciences Centre
London, Ontario, Canada
The Ottawa Hospital Cancer Centre
Ottawa, Ontario, Canada
Sunnybrook Research Institute
Toronto, Ontario, Canada
CIUSSS - Hopital Maisonneuve- Rosemont
Montreal, Quebec, Canada
CIUSSS de l Est de L Ile de Montreal - Hopital Maisonneuve-Rosemont
Montreal, Quebec, Canada
CHU de Quebec-Universite Laval-Hotel Dieu de Quebec
Québec, Quebec, Canada
Aalborg University Hospital
Aalborg, , Denmark
Rigshospitalet
Copenhagen, , Denmark
Herlev Hospital
Herlev, , Denmark
Sjaellands Universitetshospital Naestved
Næstved, , Denmark
Institut de Cancerologie de l Ouest Site Paul Papin
Angers, , France
Clinique Sainte Catherine
Avignon, , France
Centre de Lutte Contre le Cancer Francois Baclesse
Caen, , France
Clinique Victor Hugo
Le Mans, , France
Centre Oscar Lambret
Lille, , France
Centre Leon Berard
Lyon, , France
Institut du Cancer de Montpellier
Montpellier, , France
Hopital Cochin
Paris, , France
Hopital Saint Louis
Paris, , France
Institut Jean Godinot
Reims, , France
Centre Medico-Chirurgical Foch
Suresnes, , France
C.H.U. de Tours - Hopital Bretonneau
Tours, , France
Institut Gustave Roussy
Villejuif, , France
Universitaetsklinikum Schleswig-Holstein. Campus Luebeck
Lübeck, Schleswig-Holstein, Germany
Universitaetsklinikum Duesseldorf
Düsseldorf, , Germany
Universitatsklinikum Hamburg-Eppendorf
Hamburg, , Germany
Universitaetsklinikum Jena
Jena, , Germany
Universitaetsklinikum Magdeburg A.o.R.
Magdeburg, , Germany
Klinikum rechts der Isar der Technischen Universitat
München, , Germany
Universitaetsklinikum Tuebingen
Tübingen, , Germany
Orszagos Onkologiai Intezet
Budapest, , Hungary
Uzsoki Utcai Korhaz
Budapest, , Hungary
Somogy Megyei Kaposi Mor Oktato Korhaz
Kaposvár, , Hungary
Borsod-Abauj-Zemplen Megyei Korhaz es Egyetemi Oktato Korhaz
Miskolc, , Hungary
Pecsi Tudomanyegyetem AOK
Pécs, , Hungary
Jasz - Nagykun Szolnok megyei Hetenyi Geza Korhaz - Rendelointezet
Szolnok, , Hungary
Cork University Hospital
Cork, , Ireland
Beaumont Hospital
Dublin, , Ireland
Adelaide & Meath Hospital (Incl NCH)
Dublin, , Ireland
University College Hospital Galway
Galway, , Ireland
University Hospital Limerick
Limerick, , Ireland
Waterford Regional Hospital
Waterford, , Ireland
Soroka Medical Center
Beersheba, , Israel
Rambam Medical Center
Haifa, , Israel
Meir Medical Center
Kfar Saba, , Israel
Rabin Medical Center
Petah Tikva, , Israel
Chaim Sheba Medical Center
Ramat Gan, , Israel
Sourasky Medical Center
Tel Aviv, , Israel
Assaf Harofeh Medical Center
Ẕerifin, , Israel
Medical Oncology Ospedale San Donato
Arezzo, , Italy
Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori
Meldola, , Italy
Fondazione IRCCS Istituto Nazionale dei Tumori
Milan, , Italy
Istituto Nazionale Tumori Fondazione Pascale
Napoli, , Italy
Istituto Oncologico Veneto
Padua, , Italy
Nagoya University Hospital
Nagoya, Aichi-ken, Japan
National Cancer Center Hospital East
Kashiwa, Chiba, Japan
University of Tsukuba Hospital
Tsukuba, Ibaraki, Japan
Nara Medical University Hospital
Kashihara, Nara, Japan
Yamaguchi University Hospital
Ube, Yamaguchi, Japan
Osaka International Cancer Institute
Osaka, , Japan
Medical Hospital, Tokyo Medical And Dental University
Tokyo, , Japan
Yusen Logistics Co Ltd,. Haneda Logistics Center (MSD DC)
Tokyo, , Japan
Antoni van Leeuwenhoek Ziekenhuis
Amsterdam, , Netherlands
VU University Medical Center
Amsterdam, , Netherlands
Amphia Ziekenhuis
Breda, , Netherlands
Catharina Ziekenhuis
Eindhoven, , Netherlands
University Medical Center Groningen
Groningen, , Netherlands
Leningrad Regional Oncology Dispensary
Saint Petersburg, Leningrad Region, Vsevolozhsky District, Russia
Ivanovo Regional Oncology Dispensary
Ivanovo, , Russia
N.N. Blokhin NMRCO
Moscow, , Russia
Russian Scientific Center of Roentgenoradiology
Moscow, , Russia
National Medical Research Radiological Centre
Moscow, , Russia
Ryazan Regional Clinical Oncology Dispensary
Ryazan, , Russia
Pokrovskaya City Hospital
Saint Petersburg, , Russia
Clinic of Bashkortostan State Medical University
Ufa, , Russia
Seoul National University Hospital
Seoul, , South Korea
Severance Hospital Yonsei University Health System
Seoul, , South Korea
Asan Medical Center
Seoul, , South Korea
Samsung Medical Center
Seoul, , South Korea
Hospital del Mar
Barcelona, , Spain
Hospital Vall D Hebron
Barcelona, , Spain
Hospital de la Santa Creu i Sant Pau
Barcelona, , Spain
Hospital General Universitario Gregorio Maranon
Madrid, , Spain
MD Anderson Cancer Center Madrid
Madrid, , Spain
Hospital Universitario Virgen de la Victoria
Málaga, , Spain
Hospital Clinico Universitario de Santiago
Santiago de Compostela, , Spain
Instituto Valenciano de Oncologia
Valencia, , Spain
Chang Gung Medical Foundation. Kaohsiung Branch
Kaohsiung City, , Taiwan
China Medical University Hospital
Taichung, , Taiwan
National Cheng Kung University Hospital
Tainan City, , Taiwan
National Taiwan University Hospital
Taipei, , Taiwan
Taipei Veterans General Hospital
Taipei, , Taiwan
Adana Sehir Hastanesi
Adana, , Turkey (Türkiye)
Dr. Abdurrahman Yurtaslan Ankara Onkoloji EAH
Ankara, , Turkey (Türkiye)
Akdeniz Universitesi Tip Fakultesi
Antalya, , Turkey (Türkiye)
Pamukkale Unv. Tip Fak.
Denizli, , Turkey (Türkiye)
Trakya Universitesi Tip Fakultesi
Edirne, , Turkey (Türkiye)
Marmara Universitesi Pendik Arastirma ve Uyg. Hastanesi
Istanbul, , Turkey (Türkiye)
Dokuz Eylul University Faculty of Medicine
Izmir, , Turkey (Türkiye)
Samsun Medical Park Hastanesi
Samsun, , Turkey (Türkiye)
Royal Marsden NHS Trust
Sutton, Surrey, United Kingdom
Queen Elizabeth Hospital
Birmingham, , United Kingdom
Barts Health NHS Trust - St Bartholomew s Hospital
London, , United Kingdom
Royal Free London NHS Foundation Trust
London, , United Kingdom
Imperial College Healthcare NHS Trust
London, , United Kingdom
Plymouth Hospitals NHS Trust
Plymouth, , United Kingdom
Sunderland Royal Hospital
Sunderland, , United Kingdom
Countries
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References
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Cicin I, Plimack ER, Gurney H, Leibowitz R, Alekseev BY, Parnis FX, Peer A, Necchi A, Bellmunt J, Nishiyama H, Clark J, Munteanu M, Kataria R, Jia C, Powles T, Sternberg CN. Epacadostat plus pembrolizumab versus placebo plus pembrolizumab for advanced urothelial carcinoma: results from the randomized phase III ECHO-303/KEYNOTE-698 study. BMC Cancer. 2024 Jul 25;23(Suppl 1):1256. doi: 10.1186/s12885-023-11213-6.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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2017-002310-31
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
KEYNOTE-698/ECHO-303
Identifier Type: -
Identifier Source: org_study_id
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