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Brief Title: Pembrolizumab in Combination With Epacadostat or Placebo in Cisplatin-ineligible Urothelial Carcinoma (KEYNOTE-672/ECHO-307)
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)
Study ID: NCT03361865
Brief 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.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Arizona Oncology Associates PC- HOPE, Tucson, Arizona, United States
University of California Irvine Medical Center, Orange, California, United States
Yale Cancer Center, New Haven, Connecticut, United States
Woodlands Medical Specialists, PA, Pensacola, Florida, United States
Rush University Medical Center, Chicago, Illinois, United States
Quincy Medical Group, Quincy, Illinois, United States
Massachusetts General Hospital, Boston, Massachusetts, United States
GU Research Network-Urology Cancer Center, Omaha, Nebraska, United States
Comprehensive Cancer Centers of Nevada, Las Vegas, Nevada, United States
Laura and Isaac Perlmutter Cancer Center at NYU Langone, New York, New York, United States
Levine Cancer Institute, Charlotte, North Carolina, United States
Willamette Valley Cancer Institute and Research Center, Eugene, Oregon, United States
Abramson Cancer Center of the University of Pennsylvania, 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
Tennessee Oncology, PLLC/The Sarah Cannon Research Institute, Chattanooga, Tennessee, United States
University of Tennessee Medical Center Knoxville, Knoxville, Tennessee, United States
Sarah Cannon Research Institute, Nashville, Tennessee, United States
Tennessee Oncology Nashville, Nashville, Tennessee, United States
Vanderbilt-Ingram Cancer Center, Nashville, Tennessee, United States
Texas Oncology-Memorial City, Houston, Texas, United States
University of Washington, Seattle, Washington, United States
Calvary Mater Newcastle, Waratah, New South Wales, Australia
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
Institut Jules Bordet, Bruxelles, , Belgium
Grand Hopital de Charleroi - Site Notre Dame - Oncology, Charleroi, , Belgium
AZ Maria Middelares Gent, Gent, , Belgium
Universitair Ziekenhuis Gent, Gent, , Belgium
Hopital de Jolimont, Haine-Saint-Paul, , Belgium
AZ Nikolaas, Sint-Niklaas, , Belgium
GZA Sint Augustinus, Wilrijk, , Belgium
Moncton Hospital - Horizon Health Network, Moncton, New Brunswick, Canada
Cancer Centre of Southeastern Ontario at Kingston General Hospital, Kingston, Ontario, Canada
The Ottawa Hospital Cancer Centre, Ottawa, Ontario, Canada
Sunnybrook Health Science Centre, Toronto, Ontario, Canada
CIUSSS de l Est de L Ile de Montreal - Hopital Maisonneuve-Rosemont, Montreal, Quebec, Canada
CHU de Quebec - Hotel-Dieu de Quebec, Québec, Quebec, Canada
Institut de Cancerologie de l Ouest Site Paul Papin, Angers, , France
CHU de Besancon, Besançon, , France
Institut Bergonie, Bordeaux, , France
Centre Jean Perrin, Clermont-Ferrand, , France
Institut Paoli Calmettes, Marseille, , France
Centre d Oncologie de Gentilly, Nancy, , France
Hopital Europeen Georges Pompidou, Paris, , France
Centre Hospitalier Lyon Sud, Pierre-Bénite, , France
Institut Jean Godinot, Reims, , France
CHU de Strasbourg - Nouvel Hopital Civil, Strasbourg, , France
Institut Claudius Regaud, Toulouse, , France
C.H.U. de Tours - Hopital Bretonneau, Tours, , France
Institut Gustave Roussy, Villejuif, , France
Universitaetsklinikum Schleswig-Holstein. Campus Luebeck, Luebeck, Schleswig Holstein, Germany
Universitaetsklinikum Duesseldorf, Duesseldorf, , Germany
Kliniken Essen Mitte, Essen, , Germany
Universitatsklinikum Hamburg-Eppendorf, Hamburg, , Germany
Universitaetsklinikum Jena, Jena, , Germany
Universitaetsklinikum Magdeburg A.o.R., Magdeburg, , Germany
Klinikum rechts der Isar der Technischen Universitat, Muenchen, , Germany
Krankenhaus der Barmherzigen Brueder Trier, Trier, , Germany
Universitaetsklinikum Tuebingen, Tuebingen, , Germany
Cork University Hospital, Cork, , Ireland
Adelaide & Meath Hospital (Incl NCH), Dublin, , Ireland
University College Hospital Galway, Galway, , Ireland
University Hospital Limerick, Limerick, , Ireland
University Hospital Waterford, Waterford, , Ireland
Soroka Medical Center, Be'er Sheva, , Israel
Rambam Health Care Campus, Haifa, , Israel
Meir Medical Center, Kfar Saba, , Israel
Rabin Medical Center, Petach-Tikwa, , Israel
Chaim Sheba Medical Center, Ramat Gan, , Israel
Sourasky Medical Center, Tel Aviv, , Israel
Assaf Harofeh Medical Center, Zerifin, , Israel
Medical Oncology Ospedale San Donato, Arezzo, , Italy
Istituto Tumori Giovanni Paolo II, Bari, , Italy
Istituto Scientifico Romagnolo per Studio e Cura Tumori IRST, Meldola, , Italy
Istituto Nazionale dei Tumori, Milan, , Italy
Istituto Nazionale Tumori IRCCS Fondazione Pascale, Napoli, , Italy
Istituto Oncologico Veneto, Padova, , Italy
Nagoya University Hospital, Nagoya, Aichi, Japan
National Cancer Center Hospital East, Kashiwa, Chiba, Japan
University of Tsukuba Hospital, Tsukuba, Ibaraki, Japan
Nara Medical University Hospital, Kashihara, Nara, Japan
Kindai University Hospital, Osakasayama, Osaka, Japan
Yamaguchi University Hospital, Ube, Yamaguchi, Japan
Tokushima University Hospital, Tokushima, , Japan
Medical Hospital, Tokyo Medical And Dental University, Tokyo, , Japan
The Cancer Institute Hospital of JFCR, Tokyo, , Japan
Chungnam National University Hospital, Daejeon, , Korea, Republic of
Seoul National University Hospital, Seoul, , Korea, Republic of
Severance Hospital Yonsei University Health System, Seoul, , Korea, Republic of
Asan Medical Center, Seoul, , Korea, Republic of
Samsung Medical Center, Seoul, , Korea, Republic of
Amphia Ziekenhuis, Breda, Brabant, Netherlands
Antoni van Leeuwenhoek Ziekenhuis, Amsterdam, , Netherlands
VU University Medical Center, Amsterdam, , Netherlands
Catharina Ziekenhuis, Eindhoven, , Netherlands
University Medical Center Groningen, Groningen, , Netherlands
Erasmus MC, Rotterdam, , Netherlands
Beskidzkie Centrum Onkologii im. Jana Pawla II, Bielsko-Biala, , Poland
Wojewodzkie Centrum Szpitalne Kotliny Jeleniogorskiej, Jelenia Góra, , Poland
Uniwersyteckie Centrum Kliniczne Slaskiego Uniwersytetu Medycznego, Katowice, , Poland
GLOBE Badania Kliniczne Oddzial we Wroclawiu, Komorowice, , Poland
Europejskie Centrum Zdrowia Otwock, Otwock, , Poland
Urologica Praktyka Lekarska Adam Marcheluk, Siedlce, , Poland
Samodzielny Publiczny Szpital Kliniczny Nr 2 PUM w Szczecinie, Szczecin, , Poland
Magodent Szpital Elblaska, Warszawa, , Poland
Szpital Sw. Elzbiety Mokotowskie Centrum Medyczne, Warszawa, , Poland
Leningrad Regional Oncology Dispensary, Saint Petersburg, Leningrad Region, Vsevolozhsky District, Russian Federation
Ivanovo Regional Oncology Dispensary, Ivanovo, , Russian Federation
N.N. Blokhin NMRCO, Moscow, , Russian Federation
Russian Scientific Center of Roentgenoradiology, Moscow, , Russian Federation
National Medical Research Radiological Centre, Moscow, , Russian Federation
Ryazan Regional Clinical Oncology Dispensary, Ryazan, , Russian Federation
Pokrovskaya City Hospital, Saint Petersburg, , Russian Federation
Clinic of Bashkortostan State Medical University, Ufa, , Russian Federation
Hospital Teresa Herrera - Chuac, A Coruña, , Spain
Hospital Infanta Cristina, Badajoz, , Spain
Hospital General Universitari Vall d Hebron, Barcelona, , Spain
ICO L Hospitalet, Hospitalet de Llobregat, , Spain
Hospital Universitario Lucus Augusti, Lugo, , Spain
Xarxa Assistencial Universitaria Manresa, Manresa, , Spain
Consorci Hospitalari Parc Tauli de Sabadell, Sabadell, , Spain
Hospital Virgen del Rocio, Sevilla, , Spain
Taipei Veterans General Hospital, Taipei, Beitou, Taiwan
Chang Gung Medical Foundation - Kaohsiung, Kaohsiung, , Taiwan
China Medical University Hospital, Taichung, , Taiwan
National Cheng Kung University Hospital, Tainan, , Taiwan
National Taiwan University Hospital, Taipei, , Taiwan
MI Dnipr Regional Clinical Hospital named after I.I. Mechnikov, Dnipropetrovsk, , Ukraine
Dnipropetrovsk City Multidiscipline Clinical Hosp.4 of DRC, Dnipropetrovsk, , Ukraine
Kharkiv Regional Clinical Oncology Center, Kharkiv, , Ukraine
Kyiv City Clinical Oncology Center, Kyiv, , Ukraine
MI Odessa Regional Oncological Centre, Odesa, , Ukraine
RMI Sumy Regional Clinical Oncology Dispensary, Sumy, , Ukraine
Royal Marsden NHS Trust, Sutton, Surrey, United Kingdom
The Beatson West of Scotland Cancer Centre, Glasgow, , 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
Name: Mark Jones, MD
Affiliation: Incyte Corporation
Role: STUDY_DIRECTOR