Spots Global Cancer Trial Database for Pembrolizumab + Epacadostat vs Pembrolizumab + Placebo in Recurrent or Progressive Metastatic Urothelial Carcinoma
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Trial Identification
Brief Title: Pembrolizumab + Epacadostat vs Pembrolizumab + Placebo in Recurrent or Progressive Metastatic Urothelial Carcinoma
Official Title: A Phase 3 Randomized, Double-Blind Clinical Study of Pembrolizumab + Epacadostat vs Pembrolizumab + Placebo as a Treatment for Recurrent or Progressive Metastatic Urothelial Carcinoma in Patients Who Have Failed a First-Line Platinum-containing Chemotherapy Regimen for Advanced/Metastatic Disease (KEYNOTE-698/ECHO-303)
Study ID: NCT03374488
Conditions
Study Description
Brief Summary: The purpose of this study was to evaluate the efficacy and safety of pembrolizumab + epacadostat vs pembrolizumab + placebo as a treatment for recurrent or progressive metastatic urothelial carcinoma in patients who have failed a first-line platinum-containing chemotherapy regimen for advanced/metastatic disease.
Detailed Description:
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
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, Montréal, Quebec, Canada
CIUSSS de l Est de L Ile de Montreal - Hopital Maisonneuve-Rosemont, Montréal, Quebec, Canada
CHU de Quebec-Universite Laval-Hotel Dieu de Quebec, Québec, Quebec, Canada
CHU de Quebec-Universite Laval-Hotel Dieu de Quebec, 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, Luebeck, Schleswig Holstein, Germany
Universitaetsklinikum Duesseldorf, Duesseldorf, , 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
Universitaetsklinikum Tuebingen, Tuebingen, , 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, Be'er Sheva, , Israel
Rambam Medical Center, 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 Scientifico Romagnolo per lo Studio e la Cura dei Tumori, Meldola, , Italy
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano, , Italy
Istituto Nazionale Tumori 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
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
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
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, 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 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, , Taiwan
China Medical University Hospital, Taichung, , Taiwan
National Cheng Kung University Hospital, Tainan, , Taiwan
National Taiwan University Hospital, Taipei, , Taiwan
Taipei Veterans General Hospital, Taipei, , Taiwan
Adana Sehir Hastanesi, Adana, , Turkey
Dr. Abdurrahman Yurtaslan Ankara Onkoloji EAH, Ankara, , Turkey
Akdeniz Universitesi Tip Fakultesi, Antalya, , Turkey
Pamukkale Unv. Tip Fak., Denizli, , Turkey
Trakya Universitesi Tip Fakultesi, Edirne, , Turkey
Marmara Universitesi Pendik Arastirma ve Uyg. Hastanesi, Istanbul, , Turkey
Dokuz Eylul University Faculty of Medicine, İzmir, , Turkey
Samsun Medical Park Hastanesi, Samsun, , Turkey
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
Contact Details
Name: Mark Jones, MD
Affiliation: Incyte Corporation
Role: STUDY_DIRECTOR
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