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Brief Title: Study of Sacituzumab Govitecan-hziy (IMMU-132) Versus Treatment of Physician's Choice in Participants With Metastatic or Locally Advanced Unresectable Urothelial Cancer
Official Title: A Randomized Open-Label Phase III Study of Sacituzumab Govitecan Versus Treatment of Physician's Choice in Subjects With Metastatic or Locally Advanced Unresectable Urothelial Cancer
Study ID: NCT04527991
Brief Summary: The primary objective of this study is to assess overall survival (OS) with sacituzumab govitecan-hziy in comparison with treatment of physician's choice (TPC) in participants with metastatic or locally advanced unresectable urothelial cancer (UC).
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Mayo Clinic - Arizona, Phoenix, Arizona, United States
UCLA Hematology/ Oncology, Los Angeles, California, United States
University of California Irvine (UCIMC), Orange, California, United States
MedStar Washington Hospital Center, Washington, District of Columbia, United States
Baptist MD Anderson Cancer Center, Jacksonville, Florida, United States
Boca Raton Clinical Research Global USA - Plantation, Plantation, Florida, United States
University of Iowa Hospitals and Clinics, Iowa City, Iowa, United States
University of Maryland School of Medicine, Baltimore, Maryland, United States
Beth Israel Deaconess Medical Center, Boston, Massachusetts, United States
Montefiore Medical Center, Bronx, New York, United States
Roswell Park Cancer Institute, Buffalo, New York, United States
Weill Cornell Medical College, New York, New York, United States
Cleveland Clinic, Cleveland, Ohio, United States
Oklahoma Cancer Specialists and Research Institute (OCSRI), Tulsa, Oklahoma, United States
Penn State Hershey Cancer Institute, Hershey, Pennsylvania, United States
Thompson Oncology Group - Knoxville Downtown, Knoxville, Tennessee, United States
University Cancer Specialists - Knoxville, Knoxville, Tennessee, United States
Harold C. Simmons Comprehensive Cancer Center, Dallas, Texas, United States
Center for Cancer and Blood Disorders, Fort Worth, Texas, United States
Seattle Cancer Care Alliance (SCCA), Seattle, Washington, United States
Summit Cancer Centers, Spokane, Washington, United States
Chris O'Brien Lifehouse, North Ryde, New South Wales, Australia
Calvary Mater Newcastle, Waratah, New South Wales, Australia
Westmead Hospital, Westmead, New South Wales, Australia
Icon Cancer Centre Wesley, Auchenflower, Queensland, Australia
Southern Adelaide Local Health Network Incorporated, Bedford Park, South Australia, Australia
Ashford Cancer Centre Research - ICON Cancer Centre Adelaide, Kurralta Park, South Australia, Australia
ICON Cancer Centre Hobart, Hobart, Tasmania, Australia
Monash Health, Clayton, Victoria, Australia
Austin Health, Heidelberg, Victoria, Australia
Peter MacCallum Cancer Centre, Melbourne, Victoria, Australia
Sunshine Hospital, Saint Albans, Victoria, Australia
Liverpool Hospital, Nedlands, Western Australia, Australia
Sir Charles Gairdner Hospital, Nedlands, Western Australia, Australia
Universitätsklinik für Innere Medizin Graz, Graz, , Austria
Ordensklinikum Linz GmbH Barmherzige Schwestern, Linz, , Austria
Krankenhaus Der Barmherzigen Bruder Wien, Wien, , Austria
Grand Hôpital De Charleroi - Notre Dame, Charleroi, , Belgium
Az Maria Middelares Ghent, Gent, , Belgium
Universitair Ziekenhuis Gent, Gent, , Belgium
Universitair Ziekenhuis Leuven, Leuven, , Belgium
Centre Hospitalier Universitaire de Liège, Liège, , Belgium
Multiprofile Hospital for Active Treatment Heart and Brain EAD, Pleven, , Bulgaria
Specialized Hospital for Active Treatment of Oncological Diseases - Sofia District, Sofia, , Bulgaria
Cross Cancer Institute, Edmonton, , Canada
qeii health sciences centre - VG site, Halifax, , Canada
Juravinski Hospital and Cancer Centre, Hamilton, , Canada
London Health Sciences Centre, London, , Canada
Jewish General Hospital, Montréal, , Canada
McGill University Health Centre, Montréal, , Canada
R.S. McLaughlin Durham Regional Cancer Centre, Oshawa, , Canada
Princess Margaret Cancer Centre, Toronto, , Canada
British Columbia Cancer Agency-Vancouver Centre, Vancouver, , Canada
Peking University First Hospital, Beijing, , China
Chinese People's Liberation Army General Hospital - 301 Hospital, Beijing, , China
Beijing Cancer Hospital, Beijing, , China
Chinese Academy of Medical Sciences Cancer Hospital, Beijing, , China
1st Hospital Jilin University, Changchun, , China
Hunan Cancer Hospital - Xiangya Hospital - Central South University, Changsha, , China
West China Hospital Sichuan University, Chengdu, , China
Sichuan Academy of Medical Sciences & Sichuan Provincial People's Hospital, Chengdu, , China
Chongqing University Cancer Hospital, Chongqing, , China
The First Affiliated Hospital of Fujian Medical University, Fujian, , China
Union Hospital of Fujian Medical University, Fuzhou, , China
Sun Yat-Sen University Cancer Center, Guangzhou, , China
Zhejiang Provincial People's Hospital - Zhaohui, Hangzhou, , China
Cancer Hospital of the University of Chinese Academy of Sciences Zhejiang Cancer Hospital, Hangzhou, , China
Anhui Provincial Cancer Hospital, Hefei, , China
Qilu Hospital of Shandong University, Jinan, , China
The First Affiliated Hospital of Nanchang University, Nanchang, , China
Nanjing Drum Tower Hospital, Nanjing, , China
Liaoning Cancer Hospital and Institute, Shenyang, , China
Tianjin Medical University Cancer Institute & Hospital, Tianjin, , China
Affiliated Tumor Hospital of Xinjiang Medical University, Urumqi, , China
The First Affiliated Hospital of Wenzhou Medical University, Wenzhou, , China
Union Hospital Tongji Medical College Huazhong University of Science and Technology, Wuhan, , China
Clinical Hospital Centre Split, Split, , Croatia
Clinical Hospital Centre "Sestre Milosrdnice", Zagreb, , Croatia
University Hospital Centre Zagreb, Zagreb, , Croatia
Fakultni nemocnice Olomouc, Olomouc, , Czechia
Urocentrum Praha, Praha 2, , Czechia
Ramsay Health Clinic Belharra, Bayonne, , France
CHU Saint Andre, Bordeaux, , France
Centre Hospiltalier Universitaire Brest - Hôpital Morvan, Brest, , France
Centre Francois Baclesse, Caen Cedex 5, , France
Centre Jean Perrin, Clermont-Ferrand, , France
Centre Georges- Francois Leclerc, Dijon, , France
Centre Hospitalier Departemental Vendee, La Roche-Sur-Yon Cedex, , France
Centre Oscar Lambret, Lille, , France
Centre Leon Berard, Lyon, , France
Institut Régional du Cancer de Montpellier ICM Val d' Aurelle, Montpellier, , France
Centre Antoine Lacassagne, Nice Cedex 2, , France
Centre Hospitalier Universitaire de Nimes, Nimes, , France
Hôpital Européen Georges-Pompidou, Paris, , France
Centre Eugene Marquis, Rennes Cedex, , France
Centre Hospitalier Privé Saint-Grégoire, Saint-Grégoire, , France
Les Hôpitaux Universitaires de Strasbourg, Strasbourg cedex, , France
Hôpital Foch, Suresnes, , France
Institut Claudius Regaud, Toulouse Cedex 9, , France
Institut Gustave Roussy, Villejuif Cedex, , France
High Technology Hospital MedCenter, Batumi, , Georgia
New Hospitals, Tbilisi, , Georgia
L. Managadze National Center of Urology, Tbilisi, , Georgia
Evex Medical corporation, Tbilisi, , Georgia
Jerarsi Clinic, Tbilisi, , Georgia
Universitatsklinik Dresden, Dresden, , Germany
Malteser Waldkrankenhaus Erlangen, Erlangen, , Germany
Universitätsklinikum Essen, Essen, , Germany
Centrum fur Hamatologie und Onkologie Bethanien, Frankfurt/Main, , Germany
Asklepios Klinik Altona, Hamburg, , Germany
Institut Für Versorgungsforschung in Der Onkologie, Koblenz, , Germany
Universitatsklinikum Munster, Münster, , Germany
Studienpraxis Urologie, Nürtingen, , Germany
Universitätsklinikum Tübingen, Tübingen, , Germany
Charité Universitätsmedizin Berlin - Campus Benjamin Franklin, Wien, , Germany
401 General Military Hospital of Athens, Athens, , Greece
Henry Dunant Hospital, Athens, , Greece
Alexandra General Hospital, Athens, , Greece
Attikon Hospital, Chaidari, , Greece
Regional University General Hospital of Herakleio, Crete, Herakleio, , Greece
University Hospital Of Ioannina, Ioannina, , Greece
University Hospital of Larissa, Larisa, , Greece
Athens Medical Center, Maroussi, , Greece
University Hospital of Patras, Patra, , Greece
Bioclinic - Thessaloniki, Thessaloniki, , Greece
Theagenio Anticancer Hospital of Thessaloniki, Thessaloniki, , Greece
Anassa General Clinic, Thessaloniki, , Greece
Interbalkan Medical Center of Thessaloniki, Thessaloniki, , Greece
Prince of Wales Hospital, Hong Kong, , Hong Kong
Queen Mary Hospital, Hong Kong, , Hong Kong
Hong Kong United Oncology Centre, Kowloon, , Hong Kong
Tallaght University Hospital, Dublin, , Ireland
University Hospital Waterford, Waterford, , Ireland
Shamir Medical Center (Assaf Harofeh), Be'er Ya'akov, , Israel
Rambam Health Care Campus, Haifa, , Israel
Hadassah University Hospital Ein Kerem, Jerusalem, , Israel
Meir Medical Center, Kfar-Sava, , Israel
Rabin Medical Center, Petach Tikva, , Israel
Tel Aviv Medical Center (Ichilov Hospital), Tel Aviv, , Israel
Chaim Sheba Medical Center, Tel Hashomer, , Israel
Ospedale San Donato, Arezzo, , Italy
Centro di Riferimento Oncologico di Aviano, Aviano, , Italy
Istituto Tumori Bari Giovanni Paolo II - IRCCS, Bari, , Italy
Istituto di Candiolo - Fondazione del Piemonte per l'Oncologia, Candiolo (TO), , Italy
Ospedale Policlinico San Martino, Genova, , Italy
Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori, Meldola, , Italy
Ospedale San Raffaele, Milan, , Italy
Azienda Ospedaliero Universitaria Maggiore Della Carita, Novara, , Italy
Azienda Ospedaliero Universitaria Pisana, Pisa, , Italy
Istituto Regina Elena, Roma, , Italy
Università Campus Bio-Medico di Roma, Rome, , Italy
Ospedale Civile Di Sondrio, Sondrio, , Italy
Azienda Ospedaliera Santa Maria di Terni, Terni, , Italy
Azienda Ospedaliero-Universitaria San Luigi Gonzaga, Torino, , Italy
Ospedale di Trento - Presidio Ospedaliero Santa Chiara, Trento, , Italy
Azienda Ospedaliera Universitaria Integrata Verona, Verona, , Italy
Pusan National University Hospital, Busan-si, , Korea, Republic of
Chungbuk National University Hospital, Cheongju, , Korea, Republic of
Chungnam National University Hospital, Daejeon, , Korea, Republic of
National Cancer Center, Goyang-si, , Korea, Republic of
Pusan National University Yangsan Hospital, Gyeongsangnam-do, , Korea, Republic of
Gachon University Gil Medical Center, Incheon, , Korea, Republic of
Seoul National University Bundang Hospital, Seongnam-si, , 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
The Catholic University of Korea Seoul Saint Mary's Hospital, Seoul, , Korea, Republic of
The Catholic University of Korea Saint Vincent's Hospital, Suwon, , Korea, Republic of
Hospital de Braga, Braga, , Portugal
Unidade Local de Saúde da Guarda - Hospital Sousa Martins, Guarda, , Portugal
Centro Hospitalar de Leiria - Hospital de Santo André, Leiria, , Portugal
Centro Hospitalar de Lisboa Norte - Hospital de Santa Maria, Lisbon, , Portugal
Instituto Portugues de Oncologia do Porto Francisco Gentil, E.P.E, Porto, , Portugal
Centro Hospitalar de Tras-os-Montes e Alto Douro, Vila Real, , Portugal
BRCR Medical Center, Inc, San Juan, , Puerto Rico
National University Hospital, Singapore, , Singapore
Icon Cancer Centre Farrer Park, Singapore, , Singapore
Tan Tock Seng Hospital, Singapore, , Singapore
Hospital del Mar - Parc de Salut, Barcelona, , Spain
Hospital Universitari Vall D'Hebron, Barcelona, , Spain
Hospital Clinic de Barcelona, Barcelona, , Spain
Hospital Reina Sofia, Córdoba, , Spain
Hospital General Universitario Gregorio Maranon, Madrid, , Spain
Clínica Universidad de Navarra - Madrid, Madrid, , Spain
MD Anderson Cancer Center, Madrid, , Spain
Hospital Universitario Ramon y Cajal, Madrid, , Spain
Hospital Universitario 12 de Octubre, Madrid, , Spain
Hospital Universitario Puerta de Hierro de Majadahonda, Majadahonda, , Spain
Hospital Sant Joan de Déu de Manresa, Manresa, , Spain
Complexo Hospitalario de Ourense (CHOU), Ourense, , Spain
Clinica Universidad de Navarra, Pamplona, , Spain
Hospital Universitario Marqués de Valdecilla, Santander, , Spain
Hospital Universitario Virgen del Rocio, Sevilla, , Spain
Álvaro Cunqueiro Hospital, Vigo, , Spain
Länssjukhuset Ryhov, Jönköping, , Sweden
Universitetssjukhuset i Linköping, Linköping, , Sweden
Karolinska Universitetssjukhuset - Solna, Stockholm, , Sweden
University Hospital Basel, Basel, , Switzerland
Istituto Oncologico Della Svizzera Italiana (IOSI), Bellinzona, , Switzerland
University of Bern, Bern, , Switzerland
Hôpitaux Universitaires de Genève, Geneva, , Switzerland
Universitaetsspital Zurich - Klinik fur Medizinische Onkologie und Hematologie, Zurich, , Switzerland
Kaohsiung Veterans General Hospital, Kaohsiung, , Taiwan
Kaohsiung Chang Gung Memorial Hospital, Kaohsiung, , Taiwan
Taipei Tzu Chi General Hospital, New Taipei City, , Taiwan
Chiayi Chang Gung Memorial Hospital, Puzi, , Taiwan
China Medical University Hospital, Taichung City, , Taiwan
Taichung Veterans General Hospital, Taichung, , Taiwan
National Cheng Kung University Hospital, Tainan, , Taiwan
National Taiwan University Hospital, Taipei City, , Taiwan
Taipei Veterans General Hospital, Taipei City, , Taiwan
Chang Gung Memorial Hospital - Linkou Branch, Taoyuan, , Taiwan
Hacettepe Universitesi Tip Fakultesi- Kanser Enstitusu, Ankara, , Turkey
Trakya Universitesi Saglik Arastirma ve Uygulama Merkezi, Edirne, , Turkey
Bagcilar Medipol Mega Universite Hastanesi, Istanbul, , Turkey
Istanbul Acibadem University Maslak Hospital, Istanbul, , Turkey
T.C. Saglik Bakanligi Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi, Istanbul, , Turkey
Medical Park Izmır Hastanesi, İzmir, , Turkey
Cebeci Hastanesi, Mamak, , Turkey
VKV Amerikan Hastanesi Department of Oncology, Şişli, , Turkey
University Hospitals Birmingham NHS Foundation Trust, Birmingham, , United Kingdom
Dorset County Hospital NHS Foundation Trust, Dorchester, , United Kingdom
NHS Greater Glasgow and Clyde, Glasgow, , United Kingdom
Barts Health NHS Trust, London, , United Kingdom
Guys and Saint Thomas NHS Foundation Trust, Guy's Hospital, London, , United Kingdom
Sarah Cannon Research Institute London, London, , United Kingdom
The Christie NHS Foundation Trust, Manchester, , United Kingdom
East and North Hertfordshire NHS Trust, Middlesex, , United Kingdom
Oxford University Hospitals NHS Foundation Trust, Oxford, , United Kingdom
Swansea Bay University Health Board, Port Talbot, , United Kingdom
Royal Preston Hospital, Preston, , United Kingdom
The Royal Marsden NHS Foundation Trust, Surrey, , United Kingdom
The Royal Wolverhampton NHS Trust, Wolverhampton, , United Kingdom
Name: Gilead Study Director
Affiliation: Gilead Sciences
Role: STUDY_DIRECTOR