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Spots Global Cancer Trial Database for Study of Sacituzumab Govitecan-hziy (IMMU-132) Versus Treatment of Physician's Choice in Participants With Metastatic or Locally Advanced Unresectable Urothelial Cancer

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Trial Identification

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

Study Description

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:

Keywords

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

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

Contact Details

Name: Gilead Study Director

Affiliation: Gilead Sciences

Role: STUDY_DIRECTOR

Useful links and downloads for this trial

Clinicaltrials.gov

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