Study of Sacituzumab Govitecan Versus Physician's Choice of Treatment in Participants With Urothelial Cancer That Cannot Be Removed or Has Spread
TROPiCS-04
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
2 other identifiers
interventional
712
26 countries
221
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Jan 2021
Typical duration for phase_3
221 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 19, 2020
CompletedFirst Posted
Study publicly available on registry
August 27, 2020
CompletedStudy Start
First participant enrolled
January 13, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 4, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
July 4, 2025
CompletedAugust 3, 2025
August 1, 2025
4.5 years
August 19, 2020
August 1, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Overall Survival (OS)
OS is defined as time from the date of randomization to the date of death, regardless of cause.
Up to 3.5 years
Secondary Outcomes (13)
Progression-Free Survival (PFS) by Investigator Assessment
Up to 3.5 years
Progression-Free Survival (PFS) by Blinded Independent Central Review (BICR)
Up to 3.5 years
Objective Response Rate (ORR) by Investigator Assessment
Up to 3.5 years
Objective Response Rate (ORR) by BICR
Up to 3.5 years
Clinical Benefit Rate (CBR) by Investigator Assessment
Up to 3.5 years
- +8 more secondary outcomes
Study Arms (2)
Sacituzumab Govitecan-hziy
EXPERIMENTALParticipants will receive 10 mg/kg of sacituzumab govitecan-hziy intravenously on Day 1 and Day 8 of 21-day cycles.
Treatment of Physician's Choice
ACTIVE COMPARATORParticipants will have the choice of receiving paclitaxel, docetaxel, or vinflunine at standard of care (SOC) doses of 175, 75, and 320 mg/m\^2 respectively, every 3 weeks on Day 1 of 21-day cycles.
Interventions
Administered intravenously
Eligibility Criteria
You may qualify if:
- Individuals with histologically documented metastatic or locally advanced unresectable UC defined as
- Tumor (T) 4b, any node (N) or
- Any T, N 2-3 Tumors of upper and lower urinary tract are permitted. Mixed histologic types are allowed if urothelial is the predominant histology.
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) score of 0 or 1.
- Individuals with progression or recurrence following receipt of platinum-containing regimen and anti programmed cell death protein 1/programmed death-ligand 1 (PD-1/PD-L1) therapy for metastatic or locally advanced unresectable disease will be enrolled.
- a. Individuals with recurrence or progression ≤12 months following completion of cisplatin-containing chemotherapy given in the neo-adjuvant/adjuvant setting may utilize that line of therapy to be eligible for the study. The 12-month period is counted from completion of surgical intervention or platinum therapy, respectively. These individuals must receive anti PD-1/PD-L1 therapy in the metastatic or locally advanced unresectable setting to be eligible.
- b. Individuals who received either carboplatin or anti PD-1/PD-L1 therapy in the neo- adjuvant/adjuvant setting will not be able to count that line of therapy towards eligibility for the study.
- c. Cisplatin ineligible individuals who meet one of the below criteria and who were treated with carboplatin in the metastatic or locally advanced unresectable settings may count that line of therapy towards eligibility. They must then have received anti PD-1/PD-L1 therapy in metastatic or locally advanced unresectable setting to be eligible for the study.
- Cisplatin ineligibility is defined as meeting one of the following criteria:
- \. Creatinine Clearance \< 60 mL/min
- \. Grade ≥ 2 Audiometric Hearing Loss
- \. Grade ≥ 2 Peripheral Neuropathy
- \. New York Heart Association (NYHA) Class III heart failure
- \. ECOG PS ≥ 2
- d. Anti PD-1/PD-L1 therapy administered as part of maintenance therapy may be counted towards eligibility for the study
- +10 more criteria
You may not qualify if:
- Females who are pregnant or lactating.
- Have had a prior anti-cancer monoclonal antibody (mAb)/ antibody-drug conjugate (ADC) within 4 weeks prior to Cycle 1 Day 1 (C1D1) or have had prior chemotherapy, targeted small molecule therapy, or radiation therapy within 2 weeks prior to C1D1. Individuals participating in observational studies are eligible.
- Have received prior chemotherapy for UC with any available SOC therapies in the control arm (i.e., both prior paclitaxel and docetaxel in regions where vinflunine is not an approved therapy, or prior paclitaxel, docetaxel and vinflunine in regions where vinflunine is approved and is commercially available).
- Have not recovered (i.e., ≤ Grade 1) from AEs due to previously administered chemotherapeutic agent.
- Note: Individuals with ≤ Grade 2 neuropathy or any grade of alopecia are an exception to this criterion and will qualify for the study.
- Note: If Individuals received major surgery, they must have recovered adequately from the toxicity and/or complications from the intervention prior to starting study therapy.
- Have previously received topoisomerase 1 inhibitors.
- Have an active second malignancy.
- Note: Individuals with a history of malignancy that have been completely treated and with no evidence of active cancer for 3 years prior to enrollment, or individuals with surgically cured tumors with low risk of recurrence are allowed to enroll in the study after discussion with the medical monitor.
- Have active cardiac disease, defined as:
- Myocardial infarction or unstable angina pectoris within 6 months of C1D1.
- History of serious ventricular arrhythmia (i.e., ventricular tachycardia or ventricular fibrillation), high-grade atrioventricular block, or other cardiac arrhythmias requiring anti-arrhythmic medications (except for atrial fibrillation that is well controlled with antiarrhythmic medication); history of QT interval prolongation.
- NYHA Class III or greater congestive heart failure or left ventricular ejection fraction of \<40%.
- Have active chronic inflammatory bowel disease (ulcerative colitis, Crohn's disease) or gastrointestinal (GI) perforation within 6 months of enrollment.
- Have an active serious infection requiring anti-infective therapy (Contact medical monitor for clarification).
- +5 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Gilead Scienceslead
Study Sites (234)
Mayo Clinic - Arizona
Phoenix, Arizona, 85054, United States
UCLA Hematology/ Oncology
Los Angeles, California, 90095, United States
University of California Irvine (UCIMC)
Orange, California, 92868, United States
MedStar Washington Hospital Center
Washington D.C., District of Columbia, 20010, United States
Baptist MD Anderson Cancer Center
Jacksonville, Florida, 32207, United States
Boca Raton Clinical Research Global USA - Plantation
Plantation, Florida, 33322, United States
University of Iowa Hospitals and Clinics
Iowa City, Iowa, 52242, United States
University of Maryland School of Medicine
Baltimore, Maryland, 21201, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215, United States
Roswell Park Cancer Institute
Buffalo, New York, 14263, United States
Weill Cornell Medical College
New York, New York, 10065, United States
Montefiore Medical Center
The Bronx, New York, 10467, United States
Cleveland Clinic
Cleveland, Ohio, 44195, United States
Oklahoma Cancer Specialists and Research Institute (OCSRI)
Tulsa, Oklahoma, 74104, United States
Penn State Hershey Cancer Institute
Hershey, Pennsylvania, 17033, United States
Thompson Oncology Group - Knoxville Downtown
Knoxville, Tennessee, 37916, United States
University Cancer Specialists - Knoxville
Knoxville, Tennessee, 37920, United States
Harold C. Simmons Comprehensive Cancer Center
Dallas, Texas, 75390, United States
Center for Cancer and Blood Disorders
Fort Worth, Texas, 76104, United States
Seattle Cancer Care Alliance (SCCA)
Seattle, Washington, 98109, United States
Summit Cancer Centers
Spokane, Washington, 99208, United States
Chris O'Brien Lifehouse
North Ryde, New South Wales, 2109, Australia
Calvary Mater Newcastle
Waratah, New South Wales, 2298, Australia
Westmead Hospital
Westmead, New South Wales, 2145, Australia
Icon Cancer Centre Wesley
Auchenflower, Queensland, 4066, Australia
Southern Adelaide Local Health Network Incorporated
Bedford Park, South Australia, 5042, Australia
Ashford Cancer Centre Research - ICON Cancer Centre Adelaide
Kurralta Park, South Australia, 5037, Australia
ICON Cancer Centre Hobart
Hobart, Tasmania, 7001, Australia
Monash Health
Clayton, Victoria, 3168, Australia
Austin Health
Heidelberg, Victoria, 3084, Australia
Peter MacCallum Cancer Centre
Melbourne, Victoria, 3000, Australia
Sunshine Hospital
Saint Albans, Victoria, 3021, Australia
Liverpool Hospital
Nedlands, Western Australia, 6009, Australia
Sir Charles Gairdner Hospital
Nedlands, Western Australia, 6009, Australia
Universitätsklinik für Innere Medizin Graz
Graz, 8036, Austria
Ordensklinikum Linz GmbH Barmherzige Schwestern
Linz, 4010, Austria
Krankenhaus Der Barmherzigen Bruder Wien
Vienna, 1020, Austria
Grand Hôpital De Charleroi - Notre Dame
Charleroi, 6000, Belgium
Az Maria Middelares Ghent
Ghent, 9000, Belgium
Universitair Ziekenhuis Gent
Ghent, 9000, Belgium
Universitair Ziekenhuis Leuven
Leuven, 3000, Belgium
Centre Hospitalier Universitaire de Liège
Liège, B-4000, Belgium
Multiprofile Hospital for Active Treatment Heart and Brain EAD
Pleven, 5800, Bulgaria
Specialized Hospital for Active Treatment of Oncological Diseases - Sofia District
Sofia, 1233, Bulgaria
Cross Cancer Institute
Edmonton, T6G 1Z2, Canada
qeii health sciences centre - VG site
Halifax, B3H 2Y9, Canada
Juravinski Hospital and Cancer Centre
Hamilton, L8V 5C2, Canada
London Health Sciences Centre
London, N6A 4G5, Canada
Jewish General Hospital
Montreal, H3T 1E2, Canada
McGill University Health Centre
Montreal, H4A 3J1, Canada
R.S. McLaughlin Durham Regional Cancer Centre
Oshawa, L1G 2B9, Canada
Princess Margaret Cancer Centre
Toronto, M5G 2M9, Canada
British Columbia Cancer Agency-Vancouver Centre
Vancouver, V5Z 4E6, Canada
Peking University First Hospital
Beijing, 100034, China
Chinese People's Liberation Army General Hospital - 301 Hospital
Beijing, 100039, China
Beijing Cancer Hospital
Beijing, 100142, China
Chinese Academy of Medical Sciences Cancer Hospital
Beijing, 100730, China
1st Hospital Jilin University
Changchun, 130021, China
Hunan Cancer Hospital - Xiangya Hospital - Central South University
Changsha, 410013, China
West China Hospital Sichuan University
Chengdu, 610041, China
Sichuan Academy of Medical Sciences & Sichuan Provincial People's Hospital
Chengdu, 610072, China
Chongqing University Cancer Hospital
Chongqing, 400030, China
The First Affiliated Hospital of Fujian Medical University
Fujian, 350005, China
Union Hospital of Fujian Medical University
Fuzhou, 350001, China
Sun Yat-Sen University Cancer Center
Guangzhou, 510060, China
Zhejiang Provincial People's Hospital - Zhaohui
Hangzhou, 310014, China
Cancer Hospital of the University of Chinese Academy of Sciences Zhejiang Cancer Hospital
Hangzhou, 310022, China
Anhui Provincial Cancer Hospital
Hefei, 230031, China
Qilu Hospital of Shandong University
Jinan, 250012, China
The First Affiliated Hospital of Nanchang University
Nanchang, 330006, China
Nanjing Drum Tower Hospital
Nanjing, 210008, China
Liaoning Cancer Hospital and Institute
Shenyang, 110042, China
Tianjin Medical University Cancer Institute & Hospital
Tianjin, 300060, China
Affiliated Tumor Hospital of Xinjiang Medical University
Ürümqi, 830000, China
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, 325000, China
Union Hospital Tongji Medical College Huazhong University of Science and Technology
Wuhan, 430030, China
Clinical Hospital Centre Split
Split, 21000, Croatia
Clinical Hospital Centre "Sestre Milosrdnice"
Zagreb, 10000, Croatia
University Hospital Centre Zagreb
Zagreb, Croatia
Fakultni nemocnice Olomouc
Olomouc, 775 20, Czechia
Urocentrum Praha
Prague, 120 00, Czechia
Ramsay Health Clinic Belharra
Bayonne, France
CHU Saint Andre
Bordeaux, 33075, France
Centre Hospiltalier Universitaire Brest - Hôpital Morvan
Brest, 29200, France
Centre Francois Baclesse
Caen, 14076, France
Centre Jean Perrin
Clermont-Ferrand, 63011, France
Centre Georges- Francois Leclerc
Dijon, 21000, France
Centre Hospitalier Departemental Vendee
La Roche-sur-Yon, 85925 CEDEX 9, France
Centre Oscar Lambret
Lille, 59000, France
Centre Leon Berard
Lyon, 69373, France
Institut Régional du Cancer de Montpellier ICM Val d' Aurelle
Montpellier, 34090, France
Centre Antoine Lacassagne
Nice, 06189, France
Centre Hospitalier Universitaire de Nimes
Nîmes, 30029, France
Hôpital Européen Georges-Pompidou
Paris, 75015, France
Centre Eugene Marquis
Rennes, 35042, France
Centre Hospitalier Privé Saint-Grégoire
Saint-Grégoire, 35760, France
Les Hôpitaux Universitaires de Strasbourg
Strasbourg, 67091, France
Hôpital Foch
Suresnes, 92150, France
Institut Claudius Regaud
Toulouse, 31059, France
Institut Gustave Roussy
Villejuif, 94805, France
High Technology Hospital MedCenter
Batumi, 6000, Georgia
New Hospitals
Tbilisi, 0114, Georgia
L. Managadze National Center of Urology
Tbilisi, 0144, Georgia
Evex Medical corporation
Tbilisi, 0160, Georgia
Jerarsi Clinic
Tbilisi, 0167, Georgia
Universitatsklinik Dresden
Dresden, 01307, Germany
Malteser Waldkrankenhaus Erlangen
Erlangen, 91054, Germany
Universitätsklinikum Essen
Essen, 45147, Germany
Centrum fur Hamatologie und Onkologie Bethanien
Frankfurt am Main, 60389, Germany
Asklepios Klinik Altona
Hamburg, 22763, Germany
Institut Für Versorgungsforschung in Der Onkologie
Koblenz, 56068, Germany
Universitatsklinikum Munster
Münster, 48149, Germany
Studienpraxis Urologie
Nürtingen, 72622, Germany
Universitätsklinikum Tübingen
Tübingen, 72076, Germany
Charité Universitätsmedizin Berlin - Campus Benjamin Franklin
Wien, 1100, Germany
401 General Military Hospital of Athens
Athens, 115 25, Greece
Henry Dunant Hospital
Athens, 115 26, Greece
Alexandra General Hospital
Athens, 11528, Greece
Attikon Hospital
Chaïdári, 124 62, Greece
Regional University General Hospital of Herakleio, Crete
Herakleio, 81352, Greece
University Hospital Of Ioannina
Ioannina, 45332, Greece
University Hospital of Larissa
Larissa, 413 34, Greece
Athens Medical Center
Marousi, 151 25, Greece
University Hospital of Patras
Pátrai, 26332, Greece
Bioclinic - Thessaloniki
Thessaloniki, 546 22, Greece
Theagenio Anticancer Hospital of Thessaloniki
Thessaloniki, 546 39, Greece
Anassa General Clinic
Thessaloniki, 54623, Greece
Interbalkan Medical Center of Thessaloniki
Thessaloniki, 555 35, Greece
Prince of Wales Hospital
Hong Kong, 0, Hong Kong
Queen Mary Hospital
Hong Kong, Hong Kong
Hong Kong United Oncology Centre
Kowloon, Hong Kong
Tallaght University Hospital
Dublin, D24 NR0A, Ireland
University Hospital Waterford
Waterford, X91 ER8E, Ireland
Shamir Medical Center (Assaf Harofeh)
Be’er Ya‘aqov, 7030000, Israel
Rambam Health Care Campus
Haifa, 3109601, Israel
Hadassah University Hospital Ein Kerem
Jerusalem, 91120, Israel
Meir Medical Center
Kfar Saba, 44281, Israel
Rabin Medical Center
Petah Tikva, 4941492, Israel
Tel Aviv Medical Center (Ichilov Hospital)
Tel Aviv, 6423906, Israel
Chaim Sheba Medical Center
Tel Litwinsky, 52621, Israel
Ospedale San Donato
Arezzo, 52100, Italy
Centro di Riferimento Oncologico di Aviano
Aviano, 33081, Italy
Istituto Tumori Bari Giovanni Paolo II - IRCCS
Bari, 70124, Italy
Istituto di Candiolo - Fondazione del Piemonte per l'Oncologia
Candiolo (TO), 10060, Italy
Ospedale Policlinico San Martino
Genova, 16132, Italy
Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori
Meldola, 47014, Italy
Ospedale San Raffaele
Milan, 20132, Italy
Azienda Ospedaliero Universitaria Maggiore Della Carita
Novara, 28100, Italy
Azienda Ospedaliero Universitaria Pisana
Pisa, 56126, Italy
Istituto Regina Elena
Roma, 00144, Italy
Università Campus Bio-Medico di Roma
Rome, 00128, Italy
Ospedale Civile Di Sondrio
Sondrio, 23100, Italy
Azienda Ospedaliera Santa Maria di Terni
Terni, 05100, Italy
Azienda Ospedaliero-Universitaria San Luigi Gonzaga
Torino, 10043, Italy
Ospedale di Trento - Presidio Ospedaliero Santa Chiara
Trento, 38122, Italy
Azienda Ospedaliera Universitaria Integrata Verona
Verona, 37126, Italy
Hospital de Braga
Braga, 4710-243, Portugal
Unidade Local de Saúde da Guarda - Hospital Sousa Martins
Guarda, 6300-858, Portugal
Centro Hospitalar de Leiria - Hospital de Santo André
Leiria, 2410-197, Portugal
Centro Hospitalar de Lisboa Norte - Hospital de Santa Maria
Lisbon, 1649-035, 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, 5000, Portugal
BRCR Medical Center, Inc
San Juan, PR, 00907, Puerto Rico
National University Hospital
Singapore, 119074, Singapore
Icon Cancer Centre Farrer Park
Singapore, 217562, Singapore
Tan Tock Seng Hospital
Singapore, 308433, Singapore
Pusan National University Hospital
Busan, 49241, South Korea
Chungbuk National University Hospital
Cheongju-si, 361-711, South Korea
Chungnam National University Hospital
Daejeon, 35015, South Korea
National Cancer Center
Goyang-si, 10408, South Korea
Pusan National University Yangsan Hospital
Gyeongsangnam-do, 50612, South Korea
Gachon University Gil Medical Center
Incheon, 405-760, South Korea
Seoul National University Bundang Hospital
Seongnam-si, 13620, South Korea
Seoul National University Hospital
Seoul, 03080, South Korea
Severance Hospital, Yonsei University Health System
Seoul, 03722, South Korea
Asan Medical Center
Seoul, 05505, South Korea
Samsung Medical Center
Seoul, 06351, South Korea
The Catholic University of Korea Seoul Saint Mary's Hospital
Seoul, 137-040, South Korea
The Catholic University of Korea Saint Vincent's Hospital
Suwon, 16247, South Korea
Hospital del Mar - Parc de Salut
Barcelona, 08003, Spain
Hospital Universitari Vall D'Hebron
Barcelona, 08035, Spain
Hospital Clinic de Barcelona
Barcelona, 8036, Spain
Hospital Reina Sofia
Córdoba, 14004, Spain
Hospital General Universitario Gregorio Maranon
Madrid, 28007, Spain
Clínica Universidad de Navarra - Madrid
Madrid, 28027, Spain
MD Anderson Cancer Center
Madrid, 28033, Spain
Hospital Universitario Ramon y Cajal
Madrid, 28034, Spain
Hospital Universitario 12 de Octubre
Madrid, 28041, Spain
Hospital Universitario Puerta de Hierro de Majadahonda
Majadahonda, 28222, Spain
Hospital Sant Joan de Déu de Manresa
Manresa, 08243, Spain
Complexo Hospitalario de Ourense (CHOU)
Ourense, 32005, Spain
Clinica Universidad de Navarra
Pamplona, 31008, Spain
Hospital Universitario Marqués de Valdecilla
Santander, 39008, Spain
Hospital Universitario Virgen del Rocio
Seville, 41013, Spain
Álvaro Cunqueiro Hospital
Vigo, 36213, Spain
Länssjukhuset Ryhov
Jönköping, 553 05, Sweden
Universitetssjukhuset i Linköping
Linköping, 581 85, Sweden
Karolinska Universitetssjukhuset - Solna
Stockholm, 171 76, Sweden
University Hospital Basel
Basel, 4051, Switzerland
Istituto Oncologico Della Svizzera Italiana (IOSI)
Bellinzona, 6500, Switzerland
University of Bern
Bern, 3010, Switzerland
Hôpitaux Universitaires de Genève
Geneva, 1205, Switzerland
Universitaetsspital Zurich - Klinik fur Medizinische Onkologie und Hematologie
Zurich, 8091, Switzerland
Chiayi Chang Gung Memorial Hospital
Buzi, 613, Taiwan
Kaohsiung Veterans General Hospital
Kaohsiung City, 813, Taiwan
Kaohsiung Chang Gung Memorial Hospital
Kaohsiung City, 833, Taiwan
Taipei Tzu Chi General Hospital
New Taipei City, 231405, Taiwan
China Medical University Hospital
Taichung, 40447, Taiwan
Taichung Veterans General Hospital
Taichung, Taiwan 407, Taiwan
National Cheng Kung University Hospital
Tainan, 70403, Taiwan
National Taiwan University Hospital
Taipei, 100, Taiwan
Taipei Veterans General Hospital
Taipei, 11217, Taiwan
Chang Gung Memorial Hospital - Linkou Branch
Taoyuan District, 333, Taiwan
Hacettepe Universitesi Tip Fakultesi- Kanser Enstitusu
Ankara, 6230, Turkey (Türkiye)
Trakya Universitesi Saglik Arastirma ve Uygulama Merkezi
Edirne, 22030, Turkey (Türkiye)
Bagcilar Medipol Mega Universite Hastanesi
Istanbul, 34214, Turkey (Türkiye)
Istanbul Acibadem University Maslak Hospital
Istanbul, 34457, Turkey (Türkiye)
T.C. Saglik Bakanligi Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi
Istanbul, 34722, Turkey (Türkiye)
Medical Park Izmır Hastanesi
Izmir, 35575, Turkey (Türkiye)
Cebeci Hastanesi
Mamak, 6620, Turkey (Türkiye)
VKV Amerikan Hastanesi Department of Oncology
Şişli, 34365, Turkey (Türkiye)
University Hospitals Birmingham NHS Foundation Trust
Birmingham, B15 2WB, United Kingdom
Dorset County Hospital NHS Foundation Trust
Dorchester, DT1 2JY, United Kingdom
NHS Greater Glasgow and Clyde
Glasgow, G12 0YN, United Kingdom
Barts Health NHS Trust
London, EC1A 7BE, United Kingdom
Guys and Saint Thomas NHS Foundation Trust, Guy's Hospital
London, SE1 9RT, United Kingdom
Sarah Cannon Research Institute London
London, W1G 6AD, United Kingdom
The Christie NHS Foundation Trust
Manchester, M20 4BX, United Kingdom
East and North Hertfordshire NHS Trust
Middlesex, HA6 2RN, United Kingdom
Oxford University Hospitals NHS Foundation Trust
Oxford, OX3 7LE, United Kingdom
Swansea Bay University Health Board
Port Talbot, SA12 7BR, United Kingdom
Royal Preston Hospital
Preston, PR2 9HT, United Kingdom
The Royal Marsden NHS Foundation Trust
Surrey, SM2 5PT, United Kingdom
The Royal Wolverhampton NHS Trust
Wolverhampton, WV10 0QP, United Kingdom
Related Publications (2)
Powles T, Tagawa ST, Vulsteke C, Gross-Goupil M, Park SH, Necchi A, De Santis M, Duran I, Morales-Barrera R, Guo J, Sternberg CN, Bellmunt J, Goebell PJ, Kovalenko M, Boateng F, Sierecki M, Wang L, Sima CS, Waldes J, Bangs R, Loriot Y, Grivas P. A plain language summary of the TROPiCS-04 study: sacituzumab govitecan use after platinum-based chemotherapy and immunotherapy in people with locally advanced or metastatic cancer of the bladder, urethra, or upper urinary tract. Future Oncol. 2025 Dec;21(28):3593-3610. doi: 10.1080/14796694.2025.2579003. Epub 2025 Nov 23.
PMID: 41277126DERIVEDPowles T, Tagawa S, Vulsteke C, Gross-Goupil M, Park SH, Necchi A, De Santis M, Duran I, Morales-Barrera R, Guo J, Sternberg CN, Bellmunt J, Goebell PJ, Kovalenko M, Boateng F, Sierecki M, Wang L, Sima CS, Waldes J, Loriot Y, Grivas P. Sacituzumab govitecan in advanced urothelial carcinoma: TROPiCS-04, a phase III randomized trial. Ann Oncol. 2025 May;36(5):561-571. doi: 10.1016/j.annonc.2025.01.011. Epub 2025 Feb 11.
PMID: 39934055DERIVED
Related Links
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Gilead Study Director
Gilead Sciences
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 19, 2020
First Posted
August 27, 2020
Study Start
January 13, 2021
Primary Completion
July 4, 2025
Study Completion
July 4, 2025
Last Updated
August 3, 2025
Record last verified: 2025-08
Data Sharing
- IPD Sharing
- Will not share