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

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).

Study Overview

• Status: Completed
• Conditions: Locally Advanced or Metastatic Unresectable Urothelial Cancer
• Intervention / Treatment: Drug: Docetaxel; Drug: Sacituzumab Govitecan-hziy; Drug: Paclitaxel; Drug: Vinflunine

• Study Type: Interventional
• Enrollment (Actual): 712
• Phase: Phase 3

Contacts and Locations

Study Locations

• Australia
  • New South Wales
    • North Ryde, New South Wales, Australia, 2109
      • Chris O'Brien Lifehouse
    • Waratah, New South Wales, Australia, 2298
      • Calvary Mater Newcastle
    • Westmead, New South Wales, Australia, 2145
      • Westmead Hospital
  • Queensland
    • Auchenflower, Queensland, Australia, 4066
      • Icon Cancer Centre Wesley
  • South Australia
    • Bedford Park, South Australia, Australia, 5042
      • Southern Adelaide Local Health Network Incorporated
    • Kurralta Park, South Australia, Australia, 5037
      • Ashford Cancer Centre Research - ICON Cancer Centre Adelaide
  • Tasmania
    • Hobart, Tasmania, Australia, 7001
      • Icon Cancer Centre Hobart
  • Victoria
    • Clayton, Victoria, Australia, 3168
      • Monash Health
    • Heidelberg, Victoria, Australia, 3084
      • Austin Health
    • Melbourne, Victoria, Australia, 3000
      • Peter Maccallum Cancer Centre
    • Saint Albans, Victoria, Australia, 3021
      • Sunshine Hospital
  • Western Australia
    • Nedlands, Western Australia, Australia, 6009
      • Sir Charles Gairdner Hospital
    • Nedlands, Western Australia, Australia, 6009
      • Liverpool Hospital
• Austria
  • Graz, Austria, 8036
    • Universitätsklinik für Innere Medizin Graz
  • Linz, Austria, 4010
    • Ordensklinikum Linz GmbH Barmherzige Schwestern
  • Wien, Austria, 1020
    • Krankenhaus der Barmherzigen Brüder Wien
• Belgium
  • Charleroi, Belgium, 6000
    • Grand Hopital de Charleroi - Notre Dame
  • Gent, Belgium, 9000
    • Universitair Ziekenhuis Gent
  • Gent, Belgium, 9000
    • Az Maria Middelares Ghent
  • Leuven, Belgium, 3000
    • Universitair Ziekenhuis Leuven
  • Liège, Belgium, B-4000
    • Centre Hospitalier Universitaire de Liège
• Bulgaria
  • Pleven, Bulgaria, 5800
    • Multiprofile Hospital for Active Treatment Heart and Brain EAD
  • Sofia, Bulgaria, 1233
    • Specialized Hospital for Active Treatment of Oncological Diseases - Sofia District
• Canada
  • Edmonton, Canada, T6G 1Z2
    • Cross Cancer Institute
  • Halifax, Canada, B3H 2Y9
    • qeii health sciences centre - VG site
  • Hamilton, Canada, L8V 5C2
    • Juravinski Hospital and Cancer Centre
  • London, Canada, N6A 4G5
    • London Health Sciences Centre
  • Montréal, Canada, H3T 1E2
    • Jewish General Hospital
  • Montréal, Canada, H4A 3J1
    • McGill University Health Centre
  • Oshawa, Canada, L1G 2B9
    • R.S. McLaughlin Durham Regional Cancer Centre
  • Toronto, Canada, M5G 2M9
    • Princess Margaret Cancer Centre
  • Vancouver, Canada, V5Z 4E6
    • British Columbia Cancer Agency-Vancouver Centre
• China
  • Beijing, China, 100142
    • Beijing Cancer Hospital
  • Beijing, China, 100034
    • Peking University First Hospital
  • Beijing, China, 100039
    • Chinese People's Liberation Army General Hospital - 301 Hospital
  • Beijing, China, 100730
    • Chinese Academy of Medical Sciences Cancer Hospital
  • Changchun, China, 130021
    • 1st Hospital Jilin University
  • Changsha, China, 410013
    • Hunan Cancer Hospital - Xiangya Hospital - Central South University
  • Chengdu, China, 610041
    • West China Hospital Sichuan University
  • Chengdu, China, 610072
    • Sichuan Academy of Medical Sciences & Sichuan Provincial People's Hospital
  • Chongqing, China, 400030
    • Chongqing University Cancer Hospital
  • Fujian, China, 350005
    • The First Affiliated Hospital of Fujian Medical University
  • Fuzhou, China, 350001
    • Union Hospital of Fujian Medical University
  • Guangzhou, China, 510060
    • Sun Yat-sen University Cancer Center
  • Hangzhou, China, 310014
    • Zhejiang Provincial People's Hospital - Zhaohui
  • Hangzhou, China, 310022
    • Cancer Hospital of the University of Chinese Academy of Sciences Zhejiang Cancer Hospital
  • Hefei, China, 230031
    • Anhui Provincial Cancer Hospital
  • Jinan, China, 250012
    • Qilu Hospital of Shandong University
  • Nanchang, China, 330006
    • The First Affiliated Hospital of Nanchang University
  • Nanjing, China, 210008
    • Nanjing Drum Tower Hospital
  • Shenyang, China, 110042
    • Liaoning Cancer Hospital and Institute
  • Tianjin, China, 300060
    • Tianjin Medical University Cancer Institute & Hospital
  • Urumqi, China, 830000
    • Affiliated Tumor Hospital of Xinjiang Medical University
  • Wenzhou, China, 325000
    • The First Affiliated Hospital of Wenzhou Medical University
  • Wuhan, China, 430030
    • Union Hospital Tongji Medical College Huazhong University of Science and Technology
• Croatia
  • Split, Croatia, 21000
    • Clinical Hospital Centre Split
  • Zagreb, Croatia
    • University Hospital Centre Zagreb
  • Zagreb, Croatia, 10000
    • Clinical Hospital Centre "Sestre Milosrdnice"
• Czechia
  • Olomouc, Czechia, 775 20
    • Fakultni nemocnice Olomouc
  • Praha 2, Czechia, 120 00
    • Urocentrum Praha
• France
  • Bayonne, France
    • Ramsay Health Clinic Belharra
  • Bordeaux, France, 33075
    • CHU Saint Andre
  • Brest, France, 29200
    • Centre Hospiltalier Universitaire Brest - Hôpital Morvan
  • Caen Cedex 5, France, 14076
    • Centre Francois Baclesse
  • Clermont-Ferrand, France, 63011
    • Centre Jean Perrin
  • Dijon, France, 21000
    • Centre Georges- Francois Leclerc
  • La Roche-Sur-Yon Cedex, France, 85925 CEDEX 9
    • Centre Hospitalier Départemental Vendée
  • Lille, France, 59000
    • Centre Oscar Lambret
  • Lyon, France, 69373
    • Centre Leon Berard
  • Montpellier, France, 34090
    • Institut Régional du Cancer de Montpellier ICM Val d' Aurelle
  • Nice Cedex 2, France, 06189
    • Centre Antoine Lacassagne
  • Nimes, France, 30029
    • Centre Hospitalier Universitaire de Nīmes
  • Paris, France, 75015
    • Hôpital Européen Georges-Pompidou
  • Rennes Cedex, France, 35042
    • Centre Eugène Marquis
  • Saint-Grégoire, France, 35760
    • Centre Hospitalier Prive Saint-Gregoire
  • Strasbourg cedex, France, 67091
    • Les Hôpitaux Universitaires de Strasbourg
  • Suresnes, France, 92150
    • Hopital FOCH
  • Toulouse Cedex 9, France, 31059
    • Institut Claudius Regaud
  • Villejuif Cedex, France, 94805
    • Institut Gustave Roussy
• Georgia
  • Batumi, Georgia, 6000
    • High Technology Hospital Medcenter
  • Tbilisi, Georgia, 0114
    • New Hospitals
  • Tbilisi, Georgia, 0144
    • L. Managadze National Center of Urology
  • Tbilisi, Georgia, 0160
    • Evex Medical corporation
  • Tbilisi, Georgia, 0167
    • Jerarsi Clinic
• Germany
  • Dresden, Germany, 01307
    • Universitätsklinik Dresden
  • Erlangen, Germany, 91054
    • Malteser Waldkrankenhaus Erlangen
  • Essen, Germany, 45147
    • Universitätsklinikum Essen
  • Frankfurt/Main, Germany, 60389
    • Centrum für Hämatologie und Onkologie Bethanien
  • Hamburg, Germany, 22763
    • Asklepios Klinik Altona
  • Koblenz, Germany, 56068
    • Institut für Versorgungsforschung in der Onkologie
  • Münster, Germany, 48149
    • Universitätsklinikum Münster
  • Nürtingen, Germany, 72622
    • Studienpraxis Urologie
  • Tübingen, Germany, 72076
    • Universitätsklinikum Tübingen
  • Wien, Germany, 1100
    • Charité Universitätsmedizin Berlin - Campus Benjamin Franklin
• Greece
  • Athens, Greece, 11528
    • Alexandra General Hospital
  • Athens, Greece, 115 25
    • 401 General Military Hospital of Athens
  • Athens, Greece, 115 26
    • Henry Dunant Hospital
  • Chaidari, Greece, 124 62
    • Attikon Hospital
  • Herakleio, Greece, 81352
    • Regional University General Hospital of Herakleio, Crete
  • Ioannina, Greece, 45332
    • University Hospital of Ioannina
  • Larisa, Greece, 413 34
    • University Hospital of Larissa
  • Maroussi, Greece, 151 25
    • Athens Medical Center
  • Patra, Greece, 26332
    • University Hospital of Patras
  • Thessaloniki, Greece, 546 22
    • Bioclinic - Thessaloniki
  • Thessaloniki, Greece, 546 39
    • Theagenio Anticancer Hospital of Thessaloniki
  • Thessaloniki, Greece, 54623
    • Anassa General Clinic
  • Thessaloniki, Greece, 555 35
    • Interbalkan Medical Center of Thessaloniki
• Hong Kong
  • Hong Kong, Hong Kong
    • Queen Mary Hospital
  • Hong Kong, Hong Kong
    • Prince of Wales Hospital
  • Kowloon, Hong Kong
    • Hong Kong United Oncology Centre
• Ireland
  • Dublin, Ireland, D24 NR0A
    • Tallaght University Hospital
  • Waterford, Ireland, X91 ER8E
    • University Hospital Waterford
• Israel
  • Be'er Ya'akov, Israel, 7030000
    • Shamir Medical Center (Assaf Harofeh)
  • Haifa, Israel, 3109601
    • Rambam Health Care Campus
  • Jerusalem, Israel, 91120
    • Hadassah University Hospital Ein Kerem
  • Kfar-Sava, Israel, 44281
    • Meir Medical Center
  • Petach Tikva, Israel, 4941492
    • Rabin Medical Center
  • Tel Aviv, Israel, 6423906
    • Tel Aviv Medical Center (Ichilov Hospital)
  • Tel Hashomer, Israel, 52621
    • Chaim Sheba Medical Center
• Italy
  • Arezzo, Italy, 52100
    • Ospedale San Donato
  • Aviano, Italy, 33081
    • Centro Di Riferimento Oncologico Di Aviano
  • Bari, Italy, 70124
    • Istituto Tumori Bari Giovanni Paolo II - IRCCS
  • Candiolo (TO), Italy, 10060
    • Istituto di Candiolo - Fondazione del Piemonte per l'Oncologia
  • Genova, Italy, 16132
    • Ospedale Policlinico San Martino
  • Meldola, Italy, 47014
    • Istituto Scientifico Romagnolo Per Lo Studio e La Cura Dei Tumori
  • Milan, Italy, 20132
    • Ospedale San Raffaele
  • Novara, Italy, 28100
    • Azienda Ospedaliero Universitaria Maggiore della Carità
  • Pisa, Italy, 56126
    • Azienda Ospedaliero Universitaria Pisana
  • Roma, Italy, 00144
    • Istituto Regina Elena
  • Rome, Italy, 00128
    • Università Campus Bio-Medico di Roma
  • Sondrio, Italy, 23100
    • Ospedale Civile di Sondrio
  • Terni, Italy, 05100
    • Azienda Ospedaliera Santa Maria di Terni
  • Torino, Italy, 10043
    • Azienda Ospedaliero-Universitaria San Luigi Gonzaga
  • Trento, Italy, 38122
    • Ospedale di Trento - Presidio Ospedaliero Santa Chiara
  • Verona, Italy, 37126
    • Azienda Ospedaliera Universitaria Integrata Verona
• Korea, Republic of
  • Busan-si, Korea, Republic of, 49241
    • Pusan National University Hospital
  • Cheongju, Korea, Republic of, 361-711
    • Chungbuk National University Hospital
  • Daejeon, Korea, Republic of, 35015
    • Chungnam National University Hospital
  • Goyang-si, Korea, Republic of, 10408
    • National Cancer Center
  • Gyeongsangnam-do, Korea, Republic of, 50612
    • Pusan National University Yangsan Hospital
  • Incheon, Korea, Republic of, 405-760
    • Gachon University Gil Medical Center
  • Seongnam-si, Korea, Republic of, 13620
    • Seoul National University Bundang Hospital
  • Seoul, Korea, Republic of, 03080
    • Seoul National University Hospital
  • Seoul, Korea, Republic of, 03722
    • Severance Hospital, Yonsei University Health System
  • Seoul, Korea, Republic of, 05505
    • Asan Medical Center
  • Seoul, Korea, Republic of, 06351
    • Samsung Medical Center
  • Seoul, Korea, Republic of, 137-040
    • The Catholic University of Korea Seoul Saint Mary's Hospital
  • Suwon, Korea, Republic of, 16247
    • The Catholic University of Korea Saint Vincent's Hospital
• Portugal
  • Braga, Portugal, 4710-243
    • Hospital de Braga
  • Guarda, Portugal, 6300-858
    • Unidade Local de Saúde da Guarda - Hospital Sousa Martins
  • Leiria, Portugal, 2410-197
    • Centro Hospitalar de Leiria - Hospital de Santo André
  • Lisbon, Portugal, 1649-035
    • Centro Hospitalar de Lisboa Norte - Hospital de Santa Maria
  • Porto, Portugal
    • Instituto Portugues de Oncologia do Porto Francisco Gentil, E.P.E
  • Vila Real, Portugal, 5000
    • Centro Hospitalar de Trás-os-Montes e Alto Douro
• Puerto Rico
  • San Juan, Puerto Rico, 00907
    • BRCR Medical Center, INC
• Singapore
  • Singapore, Singapore, 119074
    • National University Hospital
  • Singapore, Singapore, 308433
    • Tan Tock Seng Hospital
  • Singapore, Singapore, 217562
    • Icon Cancer Centre Farrer Park
• Spain
  • Barcelona, Spain, 08035
    • Hospital Universitari Vall d'Hebrón
  • Barcelona, Spain, 8036
    • Hospital Clinic De Barcelona
  • Barcelona, Spain, 08003
    • Hospital del Mar - Parc de Salut
  • Córdoba, Spain, 14004
    • Hospital Reina Sofia
  • Madrid, Spain, 28027
    • Clinica Universidad de Navarra - Madrid
  • Madrid, Spain, 28034
    • Hospital Universitario Ramon y Cajal
  • Madrid, Spain, 28041
    • Hospital Universitario 12 De Octubre
  • Madrid, Spain, 28007
    • Hospital General Universitario Gregorio Marañón
  • Madrid, Spain, 28033
    • MD Anderson Cancer Center
  • Majadahonda, Spain, 28222
    • Hospital Universitario Puerta de Hierro de Majadahonda
  • Manresa, Spain, 08243
    • Hospital Sant Joan de Deu de Manresa
  • Ourense, Spain, 32005
    • Complexo Hospitalario de Ourense (CHOU)
  • Pamplona, Spain, 31008
    • Clinica Universidad de Navarra
  • Santander, Spain, 39008
    • Hospital Universitario Marqués de Valdecilla
  • Sevilla, Spain, 41013
    • Hospital Universitario Virgen del Rocio
  • Vigo, Spain, 36213
    • Alvaro Cunqueiro Hospital
• Sweden
  • Jönköping, Sweden, 553 05
    • Länssjukhuset Ryhov
  • Linköping, Sweden, 581 85
    • Universitetssjukhuset i Linköping
  • Stockholm, Sweden, 171 76
    • Karolinska Universitetssjukhuset - Solna
• Switzerland
  • Basel, Switzerland, 4051
    • University Hospital Basel
  • Bellinzona, Switzerland, 6500
    • Istituto Oncologico Della Svizzera Italiana (IOSI)
  • Bern, Switzerland, 3010
    • University of Bern
  • Geneva, Switzerland, 1205
    • Hôpitaux universitaires de Genève
  • Zurich, Switzerland, 8091
    • Universitaetsspital Zurich - Klinik fur Medizinische Onkologie und Hematologie
• Taiwan
  • Kaohsiung, Taiwan, 833
    • Kaohsiung Chang Gung Memorial Hospital
  • Kaohsiung, Taiwan, 813
    • Kaohsiung Veterans General Hospital
  • New Taipei City, Taiwan, 231405
    • Taipei Tzu Chi General Hospital
  • Puzi, Taiwan, 613
    • Chiayi Chang Gung Memorial Hospital
  • Taichung, Taiwan, Taiwan 407
    • Taichung Veterans General Hospital
  • Taichung City, Taiwan, 40447
    • China Medical University Hospital
  • Tainan, Taiwan, 70403
    • National Cheng Kung University Hospital
  • Taipei City, Taiwan, 100
    • National Taiwan University Hospital
  • Taipei City, Taiwan, 11217
    • Taipei Veterans General Hospital
  • Taoyuan, Taiwan, 333
    • Chang Gung Memorial Hospital - Linkou Branch
• Turkey
  • Ankara, Turkey, 6230
    • Hacettepe Universitesi Tip Fakultesi- Kanser Enstitusu
  • Edirne, Turkey, 22030
    • Trakya Üniversitesi Saglik Arastirma ve Uygulama Merkezi
  • Istanbul, Turkey, 34214
    • Bagcilar Medipol Mega Universite Hastanesi
  • Istanbul, Turkey, 34457
    • Istanbul Acibadem University Maslak Hospital
  • Istanbul, Turkey, 34722
    • T.C. Saglik Bakanligi Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi
  • Mamak, Turkey, 6620
    • Cebeci Hastanesi
  • İzmir, Turkey, 35575
    • Medical Park Izmır Hastanesi
  • Şişli, Turkey, 34365
    • VKV Amerikan Hastanesi Department of Oncology
• United Kingdom
  • Birmingham, United Kingdom, B15 2WB
    • University Hospitals Birmingham NHS Foundation Trust
  • Dorchester, United Kingdom, DT1 2JY
    • Dorset County Hospital Nhs Foundation Trust
  • Glasgow, United Kingdom, G12 0YN
    • NHS Greater Glasgow and Clyde
  • London, United Kingdom, EC1A 7BE
    • Barts Health NHS Trust
  • London, United Kingdom, W1G 6AD
    • Sarah Cannon Research Institute London
  • London, United Kingdom, SE1 9RT
    • Guys and Saint Thomas NHS Foundation Trust, Guy's Hospital
  • Manchester, United Kingdom, M20 4BX
    • The Christie NHS Foundation Trust
  • Middlesex, United Kingdom, HA6 2RN
    • East and North Hertfordshire NHS Trust
  • Oxford, United Kingdom, OX3 7LE
    • Oxford University Hospitals NHS Foundation Trust
  • Port Talbot, United Kingdom, SA12 7BR
    • Swansea Bay University Health Board
  • Preston, United Kingdom, PR2 9HT
    • Royal Preston Hospital
  • Surrey, United Kingdom, SM2 5PT
    • The Royal Marsden NHS Foundation Trust
  • Wolverhampton, United Kingdom, WV10 0QP
    • The Royal Wolverhampton NHS Trust
• United States
  • Arizona
    • Phoenix, Arizona, United States, 85054
      • Mayo Clinic - Arizona
  • California
    • Los Angeles, California, United States, 90095
      • UCLA Hematology/ Oncology
    • Orange, California, United States, 92868
      • University of California Irvine (UCIMC)
  • District of Columbia
    • Washington, District of Columbia, United States, 20010
      • Medstar Washington Hospital Center
  • Florida
    • Jacksonville, Florida, United States, 32207
      • Baptist MD Anderson Cancer Center
    • Plantation, Florida, United States, 33322
      • Boca Raton Clinical Research Global USA - Plantation
  • Iowa
    • Iowa City, Iowa, United States, 52242
      • University of Iowa Hospitals and Clinics
  • Maryland
    • Baltimore, Maryland, United States, 21201
      • University of Maryland School of Medicine
  • Massachusetts
    • Boston, Massachusetts, United States, 02215
      • Beth Israel Deaconess Medical Center
  • New York
    • Bronx, New York, United States, 10467
      • Montefiore Medical Center
    • Buffalo, New York, United States, 14263
      • Roswell Park Cancer Institute
    • New York, New York, United States, 10065
      • Weill Cornell Medical College
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • Cleveland Clinic
  • Oklahoma
    • Tulsa, Oklahoma, United States, 74104
      • Oklahoma Cancer Specialists and Research Institute (OCSRI)
  • Pennsylvania
    • Hershey, Pennsylvania, United States, 17033
      • Penn State Hershey Cancer Institute
  • Tennessee
    • Knoxville, Tennessee, United States, 37916
      • Thompson Oncology Group - Knoxville Downtown
    • Knoxville, Tennessee, United States, 37920
      • University Cancer Specialists - Knoxville
  • Texas
    • Dallas, Texas, United States, 75390
      • Harold C. Simmons Comprehensive Cancer Center
    • Fort Worth, Texas, United States, 76104
      • Center for Cancer and Blood Disorders
  • Washington
    • Seattle, Washington, United States, 98109
      • Seattle Cancer Care Alliance (SCCA)
    • Spokane, Washington, United States, 99208
      • Summit Cancer Centers

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Key Inclusion Criteria:

1. 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.
2. Eastern Cooperative Oncology Group (ECOG) performance status (PS) score of 0 or 1.

3. 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:

       • 1. Creatinine Clearance < 60 mL/min
       • 2. Grade ≥ 2 Audiometric Hearing Loss
       • 3. Grade ≥ 2 Peripheral Neuropathy
       • 4. New York Heart Association (NYHA) Class III heart failure
       • 5. ECOG PS ≥ 2
   • d. Anti PD-1/PD-L1 therapy administered as part of maintenance therapy may be counted towards eligibility for the study
   • e. Individuals who have progressed after receiving enfortumab vedotin in prior lines of therapy, and individuals who are either ineligible or unable to tolerate enfortumab vedotin therapy, are eligible to enroll in the study
   • f. Individuals who received only concurrent chemoradiation for bladder preservation without further systemic therapy are not eligible to enroll in the study. The substitution of carboplatin for cisplatin does not constitute a new regimen provided no new chemotherapeutic agents were added to the regimen and no progression was noted prior to the change in platinum.
4. Individuals with previously treated brain metastases may participate in the study provided they have stable CNS disease for at least 4 weeks prior to the first dose of study drug and stabilization of all neurologic symptoms, have no evidence of new or enlarging brain metastases, and are not using steroids >20 mg of prednisone (or equivalent) daily for brain metastases for at least 7 days prior to first dose of the study drug.
5. Adequate hematologic counts without transfusion or growth factor support within 2 weeks of study drug initiation (hemoglobin ≥ 9 g/dL, absolute neutrophil count (ANC) ≥1,500/mm^3, and platelets ≥100,000/µL).

6. Adequate hepatic function (bilirubin ≤1.5x institutional upper limit of normal (IULN), aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 x IULN or ≤ 5 x IULN if known liver metastases and serum albumin >3 g/dL).

   Docetaxel will only be option in TPC arm for Individuals with a total bilirubin ≤1 x IULN, and an AST and/or ALT ≤1.5x IULN if alkaline phosphatase is also >2.5 x IULN.

7. Creatinine clearance ≥30 mL/min as assessed by the Cockcroft-Gault equation or other validated instruments (e.g. Modification of Diet in Renal Disease (MDRD) equation).
8. Females of childbearing potential must have a negative urine or serum pregnancy test within 72 hours prior to receiving the first dose of study drug. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.
9. Females of childbearing potential must be willing to use 2 methods of birth control or be surgically sterile or abstain from heterosexual activity for the course of the study through 6 months after the last dose of study drug. Individuals of childbearing potential are those who have not been surgically sterilized or have not been free from menses for >2 years.
10. Males must agree to use an adequate method of contraception starting with the first dose of study therapy through 6 months after the last dose of study therapy.

Key Exclusion Criteria:

1. Females who are pregnant or lactating.
2. 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.
3. 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).

4. 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.
5. Have previously received topoisomerase 1 inhibitors.

6. 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.

7. 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%.
8. Have active chronic inflammatory bowel disease (ulcerative colitis, Crohn's disease) or gastrointestinal (GI) perforation within 6 months of enrollment.
9. Have an active serious infection requiring anti-infective therapy (Contact medical monitor for clarification).
10. Have known history of Human Immunodeficiency Virus (HIV)-1/2 with undetectable viral load and on medications that may interfere with SN-38 metabolism.
11. Have active Hepatitis B Virus (HBV) or Hepatitis C Virus (HCV). In individuals with a history of HBV or HCV, individuals with a detectable viral load will be excluded.
12. Have other concurrent medical or psychiatric conditions that, in the investigator's opinion, may be likely to confound study interpretation or prevent completion of study procedures and follow-up examinations.
13. Have inability to tolerate or are allergic to any potential TPC agent or sacituzumab govitecan-hziy or unable or unwilling to receive the doses specified in the protocol.
14. Have inability to complete all specified study procedures for any reason.

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Sacituzumab Govitecan-hziy; Participants will receive 10 mg/kg of sacituzumab govitecan-hziy intravenously on Day 1 and Day 8 of 21-day cycles.	Drug: Sacituzumab Govitecan-hziy; Administered intravenously; Other Names: IMMU-132; GS-0132; Trodelvy™
Active Comparator: Treatment of Physician's Choice; Participants 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.	Drug: Docetaxel; Administered intravenously; Other Names: Taxotere®; Drug: Paclitaxel; Administered intravenously; Other Names: Taxol®; Drug: Vinflunine; Administered intravenously; Other Names: Javlor ®

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Progression-Free Survival (PFS) by Investigator Assessment	PFS is defined as the time from the date of randomization to the date of the first objectively documented disease progression, per response evaluation criteria in solid tumors version 1.1 (RECIST v1.1) criteria, as determined by investigator assessment, or death regardless of cause, whichever occurs first.	Up to 3.5 years
Progression-Free Survival (PFS) by Blinded Independent Central Review (BICR)	PFS is defined as the time from the date of randomization to the date of the first objectively documented disease progression, per RECIST v1.1 criteria as determined by BICR, or death regardless of cause, whichever occurs first.	Up to 3.5 years
Objective Response Rate (ORR) by Investigator Assessment	ORR is defined as the proportion of participants who achieved a complete response or partial response as best overall response (BOR). BOR is determined per RECIST 1.1 as determined by investigator assessment.	Up to 3.5 years
Objective Response Rate (ORR) by BICR	ORR is defined as the proportion of participants who achieved a complete response or partial response as best overall response (BOR). BOR is determined per RECIST 1.1 as determined by BICR.	Up to 3.5 years
Clinical Benefit Rate (CBR) by Investigator Assessment	CBR is defined as the percentage of patients with advanced or metastatic cancer who have achieved complete response, partial response and stable disease for greater than or equal to 6 months to therapeutic intervention in a clinical study. CBR will be determined per RECIST v1.1 by investigator assessment.	Up to 3.5 years
Clinical Benefit Rate (CBR) by BICR	CBR is defined as the percentage of participants with advanced or metastatic cancer who have achieved complete response, partial response and stable disease for greater than or equal to 6 months to therapeutic intervention in a clinical study. CBR will be determined per RECIST v1.1 by BICR.	Up to 3.5 years
Duration of Objective Tumor Response (DOR) by Investigator Assessment	DOR is defined as the time from the date when the criteria is first met for a complete response or partial response to the first date that disease progression is documented per RECIST 1.1 as determined by investigator assessment, or date of death, whichever occurs first.	Up to 3.5 years
Duration of Objective Tumor Response (DOR) by BICR	DOR is defined as the time from the date when the criteria is first met for a complete response or partial response to the first date that disease progression is documented per RECIST 1.1 as determined by BICR, or date of death, whichever occurs first.	Up to 3.5 years
Percentage of Participants Experiencing any Treatment Emergent Adverse Events		Up to 3.5 years
Percentage of Participants Experiencing any Serious Treatment Emergent Adverse Events		Up to 3.5 years
Percentage of Participants Experiencing any Clinically Significant Laboratory Abnormalities		Up to 3.5 years
European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC-QLQ-C30) Score	The EORTC QLQ-C30 is a questionnaire to assess quality of life of cancer patients, it is composed of 30 questions (items) resulting in 5 functional scales, 1 global health status scale, 3 symptom scales, and 6 single items. Scoring of the QLQ-C30 is performed according to QLQ-C30 Scoring manual. All of the scales and single-item measures range in score from 0 to 100. Higher score for the functioning scales and global health status denote a better level of functioning (i.e. a better state of the participant), while higher scores on the symptom and single-item scales indicate a higher level of symptoms (i.e. a worse state of the participant).	Up to 3.5 years
European Quality of Life 5-Dimensions 5 Levels Instrument (EuroQOL EQ-5D-5L) Score	The EQ-5D-5L is a standard measure of health-related quality of life. The tool consists of the EQ-5D-5L descriptive part and the EQ visual analogue scale (VAS). The descriptive part comprises 5 dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression). Each of these 5 dimensions has 5 levels (no problem, slight problems, moderate problems, severe problems, and extreme problems). Results for each of the 5 dimensions are combined into a 5-digit number to describe the participant's health state. The EQ-VAS records the participant's health on a 0-100 mm VAS scale, with 0 indicating "the worst health you can imagine" and 100 indicating "the best health you can imagine." Higher scores of EQ VAS indicate better health.	Up to 3.5 years

Collaborators and Investigators

• Sponsor: Gilead Sciences
• Collaborators: Everest Medicines
• Investigators: Study Director: Gilead Study Director, Gilead Sciences

Publications and helpful links

Helpful Links

• Gilead Clinical Trials Website

Study record dates

Study Major Dates

• Study Start (Actual): January 13, 2021
• Primary Completion (Actual): July 4, 2025
• Study Completion (Actual): July 4, 2025

Study Registration Dates

• First Submitted: August 19, 2020
• First Submitted That Met QC Criteria: August 22, 2020
• First Posted (Actual): August 27, 2020

Study Record Updates

• Last Update Posted (Actual): August 3, 2025
• Last Update Submitted That Met QC Criteria: August 1, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Antineoplastic Agents; Immunologic Factors; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Antineoplastic Agents, Phytogenic; Immunoconjugates; Docetaxel; Sacituzumab govitecan; Paclitaxel
• Other Study ID Numbers: IMMU-132-13; 2024-513870-23 (Other Identifier: EU CT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No