AzTrials
AzTrials

Locally Advanced or Metastatic Unresectable Urothelial CancerPhase 3TROPiCS-04NCT04527991

Study of Sacituzumab Govitecan Versus Physician's Choice of Treatment in Participants With Urothelial Cancer That Cannot Be Removed or Has Spread

A Phase 3 study testing Sacituzumab Govitecan-hziy, Paclitaxel and Docetaxel in people with Locally Advanced or Metastatic Unresectable Urothelial Cancer, run by Gilead Sciences at 234 sites in 27 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial 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). Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Sacituzumab Govitecan-hziy, Paclitaxel and Docetaxel
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
711 participants
Where
234 sitesin 27 countries
Study dates
13 Jan 2021to 4 Jul 2025
Phase
Phase 3

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
  • 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.
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  • 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.
  • 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
  • Anti PD-1/PD-L1 therapy administered as part of maintenance therapy may be counted towards eligibility for the study
  • 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
  • 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.
  • Individuals with previously treated brain metastases may participate in the study provided they have stable central nervous system 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.
  • 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).
  • 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.
  • 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).
  • 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.
  • 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.
  • 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.

Who cannot join

  • 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 standard of care (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 adverse events 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.
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  • 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).
  • Have known history of Human Immunodeficiency Virus (HIV)-1/2 with undetectable viral load and on medications that may interfere with SN-38 metabolism.
  • 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.
  • 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.
  • 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.
  • Have inability to complete all specified study procedures for any reason.
  • Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Trial locations and contacts

234 sites in 27 countries.

234 sites in 27 countries

China23 sites

  • Peking University First Hospital

    Beijing, 100034

  • Chinese People's Liberation Army General Hospital - 301 Hospital

    Beijing, 100039

  • Beijing Cancer Hospital

    Beijing, 100142

  • Chinese Academy of Medical Sciences Cancer Hospital

    Beijing, 100730

  • 1st Hospital Jilin University

    Changchun, 130021

  • Hunan Cancer Hospital - Xiangya Hospital - Central South University

    Changsha, 410013

  • West China Hospital Sichuan University

    Chengdu, 610041

  • Sichuan Academy of Medical Sciences & Sichuan Provincial People's Hospital

    Chengdu, 610072

  • Chongqing University Cancer Hospital

    Chongqing, 400030

  • The First Affiliated Hospital of Fujian Medical University

    Fujian, 350005

  • Union Hospital of Fujian Medical University

    Fuzhou, 350001

  • Sun Yat-Sen University Cancer Center

    Guangzhou, 510060

  • Zhejiang Provincial People's Hospital - Zhaohui

    Hangzhou, 310014

  • Cancer Hospital of the University of Chinese Academy of Sciences Zhejiang Cancer Hospital

    Hangzhou, 310022

  • Anhui Provincial Cancer Hospital

    Hefei, 230031

  • Qilu Hospital of Shandong University

    Jinan, 250012

  • The First Affiliated Hospital of Nanchang University

    Nanchang, 330006

  • Nanjing Drum Tower Hospital

    Nanjing, 210008

  • Liaoning Cancer Hospital and Institute

    Shenyang, 110042

  • Tianjin Medical University Cancer Institute & Hospital

    Tianjin, 300060

  • Affiliated Tumor Hospital of Xinjiang Medical University

    Ürümqi, 830000

  • The First Affiliated Hospital of Wenzhou Medical University

    Wenzhou, 325000

  • Union Hospital Tongji Medical College Huazhong University of Science and Technology

    Wuhan, 430030

Other trials in China

United States21 sites

  • University of Maryland School of Medicine

    Baltimore, Maryland, 21201

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts, 02215

  • Roswell Park Cancer Institute

    Buffalo, New York, 14263

  • Cleveland Clinic

    Cleveland, Ohio, 44195

  • Harold C. Simmons Comprehensive Cancer Center

    Dallas, Texas, 75390

  • Center for Cancer and Blood Disorders

    Fort Worth, Texas, 76104

  • Penn State Hershey Cancer Institute

    Hershey, Pennsylvania, 17033

  • University of Iowa Hospitals and Clinics

    Iowa City, Iowa, 52242

  • Baptist MD Anderson Cancer Center

    Jacksonville, Florida, 32207

  • Thompson Oncology Group - Knoxville Downtown

    Knoxville, Tennessee, 37916

  • University Cancer Specialists - Knoxville

    Knoxville, Tennessee, 37920

  • UCLA Hematology/ Oncology

    Los Angeles, California, 90095

  • Weill Cornell Medical College

    New York, New York, 10065

  • University of California Irvine (UCIMC)

    Orange, California, 92868

  • Mayo Clinic - Arizona

    Phoenix, Arizona, 85054

  • Boca Raton Clinical Research Global USA - Plantation

    Plantation, Florida, 33322

  • Seattle Cancer Care Alliance (SCCA)

    Seattle, Washington, 98109

  • Summit Cancer Centers

    Spokane, Washington, 99208

  • Montefiore Medical Center

    The Bronx, New York, 10467

  • Oklahoma Cancer Specialists and Research Institute (OCSRI)

    Tulsa, Oklahoma, 74104

  • MedStar Washington Hospital Center

    Washington D.C., District of Columbia, 20010

Other trials in United States

France19 sites

  • Ramsay Health Clinic Belharra

    Bayonne

  • CHU Saint Andre

    Bordeaux, 33075

  • Centre Hospiltalier Universitaire Brest - Hôpital Morvan

    Brest, 29200

  • Centre Francois Baclesse

    Caen, 14076

  • Centre Jean Perrin

    Clermont-Ferrand, 63011

  • Centre Georges- Francois Leclerc

    Dijon, 21000

  • Centre Hospitalier Departemental Vendee

    La Roche-sur-Yon, 85925 CEDEX 9

  • Centre Oscar Lambret

    Lille, 59000

  • Centre Leon Berard

    Lyon, 69373

  • Institut Régional du Cancer de Montpellier ICM Val d' Aurelle

    Montpellier, 34090

  • Centre Antoine Lacassagne

    Nice, 06189

  • Centre Hospitalier Universitaire de Nimes

    Nîmes, 30029

  • Hôpital Européen Georges-Pompidou

    Paris, 75015

  • Centre Eugene Marquis

    Rennes, 35042

  • Centre Hospitalier Privé Saint-Grégoire

    Saint-Grégoire, 35760

  • Les Hôpitaux Universitaires de Strasbourg

    Strasbourg, 67091

  • Hôpital Foch

    Suresnes, 92150

  • Institut Claudius Regaud

    Toulouse, 31059

  • Institut Gustave Roussy

    Villejuif, 94805

Other trials in France

Italy16 sites

  • Ospedale San Donato

    Arezzo, 52100

  • Centro di Riferimento Oncologico di Aviano

    Aviano, 33081

  • Istituto Tumori Bari Giovanni Paolo II - IRCCS

    Bari, 70124

  • Istituto di Candiolo - Fondazione del Piemonte per l'Oncologia

    Candiolo (TO), 10060

  • Ospedale Policlinico San Martino

    Genova, 16132

  • Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori

    Meldola, 47014

  • Ospedale San Raffaele

    Milan, 20132

  • Azienda Ospedaliero Universitaria Maggiore Della Carita

    Novara, 28100

  • Azienda Ospedaliero Universitaria Pisana

    Pisa, 56126

  • Istituto Regina Elena

    Roma, 00144

  • Università Campus Bio-Medico di Roma

    Rome, 00128

  • Ospedale Civile Di Sondrio

    Sondrio, 23100

  • Azienda Ospedaliera Santa Maria di Terni

    Terni, 05100

  • Azienda Ospedaliero-Universitaria San Luigi Gonzaga

    Torino, 10043

  • Ospedale di Trento - Presidio Ospedaliero Santa Chiara

    Trento, 38122

  • Azienda Ospedaliera Universitaria Integrata Verona

    Verona, 37126

Other trials in Italy

Spain16 sites

  • Hospital del Mar - Parc de Salut

    Barcelona, 08003

  • Hospital Universitari Vall D'Hebron

    Barcelona, 08035

  • Hospital Clinic de Barcelona

    Barcelona, 8036

  • Hospital Reina Sofia

    Córdoba, 14004

  • Hospital General Universitario Gregorio Maranon

    Madrid, 28007

  • Clínica Universidad de Navarra - Madrid

    Madrid, 28027

  • MD Anderson Cancer Center

    Madrid, 28033

  • Hospital Universitario Ramon y Cajal

    Madrid, 28034

  • Hospital Universitario 12 de Octubre

    Madrid, 28041

  • Hospital Universitario Puerta de Hierro de Majadahonda

    Majadahonda, 28222

  • Hospital Sant Joan de Déu de Manresa

    Manresa, 08243

  • Complexo Hospitalario de Ourense (CHOU)

    Ourense, 32005

  • Clinica Universidad de Navarra

    Pamplona, 31008

  • Hospital Universitario Marqués de Valdecilla

    Santander, 39008

  • Hospital Universitario Virgen del Rocio

    Seville, 41013

  • Álvaro Cunqueiro Hospital

    Vigo, 36213

Other trials in Spain

Australia13 sites

  • Icon Cancer Centre Wesley

    Auchenflower, Queensland, 4066

  • Southern Adelaide Local Health Network Incorporated

    Bedford Park, South Australia, 5042

  • Monash Health

    Clayton, Victoria, 3168

  • Austin Health

    Heidelberg, Victoria, 3084

  • ICON Cancer Centre Hobart

    Hobart, Tasmania, 7001

  • Ashford Cancer Centre Research - ICON Cancer Centre Adelaide

    Kurralta Park, South Australia, 5037

  • Peter MacCallum Cancer Centre

    Melbourne, Victoria, 3000

  • Liverpool Hospital

    Nedlands, Western Australia, 6009

  • Sir Charles Gairdner Hospital

    Nedlands, Western Australia, 6009

  • Chris O'Brien Lifehouse

    North Ryde, New South Wales, 2109

  • Sunshine Hospital

    Saint Albans, Victoria, 3021

  • Calvary Mater Newcastle

    Waratah, New South Wales, 2298

  • Westmead Hospital

    Westmead, New South Wales, 2145

Other trials in Australia

Greece13 sites

  • 401 General Military Hospital of Athens

    Athens, 115 25

  • Henry Dunant Hospital

    Athens, 115 26

  • Alexandra General Hospital

    Athens, 11528

  • Attikon Hospital

    Chaïdári, 124 62

  • Regional University General Hospital of Herakleio, Crete

    Herakleio, 81352

  • University Hospital Of Ioannina

    Ioannina, 45332

  • University Hospital of Larissa

    Larissa, 413 34

  • Athens Medical Center

    Marousi, 151 25

  • University Hospital of Patras

    Pátrai, 26332

  • Bioclinic - Thessaloniki

    Thessaloniki, 546 22

  • Theagenio Anticancer Hospital of Thessaloniki

    Thessaloniki, 546 39

  • Anassa General Clinic

    Thessaloniki, 54623

  • Interbalkan Medical Center of Thessaloniki

    Thessaloniki, 555 35

Other trials in Greece

South Korea13 sites

  • Pusan National University Hospital

    Busan, 49241

  • Chungbuk National University Hospital

    Cheongju-si, 361-711

  • Chungnam National University Hospital

    Daejeon, 35015

  • National Cancer Center

    Goyang-si, 10408

  • Pusan National University Yangsan Hospital

    Gyeongsangnam-do, 50612

  • Gachon University Gil Medical Center

    Incheon, 405-760

  • Seoul National University Bundang Hospital

    Seongnam-si, 13620

  • Seoul National University Hospital

    Seoul, 03080

  • Severance Hospital, Yonsei University Health System

    Seoul, 03722

  • Asan Medical Center

    Seoul, 05505

  • Samsung Medical Center

    Seoul, 06351

  • The Catholic University of Korea Seoul Saint Mary's Hospital

    Seoul, 137-040

  • The Catholic University of Korea Saint Vincent's Hospital

    Suwon, 16247

Other trials in South Korea

United Kingdom13 sites

  • University Hospitals Birmingham NHS Foundation Trust

    Birmingham, B15 2WB

  • Dorset County Hospital NHS Foundation Trust

    Dorchester, DT1 2JY

  • NHS Greater Glasgow and Clyde

    Glasgow, G12 0YN

  • Barts Health NHS Trust

    London, EC1A 7BE

  • Guys and Saint Thomas NHS Foundation Trust, Guy's Hospital

    London, SE1 9RT

  • Sarah Cannon Research Institute London

    London, W1G 6AD

  • The Christie NHS Foundation Trust

    Manchester, M20 4BX

  • East and North Hertfordshire NHS Trust

    Middlesex, HA6 2RN

  • Oxford University Hospitals NHS Foundation Trust

    Oxford, OX3 7LE

  • Swansea Bay University Health Board

    Port Talbot, SA12 7BR

  • Royal Preston Hospital

    Preston, PR2 9HT

  • The Royal Marsden NHS Foundation Trust

    Surrey, SM2 5PT

  • The Royal Wolverhampton NHS Trust

    Wolverhampton, WV10 0QP

Other trials in United Kingdom

Germany10 sites

  • Universitatsklinik Dresden

    Dresden, 01307

  • Malteser Waldkrankenhaus Erlangen

    Erlangen, 91054

  • Universitätsklinikum Essen

    Essen, 45147

  • Centrum fur Hamatologie und Onkologie Bethanien

    Frankfurt am Main, 60389

  • Asklepios Klinik Altona

    Hamburg, 22763

  • Institut Für Versorgungsforschung in Der Onkologie

    Koblenz, 56068

  • Universitatsklinikum Munster

    Münster, 48149

  • Studienpraxis Urologie

    Nürtingen, 72622

  • Universitätsklinikum Tübingen

    Tübingen, 72076

  • Charité Universitätsmedizin Berlin - Campus Benjamin Franklin

    Wien, 1100

Other trials in Germany

Taiwan10 sites

  • Chiayi Chang Gung Memorial Hospital

    Buzi, 613

  • Kaohsiung Veterans General Hospital

    Kaohsiung City, 813

  • Kaohsiung Chang Gung Memorial Hospital

    Kaohsiung City, 833

  • Taipei Tzu Chi General Hospital

    New Taipei City, 231405

  • China Medical University Hospital

    Taichung, 40447

  • Taichung Veterans General Hospital

    Taichung, Taiwan 407

  • National Cheng Kung University Hospital

    Tainan, 70403

  • National Taiwan University Hospital

    Taipei, 100

  • Taipei Veterans General Hospital

    Taipei, 11217

  • Chang Gung Memorial Hospital - Linkou Branch

    Taoyuan, 333

Other trials in Taiwan

Canada9 sites

  • Cross Cancer Institute

    Edmonton, T6G 1Z2

  • qeii health sciences centre - VG site

    Halifax, B3H 2Y9

  • Juravinski Hospital and Cancer Centre

    Hamilton, L8V 5C2

  • London Health Sciences Centre

    London, N6A 4G5

  • Jewish General Hospital

    Montreal, H3T 1E2

  • McGill University Health Centre

    Montreal, H4A 3J1

  • R.S. McLaughlin Durham Regional Cancer Centre

    Oshawa, L1G 2B9

  • Princess Margaret Cancer Centre

    Toronto, M5G 2M9

  • British Columbia Cancer Agency-Vancouver Centre

    Vancouver, V5Z 4E6

Other trials in Canada

Turkey (Türkiye)8 sites

  • Hacettepe Universitesi Tip Fakultesi- Kanser Enstitusu

    Ankara, 6230

  • Trakya Universitesi Saglik Arastirma ve Uygulama Merkezi

    Edirne, 22030

  • Bagcilar Medipol Mega Universite Hastanesi

    Istanbul, 34214

  • Istanbul Acibadem University Maslak Hospital

    Istanbul, 34457

  • T.C. Saglik Bakanligi Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi

    Istanbul, 34722

  • Medical Park Izmır Hastanesi

    Izmir, 35575

  • Cebeci Hastanesi

    Mamak, 6620

  • VKV Amerikan Hastanesi Department of Oncology

    Şişli, 34365

Other trials in Turkey (Türkiye)

Israel7 sites

  • Shamir Medical Center (Assaf Harofeh)

    Be’er Ya‘aqov, 7030000

  • Rambam Health Care Campus

    Haifa, 3109601

  • Hadassah University Hospital Ein Kerem

    Jerusalem, 91120

  • Meir Medical Center

    Kfar Saba, 44281

  • Rabin Medical Center

    Petah Tikva, 4941492

  • Tel Aviv Medical Center (Ichilov Hospital)

    Tel Aviv, 6423906

  • Chaim Sheba Medical Center

    Tel Litwinsky, 52621

Other trials in Israel

Portugal6 sites

  • Hospital de Braga

    Braga, 4710-243

  • Unidade Local de Saúde da Guarda - Hospital Sousa Martins

    Guarda, 6300-858

  • Centro Hospitalar de Leiria - Hospital de Santo André

    Leiria, 2410-197

  • Centro Hospitalar de Lisboa Norte - Hospital de Santa Maria

    Lisbon, 1649-035

  • Instituto Portugues de Oncologia do Porto Francisco Gentil, E.P.E

    Porto

  • Centro Hospitalar de Tras-os-Montes e Alto Douro

    Vila Real, 5000

Other trials in Portugal

Belgium5 sites

  • Grand Hôpital De Charleroi - Notre Dame

    Charleroi, 6000

  • Az Maria Middelares Ghent

    Ghent, 9000

  • Universitair Ziekenhuis Gent

    Ghent, 9000

  • Universitair Ziekenhuis Leuven

    Leuven, 3000

  • Centre Hospitalier Universitaire de Liège

    Liège, B-4000

Other trials in Belgium

Georgia5 sites

  • High Technology Hospital MedCenter

    Batumi, 6000

  • New Hospitals

    Tbilisi, 0114

  • L. Managadze National Center of Urology

    Tbilisi, 0144

  • Evex Medical corporation

    Tbilisi, 0160

  • Jerarsi Clinic

    Tbilisi, 0167

Other trials in Georgia

Switzerland5 sites

  • University Hospital Basel

    Basel, 4051

  • Istituto Oncologico Della Svizzera Italiana (IOSI)

    Bellinzona, 6500

  • University of Bern

    Bern, 3010

  • Hôpitaux Universitaires de Genève

    Geneva, 1205

  • Universitaetsspital Zurich - Klinik fur Medizinische Onkologie und Hematologie

    Zurich, 8091

Other trials in Switzerland

Austria3 sites

  • Universitätsklinik für Innere Medizin Graz

    Graz, 8036

  • Ordensklinikum Linz GmbH Barmherzige Schwestern

    Linz, 4010

  • Krankenhaus Der Barmherzigen Bruder Wien

    Vienna, 1020

Other trials in Austria

Croatia3 sites

  • Clinical Hospital Centre Split

    Split, 21000

  • Clinical Hospital Centre "Sestre Milosrdnice"

    Zagreb, 10000

  • University Hospital Centre Zagreb

    Zagreb

Other trials in Croatia

Hong Kong3 sites

  • Prince of Wales Hospital

    Hong Kong, 0

  • Queen Mary Hospital

    Hong Kong

  • Hong Kong United Oncology Centre

    Kowloon

Other trials in Hong Kong

Singapore3 sites

  • National University Hospital

    Singapore, 119074

  • Icon Cancer Centre Farrer Park

    Singapore, 217562

  • Tan Tock Seng Hospital

    Singapore, 308433

Other trials in Singapore

Sweden3 sites

  • Länssjukhuset Ryhov

    Jönköping, 553 05

  • Universitetssjukhuset i Linköping

    Linköping, 581 85

  • Karolinska Universitetssjukhuset - Solna

    Stockholm, 171 76

Other trials in Sweden

Bulgaria2 sites

  • Multiprofile Hospital for Active Treatment Heart and Brain EAD

    Pleven, 5800

  • Specialized Hospital for Active Treatment of Oncological Diseases - Sofia District

    Sofia, 1233

Other trials in Bulgaria

Czechia2 sites

  • Fakultni nemocnice Olomouc

    Olomouc, 775 20

  • Urocentrum Praha

    Prague, 120 00

Other trials in Czechia

Ireland2 sites

  • Tallaght University Hospital

    Dublin, D24 NR0A

  • University Hospital Waterford

    Waterford, X91 ER8E

Other trials in Ireland

Puerto Rico1 site

  • BRCR Medical Center, Inc

    San Juan, PR, 00907

Other trials in Puerto Rico

About this study

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

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).

Being tested
Sacituzumab Govitecan-hziy, Paclitaxel, Docetaxel, Vinflunine

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Sacituzumab Govitecan-hziyDrug

    Also called IMMU-132, Trodelvy™, GS-0132

    Administered intravenously

  • PaclitaxelDrug

    Also called Taxol®

    Administered intravenously

  • DocetaxelDrug

    Also called Taxotere®

    Administered intravenously

  • VinflunineDrug

    Also called Javlor ®

    Administered intravenously

Study groups in NCT04527991
Study groupRoleWhat they receive
Sacituzumab Govitecan-hziy (SG)ExperimentalParticipants will receive 10 mg/kg of SG intravenously (IV) on Day 1 and Day 8 of each 21-day cycle until disease progression, unacceptable toxicity, withdrawal of consent, or another treatment discontinuation criterion is met.
Receives: Drug: Sacituzumab Govitecan-hziy
Treatment of Physician's ChoiceActive comparatorParticipants will receive 1 of 3 standard-of-care chemotherapeutic options, as determined by the investigator prior to randomization, and will continue to receive the same treatment for the duration of the study until disease progression, unacceptable toxicity, withdrawal of consent, or another treatment discontinuation criterion is met. Paclitaxel 175 mg/m^2 IV on Day 1 of every 21-day cycle or Docetaxel 75 mg/m^2 IV on Day 1 of every 21-day cycle or Vinflunine 320 mg/m^2 IV on Day 1 of every 21-day cycle (in countries where vinflunine was approved and was commercially available).
Receives: Drug: Paclitaxel; Drug: Docetaxel; Drug: Vinflunine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall Survival (OS)

    OS was defined as time from the date of randomization to the date of death, regardless of cause. Kaplan-Meier (KM) estimates were used for analysis.

    Measured: Up to 42 months

Secondary outcomes (12)

  1. Progression-Free Survival (PFS) by Investigator Assessment

    PFS was defined as the time from the date of randomization to the date of the first objectively documented disease progression (PD), per response evaluation criteria in solid tumors (RECIST) v1.1 criteria as determined by investigator assessment, or death regardless of cause, whichever occurs first. PD was defined as ≥20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression). KM estimates were used for analysis.

    Measured: Up to 42 months

  2. 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 (PD), per RECIST v1.1 criteria as determined by BICR, or death regardless of cause, whichever occurs first. PD was defined in outcome measure (OM) #2. KM estimates were used for analysis.

    Measured: Up to 42 months

  3. Objective Response Rate (ORR) by Investigator Assessment

    ORR was defined as the percentage of participants who achieved a complete response (CR) or partial response (PR) as best overall response (BOR) as assessed by investigator assessment. CR was defined as disappearance of all target lesions. PR was defined as ≥30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum longest diameter. Percentages were rounded off.

    Measured: Up to 42 months

  4. Objective Response Rate (ORR) by BICR

    ORR was defined as the percentage of participants who achieved a CR or PR as BOR as assessed by BICR. CR and PR are defined in OM#4. Percentages were rounded off.

    Measured: Up to 42 months

  5. Clinical Benefit Rate (CBR) by Investigator Assessment

    CBR was defined as the percentage of participants who achieved a BOR of confirmed CR, PR, or stable disease (SD) for ≥ 6 months, per RECIST v1.1, as assessed by investigator assessment. SD is defined as Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum longest diameter since the treatment started; PD was defined in OM#2; BOR, CR and PR are defined in OM#4. Percentages were rounded off.

    Measured: Up to 42 months

  6. Clinical Benefit Rate (CBR) by BICR

    CBR was defined as the percentage of participants who achieved a BOR of confirmed CR, PR, or SD for ≥ 6 months, per RECIST v1.1, as assessed by BICR. PD was defined in OM#2; BOR, CR and PR are defined in OM#4; SD was defined in OM#6. Percentages were rounded off.

    Measured: Up to 42 months

  7. Duration of Objective Tumor Response (DOR) by Investigator Assessment

    DOR was defined as the time from the date when the criteria is first met for a CR or PR to the first date that PD is documented per RECIST 1.1 as determined by investigator assessment, or date of death, whichever occurs first. KM estimates were used in analysis. PD was defined in OM#2, CR and PR are defined in OM#4.

    Measured: Up to 42 months

  8. Duration of Objective Tumor Response (DOR) by BICR

    DOR was defined as the time from the date when the criteria is first met for a CR or PR to the first date that PD is documented per RECIST 1.1 as determined by BICR, or date of death, whichever occurs first. KM estimates were used in analysis. PD was defined in OM#2, CR and PR are defined in OM#4.

    Measured: Up to 42 months

  9. Percentage of Participants Experiencing Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs)

    An adverse event (AE) was defined as any unfavorable and unintended sign, symptom, or disease temporally associated with the use of an investigational product or other protocol-imposed intervention, regardless of attribution. The SAE was defined as any untoward medical occurrence that at any dose which was fatal (results in death) or life-threatening or required inpatient hospitalization or prolongation of existing hospitalization or resulted in persistent or significant disability/incapacity or is a congenital anomaly/birth defect or an important medical event. TEAEs were defined as an AE that onset in the period from the first dose of study treatment to 30 days after the last dose of study treatment. Percentages were rounded off.

    Measured: From first dose up to 33.6 months

  10. Percentage of Participants Experiencing Grade 3 or 4 Laboratory Abnormalities

    A laboratory abnormality was defined as an increase of at least 1 toxicity grade from baseline at any time of postbaseline up to and including the date of last study drug dose plus 30 days. Severity grades were defined by Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. 1 = mild, 2 = moderate, 3 = severe, 4 = life-threatening, 5 = death. Percentages were rounded off.

    Measured: From first dose up to 33.6 months

  11. European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (QLQ) Core 30 (EORTC-QLQ-C30) Domain Score

    The EORTC QLQ-C30 is a questionnaire to assess quality of life of cancer participants, it is composed of 30 questions (items) resulting in 5 functional scales, 1 global health status scale, 3 symptom scales, and 6 single items. Domain scores were reported for following scales: Physical Functioning, Global Health Status, Pain, and Fatigue Score. Scoring of the QLQ-C30 was 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). For Symptom scales, a lower score means better quality of life. For Global Health Status and Functional Scales, a higher score signifies better quality of life.

    Measured: Baseline (Day 0)

  12. Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (QLQ) Core 30 (EORTC-QLQ-C30) Domain Score

    The EORTC QLQ-C30 is a questionnaire to assess quality of life of cancer participants, it is composed of 30 questions (items) resulting in 5 functional scales, 1 global health status scale, 3 symptom scales, and 6 single items. Domain scores were reported for following scales: Physical Functioning, Global Health Status, Pain, and Fatigue Score. Scoring of the QLQ-C30 was 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). For Symptom scales, a lower score means better quality of life. For Global Health Status and Functional Scales, a higher score signifies better quality of life.

    Measured: Cycle 5 Day 1; Cycle length = 21 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Aug 2020
  2. Study start13 Jan 2021
  3. Primary completion4 Jul 2025
  4. Study completion4 Jul 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
711 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04527991
Sponsor's protocol ID
IMMU-132-13
Other IDs
2024-513870-23
Acronym
TROPiCS-04
Status last verified
May 2026
First submitted
19 Aug 2020
Last updated
2 Jun 2026
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Powles 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.

    PubMed 39934055

  • Grivas P, Tagawa S, Bellmunt J, De Santis M, Duran I, Goebell PJ, et al. TROPiCS-04: Study of Sacituzumab Govitecan in Metastatic or Locally Advanced Unresectable Urothelial Cancer That Has Progressed After Platinum and Checkpoint Inhibitor Therapy. [Poster TPS498]. American Society of Clinical Oncology Genitourinary Cancers Symposium (ASCO GU); 2021 February 11-13; Virtual meeting.

  • Grivas P., Powles T., Vulsteke C., Gross-Goupil M., Park S. et al. LBA9 TROPiCS-04, a randomized phase III study of sacituzumab govitecan (SG) vs chemotherapy (CT) in pretreated advanced urothelial carcinoma (aUC): Overall survival (OS) and safety analysis. Annals of Oncology, Volume 35, Supplement 4, S1505-S1507, December 2024.

  • Vulsteke C, Grivas P, Tagawa ST, Bellmunt J, De Santis M, Duran I, et al. TROPiCS-04: Study of Sacituzumab Govitecan (SG) in Patients (Pts) With Locally Advanced (LA) Unresectable or M etastatic Urothelial Cancer (mUC) That Has Progressed After Prior Platinum (PLT) and Checkpoint Inhibitor (CPI) Therapy. [Poster TPS582]. American Society of Clinical Oncology Genitourinary (ASCO-GU); 2022 February 17-19; Annual Meeting.

  • 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.

    PubMed 41277126

  • Klumper N, Cox A, Sjodahl G, Roghmann F, Bolenz C, Hartmann A, Grunwald V, Faltas BM, Holzel M, Eckstein M. Pre-treatment metastatic biopsy: a step towards precision oncology for urothelial cancer. Nat Rev Urol. 2025 May;22(5):256-267. doi: 10.1038/s41585-024-00951-2. Epub 2024 Oct 29.

    PubMed 39472646

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