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Promising drug targets Hard-to-Treat bladder cancer

NCT ID NCT03547973

Disease control Sponsor: Gilead Sciences Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Sep 02, 2026 · Updated 2 times

Summary

This study tests a drug called sacituzumab govitecan in people with advanced bladder cancer that has spread and cannot be removed by surgery. The goal is to see if the drug can shrink tumors and control the cancer. About 827 adults with good organ function and a life expectancy of at least 3 months are being enrolled.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

502 people

The number who actually took part.

Started

Aug 2018

Expected to finish

Apr 2030

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Key Inclusion Criteria: Inclusion Criteria for All Cohorts: * Female or male individuals, ≥ 18 years of age (19 Years old for South Korea). * Eastern Cooperative Oncology Group (ECOG) Performance status score of 0 or 1. * Adequate renal and hepatic function. * Adequate hematologic parameters without transfusional support. * Individuals must have a 3-month life expectancy. Additional Inclusion Criteria for Cohorts 1 to 6: * Cohort 1: Have had progression or recurrence of urothelial cancer following receipt of platinum-containing regimen (cisplatin or carboplatin): 1. Received a first-line platinum-containing regimen in the metastatic setting or for inoperable locally advanced disease; 2. Or received neo/adjuvant platinum-containing therapy for localized muscle-invasive urothelial cancer, with recurrence/progression ≤12 months following completion of therapy. * Cohort 1: In addition to above criterion, have had progression or recurrence of urothelial cancer following receipt of an Anti-programmed Cell Death Protein 1 (anti-PD-1)/ Anti-programmed Death Ligand 1 (PD-L1) therapy. * Cohort 2: Were ineligible for platinum-based therapy for first line metastatic disease and have had progression or recurrence of urothelial cancer after a first-line therapy for metastatic disease with anti-PD-1/PD-L1 therapy. Individual may not have received any platinum for treatment of recurrent, metastatic or advanced disease. * Cohort 3: Progression or recurrence of UC following a platinum containing regimen in the metastatic setting, or progression or recurrence of UC within 12 months of completion of platinum-based therapy as neoadjuvant or adjuvant therapy. * Cohort 4: Individual has not received any platinum-based chemotherapy in the metastatic or unresectable locally advanced setting. Creatinine clearance of at least 50 mL/min calculated by Cockcroft-Gault formula or another validated tool. For individuals receiving cisplatin at 70 mg/m\^2 on Day 1 of every 21-day cycle, a creatinine clearance of least 60 mL/min calculated by Cockcroft -Gault formula or another validated tool is required. Individuals with creatinine clearance between 50 to 59 mL/min are to receive a split dose of cisplatin (35 mg/m\^2 Day 1 and Day 8 of every 21-day cycle). * Cohorts 4, 5, 6: Archival tumor tissue comprising muscle-invasive or metastatic urothelial carcinoma, or a biopsy of metastatic urothelial carcinoma. * Cohort 5: Individuals received at least 4 cycles and no more than 6 cycles of GEM + cisplatin. No other chemotherapy regimens are allowed in this cohort, with the exception of prior adjuvant or neoadjuvant systemic therapy with curative intent after \> 12 months from completion of therapy. * No evidence of progressive disease following completion of first-line chemotherapy (ie, CR, PR, or SD per RECIST v1.1 guidelines as per investigator). * Treatment-free interval of 4 to 10 weeks since the last dose of chemotherapy. * Cohort 6: Cis-ineligible and no prior therapy for metastatic disease or for unresectable locally advanced disease. Checkpoint inhibitor therapy naïve or \>12 months from completion of adjuvant therapy are permitted. * Cohorts 4 and 6: Have measurable disease by CT or MRI as per RECIST 1.1 criteria. Tumor lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions. * Cohorts 1, 2, 3 and 5: Creatinine clearance ≥ 30 mL/min as calculated by the Cockcroft-Gault formula unless otherwise specified Additional Inclusion Criteria for Cohort 7: * No prior systemic therapy for locally advanced or metastatic UC. Therapy in the curative setting is allowed provided recurrence is \> 12 months since the last dose of systemic therapy. * Archival tumor tissue comprising muscle-invasive or metastatic urothelial carcinoma, or a biopsy of metastatic urothelial carcinoma. * Have measurable disease by CT or MRI as per RECIST 1.1 criteria. Tumor lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions. Key Exclusion Criteria: Exclusion Criteria for All cohorts: * Females who are pregnant or lactating. * Has had a prior anti-cancer monoclonal antibody (mAb) within 4 weeks prior to study Day 1 or who has not recovered (i.e., ≤ Grade 1 or at baseline) from adverse events due to agents administered more than 4 weeks earlier. * Has an active second malignancy. * Has known active Hepatitis B or Hepatitis C. * Has other concurrent medical or psychiatric conditions. * Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis. * Has an active second malignancy. Additional Exclusion Criteria for Cohorts 1 to 6: * For Cohort 5: Alopecia, sensory neuropathy Grade ≤2 is acceptable, or other Grade \<\< 2 adverse events not constituting a safety risk based on the investigator's judgment are acceptable. * Cohort 3: Has received anti-PD-1/PD-L1 therapy previously. * Cohorts 3 to 6: Has an active autoimmune disease that required systemic treatment in past 2 years (ie, with use of disease-modifying agents, corticosteroids, or immunosuppressive drugs). Replacement therapy (eg, thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment. * Cohorts 3 to 6: Has received a live vaccine within 30 days prior to the first dose of study drug(s), has history or evidence of interstitial lung disease (ILD) or non-infectious pneumonitis. * Cohort 4: Refractory to platinum (i.e., relapsed ≤ 12 months after completion of chemotherapy) in the neoadjuvant/adjuvant setting. * Cohorts 4, 5, and 6: For individuals who received prior CPI, a treatment-free interval \>12 months between the last treatment administration and the date of recurrence is required. Additional Exclusion Criteria for Cohort 7: * Have had a prior anticancer therapy within 12 months prior to C1D1 or prior radiation therapy within 2 weeks prior to C1D1. Individuals participating in observational studies are eligible. Use of other investigational drugs (drugs not marketed for any indication) within 28 days or 5 half-lives (whichever is longer) of first dose of investigational product. * Have a history of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis on screening chest CT scan. * Have a Child-Pugh score of B or C. * Individuals with uncontrolled diabetes. * Have active keratitis or corneal ulcerations. * Participants with ongoing sensory or motor neuropathy Grade ≥ 2. Note: Other protocol defined Inclusion/Exclusion criteria may apply.

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Conditions

The condition(s) this trial relates to.

bladder transitional cell carcinoma urothelial carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Metastatic urothelial cancer

Contacts and locations

Locations

  • ASST Cremona

    Cremona, 26100, Italy

  • Anassa General Clinic, Oncology-Chemotherapy Department

    Volos, 38333, Greece

  • Ankara Sehir Hastanesi

    Ankara, 06550, Turkey (Türkiye)

  • Asan Medical Center

    Seoul, 5505, South Korea

  • Athens Medical Center, Oncology Department

    Marousi, 15125, Greece

  • Azienda Ospedaliera Santa Maria di Temi

    Terni, 05100, Italy

  • Azienda Ospedaliero Universitaria Maggiore della Carita

    Novara, 28100, Italy

  • Azienda Ospedaliero-Universitaria Pisana

    Pisa, 56126, Italy

  • Barts Health NHS Trust

    London, E1 1BB, United Kingdom

  • Baskent Universitesi Adana Dr.Turgut Noyan Uygulama ve Arastima Merkezi

    Seyhan, 01250, Turkey (Türkiye)

  • CEIC Hospital Vall d'Hebron

    Barcelona, 08035, Spain

  • CHU de Rouen

    Rouen, 76031, France

  • Centre Antoine Lacassagne

    Nice, 06189, France

  • Centre Eugene Marquis

    Rennes, 35042, France

  • Centre Hospitalier Departmental (CHD) Vendee

    La Roche-sur-Yon, 85925, France

  • Centre Hospitalier Prive Saint-Gregoire

    Rennes, 35000, France

  • Centre Hospitalier Regional Universitaire (CHRU) de Besancon, Hopital Jean Minjoz

    Besançon, 25000, France

  • Centre Hospitalier Regional Universitaire Brest

    Brest, 29200, France

  • Centre Hospitalier Universitaire De Nimes - Hopital Universitaire Caremeau

    Nîmes, 30029, France

  • Centre Jean Perrin

    Clermont-Ferrand, 63011, France

  • Centre Leon Berard

    Lyon, 69373, France

  • Centre Oscar Lambret

    Lille, 59000, France

  • Centro Ricerche Cliniche di Verona srl

    Verona, 37126, Italy

  • Centro di Riferimento Oncologico IRCCS

    Aviano, 33081, Italy

  • Centrum fur Hamatologie und Onkologie Bethanien

    Frankfurt, 60389, Germany

  • Chonnam National University Hospital

    Gwangju, 61469, South Korea

  • Chonnam National University Hwasun Hospital

    Hwasun, 519-763, South Korea

  • Complejo Hospitalario Universitario Insular Materno Infantil

    Las Palmas, 35016, Spain

  • Complejo Hospitalario Universitario de Santiago

    Santiago de Compostela, 15706, Spain

  • Complejo Hospitalario de Ourense

    Ourense, 32005, Spain

  • Dicle Universitesi Tip Fakultesi Hastanesi

    Diyarbakır, 21280, Turkey (Türkiye)

  • Drug Shipping Address: New York-Presbyterian Hospital

    New York, New York, 10065, United States

  • East and North Hertfordshire NHS Trust

    Northwood, HA6 2JW, United Kingdom

  • Fondazione IRCCS Istituto Nazionale dei Tumori

    Milan, 20133, Italy

  • General Hospital of Patras Agios Andreas

    Pátrai, 26335, Greece

  • Groupement Hospitalier Pitie-Salpetriere

    Paris, 75013, France

  • Henry Dunant Hospital Center, 4th Oncology Department

    Athens, 11526, Greece

  • Henry-Joyce Cancer Clinic

    Nashville, Tennessee, 37232, United States

  • Hopital Cochin

    Paris, 75014, France

  • Hopital European Georges-Pompidou (HEGP)

    Paris, 33000, France

  • Hopital Saint Andre (CHU de Bordeaux)

    Bordeaux, 33000, France

  • Hospital Clinic de Barcelona

    Barcelona, 08023, Spain

  • Hospital Clinico Universitario de Valencia

    Valencia, 46010, Spain

  • Hospital Foch

    Suresnes, 92150, France

  • Hospital Sant Joan de Deu

    Manresa, 08243, Spain

  • Hospital Universitario 12 de Octubre

    Madrid, 28041, Spain

  • Hospital Universitario Clinico San Carlos

    Madrid, 28040, Spain

  • Hospital Universitario La Paz

    Madrid, 28046, Spain

  • Hospital Universitario Marques de Valdecilla

    Santander, 39008, Spain

  • Hospital Universitario Miguel Servet

    Zaragoza, 50009, Spain

  • Hospital Universitario Puera de Hierro Majadahonda

    Majadahonda, 28222, Spain

  • Hospital Universitario Ramon Y Cajal

    Madrid, 28034, Spain

  • Hospital Universitario Reina Sofia

    Córdoba, 14004, Spain

  • Hospital del Mar

    Barcelona, 08003, Spain

  • Hospitaux Universitaires de Strasbourg - Hopital Civil

    Strasbourg, 67200, France

  • Houston Methodist Hospital, Houston Methodist Cancer Center

    Houston, Texas, 77030, United States

  • IRCCS Ospedale San Raffaele

    Milan, 20133, Italy

  • Institut Catala d'Oncologia Badalona - Hospital Universitari Germans Trias i Pujol

    Badalona, 08916, Spain

  • Institut Claudius Regaud

    Toulouse, 31059, France

  • Institut Gustave Roussy

    Villejuif, 94800, France

  • Institut Paoli Calmettes

    Marseille, 13273, France

  • Institut de Cancerologie de Lorraine

    Vandœuvre-lès-Nancy, 54519, France

  • Institut für Versorgungsforschung in der Onkologie

    Koblenz, 56068, Germany

  • Instituto Nazionale Tumori Regina Elena - IFO

    Roma, 00144, Italy

  • Istanbul Universitesi Cerrahpasa Tip Fakultesi Hastanesi

    Istanbul, 34098, Turkey (Türkiye)

  • Istituto Oncologico Veneto IRCCS - Ospedale Busonera

    Padova, 35128, Italy

  • Istituto Romagnolo per Io Studio dei Tumori (IRST) "Dino Amadori"

    Meldola, 47014, Italy

  • Izmir Medical Point Hastanesi, Medikal Onkoloji Departmant

    Izmir, 35575, Turkey (Türkiye)

  • Karmanos Cancer Institute

    Detroit, Michigan, 48201, United States

  • Keimyung University Dongsan Hospital

    Daegu, 42601, South Korea

  • Klinikum rechts der Isar der Technischen Universität München, Urologische Klinik und Poloklinik

    München, 81675, Germany

  • Korea University - Anam Hospital

    Seongbuk-Gu, South Korea

  • Kyungpook National University Chilgok Hospital

    Daegu, 41404, South Korea

  • Laura & Isaac Perlmutter Cancer Center at NYU Langone Health

    New York, New York, 10016, United States

  • MD Anderson Cancer Centre

    Madrid, 28033, Spain

  • Marien Hospital Herne

    Herne, 44625, Germany

  • Mays Cancer Center

    San Antonio, Texas, 78229, United States

  • Medical University of Southern Carolina

    Charleston, South Carolina, 29425, United States

  • Medipol Mega Universite Hastanesi

    Istanbul, 34214, Turkey (Türkiye)

  • Moffitt Cancer Center

    Tampa, Florida, 33612, United States

  • Mount Sinai Comprehensive Cancer Center

    Miami Beach, Florida, 33140, United States

  • National Cancer Center

    Goyang-si, 10408, South Korea

  • Norton Cancer Institute, Downtown

    Louisville, Kentucky, 40202, United States

  • Oncology Hematology Associates of Southwest Virginia, Inc., DBA Blue Ridge Cancer Care

    Roanoke, Virginia, 24014, United States

  • Ospedale Policlinico San Martino IRCCS

    Genoa, 16132, Italy

  • Ospedale San Donato

    Arezzo, 52100, Italy

  • Precision Cancer Research / New Mexico Oncology & Hematology Consultants

    Albuquerque, New Mexico, 87109, United States

  • Pusan National University Yangsan Hospital

    Yangsan, 50612, South Korea

  • Rocky Mountain Cancer Centers

    Littleton, Colorado, 80120, United States

  • Roswell Park Cancer Institute

    Buffalo, New York, 14263, United States

  • SMG-SNU Boramae Medical Center

    Seoul, 07061, South Korea

  • Samsung Medical Center

    Seoul, 06351, South Korea

  • Seattle Cancer Care Alliance

    Seattle, Washington, 98109, United States

  • Seoul National University Hospital

    Seoul, 03080, South Korea

  • Smilow Cancer Hospital at Yale-New Haven

    New Haven, Connecticut, 06510, United States

  • Southern Illinois University School of Medicine, Simmons Cancer Institute

    Springfield, Illinois, 62702, United States

  • St. Luke's Hosptial - Bethlehem Campus

    Easton, Pennsylvania, 18045, United States

  • Stony Brook Cancer Center

    Stony Brook, New York, 11794, United States

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

    Istanbul, 34722, Turkey (Türkiye)

  • The Catholic University of Korea, St. Vincent's Hospital

    Suwon, 16247, South Korea

  • The Royal Marsden NHS Foundation Trust

    Surrey, SM2 5PT, United Kingdom

  • The University of Arizona Cancer Center-North Campus

    Tucson, Arizona, 85719, United States

  • Thompson Oncology Group - Knoxville West

    Knoxville, Tennessee, 37932, United States

  • Trakya Universitesi Saglik Arastirma ve Uygulama Merkezi

    Edrine, 22030, Turkey (Türkiye)

  • Universitat Regensburg

    Regensburg, 93053, Germany

  • Universitatsklinikum Freiburg

    Freiburg im Breisgau, 79106, Germany

  • Universitatsklinikum Hamburg-Eppendorf

    Hamburg, 20246, Germany

  • Universitatsklinikum Jena

    Jena, 07743, Germany

  • Universitatsklinikum Munster, Klinik fur Urologie und Kinderurologie

    Münster, 48149, Germany

  • Universitatsklinikum Tubingen, Klinik fur Urologie

    Tübingen, 72076, Germany

  • University General Hospital of Ioannina, Oncology Department

    Ioannina, 45500, Greece

  • University Hospital Heidelberg

    Heidelberg, 69120, Germany

  • University Hospitals Birmingham NHS Foundation Trust

    Birmingham, B9 5SS, United Kingdom

  • University of California San Francisco

    San Francisco, California, 94158, United States

  • University of Chicago Medical Center

    Chicago, Illinois, 60637, United States

  • University of Illinois Cancer Center

    Chicago, Illinois, 60612, United States

  • University of Michigan

    Ann Arbor, Michigan, 48109, United States

  • University of Utah - Huntsman Cancer Hospital (IP Shipping Address)

    Salt Lake City, Utah, 84112, United States

  • University of Wisconsin Clinical Science Center

    Madison, Wisconsin, 53705, United States

  • Universitätsklinikum Carl Gustav Carus an der TU Dresden

    Mainz, 55131, Germany

  • Universitätsklinikum Frankfurt, Klinik für Urologie

    Frankfurt, 60590, Germany

  • Universitätsklinikum Magdeburg

    Magdeburg, 39120, Germany

  • Urologicum Duisburg

    Duisburg, 47179, Germany

  • Virginia Oncology Associates

    Hampton, Virginia, 23666, United States

  • Winship Cancer Institute, Emory University

    Atlanta, Georgia, 30322, United States

  • Woodlands Medical Specialists, PA

    Pensacola, Florida, 32503, United States

  • Yonsei University - Wonju Severance Christian Hospital

    Wŏnju, 26426, South Korea

  • Yonsei University Health System, Severance Hospital

    Seoul, 03722, South Korea

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