Back to Trials
NCT03547973PHASE2Recruiting

Study of Sacituzumab Govitecan in Participants With Urothelial Cancer That Cannot Be Removed or Has Spread

Gilead Sciences

Start Date

8/13/2018

Completion Date

4/1/2030

Summary

The objective of this study is to evaluate the efficacy and safety of sacituzumab govitecan-hziy monotherapy and with novel combinations in participants with metastatic urothelial cancer (mUC).

Detailed Description

Non-Randomized for Cohorts 1,2,3, and 4; Randomized for Cohorts 5, 6, and 7. Cohort 5 has been cancelled, effective December 2023.

Eligibility Criteria

Age Range: 18 years to No maximum

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.

Interventions

DRUG

Sacituzumab Govitecan-hziy

DRUG

Pembrolizumab

DRUG

Cisplatin

DRUG

Avelumab

DRUG

Zimberelimab

DRUG

Carboplatin

DRUG

Gemcitabine

DRUG

Domvanalimab

DRUG

Enfortumab Vedotin

Interested in This Trial?

Contact the trial locations directly using the information below to learn more about enrollment.

Expressing interest lets you review the study and consent before we connect you with the research site.

Conditions

Metastatic Urothelial Cancer

Locations

The University of Arizona Cancer Center-North Campus

Tucson, Arizona 85719

United States

USC/Norris Comprehensive Cancer Center

Los Angeles, California 90033

United States

University of California San Francisco

San Francisco, California 94158

United States

Rocky Mountain Cancer Centers

Littleton, Colorado 80120

United States

Smilow Cancer Hospital at Yale-New Haven

New Haven, Connecticut 06510

United States

Eastern Connecticut Hematology and Oncology Associates

Norwich, Connecticut 06360

United States

Mount Sinai Comprehensive Cancer Center

Miami Beach, Florida 33140

United States

Woodlands Medical Specialists, PA

Pensacola, Florida 32503

United States

Moffitt Cancer Center

Tampa, Florida 33612

United States

Winship Cancer Institute, Emory University

Atlanta, Georgia 30322

United States

University of Illinois Cancer Center

Chicago, Illinois 60612

United States

University of Chicago Medical Center

Chicago, Illinois 60637

United States

Southern Illinois University School of Medicine, Simmons Cancer Institute

Springfield, Illinois 62702

United States

Indiana University Melvin and Bren Simon Cancer Center

Indianapolis, Indiana 46202

United States

Norton Cancer Institute, Downtown

Louisville, Kentucky 40202

United States

Maryland Oncology Hematology, P.A.

Brandywine, Maryland 20613

United States

University of Michigan

Ann Arbor, Michigan 48109

United States

Karmanos Cancer Institute

Detroit, Michigan 48201

United States

Oncology Hematology West PC dba Nebraska Cancer Specialists

Omaha, Nebraska 68130

United States

Precision Cancer Research / New Mexico Oncology & Hematology Consultants

Albuquerque, New Mexico 87109

United States

Roswell Park Cancer Institute

Buffalo, New York 14263

United States

Laura & Isaac Perlmutter Cancer Center at NYU Langone Health

New York, New York 10016

United States

Drug Shipping Address: New York-Presbyterian Hospital

New York, New York 10065

United States

Stony Brook Cancer Center

Stony Brook, New York 11794

United States

St. Luke's Hosptial - Bethlehem Campus

Easton, Pennsylvania 18045

United States

Medical University of Southern Carolina

Charleston, South Carolina 29425

United States

Thompson Oncology Group - Knoxville West

Knoxville, Tennessee 37932

United States

Henry-Joyce Cancer Clinic

Nashville, Tennessee 37232

United States

Houston Methodist Hospital, Houston Methodist Cancer Center

Houston, Texas 77030

United States

Mays Cancer Center

San Antonio, Texas 78229

United States

Renovatio Clinical

The Woodlands, Texas 77380

United States

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

Salt Lake City, Utah 84112

United States

University of Virginia Cancer Center

Charlottesville, Virginia 22903

United States

Virginia Oncology Associates

Hampton, Virginia 23666

United States

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

Roanoke, Virginia 24014

United States

Seattle Cancer Care Alliance

Seattle, Washington 98109

United States

University of Wisconsin Clinical Science Center

Madison, Wisconsin 53705

United States

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

Besançon, 25000

France

Hopital Saint Andre (CHU de Bordeaux)

Bordeaux, 33000

France

Centre Hospitalier Regional Universitaire Brest

Brest, 29200

France

Centre Jean Perrin

Clermont-Ferrand, 63011

France

Centre Hospitalier Departmental (CHD) Vendee

La Roche-sur-Yon, 85925

France

Centre Oscar Lambret

Lille, 59000

France

Centre Leon Berard

Lyon, 69373

France

Institut Paoli Calmettes

Marseille, 13273

France

Centre Antoine Lacassagne

Nice, 06189

France

Centre Hospitalier Universitaire De Nimes - Hopital Universitaire Caremeau

Nîmes, 30029

France

Hopital European Georges-Pompidou (HEGP)

Paris, 33000

France

Groupement Hospitalier Pitie-Salpetriere

Paris, 75013

France

Hopital Cochin

Paris, 75014

France

Centre Hospitalier Prive Saint-Gregoire

Rennes, 35000

France

Centre Eugene Marquis

Rennes, 35042

France

CHU de Rouen

Rouen, 76031

France

Hospitaux Universitaires de Strasbourg - Hopital Civil

Strasbourg, 67200

France

Hospital Foch

Suresnes, 92150

France

Institut Claudius Regaud

Toulouse, 31059

France

Institut de Cancerologie de Lorraine

Vandœuvre-lès-Nancy, 54519

France

Institut Gustave Roussy

Villejuif, 94800

France

Urologicum Duisburg

Duisburg, 47179

Germany

Centrum fur Hamatologie und Onkologie Bethanien

Frankfurt, 60389

Germany

Universitätsklinikum Frankfurt, Klinik für Urologie

Frankfurt, 60590

Germany

Universitatsklinikum Freiburg

Freiburg im Breisgau, 79106

Germany

Universitatsklinikum Hamburg-Eppendorf

Hamburg, 20246

Germany

University Hospital Heidelberg

Heidelberg, 69120

Germany

Marien Hospital Herne

Herne, 44625

Germany

Universitatsklinikum Jena

Jena, 07743

Germany

Institut für Versorgungsforschung in der Onkologie

Koblenz, 56068

Germany

Universitätsklinikum Magdeburg

Magdeburg, 39120

Germany

Universitätsklinikum Carl Gustav Carus an der TU Dresden

Mainz, 55131

Germany

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

München, 81675

Germany

Universitatsklinikum Munster, Klinik fur Urologie und Kinderurologie

Münster, 48149

Germany

Universitat Regensburg

Regensburg, 93053

Germany

Universitatsklinikum Tubingen, Klinik fur Urologie

Tübingen, 72076

Germany

Henry Dunant Hospital Center, 4th Oncology Department

Athens, 11526

Greece

University General Hospital of Ioannina, Oncology Department

Ioannina, 45500

Greece

Athens Medical Center, Oncology Department

Marousi, 15125

Greece

General Hospital of Patras Agios Andreas

Pátrai, 26335

Greece

Anassa General Clinic, Oncology-Chemotherapy Department

Volos, 38333

Greece

Ospedale San Donato

Arezzo, 52100

Italy

Centro di Riferimento Oncologico IRCCS

Aviano, 33081

Italy

ASST Cremona

Cremona, 26100

Italy

Ospedale Policlinico San Martino IRCCS

Genoa, 16132

Italy

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

Meldola, 47014

Italy

Fondazione IRCCS Istituto Nazionale dei Tumori

Milan, 20133

Italy

IRCCS Ospedale San Raffaele

Milan, 20133

Italy

Azienda Ospedaliero Universitaria Maggiore della Carita

Novara, 28100

Italy

Istituto Oncologico Veneto IRCCS - Ospedale Busonera

Padova, 35128

Italy

Azienda Ospedaliero-Universitaria Pisana

Pisa, 56126

Italy

Instituto Nazionale Tumori Regina Elena - IFO

Roma, 00144

Italy

Azienda Ospedaliera Santa Maria di Temi

Terni, 05100

Italy

Centro Ricerche Cliniche di Verona srl

Verona, 37126

Italy

Kyungpook National University Chilgok Hospital

Daegu, 41404

South Korea

Keimyung University Dongsan Hospital

Daegu, 42601

South Korea

National Cancer Center

Goyang-si, 10408

South Korea

Chonnam National University Hospital

Gwangju, 61469

South Korea

Chonnam National University Hwasun Hospital

Hwasun, 519-763

South Korea

Korea University - Anam Hospital

Seongbuk-Gu,

South Korea

Seoul National University Hospital

Seoul, 03080

South Korea

Yonsei University Health System, Severance Hospital

Seoul, 03722

South Korea

Samsung Medical Center

Seoul, 06351

South Korea

SMG-SNU Boramae Medical Center

Seoul, 07061

South Korea

Asan Medical Center

Seoul, 5505

South Korea

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

Suwon, 16247

South Korea

Yonsei University - Wonju Severance Christian Hospital

Wŏnju, 26426

South Korea

Pusan National University Yangsan Hospital

Yangsan, 50612

South Korea

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

Badalona, 08916

Spain

Hospital del Mar

Barcelona, 08003

Spain

Hospital Clinic de Barcelona

Barcelona, 08023

Spain

CEIC Hospital Vall d'Hebron

Barcelona, 08035

Spain

Hospital Universitario Reina Sofia

Córdoba, 14004

Spain

Complejo Hospitalario Universitario Insular Materno Infantil

Las Palmas, 35016

Spain

MD Anderson Cancer Centre

Madrid, 28033

Spain

Hospital Universitario Ramon Y Cajal

Madrid, 28034

Spain

Hospital Universitario Clinico San Carlos

Madrid, 28040

Spain

Hospital Universitario 12 de Octubre

Madrid, 28041

Spain

Hospital Universitario La Paz

Madrid, 28046

Spain

Hospital Universitario Puera de Hierro Majadahonda

Majadahonda, 28222

Spain

Hospital Sant Joan de Deu

Manresa, 08243

Spain

Complejo Hospitalario de Ourense

Ourense, 32005

Spain

Hospital Universitario Marques de Valdecilla

Santander, 39008

Spain

Complejo Hospitalario Universitario de Santiago

Santiago de Compostela, 15706

Spain

Hospital Clinico Universitario de Valencia

Valencia, 46010

Spain

Hospital Universitario Miguel Servet

Zaragoza, 50009

Spain

Ankara Sehir Hastanesi

Ankara, 06550

Turkey (Türkiye)

Dicle Universitesi Tip Fakultesi Hastanesi

Diyarbakır, 21280

Turkey (Türkiye)

Trakya Universitesi Saglik Arastirma ve Uygulama Merkezi

Edrine, 22030

Turkey (Türkiye)

Istanbul Universitesi Cerrahpasa Tip Fakultesi Hastanesi

Istanbul, 34098

Turkey (Türkiye)

Medipol Mega Universite Hastanesi

Istanbul, 34214

Turkey (Türkiye)

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

Istanbul, 34722

Turkey (Türkiye)

Izmir Medical Point Hastanesi, Medikal Onkoloji Departmant

Izmir, 35575

Turkey (Türkiye)

Baskent Universitesi Adana Dr.Turgut Noyan Uygulama ve Arastima Merkezi

Seyhan, 01250

Turkey (Türkiye)

University Hospitals Birmingham NHS Foundation Trust

Birmingham, B9 5SS

United Kingdom

Barts Health NHS Trust

London, E1 1BB

United Kingdom

East and North Hertfordshire NHS Trust

Northwood, HA6 2JW

United Kingdom

The Royal Marsden NHS Foundation Trust

Surrey, SM2 5PT

United Kingdom