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RECRUITING

NCT03547973

PHASE2

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

Sponsor: Gilead Sciences

View on ClinicalTrials.gov

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).

Official title: A Phase II Open-Label Study of Sacituzumab Govitecan in Unresectable Locally Advanced/Metastatic Urothelial Cancer

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

827

Start Date

2018-08-13

Completion Date

2030-04

Last Updated

2026-03-16

Healthy Volunteers

No

Conditions

Metastatic Urothelial Cancer

Interventions

DRUG

Sacituzumab Govitecan-hziy

Administered intravenously.

DRUG

Pembrolizumab

Administered per package insert

DRUG

Cisplatin

Administered per package insert

DRUG

Avelumab

Administered per package insert

DRUG

Zimberelimab

Administered intravenously

DRUG

Carboplatin

Administered per package insert

DRUG

Gemcitabine

Administered per package insert

DRUG

Domvanalimab

Administered intravenously

DRUG

Enfortumab Vedotin

Administered intravenously

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.

Locations (135)

The University of Arizona Cancer Center-North Campus

Tucson, Arizona, United States

USC/Norris Comprehensive Cancer Center

Los Angeles, California, United States

University of California San Francisco

San Francisco, California, United States

Rocky Mountain Cancer Centers

Littleton, Colorado, United States

Smilow Cancer Hospital at Yale-New Haven

New Haven, Connecticut, United States

Eastern Connecticut Hematology and Oncology Associates

Norwich, Connecticut, United States

Mount Sinai Comprehensive Cancer Center

Miami Beach, Florida, United States

Woodlands Medical Specialists, PA

Pensacola, Florida, United States

Moffitt Cancer Center

Tampa, Florida, United States

Winship Cancer Institute, Emory University

Atlanta, Georgia, United States

University of Illinois Cancer Center

Chicago, Illinois, United States

University of Chicago Medical Center

Chicago, Illinois, United States

Southern Illinois University School of Medicine, Simmons Cancer Institute

Springfield, Illinois, United States

Indiana University Melvin and Bren Simon Cancer Center

Indianapolis, Indiana, United States

Norton Cancer Institute, Downtown

Louisville, Kentucky, United States

Maryland Oncology Hematology, P.A.

Brandywine, Maryland, United States

University of Michigan

Ann Arbor, Michigan, United States

Karmanos Cancer Institute

Detroit, Michigan, United States

Oncology Hematology West PC dba Nebraska Cancer Specialists

Omaha, Nebraska, United States

Precision Cancer Research / New Mexico Oncology & Hematology Consultants

Albuquerque, New Mexico, United States

Roswell Park Cancer Institute

Buffalo, New York, United States

Laura & Isaac Perlmutter Cancer Center at NYU Langone Health

New York, New York, United States

Drug Shipping Address: New York-Presbyterian Hospital

New York, New York, United States

Stony Brook Cancer Center

Stony Brook, New York, United States

St. Luke's Hosptial - Bethlehem Campus

Easton, Pennsylvania, United States

Medical University of Southern Carolina

Charleston, South Carolina, United States

Thompson Oncology Group - Knoxville West

Knoxville, Tennessee, United States

Henry-Joyce Cancer Clinic

Nashville, Tennessee, United States

Houston Methodist Hospital, Houston Methodist Cancer Center

Houston, Texas, United States

Mays Cancer Center

San Antonio, Texas, United States

Renovatio Clinical

The Woodlands, Texas, United States

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

Salt Lake City, Utah, United States

University of Virginia Cancer Center

Charlottesville, Virginia, United States

Virginia Oncology Associates

Hampton, Virginia, United States

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

Roanoke, Virginia, United States

Seattle Cancer Care Alliance

Seattle, Washington, United States

University of Wisconsin Clinical Science Center

Madison, Wisconsin, United States

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

Besançon, France

Hopital Saint Andre (CHU de Bordeaux)

Bordeaux, France

Centre Hospitalier Regional Universitaire Brest

Brest, France

Centre Jean Perrin

Clermont-Ferrand, France

Centre Hospitalier Departmental (CHD) Vendee

La Roche-sur-Yon, France

Centre Oscar Lambret

Lille, France

Centre Leon Berard

Lyon, France

Institut Paoli Calmettes

Marseille, France

Centre Antoine Lacassagne

Nice, France

Centre Hospitalier Universitaire De Nimes - Hopital Universitaire Caremeau

Nîmes, France

Hopital European Georges-Pompidou (HEGP)

Paris, France

Groupement Hospitalier Pitie-Salpetriere

Paris, France

Hopital Cochin

Paris, France

Centre Hospitalier Prive Saint-Gregoire

Rennes, France

Centre Eugene Marquis

Rennes, France

CHU de Rouen

Rouen, France

Hospitaux Universitaires de Strasbourg - Hopital Civil

Strasbourg, France

Hospital Foch

Suresnes, France

Institut Claudius Regaud

Toulouse, France

Institut de Cancerologie de Lorraine

Vandœuvre-lès-Nancy, France

Institut Gustave Roussy

Villejuif, France

Urologicum Duisburg

Duisburg, Germany

Centrum fur Hamatologie und Onkologie Bethanien

Frankfurt, Germany

Universitätsklinikum Frankfurt, Klinik für Urologie

Frankfurt, Germany

Universitatsklinikum Freiburg

Freiburg im Breisgau, Germany

Universitatsklinikum Hamburg-Eppendorf

Hamburg, Germany

University Hospital Heidelberg

Heidelberg, Germany

Marien Hospital Herne

Herne, Germany

Universitatsklinikum Jena

Jena, Germany

Institut für Versorgungsforschung in der Onkologie

Koblenz, Germany

Universitätsklinikum Magdeburg

Magdeburg, Germany

Universitätsklinikum Carl Gustav Carus an der TU Dresden

Mainz, Germany

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

München, Germany

Universitatsklinikum Munster, Klinik fur Urologie und Kinderurologie

Münster, Germany

Universitat Regensburg

Regensburg, Germany

Universitatsklinikum Tubingen, Klinik fur Urologie

Tübingen, Germany

Henry Dunant Hospital Center, 4th Oncology Department

Athens, Greece

University General Hospital of Ioannina, Oncology Department

Ioannina, Greece

Athens Medical Center, Oncology Department

Marousi, Greece

General Hospital of Patras Agios Andreas

Pátrai, Greece

Anassa General Clinic, Oncology-Chemotherapy Department

Volos, Greece

Ospedale San Donato

Arezzo, Italy

Centro di Riferimento Oncologico IRCCS

Aviano, Italy

ASST Cremona

Cremona, Italy

Ospedale Policlinico San Martino IRCCS

Genoa, Italy

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

Meldola, Italy

Fondazione IRCCS Istituto Nazionale dei Tumori

Milan, Italy

IRCCS Ospedale San Raffaele

Milan, Italy

Azienda Ospedaliero Universitaria Maggiore della Carita

Novara, Italy

Istituto Oncologico Veneto IRCCS - Ospedale Busonera

Padova, Italy

Azienda Ospedaliero-Universitaria Pisana

Pisa, Italy

Instituto Nazionale Tumori Regina Elena - IFO

Roma, Italy

Azienda Ospedaliera Santa Maria di Temi

Terni, Italy

Centro Ricerche Cliniche di Verona srl

Verona, Italy

Kyungpook National University Chilgok Hospital

Daegu, South Korea

Keimyung University Dongsan Hospital

Daegu, South Korea

National Cancer Center

Goyang-si, South Korea

Chonnam National University Hospital

Gwangju, South Korea

Chonnam National University Hwasun Hospital

Hwasun, South Korea

Korea University - Anam Hospital

Seongbuk-Gu, South Korea

Seoul National University Hospital

Seoul, South Korea

Yonsei University Health System, Severance Hospital

Seoul, South Korea

Samsung Medical Center

Seoul, South Korea

SMG-SNU Boramae Medical Center

Seoul, South Korea

Asan Medical Center

Seoul, South Korea

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

Suwon, South Korea

Yonsei University - Wonju Severance Christian Hospital

Wŏnju, South Korea

Pusan National University Yangsan Hospital

Yangsan, South Korea

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

Badalona, Spain

Hospital del Mar

Barcelona, Spain

Hospital Clinic de Barcelona

Barcelona, Spain

CEIC Hospital Vall d'Hebron

Barcelona, Spain

Hospital Universitario Reina Sofia

Córdoba, Spain

Complejo Hospitalario Universitario Insular Materno Infantil

Las Palmas, Spain

MD Anderson Cancer Centre

Madrid, Spain

Hospital Universitario Ramon Y Cajal

Madrid, Spain

Hospital Universitario Clinico San Carlos

Madrid, Spain

Hospital Universitario 12 de Octubre

Madrid, Spain

Hospital Universitario La Paz

Madrid, Spain

Hospital Universitario Puera de Hierro Majadahonda

Majadahonda, Spain

Hospital Sant Joan de Deu

Manresa, Spain

Complejo Hospitalario de Ourense

Ourense, Spain

Hospital Universitario Marques de Valdecilla

Santander, Spain

Complejo Hospitalario Universitario de Santiago

Santiago de Compostela, Spain

Hospital Clinico Universitario de Valencia

Valencia, Spain

Hospital Universitario Miguel Servet

Zaragoza, Spain

Ankara Sehir Hastanesi

Ankara, Turkey (Türkiye)

Dicle Universitesi Tip Fakultesi Hastanesi

Diyarbakır, Turkey (Türkiye)

Trakya Universitesi Saglik Arastirma ve Uygulama Merkezi

Edrine, Turkey (Türkiye)

Istanbul Universitesi Cerrahpasa Tip Fakultesi Hastanesi

Istanbul, Turkey (Türkiye)

Medipol Mega Universite Hastanesi

Istanbul, Turkey (Türkiye)

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

Istanbul, Turkey (Türkiye)

Izmir Medical Point Hastanesi, Medikal Onkoloji Departmant

Izmir, Turkey (Türkiye)

Baskent Universitesi Adana Dr.Turgut Noyan Uygulama ve Arastima Merkezi

Seyhan, Turkey (Türkiye)

University Hospitals Birmingham NHS Foundation Trust

Birmingham, United Kingdom

Barts Health NHS Trust

London, United Kingdom

East and North Hertfordshire NHS Trust

Northwood, United Kingdom

The Royal Marsden NHS Foundation Trust

Surrey, United Kingdom