Actively Recruiting
Study of Sacituzumab Govitecan in Participants With Urothelial Cancer That Cannot Be Removed or Has Spread
Led by Gilead Sciences · Updated on 2026-03-16
827
Participants Needed
135
Research Sites
607 weeks
Total Duration
On this page
Sponsors
G
Gilead Sciences
Lead Sponsor
M
Merck KGaA, Darmstadt, Germany
Collaborating Sponsor
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official Title
Study of Sacituzumab Govitecan in Participants With Urothelial Cancer That Cannot Be Removed or Has Spread
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female or male individuals 18 years of age or older (19 years in South Korea)
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Adequate kidney and liver function
- Adequate blood cell counts without need for transfusions
- Life expectancy of at least 3 months
- Cohorts 1 to 6: Various prior treatments with platinum chemotherapy and immunotherapy as specified per cohort
- Cohorts 4 and 6: Measurable disease by CT or MRI per RECIST 1.1 criteria
- Cohort 7: No prior systemic therapy for locally advanced or metastatic urothelial cancer
- Archival or biopsy tumor tissue available for analysis
- Creatinine clearance thresholds as specified by cohort
You will not qualify if you...
- Pregnant or breastfeeding females
- Recent use of anti-cancer monoclonal antibodies within 4 weeks before study start or unresolved side effects
- Active second cancer
- Known active Hepatitis B or C infection
- Other concurrent medical or psychiatric conditions
- Active brain metastases or carcinomatous meningitis
- Specific cohort exclusions including prior therapies, autoimmune diseases requiring recent treatment, recent live vaccines, lung disease, uncontrolled diabetes, active eye infections, and significant neuropathy
- Cohort 7: Prior anticancer therapy within 12 months or prior radiation within 2 weeks before study start
- Child-Pugh score B or C liver function
- Participation in other investigational drug studies within specified time frames
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 135 locations
1
The University of Arizona Cancer Center-North Campus
Tucson, Arizona, United States, 85719
Actively Recruiting
2
USC/Norris Comprehensive Cancer Center
Los Angeles, California, United States, 90033
Withdrawn
3
University of California San Francisco
San Francisco, California, United States, 94158
Actively Recruiting
4
Rocky Mountain Cancer Centers
Littleton, Colorado, United States, 80120
Actively Recruiting
5
Smilow Cancer Hospital at Yale-New Haven
New Haven, Connecticut, United States, 06510
Actively Recruiting
6
Eastern Connecticut Hematology and Oncology Associates
Norwich, Connecticut, United States, 06360
Withdrawn
7
Mount Sinai Comprehensive Cancer Center
Miami Beach, Florida, United States, 33140
Actively Recruiting
8
Woodlands Medical Specialists, PA
Pensacola, Florida, United States, 32503
Actively Recruiting
9
Moffitt Cancer Center
Tampa, Florida, United States, 33612
Actively Recruiting
10
Winship Cancer Institute, Emory University
Atlanta, Georgia, United States, 30322
Completed
11
University of Illinois Cancer Center
Chicago, Illinois, United States, 60612
Actively Recruiting
12
University of Chicago Medical Center
Chicago, Illinois, United States, 60637
Actively Recruiting
13
Southern Illinois University School of Medicine, Simmons Cancer Institute
Springfield, Illinois, United States, 62702
Actively Recruiting
14
Indiana University Melvin and Bren Simon Cancer Center
Indianapolis, Indiana, United States, 46202
Withdrawn
15
Norton Cancer Institute, Downtown
Louisville, Kentucky, United States, 40202
Actively Recruiting
16
Maryland Oncology Hematology, P.A.
Brandywine, Maryland, United States, 20613
Withdrawn
17
University of Michigan
Ann Arbor, Michigan, United States, 48109
Actively Recruiting
18
Karmanos Cancer Institute
Detroit, Michigan, United States, 48201
Actively Recruiting
19
Oncology Hematology West PC dba Nebraska Cancer Specialists
Omaha, Nebraska, United States, 68130
Withdrawn
20
Precision Cancer Research / New Mexico Oncology & Hematology Consultants
Albuquerque, New Mexico, United States, 87109
Completed
21
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263
Actively Recruiting
22
Laura & Isaac Perlmutter Cancer Center at NYU Langone Health
New York, New York, United States, 10016
Actively Recruiting
23
Drug Shipping Address: New York-Presbyterian Hospital
New York, New York, United States, 10065
Actively Recruiting
24
Stony Brook Cancer Center
Stony Brook, New York, United States, 11794
Completed
25
St. Luke's Hosptial - Bethlehem Campus
Easton, Pennsylvania, United States, 18045
Actively Recruiting
26
Medical University of Southern Carolina
Charleston, South Carolina, United States, 29425
Actively Recruiting
27
Thompson Oncology Group - Knoxville West
Knoxville, Tennessee, United States, 37932
Actively Recruiting
28
Henry-Joyce Cancer Clinic
Nashville, Tennessee, United States, 37232
Actively Recruiting
29
Houston Methodist Hospital, Houston Methodist Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
30
Mays Cancer Center
San Antonio, Texas, United States, 78229
Actively Recruiting
31
Renovatio Clinical
The Woodlands, Texas, United States, 77380
Withdrawn
32
University of Utah - Huntsman Cancer Hospital (IP Shipping Address)
Salt Lake City, Utah, United States, 84112
Actively Recruiting
33
University of Virginia Cancer Center
Charlottesville, Virginia, United States, 22903
Withdrawn
34
Virginia Oncology Associates
Hampton, Virginia, United States, 23666
Actively Recruiting
35
Oncology Hematology Associates of Southwest Virginia, Inc., DBA Blue Ridge Cancer Care
Roanoke, Virginia, United States, 24014
Actively Recruiting
36
Seattle Cancer Care Alliance
Seattle, Washington, United States, 98109
Actively Recruiting
37
University of Wisconsin Clinical Science Center
Madison, Wisconsin, United States, 53705
Actively Recruiting
38
Centre Hospitalier Regional Universitaire (CHRU) de Besancon, Hopital Jean Minjoz
Besançon, France, 25000
Actively Recruiting
39
Hopital Saint Andre (CHU de Bordeaux)
Bordeaux, France, 33000
Actively Recruiting
40
Centre Hospitalier Regional Universitaire Brest
Brest, France, 29200
Actively Recruiting
41
Centre Jean Perrin
Clermont-Ferrand, France, 63011
Actively Recruiting
42
Centre Hospitalier Departmental (CHD) Vendee
La Roche-sur-Yon, France, 85925
Actively Recruiting
43
Centre Oscar Lambret
Lille, France, 59000
Actively Recruiting
44
Centre Leon Berard
Lyon, France, 69373
Actively Recruiting
45
Institut Paoli Calmettes
Marseille, France, 13273
Actively Recruiting
46
Centre Antoine Lacassagne
Nice, France, 06189
Actively Recruiting
47
Centre Hospitalier Universitaire De Nimes - Hopital Universitaire Caremeau
Nîmes, France, 30029
Actively Recruiting
48
Hopital European Georges-Pompidou (HEGP)
Paris, France, 33000
Actively Recruiting
49
Groupement Hospitalier Pitie-Salpetriere
Paris, France, 75013
Actively Recruiting
50
Hopital Cochin
Paris, France, 75014
Actively Recruiting
51
Centre Hospitalier Prive Saint-Gregoire
Rennes, France, 35000
Actively Recruiting
52
Centre Eugene Marquis
Rennes, France, 35042
Actively Recruiting
53
CHU de Rouen
Rouen, France, 76031
Actively Recruiting
54
Hospitaux Universitaires de Strasbourg - Hopital Civil
Strasbourg, France, 67200
Actively Recruiting
55
Hospital Foch
Suresnes, France, 92150
Actively Recruiting
56
Institut Claudius Regaud
Toulouse, France, 31059
Actively Recruiting
57
Institut de Cancerologie de Lorraine
Vandœuvre-lès-Nancy, France, 54519
Actively Recruiting
58
Institut Gustave Roussy
Villejuif, France, 94800
Actively Recruiting
59
Urologicum Duisburg
Duisburg, Germany, 47179
Completed
60
Centrum fur Hamatologie und Onkologie Bethanien
Frankfurt, Germany, 60389
Actively Recruiting
61
Universitätsklinikum Frankfurt, Klinik für Urologie
Frankfurt, Germany, 60590
Actively Recruiting
62
Universitatsklinikum Freiburg
Freiburg im Breisgau, Germany, 79106
Actively Recruiting
63
Universitatsklinikum Hamburg-Eppendorf
Hamburg, Germany, 20246
Actively Recruiting
64
University Hospital Heidelberg
Heidelberg, Germany, 69120
Actively Recruiting
65
Marien Hospital Herne
Herne, Germany, 44625
Actively Recruiting
66
Universitatsklinikum Jena
Jena, Germany, 07743
Actively Recruiting
67
Institut für Versorgungsforschung in der Onkologie
Koblenz, Germany, 56068
Actively Recruiting
68
Universitätsklinikum Magdeburg
Magdeburg, Germany, 39120
Actively Recruiting
69
Universitätsklinikum Carl Gustav Carus an der TU Dresden
Mainz, Germany, 55131
Actively Recruiting
70
Klinikum rechts der Isar der Technischen Universität München, Urologische Klinik und Poloklinik
München, Germany, 81675
Actively Recruiting
71
Universitatsklinikum Munster, Klinik fur Urologie und Kinderurologie
Münster, Germany, 48149
Actively Recruiting
72
Universitat Regensburg
Regensburg, Germany, 93053
Actively Recruiting
73
Universitatsklinikum Tubingen, Klinik fur Urologie
Tübingen, Germany, 72076
Actively Recruiting
74
Henry Dunant Hospital Center, 4th Oncology Department
Athens, Greece, 11526
Actively Recruiting
75
University General Hospital of Ioannina, Oncology Department
Ioannina, Greece, 45500
Actively Recruiting
76
Athens Medical Center, Oncology Department
Marousi, Greece, 15125
Actively Recruiting
77
General Hospital of Patras Agios Andreas
Pátrai, Greece, 26335
Actively Recruiting
78
Anassa General Clinic, Oncology-Chemotherapy Department
Volos, Greece, 38333
Actively Recruiting
79
Ospedale San Donato
Arezzo, Italy, 52100
Actively Recruiting
80
Centro di Riferimento Oncologico IRCCS
Aviano, Italy, 33081
Actively Recruiting
81
ASST Cremona
Cremona, Italy, 26100
Actively Recruiting
82
Ospedale Policlinico San Martino IRCCS
Genoa, Italy, 16132
Actively Recruiting
83
Istituto Romagnolo per Io Studio dei Tumori (IRST) "Dino Amadori"
Meldola, Italy, 47014
Actively Recruiting
84
Fondazione IRCCS Istituto Nazionale dei Tumori
Milan, Italy, 20133
Actively Recruiting
85
IRCCS Ospedale San Raffaele
Milan, Italy, 20133
Actively Recruiting
86
Azienda Ospedaliero Universitaria Maggiore della Carita
Novara, Italy, 28100
Actively Recruiting
87
Istituto Oncologico Veneto IRCCS - Ospedale Busonera
Padova, Italy, 35128
Actively Recruiting
88
Azienda Ospedaliero-Universitaria Pisana
Pisa, Italy, 56126
Actively Recruiting
89
Instituto Nazionale Tumori Regina Elena - IFO
Roma, Italy, 00144
Actively Recruiting
90
Azienda Ospedaliera Santa Maria di Temi
Terni, Italy, 05100
Actively Recruiting
91
Centro Ricerche Cliniche di Verona srl
Verona, Italy, 37126
Actively Recruiting
92
Kyungpook National University Chilgok Hospital
Daegu, South Korea, 41404
Actively Recruiting
93
Keimyung University Dongsan Hospital
Daegu, South Korea, 42601
Actively Recruiting
94
National Cancer Center
Goyang-si, South Korea, 10408
Actively Recruiting
95
Chonnam National University Hospital
Gwangju, South Korea, 61469
Actively Recruiting
96
Chonnam National University Hwasun Hospital
Hwasun, South Korea, 519-763
Actively Recruiting
97
Korea University - Anam Hospital
Seongbuk-Gu, South Korea
Actively Recruiting
98
Seoul National University Hospital
Seoul, South Korea, 03080
Actively Recruiting
99
Yonsei University Health System, Severance Hospital
Seoul, South Korea, 03722
Actively Recruiting
100
Samsung Medical Center
Seoul, South Korea, 06351
Actively Recruiting
101
SMG-SNU Boramae Medical Center
Seoul, South Korea, 07061
Actively Recruiting
102
Asan Medical Center
Seoul, South Korea, 5505
Actively Recruiting
103
The Catholic University of Korea, St. Vincent's Hospital
Suwon, South Korea, 16247
Actively Recruiting
104
Yonsei University - Wonju Severance Christian Hospital
Wŏnju, South Korea, 26426
Not Yet Recruiting
105
Pusan National University Yangsan Hospital
Yangsan, South Korea, 50612
Actively Recruiting
106
Institut Catala d'Oncologia Badalona - Hospital Universitari Germans Trias i Pujol
Badalona, Spain, 08916
Active, Not Recruiting
107
Hospital del Mar
Barcelona, Spain, 08003
Actively Recruiting
108
Hospital Clinic de Barcelona
Barcelona, Spain, 08023
Actively Recruiting
109
CEIC Hospital Vall d'Hebron
Barcelona, Spain, 08035
Actively Recruiting
110
Hospital Universitario Reina Sofia
Córdoba, Spain, 14004
Actively Recruiting
111
Complejo Hospitalario Universitario Insular Materno Infantil
Las Palmas, Spain, 35016
Actively Recruiting
112
MD Anderson Cancer Centre
Madrid, Spain, 28033
Actively Recruiting
113
Hospital Universitario Ramon Y Cajal
Madrid, Spain, 28034
Actively Recruiting
114
Hospital Universitario Clinico San Carlos
Madrid, Spain, 28040
Actively Recruiting
115
Hospital Universitario 12 de Octubre
Madrid, Spain, 28041
Actively Recruiting
116
Hospital Universitario La Paz
Madrid, Spain, 28046
Actively Recruiting
117
Hospital Universitario Puera de Hierro Majadahonda
Majadahonda, Spain, 28222
Actively Recruiting
118
Hospital Sant Joan de Deu
Manresa, Spain, 08243
Actively Recruiting
119
Complejo Hospitalario de Ourense
Ourense, Spain, 32005
Actively Recruiting
120
Hospital Universitario Marques de Valdecilla
Santander, Spain, 39008
Actively Recruiting
121
Complejo Hospitalario Universitario de Santiago
Santiago de Compostela, Spain, 15706
Actively Recruiting
122
Hospital Clinico Universitario de Valencia
Valencia, Spain, 46010
Actively Recruiting
123
Hospital Universitario Miguel Servet
Zaragoza, Spain, 50009
Actively Recruiting
124
Ankara Sehir Hastanesi
Ankara, Turkey (Türkiye), 06550
Actively Recruiting
125
Dicle Universitesi Tip Fakultesi Hastanesi
Diyarbakır, Turkey (Türkiye), 21280
Actively Recruiting
126
Trakya Universitesi Saglik Arastirma ve Uygulama Merkezi
Edrine, Turkey (Türkiye), 22030
Actively Recruiting
127
Istanbul Universitesi Cerrahpasa Tip Fakultesi Hastanesi
Istanbul, Turkey (Türkiye), 34098
Actively Recruiting
128
Medipol Mega Universite Hastanesi
Istanbul, Turkey (Türkiye), 34214
Actively Recruiting
129
T.C. Saglik Bakanligi Goztepe Prof Dr. Suleyman Yalcin Sehir Hastanesi
Istanbul, Turkey (Türkiye), 34722
Actively Recruiting
130
Izmir Medical Point Hastanesi, Medikal Onkoloji Departmant
Izmir, Turkey (Türkiye), 35575
Actively Recruiting
131
Baskent Universitesi Adana Dr.Turgut Noyan Uygulama ve Arastima Merkezi
Seyhan, Turkey (Türkiye), 01250
Actively Recruiting
132
University Hospitals Birmingham NHS Foundation Trust
Birmingham, United Kingdom, B9 5SS
Actively Recruiting
133
Barts Health NHS Trust
London, United Kingdom, E1 1BB
Actively Recruiting
134
East and North Hertfordshire NHS Trust
Northwood, United Kingdom, HA6 2JW
Actively Recruiting
135
The Royal Marsden NHS Foundation Trust
Surrey, United Kingdom, SM2 5PT
Actively Recruiting
Research Team
G
Gilead Clinical Study Information Center
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
16
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