NCT03547973 · Gilead Sciences
Study of Sacituzumab Govitecan in Participants With Urothelial Cancer That Cannot Be Removed or Has Spread
(TROPHY U-01)
What this study is about
The objective of this study is to evaluate the effectiveness and safety of sacituzumab govitecan-hziy treatment given alone and with novel combinations in participants with metastatic urothelial cancer (mUC).
View original scientific description
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).
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
Primary outcome measures
Overall Response Rate (ORR) Based on Central Review by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) Criteria (Cohorts 1 to 4 and 6)
Time frame: Up to Survival Follow-up Visit (maximum of 2 years after Safety Follow-up Visit (30 days after last dose date))
ORR will be defined as the rate of the best overall response as Complete Response (CR) or Partial Response (PR) and based on central review by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) criteria.
Progression free survival (PFS) Based on Central Review by RECIST 1.1 criteria (Cohort 5)
Time frame: Up to Survival Follow-up Visit (maximum of 2 years after Safety Follow-up Visit (30 days after last dose date))
PFS will be defined as the time from first dose until objective tumor progression, as assessed based on central review, or death, whichever comes first.
ORR Based on Investigator Review by RECIST 1.1 Criteria (Cohort 7)
Time frame: Up to Survival Follow-up Visit (maximum of 2 years after Safety Follow-up Visit (30 days after last dose date))
ORR will be defined as the rate of the best overall response as Complete Response (CR) or Partial Response (PR) and based on investigator review by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) criteria.
Percentage of Participants Experiencing Treatment Emergent Adverse Events (TEAEs) (Cohort 7)
Time frame: First dose date up to last dose date plus 30 days (approximately 3 years)
Percentage of Participants Experiencing any Clinically Significant Laboratory Abnormalities (Cohort 7)
Time frame: First dose date up to last dose date plus 30 days (approximately 3 years)
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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
Where
- Tucson, Arizona
- Los Angeles, California
- San Francisco, California
- Littleton, Colorado
- New Haven, Connecticut
- Norwich, Connecticut
- Miami Beach, Florida
- Pensacola, Florida
- Tampa, Florida
- Atlanta, Georgia
- Chicago, Illinois
- Springfield, Illinois
And 23 more locations — see the full list below.
Collaborators
Merck KGaA, Darmstadt, Germany
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Mar 16, 2026 · Source of record for eligibility and locations