Study of Sacituzumab Govitecan in Participants With Urothelial Cancer That Cannot Be Removed or Has Spread
← catalyst calendarNCT03547973 · readout ≤ 1,350 d
Sponsored by Gilead Sciences (industry) · GILD — their whole pipeline →. With Merck KGaA, Darmstadt, Germany.
Phase
Phase 2
Status
Recruiting
Study type
Interventional
Design
Non randomized · None · Treatment
Enrollment
827estimated
Sites
135
Countries
France, Germany, Greece +6
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2018-08-13 | actual | When the study began enrolling |
| Primary completion | Apr 2030 | estimated | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | Apr 2030 | estimated | The whole study's end, after follow-up |
| First posted | 2018-06-06 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-03-16 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Condition
- Metastatic Urothelial Cancer
Interventions
- Drug: Sacituzumab Govitecan-hziy — also filed as IMMU-132, Trodelvy™
- Drug: Pembrolizumab — also filed as KEYTRUDA®
- Drug: Cisplatin
- Drug: Avelumab — also filed as BAVENCIO®
- Drug: Zimberelimab
- Drug: Carboplatin
- Drug: Gemcitabine
- Drug: Domvanalimab
- Drug: Enfortumab Vedotin
Primary outcomes
what the primary-completion date above is the date OFOverall 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)
measured Up to Survival Follow-up Visit (maximum of 2 years after Safety Follow-up Visit (30 days after last dose date))
Progression free survival (PFS) Based on Central Review by RECIST 1.1 criteria (Cohort 5)
measured Up to Survival Follow-up Visit (maximum of 2 years after Safety Follow-up Visit (30 days after last dose date))
ORR Based on Investigator Review by RECIST 1.1 Criteria (Cohort 7)
measured Up to Survival Follow-up Visit (maximum of 2 years after Safety Follow-up Visit (30 days after last dose date))
Percentage of Participants Experiencing Treatment Emergent Adverse Events (TEAEs) (Cohort 7)
measured 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)
measured First dose date up to last dose date plus 30 days (approximately 3 years)
Publications
- PMID 39186707 — linked by the registry
- PMID 38682560 — linked by the registry
- PMID 38261969 — linked by the registry
- PMID 33929895 — linked by the registry
Linked on the registry record. A “linked by the registry” entry is NLM's own automated PubMed match, not a claim by the sponsor that the paper reports this study.
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