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NCT04527991 · ClinicalTrials.gov registry record · Phase 3

Study of Sacituzumab Govitecan Versus Physician's Choice of Treatment in Participants With Urothelial Cancer That Cannot Be Removed or Has Spread

A Phase 3 study, sponsored by Gilead Sciences.

Completed
Registry status
Phase 3
Development phase
711
Enrollment target

NCT04527991: Completed Phase 3 study, sponsored by Gilead Sciences.

NCT04527991 is a Phase 3 study that has completed, run by Gilead Sciences. The registered enrollment target is 711 participants, roughly in line with the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT04527991, a Phase 3 study, has completed, sponsored by Gilead Sciences.

COMPLETED
Registry status
Phase 3
Development phase
711 participants
Enrollment target

Study Summary

The primary objective of this study is to assess overall survival (OS) with sacituzumab govitecan-hziy in comparison with treatment of physician's choice (TPC) in participants with metastatic or locally advanced unresectable urothelial cancer (UC).

Primary Outcome

OS was defined as time from the date of randomization to the date of death, regardless of cause. Kaplan-Meier (KM) estimates were used for analysis.

Interventions

  • DRUG Docetaxel
  • DRUG Paclitaxel
  • DRUG Sacituzumab Govitecan-hziy
  • DRUG Vinflunine

Trial Details

FieldValue
Enrollment Target 711 participants
Start Date 2021-01-13
Est. Completion 2025-07-04
Phase Phase 3
Gilead Sciences

504 total trials

What the finished NCT04527991 record still lists

NCT04527991 is an interventional study that assigns participants to a tested intervention. The registered 711 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target.

The record links to 0 conditions, and to 4 interventions - of which Docetaxel is the first listed.

NCT04527991 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT04527991 about?

NCT04527991 is a clinical study titled "Study of Sacituzumab Govitecan Versus Physician's Choice of Treatment in Participants With Urothelial Cancer That Cannot Be Removed or Has Spread". The primary objective of this study is to assess overall survival (OS) with sacituzumab govitecan-hziy in comparison with treatment of physician's choice (TPC) in participants with metastatic or locally advanced unresectable urothelial cancer (UC).

What is the current status of trial NCT04527991?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 711 participants. The study started on 2021-01-13. Estimated completion is 2025-07-04.

What interventions are being tested in trial NCT04527991?

The interventions under investigation include: Docetaxel (DRUG), Paclitaxel (DRUG), Sacituzumab Govitecan-hziy (DRUG), Vinflunine (DRUG).

Who is sponsoring clinical trial NCT04527991?

This trial is sponsored by Gilead Sciences, which has 504 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT04527991's enrollment target sits among peer trials

711 501st of 2000 higher than 1,499 of 2,000 other Phase 3 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT04527991, the US trial registry maintained by the National Library of Medicine. NCT04527991 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.