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NCT03474107 · ClinicalTrials.gov registry record · Phase 3
A Study to Evaluate Enfortumab Vedotin Versus (vs) Chemotherapy in Subjects With Previously Treated Locally Advanced or Metastatic Urothelial Cancer (EV-301)
A Phase 3 study, sponsored by Astellas Pharma Global Development.
- Completed
- Registry status
- Phase 3
- Development phase
- 608
- Enrollment target
NCT03474107: Completed Phase 3 study, sponsored by Astellas Pharma Global Development.
NCT03474107 is a Phase 3 study that has completed, run by Astellas Pharma Global Development. The registered enrollment target is 608 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (21% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03474107, a Phase 3 study, has completed, sponsored by Astellas Pharma Global Development.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 608 participants
- Enrollment target
Study Summary
The purpose of this study was to compare the overall survival (OS) of participants with locally advanced or metastatic urothelial cancer treated with enfortumab vedotin (EV) to the OS of participants treated with chemotherapy. This study compared progression-free survival on study therapy (PFS1); the overall response rate (ORR) and the disease control rate (DCR) per Response Evaluation Criteria in Solid Tumors (RECIST) V1.1 of participants treated with EV to participants treated with chemotherapy. In addition, this study evaluated the duration of response (DOR) per RECIST V1.1 of EV and chemotherapy and assessed the safety and tolerability of EV, as well as, the quality of life (QOL) and Patient Reported Outcomes (PRO) parameters.
Primary Outcome
OS was defined as the time from the date of randomization until the documented date of death from any cause. OS was analyzed using Kaplan-Meier estimates. Participants who were still alive at the time of data cutoff date were to be censored at the last known alive date or at the data cutoff date, whichever was earlier.
Interventions
- DRUG Docetaxel
- DRUG Enfortumab Vedotin
- DRUG Paclitaxel
- DRUG Vinflunine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 608 participants |
| Start Date | 2018-06-27 |
| Est. Completion | 2025-11-27 |
| Phase | Phase 3 |
What the finished NCT03474107 record still lists
NCT03474107 is an interventional study that assigns participants to a tested intervention. The registered 608 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (21% lower).
The record links to 0 conditions, and to 4 interventions - of which Docetaxel is the first listed.
NCT03474107 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03474107 about?
NCT03474107 is a clinical study titled "A Study to Evaluate Enfortumab Vedotin Versus (vs) Chemotherapy in Subjects With Previously Treated Locally Advanced or Metastatic Urothelial Cancer (EV-301)". The purpose of this study was to compare the overall survival (OS) of participants with locally advanced or metastatic urothelial cancer treated with enfortumab vedotin (EV) to the OS of participants treated with chemotherapy. This study compared progression-free survival on study therapy (PFS1); t...
What is the current status of trial NCT03474107?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 608 participants. The study started on 2018-06-27. Estimated completion is 2025-11-27.
What interventions are being tested in trial NCT03474107?
The interventions under investigation include: Docetaxel (DRUG), Enfortumab Vedotin (DRUG), Paclitaxel (DRUG), Vinflunine (DRUG).
Who is sponsoring clinical trial NCT03474107?
This trial is sponsored by Astellas Pharma Global Development, which has 168 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03474107's enrollment target sits among peer trials
608 603rd of 2000 higher than 1,396 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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