A Study to Evaluate Enfortumab Vedotin Versus (vs) Chemotherapy in Subjects With Previously Treated Locally Advanced or Metastatic Urothelial Cancer (EV-301)
Public ClinicalTrials.gov record NCT03474107. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
An Open-Label, Randomized Phase 3 Study to Evaluate Enfortumab Vedotin vs Chemotherapy in Subjects With Previously Treated Locally Advanced or Metastatic Urothelial Cancer (EV-301)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT03474107
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 608 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jun 27, 2018 (Actual)
- Primary completion
- Jul 15, 2020 (Actual)
- Completion
- Nov 27, 2025 (Actual)
- Last update posted
- Jan 9, 2026
2018 – 2025
United States locations
- U.S. sites
- 25
- U.S. states
- 17
- U.S. cities
- 24
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| UCI Chao Family Comprehensive Cancer Center | Orange | California | 92868 | — |
| University of California | Sacramento | California | 95817 | — |
| Innovative Clinical Research | Whittier | California | 90606 | — |
| University of Colorado | Denver | Colorado | 80045 | — |
| Smilow Cancer Hospital at Yale-New Haven | New Haven | Connecticut | 06510 | — |
| Sylvester Comprehensive Cancer Center | Miami | Florida | 33136 | — |
| Florida Hospital | Orlando | Florida | 32804 | — |
| Rush University Medical Center | Chicago | Illinois | 60612 | — |
| Norton Cancer Institute | Louisville | Kentucky | 40207 | — |
| Dana-Farber Cancer Institute | Boston | Massachusetts | 02215 | — |
| Nebraska Cancer Specialists | Omaha | Nebraska | 68130 | — |
| Roswell Park Cancer Institute | Buffalo | New York | 14263 | — |
| Long Island Jewish Medical Center | Lake Success | New York | 11042 | — |
| Sidney Kimmel Center for Prostate and Urologic Cancers | New York | New York | 10065 | — |
| Montefiore Medical Center | The Bronx | New York | 10467 | — |
| White Plains Hospital Center for Cancer Care - Oncology Site | White Plains | New York | 10601 | — |
| Toledo Clinic Cancer Center | Toledo | Ohio | 43623 | — |
| Providence Portland Med Center | Portland | Oregon | 97213 | — |
| University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | — |
| Fox Chase Cancer Center | Philadelphia | Pennsylvania | 19111 | — |
| Lifespan Rhode Island Hospital | Providence | Rhode Island | 02903 | — |
| Saint Francis Hospital | Greenville | South Carolina | 29607 | — |
| HOPE Cancer Center of East Texas | Tyler | Texas | 75701 | — |
| Benaroya Research Institute at Virginia Mason | Seattle | Washington | 98101 | — |
| Medical College of Wisconsin | Milwaukee | Wisconsin | 53226 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 133 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03474107, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jan 9, 2026 · Synced Oct 29, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT03474107 live on ClinicalTrials.gov.