Enfortumab Vedotin and Pembrolizumab vs. Chemotherapy Alone in Untreated Locally Advanced or Metastatic Urothelial Cancer
Public ClinicalTrials.gov record NCT04223856. 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, Controlled Phase 3 Study of Enfortumab Vedotin in Combination With Pembrolizumab Versus Chemotherapy Alone in Previously Untreated Locally Advanced or Metastatic Urothelial Cancer
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This study is being done to see how well two drugs (enfortumab vedotin and pembrolizumab) work together to treat patients with urothelial cancer. The study will compare these drugs to other drugs that are usually used to treat this cancer (standard of care). The patients in this study will have cancer that has spread from their urinary system to other parts of their body.
Study identification
- NCT ID
- NCT04223856
- Recruitment status
- Active, not recruiting
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 886 participants
Conditions and interventions
Conditions
Interventions
- Enfortumab vedotin Drug
- Pembrolizumab Drug
- Cisplatin Drug
- Carboplatin Drug
- Gemcitabine Drug
Drug
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
- Mar 30, 2020 (Actual)
- Primary completion
- Aug 8, 2023 (Actual)
- Completion
- Mar 1, 2028 (Estimated)
- Last update posted
- May 29, 2026
2020 – 2028
United States locations
- U.S. sites
- 34
- U.S. states
- 22
- U.S. cities
- 31
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Ironwood Cancer & Research Centers - Chandler | Chandler | Arizona | 85224 | — |
| Arizona Oncology Associates PD - HOPE | Tucson | Arizona | 85710 | — |
| Providence St Joseph Medical Center | Burbank | California | 91505 | — |
| City of Hope National Medical Center | Duarte | California | 91010 | — |
| University of California Los Angeles Medical Center | Los Angeles | California | 90095 | — |
| University of California Irvine - Newport | Orange | California | 92868 | — |
| Rocky Mountain Cancer Centers - Aurora | Aurora | Colorado | 80012 | — |
| University of Colorado Hospital / University of Colorado | Aurora | Colorado | 80045 | — |
| Cancer Centers of Colorado - Denver | Denver | Colorado | 80218 | — |
| Yale Cancer Center | New Haven | Connecticut | 06520 | — |
| Eastern CT Hematology and Oncology Associates | Norwich | Connecticut | 06360 | — |
| Lombardi Cancer Center / Georgetown University Medical Center | Washington D.C. | District of Columbia | 20007 | — |
| H. Lee Moffitt Cancer Center and Research Institute | Tampa | Florida | 33612 | — |
| Winship Cancer Institute / Emory University School of Medicine | Atlanta | Georgia | 30322 | — |
| Georgia Cancer Specialists / Northside Hospital Cancer Institute | Marietta | Georgia | 30060 | — |
| Louisiana State University/ East Jefferson General Hospital | Metairie | Louisiana | 70006 | — |
| Maine Health Cancer Care | Biddeford | Maine | 04046 | — |
| Johns Hopkins Medical Center | Baltimore | Maryland | 21231 | — |
| Comprehensive Cancer Centers of Nevada | Las Vegas | Nevada | 89169 | — |
| New Mexico Cancer Center | Albuquerque | New Mexico | 87109 | — |
| New York University (NYU) Cancer Institute | New York | New York | 10016 | — |
| Mount Sinai Medical Center | New York | New York | 10029 | — |
| Memorial Sloan Kettering Cancer Center | New York | New York | 10065 | — |
| Vidant Medical Center | Greenville | North Carolina | 27834 | — |
| The Cleveland Clinic | Cleveland | Ohio | 44195 | — |
| Toledo Clinic Cancer Center | Toledo | Ohio | 43623 | — |
| Hillman Cancer Center / University of Pittsburgh Medical Center | Pittsburgh | Pennsylvania | 15232 | — |
| Saint Francis Hospital / Bon Secours - South Carolina | Greenville | South Carolina | 29607 | — |
| West Cancer Center & Research Institute | Germantown | Tennessee | 38138 | — |
| University of Texas Southwestern Medical Center | Dallas | Texas | 75390 | — |
| UT Health East Texas Hope Cancer Center | Tyler | Texas | 75701 | — |
| Huntsman Cancer Institute | Salt Lake City | Utah | 84112 | — |
| University of Virginia | Charlottesville | Virginia | 22908 | — |
| Seattle Cancer Care Alliance / University of Washington | Seattle | Washington | 98109 | — |
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 226 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04223856, 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 May 29, 2026 · Synced Oct 27, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT04223856 live on ClinicalTrials.gov.