Perioperative Enfortumab Vedotin (EV) Plus Pembrolizumab (MK-3475) Versus Neoadjuvant Chemotherapy for Cisplatin-Eligible Muscle Invasive Bladder Cancer (MIBC) (MK-3475-B15/ KEYNOTE-B15 / EV-304)
Public ClinicalTrials.gov record NCT04700124. 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
A Phase 3, Randomized, Open-label Study to Evaluate Perioperative Enfortumab Vedotin Plus Pembrolizumab (MK-3475) Versus Neoadjuvant Gemcitabine and Cisplatin in Cisplatin-eligible Participants With Muscle-invasive Bladder Cancer (KEYNOTE-B15 / EV-304)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The purpose of this study is to assess the antitumor efficacy and safety of perioperative enfortumab vedotin (EV) plus pembrolizumab and radical cystectomy (RC) + pelvic lymph node dissection (PLND) compared with the current standard of care (neoadjuvant chemotherapy \[gemcitabine plus cisplatin\] and RC + PLND) for participants with MIBC who are cisplatin-eligible. The primary hypothesis is perioperative EV and pembrolizumab and RC + PLND (Arm A) will achieve superior event free survival (EFS) compared with neoadjuvant gemcitabine + cisplatin and RC + PLND (Arm B).
Study identification
- NCT ID
- NCT04700124
- Recruitment status
- Active, not recruiting
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 808 participants
Conditions and interventions
Conditions
Interventions
- Pembrolizumab Biological
- Enfortumab vedotin (EV) Biological
- RC + PLND Procedure
- Gemcitabine Drug
- Cisplatin Drug
Biological · Procedure · 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
- Apr 20, 2021
- Primary completion
- Oct 26, 2025
- Completion
- May 17, 2028
- Last update posted
- Jul 15, 2026
2021 – 2028
United States locations
- U.S. sites
- 22
- U.S. states
- 15
- U.S. cities
- 22
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Mayo Clinic in Arizona - Phoenix ( Site 0043) | Phoenix | Arizona | 85054 | — |
| St Joseph Heritage Healthcare-Oncology ( Site 0035) | Fullerton | California | 92835 | — |
| UCLA Hematology/Oncology - Westwood (Building 200 Suite 140)-Department of Urology/Institute of Uro ( Site 0005) | Los Angeles | California | 90095 | — |
| University of California San Francisco ( Site 0010) | San Francisco | California | 94158 | — |
| Stanford University ( Site 0023) | Stanford | California | 94305 | — |
| University of Colorado, Anschutz Cancer Pavilion ( Site 0009) | Aurora | Colorado | 80045 | — |
| UF Health ( Site 0031) | Gainesville | Florida | 32608 | — |
| Indiana University Melvin and Bren Simon Cancer Center ( Site 0050) | Indianapolis | Indiana | 46202 | — |
| University of Iowa Hospital and Clinics ( Site 0029) | Iowa City | Iowa | 52242 | — |
| University of Louisville, James Graham Brown Cancer Center ( Site 0022) | Louisville | Kentucky | 40202 | — |
| Icahn School of Medicine at Mount Sinai ( Site 0011) | New York | New York | 10029 | — |
| White Plains Hospital ( Site 0039) | White Plains | New York | 10601 | — |
| Duke University Medical Center ( Site 0017) | Durham | North Carolina | 27710 | — |
| Wake Forest Baptist Health ( Site 0014) | Winston-Salem | North Carolina | 27157 | — |
| Oregon Health and Science University ( Site 0028) | Portland | Oregon | 97239-3011 | — |
| MidLantic Urology ( Site 0002) | Bala-Cynwyd | Pennsylvania | 19004 | — |
| Saint Francis Cancer Center ( Site 0008) | Greenville | South Carolina | 29607 | — |
| The University of Tennessee Medical Center ( Site 0034) | Knoxville | Tennessee | 37920 | — |
| UT Southwestern Medical Center ( Site 0003) | Dallas | Texas | 75390 | — |
| Houston Methodist Urology Associates ( Site 0033) | Houston | Texas | 77030 | — |
| Urology of San Antonio ( Site 0020) | San Antonio | Texas | 78229 | — |
| University of Wisconsin Hospital and Clinics ( Site 0037) | Madison | Wisconsin | 53792 | — |
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 166 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04700124, 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 Jul 15, 2026 · Synced Sep 3, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT04700124 live on ClinicalTrials.gov.