Perioperative Pembrolizumab (MK-3475) Plus Cystectomy or Perioperative Pembrolizumab Plus Enfortumab Vedotin Plus Cystectomy Versus Cystectomy Alone in Participants Who Are Cisplatin-ineligible or Decline Cisplatin With Muscle-invasive Bladder Cancer (MK-3475-905/KEYNOTE-905/EV-303)
Public ClinicalTrials.gov record NCT03924895. 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 Randomized Phase 3 Study Evaluating Cystectomy With Perioperative Pembrolizumab and Cystectomy With Perioperative Enfortumab Vedotin and Pembrolizumab Versus Cystectomy Alone in Participants Who Are Cisplatin-Ineligible or Decline Cisplatin With Muscle-Invasive Bladder Cancer (KEYNOTE-905/EV-303)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This is a study of perioperative pembrolizumab or enfortumab vedotin in combination with pembrolizumab in participants who are cisplatin-ineligible or decline cisplatin with muscle-invasive bladder cancer (MIBC). The primary hypothesis is that perioperative pembrolizumab plus radical cystectomy (RC) plus pelvic lymph node dissection (PLND) and perioperative enfortumab vedotin in combination with pembrolizumab plus RC+PLND will achieve superior event-free survival (EFS) compared with RC+PLND alone. With Amendment 5, outcome measures for programmed cell death ligand 1 (PD-L1) combined positive score (CPS) were removed. With Amendment 8, the primary outcome measure of pathologic complete response (pCR) rates was changed to a secondary outcome measure.
Study identification
- NCT ID
- NCT03924895
- Recruitment status
- Active, not recruiting
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 595 participants
Conditions and interventions
Conditions
Interventions
- Pembrolizumab Drug
- Surgery (radical cystectomy (RC) plus Pelvic Lymph Node Dissection [PLND]) Procedure
- Enfortumab Vedotin Drug
Drug · Procedure
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
- Jul 24, 2019 (Actual)
- Primary completion
- Jun 6, 2025 (Actual)
- Completion
- Dec 15, 2027 (Estimated)
- Last update posted
- Jun 30, 2026
2019 – 2027
United States locations
- U.S. sites
- 39
- U.S. states
- 26
- U.S. cities
- 34
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of South Alabama, Mitchell Cancer Institute ( Site 1582) | Mobile | Alabama | 36604 | — |
| CARTI Cancer Center ( Site 1577) | Little Rock | Arkansas | 72205 | — |
| St. Joseph Heritage Healthcare ( Site 0046) | Fullerton | California | 92835 | — |
| Scripps MD Anderson ( Site 0010) | La Jolla | California | 92037 | — |
| Hoag Memorial Hospital Presbyterian ( Site 1595) | Newport Beach | California | 92663 | — |
| John Wayne Cancer Institute ( Site 0075) | Santa Monica | California | 90404 | — |
| University of Colorado Hospital ( Site 0098) | Aurora | Colorado | 80045 | — |
| Georgetown University Medical Center ( Site 0022) | Washington D.C. | District of Columbia | 20007 | — |
| Emory School of Medicine ( Site 0006) | Atlanta | Georgia | 30322 | — |
| John H. Stroger Jr. Hospital of Cook County ( Site 1551) | Chicago | Illinois | 60612 | — |
| University of Chicago ( Site 0068) | Chicago | Illinois | 60637 | — |
| Parkview Cancer Institute ( Site 0077) | Fort Wayne | Indiana | 46845 | — |
| Indiana University Melvin and Bren Simon Comprehensive Cancer Center ( Site 0004) | Indianapolis | Indiana | 46202 | — |
| Wichita Urology Group ( Site 0059) | Wichita | Kansas | 67226 | — |
| Tulane University School of Medicine ( Site 0088) | New Orleans | Louisiana | 70112 | — |
| New England Cancer Specialists ( Site 0070) | Westbrook | Maine | 04092 | — |
| Greater Baltimore Medical Center ( Site 0014) | Baltimore | Maryland | 21204 | — |
| Dana-Farber Cancer Institute ( Site 1596) | Boston | Massachusetts | 02215 | — |
| M Health Fairview Ridges Hospital ( Site 1555) | Burnsville | Minnesota | 55337 | — |
| Morristown Medical Center ( Site 0015) | Morristown | New Jersey | 07960 | — |
| UNM Comprehensive Cancer Center-Clinical Research Office ( Site 0045) | Albuquerque | New Mexico | 87106 | — |
| Northwell Health - Monter Cancer Center ( Site 0083) | Lake Success | New York | 11042 | — |
| New York University Perlmutter Cancer Center ( Site 0008) | New York | New York | 10016 | — |
| Icahn School of Medicine at Mount Sinai ( Site 0031) | New York | New York | 10029 | — |
| Cleveland Clinic Main ( Site 1576) | Cleveland | Ohio | 44195 | — |
| Oklahoma Cancer Specialists and Research Institute, LLC ( Site 0021) | Tulsa | Oklahoma | 74146 | — |
| Providence Portland Medical Center [Portland, OR] ( Site 0095) | Portland | Oregon | 97213 | — |
| MidLantic Urology ( Site 0089) | Bala-Cynwyd | Pennsylvania | 19004 | — |
| Abramson Cancer Center of the University of Pennsylvania ( Site 0074) | Philadelphia | Pennsylvania | 19104 | — |
| Thomas Jefferson University ( Site 1579) | Philadelphia | Pennsylvania | 19107 | — |
| Fox Chase Cancer Center ( Site 0055) | Philadelphia | Pennsylvania | 19111 | — |
| Allegheny General Hospital ( Site 0048) | Pittsburgh | Pennsylvania | 15212 | — |
| Bon Secours St. Francis Health System ( Site 1572) | Greenville | South Carolina | 29607 | — |
| Carolina Urologic Research Center ( Site 0062) | Myrtle Beach | South Carolina | 29572 | — |
| Urology Associates [Nashville, TN] ( Site 0053) | Nashville | Tennessee | 37209 | — |
| Vanderbilt University Medical Center ( Site 0017) | Nashville | Tennessee | 37232 | — |
| Texas Oncology-Baylor Sammons Cancer Center ( Site 1552) | Dallas | Texas | 75246 | — |
| Inova Schar Cancer Institute ( Site 0007) | Fairfax | Virginia | 22031 | — |
| Charleston Area Medical Center ( Site 0023) | Charleston | West Virginia | 25304 | — |
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 203 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03924895, 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 Jun 30, 2026 · Synced Oct 26, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT03924895 live on ClinicalTrials.gov.