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)
Condition(s) studied
Investigational drug(s) / intervention(s)
Pembrolizumab: Pembrolizumab 200 mg by intravenous (IV) infusion, given on Day 1 of each 21-day cycle.
Surgery (radical cystectomy (RC) plus Pelvic Lymph Node Dissection [PLND]): Surgical RC+PLND will be done in accordance with the American Urological Association (AUA)/American Society of Clinical Oncology (ASCO)/American Society for Radiation Oncology (ASTRO)/Society of Urologic Oncology (SUO) guidelines.
Enfortumab Vedotin: Enfortumab vedotin 1.25 mg/kg by intravenous (IV) infusion, given on Days 1 and 8 of each 21-day cycle.
Study summary
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.
Eligibility
Primary outcome measure(s)
- Event-Free Survival (EFS) Between Arm C: Enfortumab Vedotin + Pembrolizumab + Surgery and Arm B: Surgery Alone — Up to approximately 53 months
EFS is defined as the time from randomization to the first occurrence of any of the following events: progression of disease that precludes radical cystectomy + pelvic lymph node dissection (RC + PLND) surgery, failure to undergo RC + PLND surgery in participants with residual disease and any radiographic disease present (biopsy-proven muscle-invasive bladder cancer \[MIBC\] will be considered an event regardless of radiographic findings), gross residual disease left behind at the time of surgery, local or distant recurrence as assessed by imaging and/or biopsy, or death due to any cause.
Trial sites (242)
| Facility | City | Region | Status |
|---|---|---|---|
| University of South Alabama, Mitchell Cancer Institute ( Site 1582) | Mobile | Alabama | |
| CARTI Cancer Center ( Site 1577) | Little Rock | Arkansas | |
| St. Joseph Heritage Healthcare ( Site 0046) | Fullerton | California | |
| Scripps MD Anderson ( Site 0010) | La Jolla | California | |
| Hoag Memorial Hospital Presbyterian ( Site 1595) | Newport Beach | California | |
| John Wayne Cancer Institute ( Site 0075) | Santa Monica | California | |
| University of Colorado Hospital ( Site 0098) | Aurora | Colorado | |
| Georgetown University Medical Center ( Site 0022) | Washington D.C. | District of Columbia | |
| Emory School of Medicine ( Site 0006) | Atlanta | Georgia | |
| John H. Stroger Jr. Hospital of Cook County ( Site 1551) | Chicago | Illinois | |
| University of Chicago ( Site 0068) | Chicago | Illinois | |
| Parkview Cancer Institute ( Site 0077) | Fort Wayne | Indiana | |
| Indiana University Melvin and Bren Simon Comprehensive Cancer Center ( Site 0004) | Indianapolis | Indiana | |
| Wichita Urology Group ( Site 0059) | Wichita | Kansas | |
| Tulane University School of Medicine ( Site 0088) | New Orleans | Louisiana | |
| New England Cancer Specialists ( Site 0070) | Westbrook | Maine | |
| Greater Baltimore Medical Center ( Site 0014) | Baltimore | Maryland | |
| Dana-Farber Cancer Institute ( Site 1596) | Boston | Massachusetts | |
| M Health Fairview Ridges Hospital ( Site 1555) | Burnsville | Minnesota | |
| Morristown Medical Center ( Site 0015) | Morristown | New Jersey | |
| UNM Comprehensive Cancer Center-Clinical Research Office ( Site 0045) | Albuquerque | New Mexico | |
| Northwell Health - Monter Cancer Center ( Site 0083) | Lake Success | New York | |
| New York University Perlmutter Cancer Center ( Site 0008) | New York | New York | |
| Icahn School of Medicine at Mount Sinai ( Site 0031) | New York | New York | |
| Cleveland Clinic Main ( Site 1576) | Cleveland | Ohio | |
| Oklahoma Cancer Specialists and Research Institute, LLC ( Site 0021) | Tulsa | Oklahoma | |
| Providence Portland Medical Center [Portland, OR] ( Site 0095) | Portland | Oregon | |
| MidLantic Urology ( Site 0089) | Bala-Cynwyd | Pennsylvania | |
| Abramson Cancer Center of the University of Pennsylvania ( Site 0074) | Philadelphia | Pennsylvania | |
| Thomas Jefferson University ( Site 1579) | Philadelphia | Pennsylvania | |
| Fox Chase Cancer Center ( Site 0055) | Philadelphia | Pennsylvania | |
| Allegheny General Hospital ( Site 0048) | Pittsburgh | Pennsylvania | |
| Bon Secours St. Francis Health System ( Site 1572) | Greenville | South Carolina | |
| Carolina Urologic Research Center ( Site 0062) | Myrtle Beach | South Carolina | |
| Urology Associates [Nashville, TN] ( Site 0053) | Nashville | Tennessee | |
| Vanderbilt University Medical Center ( Site 0017) | Nashville | Tennessee | |
| Texas Oncology-Baylor Sammons Cancer Center ( Site 1552) | Dallas | Texas | |
| Inova Schar Cancer Institute ( Site 0007) | Fairfax | Virginia | |
| Charleston Area Medical Center ( Site 0023) | Charleston | West Virginia | |
| Asociación de Beneficencia Hospital Sirio Libanés ( Site 2102) | Buenos Aires | Buenos Aires F.D. |
+ 202 more sites — see the full list on the official registry below.
More Merck Sharp & Dohme LLC trials in Turkey
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT03924895 on ClinicalTrials.gov ↗ ← All trials in Turkey