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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)
Condition: Bladder Cancer · Sponsor: Merck Sharp & Dohme LLC
About this study
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).
This description comes directly from the study's public registry record.
Talk to the study team
No contact information is available for this study as per the public registry record.
Always discuss trial participation with your own doctor first.
Locations (188)
| Mayo Clinic in Arizona - Phoenix ( Site 0043) | Phoenix, Arizona, United States | — |
| St Joseph Heritage Healthcare-Oncology ( Site 0035) | Fullerton, California, United States | — |
| UCLA Hematology/Oncology - Westwood (Building 200 Suite 140)-Department of Urology/Institute of Uro ( Site 0005) | Los Angeles, California, United States | — |
| University of California San Francisco ( Site 0010) | San Francisco, California, United States | — |
| Stanford University ( Site 0023) | Stanford, California, United States | — |
| University of Colorado, Anschutz Cancer Pavilion ( Site 0009) | Aurora, Colorado, United States | — |
| UF Health ( Site 0031) | Gainesville, Florida, United States | — |
| Indiana University Melvin and Bren Simon Cancer Center ( Site 0050) | Indianapolis, Indiana, United States | — |
| University of Iowa Hospital and Clinics ( Site 0029) | Iowa City, Iowa, United States | — |
| University of Louisville, James Graham Brown Cancer Center ( Site 0022) | Louisville, Kentucky, United States | — |
| Icahn School of Medicine at Mount Sinai ( Site 0011) | New York, New York, United States | — |
| White Plains Hospital ( Site 0039) | White Plains, New York, United States | — |
+ 176 more locations — full list on the registry record.
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Source record: clinicaltrials.gov/study/NCT04700124