Trial Details 73 Total Sites

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)

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 dual primary hypotheses are preoperative EV + pembrolizumab and RC + PLND (Arm A) will achieve superior pathologic complete response (pCR) rate and 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).

phase

Phase 3

status

Recruiting

enrollment

784

score

61

start date

2021-04-21

last updated

2022-01-12

biomarkers

N/A

New York City, New York
facility
Icahn School of Medicine at Mount Sinai ( Site 0011)
1 facility
Recruiting
Los Angeles, California
facility
UCLA Hematology/Oncology - Westwood (Building 200 Suite 140)-Department of Urology/Institute of Uro
1 facility
Recruiting
Houston, Texas
facility
Houston Methodist Urology Associates ( Site 0033)
1 facility
Recruiting
San Antonio, Texas
facility
Urology of San Antonio ( Site 0020)
1 facility
Recruiting
Dallas, Texas
facility
UT Southwestern Medical Center ( Site 0003)
1 facility
Recruiting
Portland, Oregon
facility
Oregon Health and Science University ( Site 0028)
1 facility
Recruiting
Madison, Wisconsin
facility
University of Wisconsin Hospital and Clinics ( Site 0037)
1 facility
Recruiting
Louisville, Kentucky
facility
University of Louisville, James Graham Brown Cancer Center ( Site 0022)
1 facility
Recruiting
Winston-Salem, North Carolina
facility
Wake Forest Baptist Health ( Site 0014)
1 facility
Recruiting
Knoxville, Tennessee
facility
The University of Tennessee Medical Center ( Site 0034)
1 facility
Recruiting
Fullerton, California
facility
St Joseph Heritage Healthcare-Oncology ( Site 0035)
1 facility
Recruiting
Gainesville, Florida
facility
UF Health ( Site 0031)
1 facility
Recruiting