🏛️ Verified NIH Record • Updated 2026-07-14

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) (NCT04700124)

🔵 Active, Not Recruiting Phase3 💊 Investigational Drug / Biologic Sponsor: Merck Sharp & Dohme LLC

🩺 Plain-English Summary (8th-Grade Level)

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).

Who can join: To join this study, participants generally need to meet the listed inclusion criteria (5 items) and avoid the listed exclusions (14 items).

Location: Mayo Clinic in Arizona - Phoenix ( Site 0043) — Phoenix, Arizona

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

Usually NOT eligible if any of the following apply:

  • Exclusion Criteria:
  • Has a known additional malignancy that is progressing or has required active anti-cancer treatment ≤3 years of study randomization with certain exceptions
  • Has received any prior systemic treatment for MIBC or non-invasive muscle bladder cancer (NMIBC - prior treatment for NMIBC with intravesical BCG/chemotherapy is permitted) or prior therapy with an anti- programmed cell death 1 (PD-1), anti-programmed cell death ligand 1/ ligand 2 (PD-L1/L2), or anti-cytotoxic T-lymphocyte-associated protein 4 (CTLA-4)
  • Has ≥N2 disease or metastatic disease (M1) as identified by imaging
  • Is cisplatin-ineligible, as defined by meeting any one of the cisplatin ineligibility criteria as per protocol
  • Has received prior systemic anticancer therapy including investigational agents within 3 years of randomization or any radiotherapy to the bladder
  • Has undergone partial cystectomy of the bladder to remove any NMIBC or MIBC
  • Has received a live or live attenuated vaccine within 30 days before the first dose of study intervention
  • Has a diagnosis of immunodeficiency or has a known history of human immunodeficiency virus (HIV) infection. Hepatitis B infection or known active Hepatitis C infection
  • Has a known psychiatric or substance abuse disorder
  • Has had an allogenic tissue/solid organ transplant
  • Has ongoing sensory or motor neuropathy Grade 2 or higher

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (188 Sites)

  • Mayo Clinic in Arizona - Phoenix ( Site 0043) — Phoenix, Arizona
  • St Joseph Heritage Healthcare-Oncology ( Site 0035) — Fullerton, California
  • UCLA Hematology/Oncology - Westwood (Building 200 Suite 140)-Department of Urology/Institute of Uro ( Site 0005) — Los Angeles, California
  • University of California San Francisco ( Site 0010) — San Francisco, California
  • Stanford University ( Site 0023) — Stanford, California
  • University of Colorado, Anschutz Cancer Pavilion ( Site 0009) — Aurora, Colorado
  • UF Health ( Site 0031) — Gainesville, Florida
  • Indiana University Melvin and Bren Simon Cancer Center ( Site 0050) — Indianapolis, Indiana
  • University of Iowa Hospital and Clinics ( Site 0029) — Iowa City, Iowa
  • University of Louisville, James Graham Brown Cancer Center ( Site 0022) — Louisville, Kentucky
  • Icahn School of Medicine at Mount Sinai ( Site 0011) — New York, New York
  • White Plains Hospital ( Site 0039) — White Plains, New York
  • Duke University Medical Center ( Site 0017) — Durham, North Carolina
  • Wake Forest Baptist Health ( Site 0014) — Winston-Salem, North Carolina
  • Oregon Health and Science University ( Site 0028) — Portland, Oregon
  • MidLantic Urology ( Site 0002) — Bala-Cynwyd, Pennsylvania
  • Saint Francis Cancer Center ( Site 0008) — Greenville, South Carolina
  • The University of Tennessee Medical Center ( Site 0034) — Knoxville, Tennessee
  • UT Southwestern Medical Center ( Site 0003) — Dallas, Texas
  • Houston Methodist Urology Associates ( Site 0033) — Houston, Texas
  • Urology of San Antonio ( Site 0020) — San Antonio, Texas
  • University of Wisconsin Hospital and Clinics ( Site 0037) — Madison, Wisconsin
  • Hospital Británico de Buenos Aires-Oncology ( Site 1551) — Ciudad Autónoma de Buenos Aires, Buenos Aires
  • Hospital Italiano de Buenos Aires ( Site 1554) — ABB, Buenos Aires F.D.
  • Asociación de Beneficencia Hospital Sirio Libanés ( Site 1553) — Buenos Aires, Buenos Aires F.D.

💰 Cost, Insurance & Patient Rights

  • 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
  • Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
  • Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
🏛️ View Official NIH Record ↗