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)
A Phase 3, Randomized, Open-label Study to Evaluate Perioperative Enfortumab Vedotin Plus Pembrolizumab (MK-3475) Versus Neoadjuvant Gemcitabine and Cisplatin in Cisplatin-eligible Participants With Muscle-invasive Bladder Cancer (KEYNOTE-B15 / EV-304)
🩺 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: Review the eligibility criteria below.
Location: Mayo Clinic in Arizona - Phoenix ( Site 0043) — Phoenix, Arizona
Age range: 18 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (188 Sites)
Showing the first 25 of 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.
📞 Contact the Study Coordinator
Phone: (800) 664-4580
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 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.
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- Trimodality Therapy With/Out Durvalumab to Treat Patients With Muscle-Invasive Bladder Cancer — Calgary, Alberta
- Determinants of Bladder Cancer Recurrence Study (The DETER Study) — Basking Ridge, New Jersey
- Quality of Life in Patients With Bladder Cancer — New York, New York
- A Phase II Study of Atezolizumab in Combination With Cisplatin + Gemcitabine Before Surgery to Remove the Bladder Cancer — Hartford, Connecticut
- A Diagnostic for the Early Detection of Bladder Cancer — Long Beach, California
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💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.