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)

Running, not enrolling · Phase 3

Conditions studied: Bladder Cancer

In brief

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).

Key facts

Study ID

NCT04700124

Run by

Merck Sharp & Dohme LLC

People needed

808

Starts

2021-04-21

Expected to finish

2028-05-18

Last updated by the study team

2026-07-16

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Have a histologically confirmed diagnosis of urothelial carcinoma (UC) / muscle invasive bladder cancer (MIBC) (T2-T4aN0M0 or T1-T4aN1M0) with predominant (≥50%) urothelial histology.
• Have clinically non-metastatic bladder cancer (N≤1 M0) determined by imaging (computed tomography (CT) or magnetic resonance imaging (MRI) of the chest/abdomen/pelvis
• Be deemed eligible for Radical Cystectomy (RC) + Pelvic Lymph Node Dissection (PLND)
• Have Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
• Have adequate organ function.

You may not qualify if…

• 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
• Has active keratitis (superficial punctate keratitis) or corneal ulcerations
• Has a history of uncontrolled diabetes defined as hemoglobin A1c (HbA1c) ≥8% or HbA1c 7% to <8% with associated diabetes symptoms

Where it is running

• 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
• Duke University Medical Center ( Site 0017) — Durham, North Carolina, United States
• Wake Forest Baptist Health ( Site 0014) — Winston-Salem, North Carolina, United States
• Oregon Health and Science University ( Site 0028) — Portland, Oregon, United States
• MidLantic Urology ( Site 0002) — Bala-Cynwyd, Pennsylvania, United States
• Saint Francis Cancer Center ( Site 0008) — Greenville, South Carolina, United States
• The University of Tennessee Medical Center ( Site 0034) — Knoxville, Tennessee, United States
• UT Southwestern Medical Center ( Site 0003) — Dallas, Texas, United States
• Houston Methodist Urology Associates ( Site 0033) — Houston, Texas, United States
• Urology of San Antonio ( Site 0020) — San Antonio, Texas, United States
• University of Wisconsin Hospital and Clinics ( Site 0037) — Madison, Wisconsin, United States
• Hospital Británico de Buenos Aires-Oncology ( Site 1551) — Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina
• Hospital Italiano de Buenos Aires ( Site 1554) — ABB, Buenos Aires F.D., Argentina
• Asociación de Beneficencia Hospital Sirio Libanés ( Site 1553) — Buenos Aires, Buenos Aires F.D., Argentina
• Mayo Clinic in Arizona - Phoenix ( Site 0043) — Phoenix, Arizona, United States

Full record on ClinicalTrials.gov

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