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)


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Trial ID: NCT04700124


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).

Official Title

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)

Stanford Investigator(s)

Sandy Srinivas
Sandy Srinivas

Professor of Medicine (Oncology) and, by courtesy, of Urology


Inclusion Criteria:

   - 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.

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

   - 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


biological: Pembrolizumab

biological: Enfortumab vedotin (EV)

procedure: RC + PLND

drug: Gemcitabine

drug: Cisplatin


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Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Paige Nicole Baker

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