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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)
Recruiting
I'm InterestedTrial ID: NCT04700124
Purpose
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
Professor of Medicine (Oncology) and, by courtesy, of Urology
Eligibility
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
Intervention(s):
biological: Pembrolizumab
biological: Enfortumab vedotin (EV)
procedure: RC + PLND
drug: Gemcitabine
drug: Cisplatin
Recruiting
I'm InterestedContact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Paige Nicole Baker
650-736-3687