Status:
ACTIVE_NOT_RECRUITING
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)
Lead Sponsor:
Merck Sharp & Dohme LLC
Collaborating Sponsors:
Seagen Inc.
Astellas Pharma Inc
Conditions:
Bladder Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
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) c...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 21 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 23 2026
Estimated Enrollment :
808 Patients enrolled
Trial Details
Trial ID
NCT04700124
Start Date
April 21 2021
End Date
December 23 2026
Last Update
August 26 2025
Active Locations (188)
Enter a location and click search to find clinical trials sorted by distance.
1
Mayo Clinic in Arizona - Phoenix ( Site 0043)
Phoenix, Arizona, United States, 85054
2
St Joseph Heritage Healthcare-Oncology ( Site 0035)
Fullerton, California, United States, 92835
3
UCLA Hematology/Oncology - Westwood (Building 200 Suite 140)-Department of Urology/Institute of Uro ( Site 0005)
Los Angeles, California, United States, 90095
4
University of California San Francisco ( Site 0010)
San Francisco, California, United States, 94158