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RECRUITING Phase 3 ClinicalTrials.gov

Enfortumab Vedotin in Combination With Pembrolizumab vs. Concurrent Chemoradiotherapy (cCRT) in People With Muscle Invasive Bladder Cancer (EV-309)

Sponsor: Astellas Pharma Global Development, Inc. • ClinicalTrials.gov ID: NCT07566156

Registry updated: 2026-10-19
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Description

This study is being done to see how well two drugs (enfortumab vedotin and pembrolizumab) work together as a bladder preservation approach to treat patients with muscle invasive bladder cancer. The study will compare these drugs to concurrent chemoradiotherapy that is usually used to treat this cancer (standard of care). The study will enroll patients with muscle-invasive bladder cancer (MIBC) who have cancer that has not spread outside the bladder.

Interventions

  • Enfortumab vedotin (Drug)
    Enfortumab vedotin administered as an IV infusion on Days 1 and 8 of every 3-week cycle up to cycle 9.
  • Conventional Radiotherapy (Radiation)
    64 Gy in 32 fractions over 6.5 weeks administered to the participant's bladder only or the bladder and prophylactically to pelvic nodes.
  • Hypofractionated Radiotherapy (Radiation)
    55 Gy in 20 fractions over 4 weeks administered to the participant's bladder only.
  • Cisplatin (Drug)
    40 mg of cisplatin per meter squared of body surface area, administered once weekly via IV infusion during radiation OR 20 mg of cisplatin per meter squared of body surface area per day on Days 1 and 2 weekly via IV infusion during radiation.
  • Fluorouracil (Drug)
    500 mg per meter squared of body surface area per day on Days 1-5 (week 1) and Days 22 26 (week 3) administered as continuous IV infusion during radiation in combination with mitomycin C.
  • Mitomycin C (Drug)
    12 mg per meter squared of body surface area administered as an IV bolus on Day 1 during radiation in combination with fluorouracil.
  • Gemcitabine (Drug)
    100 mg per meter squared of body surface area administered once weekly via IV infusion during radiation OR 27 mg per meter squared of body surface area administered twice weekly via IV infusion during radiation
  • Pembrolizumab (Drug)
    IV infusion on Day 1 of every 3-week cycle up to cycle 17.

Eligibility criteria

Inclusion Criteria: * Has histologically confirmed initial diagnosis of muscle-invasive bladder cancer (MIBC) with predominant urothelial histology staged cT2-T4aN0M0 * Tissue comprising muscle-invasive urothelial cancer must be submitted for clinical staging at baseline * Eligible for and agree to receive chemoradiotherapy and one of the protocol-specified radiosensitizing chemotherapy regimens * Fit for systemic therapy and elect bladder preservation, including participants who are ineligible for or have elected not to undergo cystectomy * Has Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2 Exclusion Criteria: * Advanced or metastatic disease (N+, M1), non-urothelial carcinoma, diffuse or multifocal CIS, urothelial carcinoma or histological variant at any site outside the urinary bladder within previous 24 months prior to randomization except Ta/T1/CIS of the upper urinary tract including renal pelvis and ureter if the participant had undergone complete nephrectomy * Has received any prior systemic treatment, chemoradiation, and/or radiation for MIBC or NMIBC * Prior pelvic radiation for any reason * Inadequate bladder function * Other active malignancies within 3 years prior to randomization * Previously treated with enfortumab vedotin or other MMAE-based antibody-drug conjugates (ADCs) * Previously treated with a PD(L)-1 inhibitor, defined as a PD-1 inhibitor or PD-L1 inhibitor * Uncontrolled diabetes * Currently receiving systemic antimicrobial treatment for active infection (viral, bacterial, or fungal) at the time of randomization. Routine antimicrobial prophylaxis is permitted * Known active hepatitis B, active hepatitis C, or human immunodeficiency virus (HIV) infection * Received major surgery (defined as requiring general anesthesia and \>24 hour inpatient hospitalization) within 4 weeks prior to randomization * Known severe (≥ Grade 3) hypersensitivity to any enfortumab vedotin excipient contained in the drug formulation of enfortumab vedotin * Known genetic disorders associated with radiosensitivity (eg, ataxia telangiectasia, Nijmegen breakage syndrome, Fanconi syndrome) * Active keratitis or corneal ulcerations * History of autoimmune disease that has required systemic treatment in the past 2 years * History of idiopathic pulmonary fibrosis, organizing pneumonia, drug induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis on screening chest computed tomography (CT) scan * Prior allogeneic stem cell or solid organ transplant * Received a live attenuated vaccine within 30 days prior to randomization

Conditions

Urothelial Cancer Urinary Bladder Neoplasms

Locations

  • Arkansas Urology — Little Rock, Arkansas, United States
  • Samsun Clinic - Ridley-Tree Cancer Center — Santa Barbara, California, United States
  • Rocky Mountain Cancer Center — Aurora, Colorado, United States
  • Medical Oncology Hematology Consultants — Newark, Delaware, United States
  • Hope and Healing Clinical Research LLC — Hinsdale, Illinois, United States
  • Hope and Healing Clinical Research LLC — New Lenox, Illinois, United States
  • Illinois Cancer Specialists — Niles, Illinois, United States
  • Fort Wayne Medical Oncology and Hematology — Fort Wayne, Indiana, United States
  • Comprehensive Urology — Royal Oak, Michigan, United States
  • Missouri Cancer Associates — Columbia, Missouri, United States
  • Siteman Cancer Center — St Louis, Missouri, United States
  • Icahn School of Medicine at Mount Sinai — New York, New York, United States
  • Oncology Hematology Care Clinical Trials, LLC — Fairfield, Ohio, United States
  • Williamette Valley Cancer Institute and Research Center — Eugene, Oregon, United States
  • Compass Oncology - West — Tigard, Oregon, United States
  • SCRI Oncology Partners — Nashville, Tennessee, United States
  • Texas Oncology — Austin, Texas, United States
  • Texas Oncology - Northeast Texas — Tyler, Texas, United States
  • Virginia Oncology Associates — Norfolk, Virginia, United States
  • Site CA01194 — Chicoutimi, Quebec, Canada
  • Site CA01071 — Montreal, Quebec, Canada
  • Site KR01113 — Daegu, South Korea
  • Site KR01063 — Seongnam-si, South Korea
  • Site KR01065 — Seoul, South Korea
  • Site KR01084 — Seoul, South Korea
  • Site TW01117 — Kaohsiung City, Taiwan
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record