Enfortumab vedotin with pembrolizumab versus chemoradiotherapy for muscle-invasive bladder cancer

Trial details

Who runs it

Astellas Pharma Global Development, Inc.

Trial code

NCT07566156EU 2026-525612-34-00

Record updated

28 October 2026

Original 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.Read full original descriptionShow less

A PHASE 3, OPEN-LABEL, RANDOMIZED STUDY TO EVALUATE ENFORTUMAB VEDOTIN IN COMBINATION WITH PEMBROLIZUMAB IN ADULT PARTICIPANTS WITH MUSCLE-INVASIVE BLADDER CANCER WHO ARE INELIGIBLE FOR OR HAVE ELECTED NOT TO UNDERGO CYSTECTOMY

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.

Inclusion: 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: 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; 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; Currently receiving systemic antimicrobial treatment for active infection (viral, bacterial, or fungal) at the time of randomization. Routine antimicrobial prophylaxis is permitted; Received major surgery (defined as requiring general anesthesia and >24 hour inpatient hospitalization) within 4 weeks prior to randomization; Prior allogeneic stem cell or solid organ transplant; Received a live attenuated vaccine within 30 days prior to randomization; Uncontrolled diabetes; Known active hepatitis B, active hepatitis C, or human immunodeficiency virus (HIV) infection; 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); 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; Inadequate bladder function; Active keratitis or corneal ulcerations.

ClinicalTrials.gov NCT07566156 · EU CTIS 2026-525612-34-00