eligibility_summary
Eligible: Adults ≥18, ECOG 0–2, path-confirmed urothelial carcinoma, eligible for maintenance avelumab (metastatic/locally advanced). Men with partners of childbearing potential must use dual contraception during and 130 days after. Exclusions: hepatic labs >2× ULN, neutrophils <1,000/μL, androgen or systemic hormonal therapy (5-ARIs allowed), active other malignancy needing treatment, investigational drug <2 wks, coumadin, women of childbearing potential.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Phase II, double-blind, placebo-controlled RCT in metastatic or locally advanced urothelial carcinoma testing standard maintenance avelumab plus bicalutamide vs avelumab plus placebo (2:1). Interventions and mechanisms: - Bicalutamide: oral nonsteroidal antiandrogen, a competitive androgen receptor (AR) antagonist that blocks androgen binding, AR nuclear translocation, and AR-driven transcription. - Avelumab: intravenous anti–PD-L1 IgG1 monoclonal antibody immune checkpoint inhibitor, blocks PD-L1 from engaging PD-1/B7.1 to restore T-cell activity and can trigger NK cell-mediated ADCC via its Fc. Targets/pathways: AR signaling in tumor cells, PD-L1 on tumor and immune cells, reactivating cytotoxic CD8+ T cells and NK cells. Status: Withdrawn after EV302 changed standard of care.