eligibility_summary
Inclusion: ≥18, histologic penile SCC with unresectable/metastatic disease (N1–3/M0 ineligible for or refusing surgery, TIP, or curative RT, or any M1), measurable (RECIST 1.1), ECOG 0–1, adequate marrow, liver, renal (GFR ≥30), prior therapy allowed. Exclusion: verrucous/non‑SCC or urethral tumors, ≥grade 2 neuropathy, active CNS mets, uncontrolled illness/infection, immunocompromised/HIV+, HBV/HCV, keratitis, enfortumab allergy, recent cancers, no contraception, chemo‑naïve curable cisplatin‑eligible.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Trial: NCT06104618 (Phase II, single-arm). Intervention: Enfortumab vedotin (Padcev), an antibody–drug conjugate. Mechanism: the human monoclonal antibody enfortumab targets Nectin-4 (PVRL4) on tumor cells, is internalized, and releases the cytotoxic payload monomethyl auristatin E (vedotin), a microtubule inhibitor, leading to microtubule disruption, G2/M arrest, and apoptosis (primary mechanism, any immune effector activity is secondary). Non-therapeutic procedures: CT/MRI for disease assessment. Targets: Nectin-4–expressing penile squamous carcinoma cells, downstream microtubule and cell-cycle pathways. Subgroup analysis by HPV status (p16).