eligibility_summary
Inclusion: ≥18, histologic recurrent oral cavity SCC, salvage surgery candidate, recurrence ≥3 mo post‑curative therapy, RECIST‑measurable, ECOG 0–1, tissue/biopsy, adequate counts, CrCl ≥30, AST/ALT ≤3×ULN, bilirubin ≤1.5×ULN (≤3× if Gilbert), contraception. Exclusion: recurrence <3 mo, M1, prior PD‑1/PD‑L1, steroid >10 mg, active autoimmune disease, ILD/pneumonitis, organ/stem‑cell transplant, recent other cancers (some exceptions), active infection ≤10 d, serious comorbidity, pregnant/breastfeeding, hypersensitivity.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
NCT06448026: Phase 2, single-arm neoadjuvant trial in recurrent oral cavity SCC testing cemiplimab plus cetuximab before salvage surgery, with optional adjuvant cemiplimab. Drugs/mechanisms: Cemiplimab—fully human IgG4 monoclonal antibody, immune checkpoint inhibitor that blocks PD‑1 on T cells, preventing PD‑L1/PD‑L2–mediated inhibition to restore cytotoxic T‑cell antitumor activity. Cetuximab—chimeric IgG1 monoclonal antibody against EGFR (HER1), blocks ligand binding and receptor activation, inhibiting downstream RAS/RAF/MEK/ERK and PI3K/AKT pathways, also induces ADCC via NK cells. Targets/pathways: PD‑1/PD‑L1/PD‑L2 axis on T lymphocytes and tumor/immune cells, EGFR on OCSCC cells, NK cell FcγR-mediated ADCC.