eligibility_summary
HNSCC: Cohorts 1–5 recurrent/metastatic incurable, Cohort 6 locally advanced resectable stage III/IVa. Sites: oropharynx, oral cavity, hypopharynx, larynx. p16/HPV rules: 1–3 & 6 p16−, 4 oropharynx HPV+, 5 oropharynx HPV known, PD-L1 if available/required. Measurable disease (RECIST) except 3A & 6 evaluable. AEs ≤G1, ECOG 0–1, adequate labs (Hb≥9, ANC≥1.5, Plt≥100). Exclude ILD/pneumonitis, untreated CNS mets/spinal compression, major CV dz, recent therapy (<2w/4HL, RT <7d).
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Phase 1b/2 trial in head and neck squamous cell carcinoma tests: amivantamab alone, amivantamab+pembrolizumab, amivantamab+paclitaxel, and amivantamab+pembrolizumab+carboplatin, plus a perioperative amivantamab+pembrolizumab cohort. Drug types/mechanisms: Amivantamab (bispecific IgG1 monoclonal antibody) targets EGFR and MET on tumor cells, blocks signaling, promotes receptor downregulation, and mediates immune killing via ADCC/CDC. Pembrolizumab (monoclonal antibody) is an anti-PD-1 checkpoint inhibitor that restores T-cell antitumor activity. Paclitaxel (taxane) stabilizes microtubules causing mitotic arrest. Carboplatin (platinum) forms DNA crosslinks inducing apoptosis. Targets/pathways: EGFR/MET-driven HNSCC cells and downstream RAS-RAF-MEK-ERK and PI3K-AKT, PD-1/PD-L1 axis on T cells/tumor, microtubule dynamics, DNA replication/repair.