eligibility_summary
Eligible: Histologically confirmed Stage I (T1–2N1M0) HPV-positive oropharyngeal cancer that is amenable to surgical resection and safe for neoadjuvant radiation plus Evorpacept/Pembrolizumab. Exclude: patients with a solitary lymph node <3 cm.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Phase II single-arm neoadjuvant immunoradiotherapy for resectable stage I HPV+ oropharyngeal cancer. Interventions: 1) Evorpacept (ALX148), a CD47‑blocking SIRPα–Fc fusion protein (myeloid checkpoint inhibitor) that disrupts CD47–SIRPα “don’t‑eat‑me” signaling to boost macrophage phagocytosis and dendritic cell antigen presentation. 2) Pembrolizumab, a humanized IgG4 monoclonal antibody against PD‑1 (T‑cell checkpoint inhibitor) restoring exhausted T‑cell function. 3) Stereotactic body radiotherapy (SBRT 8 Gy×3) to tumor, promoting immunogenic cell death/antigen release while sparing draining lymphatics. Targets: CD47–SIRPα axis (macrophages/DCs, tumor), PD‑1 on T cells (CD8+), and radiation‑induced innate/adaptive priming in the tumor microenvironment.