eligibility_summary
Inclusion: Adults ≥18 with HNSCC (oro/hypopharynx, oral cavity, larynx), ECOG 0–2, consent/comply, and ≥1 surface-accessible viable lesion scheduled for surgery for CIVO. Contraception: women postmenopausal/sterile or use highly effective contraception/abstain, men use barrier/abstain, no gamete donation or breastfeeding for 7 months. Exclusion: inadequate viable tumor or risky site, prior IO (CTLA-4/PD-1/PD-L1/PD-L2) ≤5y, prior topo1- or EGFR/c-MET–ADC, concurrent cancer/immune disease/active infection, pregnant/lactating/positive hCG, uncontrolled illness, organ transplant, major surgery <4 wks.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Trial: Phase 0, intratumoral microdosing in HNSCC using the CIVO device to compare localized pharmacodynamics vs pembrolizumab. Agents and mechanisms: • Rilvegostomig (AZD2936): bispecific monoclonal antibody blocking PD‑1 and TIGIT, releases dual inhibitory checkpoints on T cells (and NK cells via TIGIT) to restore antitumor activity. • Volrustomig (MEDI5752): bispecific mAb blocking PD‑1 and CTLA‑4, enhances T‑cell priming/effector function and reduces regulatory T‑cell suppression. • Sabestomig (AZD7789): bispecific mAb blocking PD‑1 and LAG‑3, reverses T‑cell exhaustion to boost antitumor responses. • AZD9592: antibody–drug conjugate targeting EGFR and c‑MET on tumor cells, delivering a topoisomerase I inhibitor payload to induce DNA damage and tumor cell kill (potentially immunogenic). • Pembrolizumab: anti‑PD‑1 IgG4 mAb checkpoint inhibitor (control). Targets/pathways: PD‑1, CTLA‑4, TIGIT, LAG‑3 on T cells/NK cells, EGFR and c‑MET on tumor cells, topoisomerase I–mediated DNA replication. Combinations: AZD9592 with each bispecific or pembrolizumab.