drugset / Trial / NCT06159621
CD40 Agonist and PD-1 Inhibitor in HNSCC
RandomizedParallel-groupOpen-labelTreatment
Summary
Prospective, open-label, phase 1 study of CD40 agonist (LVGN7409) and PD-1 inhibition (LVGN3616 or nivolumab) in patients with resectable Human Papillomavirus (HPV)-negative mucosal head/neck squamous cell carcinoma (HNSCC). This protocol proposes to study the safety and immunological effects of LVGN7409, a CD40 agonistic antibody, when administered in combination with PD-1 inhibition prior to surgical resection.
Timeline
- Start
- 2024-07-02
- Primary completion
- 2028-03-01
- Completion
- 2028-03-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | LVGN7409 | Monoclonal antibody | 1 mg/kg | — |
| Comparator | PRADUSINSTOBART | Monoclonal antibody | 300 mg | — |