Phase I Trial of Intravenous VCN-01 Oncolytic Adenovirus and Durvalumab in Patients with Head and Neck Metastatic Squamous Cell Carcinoma Refractory to Immunotherapy.
Clin Cancer ResSep 1, 2026
Clinical ResearchOncology (Medical)
Maria Jove, Irene Braña, Marc Oliva et al.
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In 30 seconds
This Phase I trial evaluated the safety and efficacy of intravenous VCN-01 oncolytic adenovirus combined with durvalumab in patients with recurrent/metastatic head and neck squamous cell carcinoma (HNSCC) refractory to immunotherapy. The sequential administration of VCN-01 and durvalumab resulted in the longest overall survival of 17.3 months in the high-dose group, with 61.1% of patients alive beyond 12 months.
Key findings
- Arm II HD showed the longest overall survival of 17.3 months.
- 61.1% of patients were alive beyond 12 months.
- Two dose-limiting toxicities occurred in arm I LD, one in arm II LD.
- Increased PD-L1 expression correlated with overall survival.
Why it matters
The findings suggest that sequential treatment with VCN-01 and durvalumab may enhance survival outcomes in patients with HNSCC who have not responded to prior immunotherapy, indicating a potential new therapeutic strategy.