Study Overview
Approximately 250 eligible patients with PD-L1 positive, R/M HNSCC will be randomly assigned to zanzalintinib in combination with pembrolizumab or pembrolizumab alone to evaluate the activity of the combination therapy on PFS by BIRC and OS vs pembrolizumab monotherapy. If phase 2 results support study continuation to phase 3, an additional 250 patients will be randomized for a total of 500 patients.