Summary
This seamless phase 2/3 randomized controlled study will evaluate the efficacy and safety
of the hexavalent OX40 agonist antibody INBRX-106 combined with the anti-PD-1 antibody
pembrolizumab versus pembrolizumab (+ placebo in phase 3) as first-line treatment for
patients with locally advanced recurrent or metastatic head and neck squamous cell
carcinoma (R/M HSNSCC) incurable by local therapies, expressing PD-L1 with a combined
proportion score (CPS) =20.