Primary Objectives:~To determine the tolerability of RiMO-301 with hypofractionated X-ray radiotherapy and a PD-1 inhibitor (pembrolizumab or nivolumab) in patients with unresectable, recurrent or metastatic head-neck cancer~To determine the efficacy of RiMO-301 with hypofractionated X-ray radiotherapy and a PD-1 inhibitor (pembrolizumab or nivolumab)~Secondary Objectives:~To evaluate progression-free survival for up to 12 months~To determine overall survival for up to 24 months~To assess patient quality of life~The target population is patients with unresectable, recurrent or metastatic head-neck cancer which is clinically accessible to intratumoral injection.
This is a prospective, open-label, single arm, non-randomized study of RiMO-301 with hypofractionated radiation and a PD-1 Inhibitor in patients with unresectable, recurrent or metastatic head-neck cancer.