Coordination Pharmaceuticals, Inc.
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.
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 me…
Inclusion Criteria: * Diagnosis of head-neck cancer that requires palliative radiotherapy * Patients with unresectable, recurrent or metastatic HNSCC, regardless if the patients have progressed on or are intolerant to platinum-based chemotherapy prior to study enrollment or if the patients are receiving pembrolizumab in the first line: * receiving a PD-1 inhibitor (pembrolizumab or nivolumab) as a standard of care, or * suitable to receive a PD-1 inhibitor (pembrolizumab or nivolumab) as a standard of care in the discretion of the treating physician or Principal Investigator * Must have…
A single dose of RiMO-301 will be administered via an intratumoral injection. PD-1 inhibitor (pembrolizumab or nivolumab) will be administered via a 30-minute intravenous infusion until disease progression or unacceptable toxicity. Patients will receive hypofractionated radiation in 5 fractions.
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