Study of RiMO-301 and Radiotherapy With PD-1 Inhibitor for the Treatment of Head-Neck Cancer

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 at least 1 target lesion that is clinically accessible to RiMO-301 injection and amenable to receive RT regimens specified in this protocol
• •The selected target lesions must be measurable on cross-sectional imaging and repeated measurements at the same location should be achievable
• •Target tumor not in the previously irradiated field or in the field irradiated at least six months prior to RiMO-301 injection and with no complications from the prior radiation course
• •RiMO-301 injection to multiple lesions (≤ 5 in total) in a single patient is allowed as long as the total tumor volume does not exceed 250 cm3
• •Patient must have recovered from acute toxic effects (≤ grade 1 CTCAEv5) of previous cancer treatments prior to enrollment
• •Have adequate bone marrow reserve and adequate liver function
• •Have a life expectancy of at least 12 weeks
• •ECOG score of 0-2
• •Age 18 years or older