University of Illinois at Chicago
The primary objective is to evaluate major pathologic response after RiMO-301 with hypofractionated radiotherapy and a PD-1 inhibitor (pembrolizumab), as assessed by clinical response rate using iRECIST criteria; determine event-free survival for up to 12 months; and determine overall survival for up to 24 months. The secondary objectives include determining event-free survival for up to 12 months and overall survival for up to 24 months.
RiMO-301 is administered intratumorally once prior to radiotherapy, with or without ultrasound/computed tomography (CT) guidance, at 30% of tumor volume(s). Radiotherapy (RT) is given starting within 1 day after RiMO-301 injection for 5 fractions of (4-5) Gray per fraction over a period of 5-15 days. PD-1 inhibitor pembrolizumab will be administered via 30-minute intravenous infusion, respectively, 200 mg once every three weeks (Q3W) with the first dose on the same day as RiMO-301 injection (+/- 1 day) for two cycles. Assessment of response will be clinically confirmed with CT imaging studies…
Inclusion Criteria: * Diagnosis of head and neck cancer that requires surgical resection * Must have at least one lesion that is clinically accessible to RiMO-301 injection and amenable to receiving hypofractionated radiotherapy * 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 * Patients must have recovered from a…
RiMO-301 will be dosed at 30% of the tumor volume on Day 0 prior to radiotherapy. The injection point will be as closed to half of the tumor depth as possible.
Pembrolizumab will be administered at 200 mg once every 3 weeks (Q3W) with the first dose on Day 0 +/- 1 day. Pembrolizumab will be given for a total of two cycles prior to surgery.
Hypofractionated radiation will will be given within 1 day after RiMO-301 injection and will continue over a period of 5-15 days. Participants will be receive 5 fractions of radiation with a dose of 4-5 Gray per fraction.
Surgical resection of the tumor will occur following neoadjuvant therapy.
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