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.
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
HPV associated head and neck cancer
Nasopharynx head and neck cancer
Have signs or symptoms of end-stage failure, major chronic illnesses other than cancer, or any severe concomitant conditions
Symptomatic central nervous system metastases and/or carcinomatous meningitis
Single group
RiMO-301
DrugRiMO-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
DrugPembrolizumab 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.
Radiation
RadiationHypofractionated 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
Procedure/SurgerySurgical resection of the tumor will occur following neoadjuvant therapy.
Efficacy of RiMO-301 when used in combination with radiotherapy and pembrolizumab as defined by clinical response rate (i.e., percentage of participants whose tumors shrink).
Clinical response rate will be assessed by utilizing iRECIST criteria to measure tumor size
Progression-free survival rate as defined by the number of patients whose disease progresses since the start of treatment
iRECIST criteria will be used to assess progression free survival rate
Overall survival rate as defined by the number of deaths among participants
Overall survival rate will be calculated based on the number of deaths
Number of Grade 3 and Grade 4 toxicities experienced by participants as defined by CTCAE version 6
CTCAE version 6 will be used to assess toxicities that are experienced
To assess the rate of Major Pathological Response (MPR)
The rate of Major Pathological Response will be defined as the proportion of participants undergoing post-neoadjuvant treatment surgical resection who are found to have no more than 10% of residual invasive cancer cells present in the collected tumor specimen
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University of Illinois at Chicago
Lead sponsor
Coordination Pharmaceuticals, Inc.
Collaborator
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