study of rimo-301 and radiotherapy with pd-1 inhibitor for the treatment of head-neck cancer

Conditions: Head Neck Cancer; Intratumoral Injection

Summary: 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 metastatic head-neck cancer which is clinically accessible to intratumoral injection.

Eligibility criteria:
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 exclusion criteria: * have signs or symptoms of end organ failure, major chronic illnesses other than cancer, or any severe concomitant conditions * symptomatic central nervous system metastases and/or carcinomatous meningitis * active autoimmune disease that has required systemic treatment in the past 2 years * ongoing clinically significant infection at or near the incident lesion * major surgery over the target area (excluding placement of vascular access) ≤21 days from beginning of the study drug or minor surgical procedures ≤7 days. no waiting is required following implantable port, enteral feeding tube and catheter placement * has received any approved or investigational anti-neoplastic agent or immunotherapy other than pd-1 inhibitors (pembrolizumab or nivolumab) within 4 weeks prior to rimo-301 injection * patients with lesions which have significant blood vessel involvement (such as carotid artery encasement) or other major structures