Overview
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.
Description
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
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