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

Recruitment & 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

Study & Design

Arm && Interventions

Group	Intervention	Description
RiMO-301	RiMO-301	Intratumoral injection of RiMO-301 followed by pembrolizumab or nivolumab followed by hypofractionated radiation

Primary Outcome Measures

Name	Time	Method
Determination of Recommended Dose	6 weeks	• The dose limiting toxicities of RiMO-301 with hypofractionated X-ray radiotherapy and a PD-1 inhibitor, as assessed by CTCAEv5, will not be observed in 33% or more patients
Evaluation of Anti-Tumor Response	12 months	• To determine the objective response rate: complete or partial response, as defined by RECIST and itRECIST

Secondary Outcome Measures

Name	Time	Method
Evaluation of Progression-Free Survival	12 months	Time from enrollment to local-regional recurrence, local-regional progression, distant progression or death from any cause, whichever occurs first
Evaluation of Overall Survival	24 months	Time from enrollment to death from any cause

Recruitment & Eligibility