Head Neck Cancer, Intratumoral Injection
Conditions
Brief 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.
Detailed 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.
Interventions
DRUGRiMO-301
A single dose of RiMO-301 will be administered via an intratumoral injection. PD-1 inhibitor (pembrolizumab or nivolumab) will be administered via a 30-minute intravenous infusion until disease progression or unacceptable toxicity. Patients will receive hypofractionated radiation in 5 fractions.
Sponsors
University of Illinois at Chicago
Coordination Pharmaceuticals, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
United States
Contacts
Primary ContactZe-Qi Xu
Outcome results
None listed