Treatment of head-neck cancer using RiMO-301, radiotherapy, and a PD-1 inhibitor
Phase 1b/2a Study of RiMO-301 and Hypofractionated Radiotherapy With A PD-1 Inhibitor for the Treatment of Unresectable, Recurrent or Metastatic Head-Neck Cancer
This study is testing a new treatment combining RiMO-301, radiation therapy, and a PD-1 inhibitor to see if it helps people with advanced head and neck cancer feel better and live longer.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 16 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Coordination Pharmaceuticals, Inc. Industry-sponsored |
| Drugs / interventions | pembrolizumab, nivolumab, chemotherapy, immunotherapy, radiation |
| Locations | 1 site (Chicago, Illinois) |
| Trial ID | NCT05838729 on ClinicalTrials.gov |
What this trial studies
This study evaluates the combination of RiMO-301, hypofractionated radiation therapy, and a PD-1 inhibitor (either pembrolizumab or nivolumab) in patients with unresectable, recurrent, or metastatic head-neck cancer. It aims to assess the tolerability and efficacy of this treatment regimen, with primary objectives focusing on patient tolerability and treatment effectiveness. Secondary objectives include evaluating progression-free survival, overall survival, and quality of life for participants over specified timeframes.
Who should consider this trial
Good fit: Ideal candidates are patients with unresectable, recurrent, or metastatic head-neck cancer who are suitable for palliative radiotherapy and have accessible target lesions for injection.
Not a fit: Patients with head-neck cancer that is resectable or those who have previously received radiation therapy to the target lesion area may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with advanced head-neck cancer who have limited treatment alternatives.
How similar studies have performed: While this approach combines established therapies, the specific combination of RiMO-301 with hypofractionated radiation and PD-1 inhibitors is novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Chicago, Illinois
- University of Illinois at Chicago — Chicago, Illinois, United States (Recruiting)
Study contacts
- Principal investigator: Lawrence Feldman, MD — University of Illinois at Chicago
- Study coordinator: Ze-Qi Xu
- Email: zq@coordinationpharma.com
- Phone: 630-415-5601
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.