Treatment of head-neck cancer using RiMO-301, radiotherapy, and a PD-1 inhibitor

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• University of Illinois at Chicago
  Chicago, Illinois, United States Recruiting

Study contacts

• Principal investigator: Lawrence Feldman, MD — University of Illinois Chicago
• Study coordinator: Ze-Qi Xu
• Email: zq@coordinationpharma.com
• Phone: 630-415-5601

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.