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

Launched by COORDINATION PHARMACEUTICALS, INC. · Apr 28, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment approach for patients with hard-to-treat head and neck cancer. Specifically, researchers are looking at a combination of a special medicine called RiMO-301, radiation therapy, and a type of immune therapy known as a PD-1 inhibitor. This study is aimed at patients whose cancer cannot be removed through surgery and has either come back or spread to other areas.

To be eligible for this trial, participants must be at least 18 years old and have a diagnosis of head and neck cancer that requires radiation treatment. They should have tumors that can be accessed for the RiMO-301 injection and have not received radiation in the targeted area recently. Patients who are currently undergoing treatment with PD-1 inhibitors like pembrolizumab or nivolumab may also qualify. Throughout the study, participants can expect to receive close monitoring and support from the medical team as they undergo the treatment. This trial is currently recruiting participants, and it’s an opportunity for patients seeking new options for managing their cancer.

Gender

ALL

Eligibility 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