RiMO-HNC-NEO1: Phase 2 Study of RiMO-301 and Hypofractionated Radiotherapy With Pembrolizumab for the Neoadjuvant Treatment of Resectable, Locally Advanced Head-Neck Cancer

Starting soon · Phase 2

Conditions studied: Head and Neck Cancer, Head Cancer, Neck Cancer

In brief

The primary objective is to evaluate major pathologic response after RiMO-301 with hypofractionated radiotherapy and a PD-1 inhibitor (pembrolizumab), as assessed by clinical response rate using iRECIST criteria; determine event-free survival for up to 12 months; and determine overall survival for up to 24 months. The secondary objectives include determining event-free survival for up to 12 months and overall survival for up to 24 months.

Key facts

Study ID

NCT07732634

Run by

University of Illinois at Chicago

People needed

20

Starts

2026-08-01

Expected to finish

2031-08-01

Last updated by the study team

2026-07-29

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Diagnosis of head and neck cancer that requires surgical resection
• Must have at least one lesion that is clinically accessible to RiMO-301 injection and amenable to receiving hypofractionated radiotherapy
• 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
• Patients must have recovered from acute toxic effects (≤ grade 1 CTCAEv6) of previous cancer treatments prior to enrollment
• Patients with locally advanced, resectable head and neck cancer:
• suitable to receive a PD-1 inhibitor (pembrolizumab) as a standard of care in the discretion of the treating physician or Principal Investigator
• suitable to receive hypofractionated radiotherapy as a standard of care in the discretion of the treating physician or Principal Investigator
• Have adequate bone marrow reserve:
• Absolute neutrophil count ≥1.5x109 cell/L
• Platelet count ≥100x109 cell/L
• Hemoglobin at least ≥9.0 g/dL unless confirmed by treating physician as not posing any increased harm to patient and approved by Sponsor (transfusion is allowed to achieve hemoglobin of ≥9.0 g/dL 14-days prior to dosing)
• Have adequate liver function:
• Total serum bilirubin no more than 1.5x upper limit of normal (ULN)
• Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5x ULN or ≤5.0x ULN in case of documented hepatic metastasis
• Alkaline phosphatase ≤5x ULN
• Have a life expectancy of at least 12 weeks (in the opinion of the investigator)
• Eastern Cooperative Oncology Group (ECOG) performance status 0-2
• Females with childbearing potential should be using adequate contraceptive measures from the time of screening until 6 months after study discontinuation, should not be breastfeeding, and must have a negative pregnancy test prior to start of dosing
• Patients must sign a study-specific informed consent form prior to study entry.

You may not qualify if…

• Diagnosis other than resectable, locally advanced head and neck cancers
• HPV associated head and neck cancer
• Nasopharynx head and neck cancer
• Have signs or symptoms of end-stage failure, major chronic illnesses other than cancer, or any severe concomitant conditions
• Symptomatic central nervous system metastases and/or carcinomatous meningitis
• Has received any approved or investigational anti-neoplastic agent or immunotherapy other than PD-1 inhibitors, pembrolizumab, within 4 weeks prior to RiMO-301 injection.
• Patients who are intolerant to pembrolizumab
• 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 the beginning of the study drug or minor surgical procedures ≤7 days. No waiting is required following implantable port, enteral feeding tube, and catheter placement
• Other severe acute or chronic medical or psychiatric conditions or laboratory abnormality that would make the patient inappropriate for enrollment in this study
• Has any mental or medical condition that prevents the patient from giving informed consent or participating in the trial
• Pregnant and nursing women are excluded because of the potential teratogenic effects and potential unknown effects on nursing newborns
• Patients with a target lesion in the field that had complications from prior radiotherapy that are not amenable to repeat irradiation in the discretion of the treating physician or Principal Investigator
• Patients with lesions that have significant blood vessel involvement (such as carotid artery encasement) or other major structures

Where it is running

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

Full record on ClinicalTrials.gov

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