Phase 2 Study of RiMO-301, Radiotherapy, and Pembrolizumab for Head and Neck Cancer
This study is testing a new combination treatment for head and neck cancer that can be removed by surgery. It involves giving three treatments before surgery: RiMO-301 (a drug injected directly into the tumor), hypofractionated radiotherapy (a type of radiation given in fewer, higher doses), and pembrolizumab (a drug that helps your immune system fight cancer). Researchers want to see how well this combination shrinks tumors (clinical response rate) and how long people live without their cancer returning or getting worse. They will also look at how long people live overall. You may be able to join if you have head and neck cancer that needs surgery and has a tumor that can be injected and treated with radiation. This study plans to enroll 20 participants, and its current status is unclear.
- Study design
- This is a Phase 2 interventional study, meaning all participants will receive the study treatments. It plans to enroll 20 participants.
- What's involved
- You would receive an injection of RiMO-301, five radiation treatments over 5-15 days, and two cycles of pembrolizumab given every three weeks, all before surgery. After surgery, you would have imaging studies and clinical evaluations.
- Compensation
- Not stated in the trial record.
- Follow-up
- Your event-free survival will be checked for up to 12 months, and overall survival will be checked for up to two years after treatment starts. Imaging studies will be done every 6 months after surgery for up to 12 months.
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NCT07732634
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
Not Yet Recruiting
PHASE2Ages 18+InterventionalTreatmentUniversity of Illinois at ChicagoInvestigator-initiated
~20 participants
Updated 2026-07-29 on ClinicalTrials.gov
What's tested:RiMO-301PembrolizumabRadiationSurgical resection
At a glance
Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Efficacy of RiMO-301 when used in combination with radiotherapy and pembrolizumab as defined by clinical response rate (i.e., percentage of participants whose tumors shrink).
Measured over Treatment start until 12 months after the start of treatment
Conditions
Where it's being run
1 sites across 1 statesIllinois1
Study leadership
- Ameen Salahudeen, MD, PhD · PRINCIPAL_INVESTIGATOR · Principal Investigator
Who to contact
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Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
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.
Exclusion
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
What this trial measures
- Efficacy of RiMO-301 when used in combination with radiotherapy and pembrolizumab as defined by clinical response rate (i.e., percentage of participants whose tumors shrink).Treatment start until 12 months after the start of treatment
Clinical response rate will be assessed by utilizing iRECIST criteria to measure tumor size