Head and Neck CancerPhase 2RiMO-HNC-NEO1NCT07732634
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
A Phase 2 study testing RiMO-301, Pembrolizumab and Radiation in people with Head and Neck Cancer and Head Cancer, run by University of Illinois Chicago at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head and Neck Cancer, Head Cancer, Neck Cancer
- What is being tested?
- RiMO-301, Pembrolizumab and Radiation
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2026to Aug 2031
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
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- 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.
Who cannot join
- 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.
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
University of Illinois at Chicago
Chicago, Illinois, 60612
Ameen Salahudeen, MD, PhD, 312-355-1625, ameen@uic.edu
Ameen Salahudeen, MD, PhD
About this study
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.
Read the detailed description
RiMO-301 is administered intratumorally once prior to radiotherapy, with or without ultrasound/computed tomography (CT) guidance, at 30% of tumor volume(s). Radiotherapy (RT) is given starting within 1 day after RiMO-301 injection for 5 fractions of (4-5) Gray per fraction over a period of 5-15 days. PD-1 inhibitor pembrolizumab will be administered via 30-minute intravenous infusion, respectively, 200 mg once every three weeks (Q3W) with the first dose on the same day as RiMO-301 injection (+/- 1 day) for two cycles. Assessment of response will be clinically confirmed with CT imaging studies performed 5 weeks after the last radiation and pathology evaluation of the resected tumor. Event-free survival will be clinically evaluated every three months up to 12 months, CT imaging studies will be performed every 6 months after surgery up to 12 months after surgery, and overall survival will be clinically evaluated up to two years.
- Conditions
- Head and Neck Cancer, Head Cancer, Neck Cancer
- Being tested
- RiMO-301, Pembrolizumab, Radiation, Surgical resection
- Medical subject headings
- Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RiMO-301Drug
RiMO-301 will be dosed at 30% of the tumor volume on Day 0 prior to radiotherapy. The injection point will be as closed to half of the tumor depth as possible.
PembrolizumabDrug
Also called Keytruda
Pembrolizumab will be administered at 200 mg once every 3 weeks (Q3W) with the first dose on Day 0 +/- 1 day. Pembrolizumab will be given for a total of two cycles prior to surgery.
RadiationRadiation
Hypofractionated radiation will will be given within 1 day after RiMO-301 injection and will continue over a period of 5-15 days. Participants will be receive 5 fractions of radiation with a dose of 4-5 Gray per fraction.
Surgical resectionProcedure or surgery
Surgical resection of the tumor will occur following neoadjuvant therapy.
| Study group | Role | What they receive |
|---|---|---|
| RiMO-301 combined with radiotherapy and pembrolizumab followed by surgical resection | Experimental | RiMO-301 will be injected intratumorally once prior to radiotherapy at 30% of tumor volume(s). Radiotherapy will start within 1 day after the RiMO-301 injection for 5 fractions of 4-5 Grays per fraction over a period of 5-15 days. Pembrolizumab 200 mg will be administered intravenously every 3 weeks (Q3W) within the first dose given on the same day as the RiMO-301 injection (+/-1 day). Pembrolizumab will continue for 2 cycles (1 cycle = 21 days). Surgical resection of the tumor will occur after the completion of neoadjuvant therapy. Receives: Drug: RiMO-301; Drug: Pembrolizumab; Radiation: Radiation; Procedure: Surgical resection |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Clinical response rate will be assessed by utilizing iRECIST criteria to measure tumor size
Measured: Treatment start until 12 months after the start of treatment
Secondary outcomes (7)
Progression-free survival rate as defined by the number of patients whose disease progresses since the start of treatment
iRECIST criteria will be used to assess progression free survival rate
Measured: Treatment start until 12 months after the start of treatment
Overall survival rate as defined by the number of deaths among participants
Overall survival rate will be calculated based on the number of deaths
Measured: Treatment start until 24 months after the start of treatment
Number of Grade 3 and Grade 4 toxicities experienced by participants as defined by CTCAE version 6
CTCAE version 6 will be used to assess toxicities that are experienced
Measured: Treatment start until 5 weeks after the last dose of radiation therapy (that is, approximately 7 weeks after treatment start)
To assess the rate of Major Pathological Response (MPR)
The rate of Major Pathological Response will be defined as the proportion of participants undergoing post-neoadjuvant treatment surgical resection who are found to have no more than 10% of residual invasive cancer cells present in the collected tumor specimen
Measured: At surgical resection
To assess the rate of Pathological Complete Response (pCR)
The rate of Pathological Complete Response will be defined as the proportion of participants undergoing post-neoadjuvant treatment surgical resection with no residual invasive cancer within the resected primary tumor and sampled regional lymph nodes
Measured: At surgical resection
To assess surgical outcomes through margin measurements at surgical resection
Surgical outcomes will be assessed through margin measurements, specifically the proportion of participants who have positive surgical margins (that is, presence of invasive tumor front at resected margin) and the proportion of people who have close surgical margins (that is, the presence of invasive tumor front <2-5 mm from the resected margin)
Measured: At surgical resection
To evaluate the change in disease staging as assessed by the proportion of patients who have a reduction in the size or extent of tumor
Tumor downstaging will be assessed by imaging and clinical staging by T or N status
Measured: Pre-treatment until 12 months after the start of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2026
- Study startAug 2026 (estimated)
- Primary completionAug 2029 (estimated)
- Study completionAug 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head and Neck CancerStudies of the same condition, open and under way.
- More trials run by University of Illinois ChicagoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Illinois Chicago
- Sponsor type
- University, hospital or other
- Collaborators
- Coordination Pharmaceuticals, Inc.
- Responsible party
- Principal investigator, Ameen Salahudeen, University of Illinois Chicago
- Investigators
- Ameen Salahudeen, MD, PhD, Principal investigator, Principal Investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07732634
- Sponsor's protocol ID
- 2026-0267
- Acronym
- RiMO-HNC-NEO1
- Status last verified
- Jul 2026
- First submitted
- 23 Jul 2026
- Last updated
- 29 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07732634
- Acronym / sponsor ID
- RiMO-HNC-NEO1 / 2026-0267
- Conditions
- Head and Neck Cancer, Head Cancer, Neck Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University of Illinois ChicagoUniversity, hospital or other
- Collaborators
- Coordination Pharmaceuticals, Inc.
- Study start
- Aug 2026 (estimated)
- Primary completion
- Aug 2029 (estimated)
- Study completion
- Aug 2031 (estimated)
- First posted
- 29 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
RiMO-301 is administered intratumorally once prior to radiotherapy, with or without ultrasound/computed tomography (CT) guidance, at 30% of tumor volume(s). Radiotherapy (RT) is given starting within 1 day after RiMO-301 injection for 5 fractions of (4-5) Gray per fraction over a period of 5-15 days. PD-1 inhibitor pembrolizumab will be administered via 30-minute intravenous infusion, respectively, 200 mg once every three weeks (Q3W) with the first dose on the same day as RiMO-301 injection (+/- 1 day) for two cycles. Assessment of response will be clinically confirmed with CT imaging studies performed 5 weeks after the last radiation and pathology evaluation of the resected tumor. Event-free survival will be clinically evaluated every three months up to 12 months, CT imaging studies will be performed every 6 months after surgery up to 12 months after surgery, and overall survival will be clinically evaluated up to two years.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| RiMO-301 combined with radiotherapy and pembrolizumab followed by surgical resection | Experimental | Drug: RiMO-301, Drug: Pembrolizumab, Radiation: Radiation, Procedure: Surgical resectionRiMO-301 will be injected intratumorally once prior to radiotherapy at 30% of tumor volume(s). Radiotherapy will start within 1 day after the RiMO-301 injection for 5 fractions of 4-5 Grays per fraction over a period of 5-15 days. Pembrolizumab 200 mg will be administered intravenously every 3 weeks (Q3W) within the first dose given on the same day as the RiMO-301 injection (+/-1 day). Pembrolizumab will continue for 2 cycles (1 cycle = 21 days). Surgical resection of the tumor will occur after the completion of neoadjuvant therapy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (20 listed)
- 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
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RiMO-301RiMO-301 will be dosed at 30% of the tumor volume on Day 0 prior to radiotherapy. The injection point will be as closed to half of the tumor depth as possible. | Drug | RiMO-301 combined with radiotherapy and pembrolizumab followed by surgical resection |
| PembrolizumabAlso: KeytrudaPembrolizumab will be administered at 200 mg once every 3 weeks (Q3W) with the first dose on Day 0 +/- 1 day. Pembrolizumab will be given for a total of two cycles prior to surgery. | Drug | RiMO-301 combined with radiotherapy and pembrolizumab followed by surgical resection |
| RadiationHypofractionated radiation will will be given within 1 day after RiMO-301 injection and will continue over a period of 5-15 days. Participants will be receive 5 fractions of radiation with a dose of 4-5 Gray per fraction. | Radiation | RiMO-301 combined with radiotherapy and pembrolizumab followed by surgical resection |
| Surgical resectionSurgical resection of the tumor will occur following neoadjuvant therapy. | Procedure or surgery | RiMO-301 combined with radiotherapy and pembrolizumab followed by surgical resection |
Primary outcome
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).
Time frame: Treatment start until 12 months after the start of treatment
Clinical response rate will be assessed by utilizing iRECIST criteria to measure tumor size
7 secondary outcomes
Progression-free survival rate as defined by the number of patients whose disease progresses since the start of treatment
Time frame: Treatment start until 12 months after the start of treatment
Overall survival rate as defined by the number of deaths among participants
Time frame: Treatment start until 24 months after the start of treatment
Number of Grade 3 and Grade 4 toxicities experienced by participants as defined by CTCAE version 6
Time frame: Treatment start until 5 weeks after the last dose of radiation therapy (that is, approximately 7 weeks after treatment start)
To assess the rate of Major Pathological Response (MPR)
Time frame: At surgical resection
To assess the rate of Pathological Complete Response (pCR)
Time frame: At surgical resection
To assess surgical outcomes through margin measurements at surgical resection
Time frame: At surgical resection
To evaluate the change in disease staging as assessed by the proportion of patients who have a reduction in the size or extent of tumor
Time frame: Pre-treatment until 12 months after the start of treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ameen Salahudeen, MD, PhD principal investigator
Principal Investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing RiMO-301, Pembrolizumab and Radiation in people with Head and Neck Cancer and Head Cancer, run by University of Illinois Chicago at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 20 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 29 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ameen Salahudeen, MD, PhD ((312) 355-1625, ameen@uic.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). (time frame: Treatment start until 12 months after the start of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2026.