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

NCT07732634 | Not Yet Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: 2026-0267
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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. The secondary objectives include determining event-free survival for up to 12 months and overall survival for up to 24 months.

Conditions

Head and Neck Cancer; Head Cancer; Neck Cancer

Outcome Measures

Primary Outcomes (1)

• 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

  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

  Treatment start until 12 months after the start of treatment

• Overall survival rate as defined by the number of deaths among participants

  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

  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)

  At surgical resection

• To assess the rate of Pathological Complete Response (pCR)

  At surgical resection

Study Arms (1)

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.

Drug: RiMO-301; Drug: Pembrolizumab; Radiation: Radiation; Procedure: Surgical resection

Interventions

RiMO-301 DRUG

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.

RiMO-301 combined with radiotherapy and pembrolizumab followed by surgical resection

Pembrolizumab DRUG

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.

Also known as: Keytruda

RiMO-301 combined with radiotherapy and pembrolizumab followed by surgical resection

Radiation RADIATION

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.

RiMO-301 combined with radiotherapy and pembrolizumab followed by surgical resection

Surgical resection PROCEDURE

Surgical resection of the tumor will occur following neoadjuvant therapy.

RiMO-301 combined with radiotherapy and pembrolizumab followed by surgical resection

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

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

Sponsors & Collaborators

• University of Illinois at Chicago: lead
• Coordination Pharmaceuticals, Inc.: collaborator

Study Sites (1)

University of Illinois at Chicago

Chicago, Illinois, 60612, United States

Location

MeSH Terms

Conditions

Head and Neck Neoplasms

Interventions

pembrolizumab; Radiation

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms

Intervention Hierarchy (Ancestors)

Physical Phenomena

Study Officials

• Ameen Salahudeen, MD, PhD

  Principal Investigator

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ameen Salahudeen, MD, PhD

CONTACT

(312) 355-1625; ameen@uic.edu

Riley Johnke

CONTACT

(312) 355-1469; johnke@uic.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 23, 2026
• First Posted: July 29, 2026
• Study Start: August 1, 2026
• Primary Completion (Estimated): August 1, 2029
• Study Completion (Estimated): August 1, 2031
• Last Updated: July 29, 2026

Record last verified: 2026-07

Locations

US (1)