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

Part of paid clinical trials in Chicago, Illinois.

Sponsor
University of Illinois at Chicago
Study ID
NCT07732634
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

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.
  • 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.
  • 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.
  • Surgical resection — PROCEDURE
    Surgical resection of the tumor will occur following neoadjuvant therapy.

Study Details

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 Dates

First listed
Jul 29, 2026
Start date
Aug 31, 2026
Status verified
Jul 2026
Primary completion
Aug 31, 2029
Completion
Aug 31, 2031

Study Design

Enrollment
20 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: RiMO-301 combined with radiotherapy and pembrolizumab followed by surgical resection
    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.

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 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of Illinois at ChicagoChicagoIllinois60612
Ameen Salahudeen, MD, PhD
[email protected]
312-355-1625
Ameen Salahudeen, MD, PhD (PRINCIPAL_INVESTIGATOR)

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By condition
Head and neck cancer
By specialty
OncologyENT
By research site
University of Illinois at Chicago· Chicago, IL

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