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

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.

NCT Number	NCT07732634
Lead Sponsor	University of Illinois at Chicago Collaborators: Coordination Pharmaceuticals, Inc.
Conditions	Head and Neck Cancer, Head Cancer, Neck Cancer
Enrollment	20 participants
Start Date	2026-08
Primary Completion	2029-08 (estimated)
Study Completion	2031-08 (estimated)
Updated on ClinicalTrials.gov	2026-07-29