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Clinical Trial Summary

This is a prospective, open-label, single arm, non-randomized study of RiMO-301 with hypofractionated radiation and a PD-1 Inhibitor in patients with unresectable, recurrent or metastatic head-neck cancer.


Clinical Trial Description

Primary Objectives: - To determine the tolerability of RiMO-301 with hypofractionated X-ray radiotherapy and a PD-1 inhibitor (pembrolizumab or nivolumab) in patients with unresectable, recurrent or metastatic head-neck cancer - To determine the efficacy of RiMO-301 with hypofractionated X-ray radiotherapy and a PD-1 inhibitor (pembrolizumab or nivolumab) Secondary Objectives: - To evaluate progression-free survival for up to 12 months - To determine overall survival for up to 24 months - To assess patient quality of life The target population is patients with unresectable, recurrent or metastatic head-neck cancer which is clinically accessible to intratumoral injection. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05838729
Study type Interventional
Source Coordination Pharmaceuticals, Inc.
Contact Ze-Qi Xu
Phone 630-415-5601
Email zq@coordinationpharma.com
Status Recruiting
Phase Phase 1/Phase 2
Start date April 3, 2023
Completion date December 1, 2026

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