The phase 2b IRX-2 Neoadjuvant Therapy in Head and Neck SCC to Provide Immune Response Enhancement (INSPIRE) study is a randomized, multicenter, multinational clinical trial intended to enroll approximately 200 patients with stage III or IVA untreated squamous cell cancer of the oral cavity who are candidates for resection with curative intent.
Eligible patients will be randomized to receive either:
IRX-2 is given with additional pharmacologic agents including a zinc-containing multivitamin, low-dose cyclophosphamide, indomethacin, and omeprazole. Like IRX-2, these additional medications are not part of the standard treatment given to patients with cancer. However, it is believed they may be beneficial in supporting IRX-2 in the promotion of an anticancer immune response and in minimizing possible side effects of other components of the regimen.
More information about the INSPIRE study is available at inspirehnc.com
For additional information on study eligibility, help in identifying study sites, and information on patient referral, please contact INSPIRE@irxtherapeutics.com