STUDY DESIGN

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 II, III, or IVA untreated squamous cell cancer (SCC) of the oral cavity who are candidates for resection with curative intent.

STUDY SCHEMA

*Enrolled subjects will be randomized 2:1 to either the Investigational Arm (Regimen 1) or the Control Arm (Regimen 2).

A 21-day regimen of IRX-2 (for 10 days), zinc-containing multivitamins, low-dose cyclophosphamide, indomethacin, and omeprazole.

As determined randomly per-protocol guidelines.

§A 10-day regimen of IRX-2 (for 5 days), zinc-containing multivitamins, low-dose cyclophosphamide, indomethacin, and omeprazole.

IRX-2 NEOADJUVANT DOSING SCHEDULE

STUDY DETAILS

IMMUNOLOGIC AND GENETIC ASSAYS

Several immunologic and genetic assays will be performed in order to better understand the immune response to the IRX-2 Regimen and the potential relationships between this response and clinical outcomes. These include:

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