A randomized trial in patients with untreated oral cancer who are candidates for curative surgery

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:

  • The IRX-2 neoadjuvant (presurgical) regimen, followed by 4 cycles of the IRX-2 booster regimen over the following year, or
  • All components of the IRX-2 neoadjuvant and booster regimens except the IRX-2 biologic, according to the same dose and schedule as patients in the first group

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

For additional information on study eligibility, help in identifying study sites, and information on patient referral, please contact