Overview

IRX-2 Regimen in Patients With Newly Diagnosed Stage II, III, or IVA Squamous Cell Carcinoma of the Oral Cavity

Status:
Active, not recruiting

Trial end date:
2022-03-01

Target enrollment:

Participant gender:

Summary

The purpose of this study is to determine whether a pre-operative regimen of the study drug, IRX-2, a human cell-derived biologic with multiple active cytokine components, plus a single dose of cyclophosphamide, followed by 21 days of indomethacin, zinc-containing multivitamins, and omeprazole is active in treatment of oral cavity cancer. The regimen is intended to stimulate an immune response against the cancer.

Phase:

Phase 2

Details

Lead Sponsor:

Brooklyn ImmunoTherapeutics, LLC
IRX Therapeutics

Treatments:

Cyclophosphamide
Indomethacin
Omeprazole
Proton Pump Inhibitors
Zinc