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

Squamous Cell Carcinoma of the Oral Cavity Clinical Trial

Official title:
A Randomized Phase 2 Trial of Neoadjuvant and Adjuvant Therapy With the IRX 2 Regimen in Patients With Newly Diagnosed Stage II, III, or IVA Squamous Cell Carcinoma of the Oral Cavity

Clinical Trial 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.

Clinical Trial Description

This study will assess the activity and safety of the IRX Regimen in participants with newly diagnosed, untreated, surgically resectable squamous cell cancer of the oral cavity. Participants will be randomly assigned to receive either Regimen 1: IRX-2 + cyclophosphamide + indomethacin + zinc + omeprazole, or Regimen 2: cyclophosphamide + indomethacin + zinc + omeprazole. The primary study hypothesis is that the Regimen 1 with IRX-2 prolongs event-free survival and overall survival when compared to Regimen 2 without IRX-2. Subjects will be randomized to either Regimen 1 or Regimen 2 on a 2:1 basis and treated prior to surgery. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02609386
Study type Interventional
Source Brooklyn ImmunoTherapeutics, LLC
Contact
Status Completed
Phase Phase 2
Start date January 11, 2016
Completion date February 28, 2022
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