NCT02609386

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 105 (actual)
• Sponsor: Brooklyn ImmunoTherapeutics, LLC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Squamous Cell Carcinoma of the Oral Cavity

Interventions

Type	Name	Description
BIOLOGICAL	IRX-2	Method of Administration: Administered for 10 days as subcutaneous bilateral injections in the upper neck.
DRUG	Cyclophosphamide	Method of Administration: Cyclophosphamide is administered once by IV
DRUG	Indomethacin	Method of Administration: Indomethacin is administered orally for 21 days.
DIETARY_SUPPLEMENT	Zinc-containing multivitamin	Method of Administration: Zinc-containing multivitamin is administered orally for 21 days.
DRUG	Omeprazole	Method of Administration: Omeprazole is administered orally for 21 days

Timeline

• Start date: 2016-01-11
• Primary completion: 2022-02-28
• Completion: 2022-02-28
• First posted: 2015-11-20
• Last updated: 2024-01-30
• Results posted: 2024-01-30

Locations

22 sites across 4 countries: United States, Brazil, Canada, United Kingdom