NCT02609386: INSPIRE

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

Completed Phase 2 Results posted Last updated 30 January 2024

What this trial tests

Phase 2 trial testing IRX-2 in Squamous Cell Carcinoma of the Oral Cavity in 105 participants. Completed in 28 February 2022.

Timeline

11 January 2016

Primary endpoint
28 February 2022

28 February 2022

Quick facts

Lead sponsor	Brooklyn ImmunoTherapeutics, LLC
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	105
Start date	11 January 2016
Primary completion	28 February 2022
Estimated completion	28 February 2022
Sites	22 locations across Brazil, United States, Canada, United Kingdom

Drugs / interventions tested

• IRX-2 — full drug profile →
• Cyclophosphamide (cyclophosphamide) — full drug profile →
• Indomethacin (INDOMETHACIN) — full drug profile →
• Zinc-containing multivitamin
• Omeprazole (omeprazole) — full drug profile →

Conditions studied

• Squamous Cell Carcinoma of the Oral Cavity — all drugs for Squamous Cell Carcinoma of the Oral Cavity →

Sponsor

Brooklyn ImmunoTherapeutics, LLC — full company profile →

Who can join

18 and older, any sex, with Squamous Cell Carcinoma of the Oral Cavity. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Immunotherapy in head and neck cancer: aiming at EXTREME precision.
   Szturz P, Vermorken JB. · · 2017 · cited 48× · PMID 28571578 · DOI 10.1186/s12916-017-0879-4
2. Immune deserts in head and neck squamous cell carcinoma: A review of challenges and opportunities for modulating the tumor immune microenvironment.
   Farlow JL, Brenner JC, Lei YL, Chinn SB. · · 2021 · cited 34× · PMID 34218062 · DOI 10.1016/j.oraloncology.2021.105420
3. Digesting the Role of JAK-STAT and Cytokine Signaling in Oral and Gastric Cancers.
   Ni Y, Low JT, Silke J, O'Reilly LA. · · 2022 · cited 33× · PMID 35844493 · DOI 10.3389/fimmu.2022.835997
4. The neoadjuvant paradigm reinvigorated: a review of pre-surgical immunotherapy in HNSCC.
   Stafford M, Kaczmar J. · · 2020 · cited 33× · PMID 32195008 · DOI 10.1186/s41199-020-00052-8
5. Changing the paradigm: the potential for targeted therapy in laryngeal squamous cell carcinoma.
   Ludwig ML, Birkeland AC, Hoesli R, Swiecicki P, et al · · 2016 · cited 26× · PMID 27144065 · DOI 10.28092/j.issn.2095-3941.2016.0010
6. Novel Immunotherapeutic Approaches for Head and Neck Squamous Cell Carcinoma.
   Bann DV, Deschler DG, Goyal N. · · 2016 · cited 22× · PMID 27669306 · DOI 10.3390/cancers8100087
7. Tumor infiltrating lymphocytes after neoadjuvant IRX-2 immunotherapy in oral squamous cell carcinoma: Interim findings from the INSPIRE trial.
   Wolf GT, Liu S, Bellile E, Sartor M, et al · · 2020 · cited 19× · PMID 32738599 · DOI 10.1016/j.oraloncology.2020.104928
8. IRX-2 natural cytokine biologic for immunotherapy in patients with head and neck cancers.
   Wolf GT, Moyer JS, Kaplan MJ, Newman JG, et al · · 2018 · cited 19× · PMID 29988729 · DOI 10.2147/ott.s165411