INSPIRE
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
Sponsor study identifier
interventional
105
4 countries
22
Study Start
January 11, 2016
Actual (reported)Primary Completion
February 28, 2022
Actual (reported)Study Completion
February 28, 2022
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
February 28, 2022
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
September 10, 2015
Actual (reported)November 20, 2015
Actual (reported)January 11, 2016
Actual (reported)February 28, 2022
Actual (reported)February 28, 2022
Actual (reported)January 30, 2024
Actual (reported)Event-free Survival (EFS)- Number of Participants With an Event
EFS is defined as the time from randomization until progression after surgery, or at surgery, if failure to resect gross disease, or at time of death from any cause after randomization.
From randomization up until the data cut-off date of June 2, 2022 (approximately 76 months)
EFS- Time to Event
EFS is defined as the time from randomization until progression after surgery, or at surgery, if failure to resect gross disease, or at time of death from any cause after randomization. Assessment of progression/disease recurrence occurred by physical exam and annual imaging for the duration of the follow up portion of the study. Median EFS was estimated using the Kaplan-Meier method.
From randomization up until the data cut-off date of June 2, 2022 (approximately 76 months)
Overall Survival (OS)- Number of Participants With an Event
From randomization up until the data cut-off date of June 2, 2022 (approximately 76 months)
OS- Time to Event
From randomization up until the data cut-off date of June 2, 2022 (approximately 76 months)
IRX Regimen with IRX-2, cyclophosphamide, indomethacin, zinc-containing multivitamin, and omeprazole as neoadjuvant and adjuvant therapy.
Regimen 1 but without IRX-2
Method of Administration: Administered for 10 days as subcutaneous bilateral injections in the upper neck.
Method of Administration: Cyclophosphamide is administered once by IV
Banner University Medical Center
Tucson, Arizona, 85742, United States
University of Arkansas For Medical Sciences
Little Rock, Arkansas, 72205, United States
USC Norris Comprehensive Cancer Center
Los Angeles, California, 90033, United States
Stanford University Medical Center
Stanford, California, 94305, United States
Emory University - Winship Cancer Center
Atlanta, Georgia, 30322, United States
University of Kentucky
Lexington, Kentucky, 40506, United States
University of Michigan
Wolf GT, Fee WE Jr, Dolan RW, Moyer JS, Kaplan MJ, Spring PM, Suen J, Kenady DE, Newman JG, Carroll WR, Gillespie MB, Freeman SM, Baltzer L, Kirkley TD, Brandwein HJ, Hadden JW. Novel neoadjuvant immunotherapy regimen safety and survival in head and neck squamous cell cancer. Head Neck. 2011 Dec;33(12):1666-74. doi: 10.1002/hed.21660. Epub 2011 Jan 31.
Berinstein NL, Wolf GT, Naylor PH, Baltzer L, Egan JE, Brandwein HJ, Whiteside TL, Goldstein LC, El-Naggar A, Badoual C, Fridman WH, White JM, Hadden JW. Increased lymphocyte infiltration in patients with head and neck cancer treated with the IRX-2 immunotherapy regimen. Cancer Immunol Immunother. 2012 Jun;61(6):771-82. doi: 10.1007/s00262-011-1134-z. Epub 2011 Nov 6.
One of the initial secondary objectives of the study was to compare the feasibility of each booster regimen (Regimen 1 vs Regimen 2) post-surgery. However, as a significant number of patients were unable to receive booster treatments due to tolerability issues and/or their post-surgery/post-adjuvant chemoradiation therapy status, booster regimens were discontinued and analysis of booster feasibility was not performed due to insufficient data for a meaningful, statistically sound analysis.
Gregory T Wolf, MD, FACS
University of Michigan Hospitals
105 participants (actual enrollment reported by the registry).
First Submitted
September 10, 2015
First Posted
November 20, 2015
Study Start
January 11, 2016
Actual (reported)Method of Administration: Indomethacin is administered orally for 21 days.
Method of Administration: Zinc-containing multivitamin is administered orally for 21 days.
Method of Administration: Omeprazole is administered orally for 21 days
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Ann Arbor, Michigan, 48109, United States
Nebraska Methodist Hospital
Omaha, Nebraska, 68114, United States
Monter Cancer Center - North Shore LIJ
New Hyde Park, New York, 11040, United States
Lenox Hill Hospital
New York, New York, 10075, United States
University of Oklahoma
Oklahoma City, Oklahoma, 73104, United States
Providence Cancer Center
Portland, Oregon, 97209, United States
Hospital of The University of Pennsylvania
Philadelphia, Pennsylvania, 19106, United States
Hospital Erasto Gaertner
Curitiba, Brazil
Instituto Goiano de Oncologia e Hematologia (INGOH)
Goiânia, Brazil
Instituto do Câncer de Londrina
Londrina, Brazil
Instituto Nacional do Cancer (INCA)
Rio de Janeiro, Brazil
Hospital de Base de São José do Rio Preto
São José do Vale do Rio Preto, Brazil
Instituto Brasileiro de Controle do Câncer
São Paulo, Brazil
Instituto do Cancer do Estado de São Paulo - ICESP
São Paulo, Brazil
Sunnybrook Research Institute
Toronto, Canada
Queen Elizabeth University Hospital Glasgow
Glasgow, United Kingdom
Wolf GT, Liu S, Bellile E, Sartor M, Rozek L, Thomas D, Nguyen A, Zarins K, McHugh JB; INSPIRE Trial Clinical Investigators. Tumor infiltrating lymphocytes after neoadjuvant IRX-2 immunotherapy in oral squamous cell carcinoma: Interim findings from the INSPIRE trial. Oral Oncol. 2020 Dec;111:104928. doi: 10.1016/j.oraloncology.2020.104928. Epub 2020 Jul 29.
Primary Completion
February 28, 2022
Actual (reported)Study Completion
February 28, 2022
Actual (reported)Last Updated
January 30, 2024
Results First Posted
January 30, 2024
Record last verified: 2024-01
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.
Source retrieved: