deltatrials
Completed PHASE2 INTERVENTIONAL 2-arm NCT02609386

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

Conditions Squamous Cell Carcinoma of the Oral Cavity
Interventions Cyclophosphamide IRX-2 Indomethacin Omeprazole Zinc-containing multivitamin
Updated 17 times since 2017 Last updated: Jan 23, 2024 Started: Jan 11, 2016 Primary completion: Feb 28, 2022 Completion: Feb 28, 2022
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

A PHASE2 clinical study on Squamous Cell Carcinoma of the Oral Cavity, this trial is completed. The trial is conducted by Brooklyn ImmunoTherapeutics, LLC and has accumulated 17 data snapshots since 2016. Oncology trials at this stage typically focus on safety, tolerability, and early efficacy signals.

Status Flow

~Jan 2017 – ~Feb 2017 · 31 days · monthly snapshot~Feb 2017 – ~Mar 2017 · 28 days · monthly snapshot~Mar 2017 – ~Nov 2017 · 8 months · monthly snapshot~Nov 2017 – ~Dec 2017 · 30 days · monthly snapshot~Dec 2017 – ~Mar 2018 · 3 months · monthly snapshot~Mar 2018 – ~Jun 2018 · 3 months · monthly snapshot~Jun 2018 – ~Jan 2019 · 7 months · monthly snapshot~Jan 2019 – ~Mar 2020 · 14 months · monthly snapshot~Mar 2020 – ~Sep 2020 · 6 months · monthly snapshot~Sep 2020 – ~Jan 2021 · 4 months · monthly snapshot~Jan 2021 – ~Nov 2022 · 22 months · monthly snapshot~Nov 2022 – ~Jun 2023 · 7 months · monthly snapshot~Jun 2023 – ~Feb 2024 · 8 months · monthly snapshot~Feb 2024 – ~Jul 2024 · 5 months · monthly snapshot~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshot~Sep 2024 – ~Sep 2025 · 12 months · monthly snapshot~Sep 2025 – present · 9 months · monthly snapshot

Change History

17 versions recorded

  1. Sep 2025 — Present [monthly]

    Completed PHASE2

  2. Sep 2024 — Sep 2025 [monthly]

    Completed PHASE2

  3. Jul 2024 — Sep 2024 [monthly]

    Completed PHASE2

  4. Feb 2024 — Jul 2024 [monthly]

    Completed PHASE2

  5. Jun 2023 — Feb 2024 [monthly]

    Completed PHASE2

    Status: Unknown Status → Completed

▶ Show 12 earlier versions

  1. Nov 2022 — Jun 2023 [monthly]

    Unknown Status PHASE2

    Status: Active Not Recruiting → Unknown Status

  2. Jan 2021 — Nov 2022 [monthly]

    Active Not Recruiting PHASE2

  3. Sep 2020 — Jan 2021 [monthly]

    Active Not Recruiting PHASE2

    Status: Unknown Status → Active Not Recruiting

  4. Mar 2020 — Sep 2020 [monthly]

    Unknown Status PHASE2

    Status: Active Not Recruiting → Unknown Status

  5. Jan 2019 — Mar 2020 [monthly]

    Active Not Recruiting PHASE2

  6. Jun 2018 — Jan 2019 [monthly]

    Active Not Recruiting PHASE2

  7. Mar 2018 — Jun 2018 [monthly]

    Active Not Recruiting PHASE2

    Status: Recruiting → Active Not Recruiting

  8. Dec 2017 — Mar 2018 [monthly]

    Recruiting PHASE2

  9. Nov 2017 — Dec 2017 [monthly]

    Recruiting PHASE2

  10. Mar 2017 — Nov 2017 [monthly]

    Recruiting PHASE2

  11. Feb 2017 — Mar 2017 [monthly]

    Recruiting PHASE2

  12. Jan 2017 — Feb 2017 [monthly]

    Recruiting PHASE2

    First recorded

Jan 2016

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • Brooklyn ImmunoTherapeutics, LLC
Data source: Brooklyn ImmunoTherapeutics, LLC

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations

Ann Arbor, United States , Atlanta, United States , Curitiba, Brazil , Glasgow, United Kingdom , Goiânia, Brazil , Lexington, United States , Little Rock, United States , Londrina, Brazil , Los Angeles, United States , New Hyde Park, United States and 11 more locations