deltatrials
Completed PHASE3 INTERVENTIONAL 3-arm NCT01265849

Efficacy and Safety Study of Leukocyte Interleukin,Injection (LI) to Treat Cancer of the Oral Cavity (IT-MATTERS)

Phase III Study of LI [Multikine®] Plus SOC (Surgery + Radiotherapy or Surgery + Concurrent Radiochemotherapy) in Subjects With Advanced Primary Squamous Cell Carcinoma of the Oral Cavity/Soft Palate vs. SOC Only

Sponsor: CEL-SCI Corporation

Conditions Squamous Cell Carcinoma of the Oral Cavity Squamous Cell Carcinoma of the Soft Palate
Interventions Cisplatin Cyclophosphamide Indomethacin LI Radiotherapy Surgery Zinc
Updated 20 times since 2017 Last updated: Aug 17, 2022 Started: Dec 31, 2010 Primary completion: May 15, 2020 Completion: Dec 4, 2020
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

Listed as NCT01265849, this PHASE3 trial focuses on Squamous Cell Carcinoma of the Oral Cavity and Squamous Cell Carcinoma of the Soft Palate and remains completed. Sponsored by CEL-SCI Corporation, it has been updated 20 times since 2010, reflecting substantial change activity. This study contributes to the evolving evidence base for cancer treatment protocols.

Status Flow

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

Change History

20 versions recorded

  1. Sep 2025 — Present [monthly]

    Completed PHASE3

  2. Sep 2024 — Sep 2025 [monthly]

    Completed PHASE3

  3. Jul 2024 — Sep 2024 [monthly]

    Completed PHASE3

  4. Sep 2022 — Jul 2024 [monthly]

    Completed PHASE3

    Status: Unknown Status → Completed

  5. May 2022 — Sep 2022 [monthly]

    Unknown Status PHASE3

    Status: Active Not Recruiting → Unknown Status

▶ Show 15 earlier versions

  1. Jan 2022 — May 2022 [monthly]

    Active Not Recruiting PHASE3

  2. Apr 2021 — Jan 2022 [monthly]

    Active Not Recruiting PHASE3

  3. Jan 2021 — Apr 2021 [monthly]

    Active Not Recruiting PHASE3

  4. Sep 2020 — Jan 2021 [monthly]

    Active Not Recruiting PHASE3

  5. May 2020 — Sep 2020 [monthly]

    Active Not Recruiting PHASE3

  6. Mar 2020 — May 2020 [monthly]

    Active Not Recruiting PHASE3

  7. Nov 2019 — Mar 2020 [monthly]

    Active Not Recruiting PHASE3

  8. Apr 2019 — Nov 2019 [monthly]

    Active Not Recruiting PHASE3

  9. Mar 2019 — Apr 2019 [monthly]

    Active Not Recruiting PHASE3

    Status: Completed → Active Not Recruiting

  10. Dec 2018 — Mar 2019 [monthly]

    Completed PHASE3

  11. Jun 2018 — Dec 2018 [monthly]

    Completed PHASE3

  12. Dec 2017 — Jun 2018 [monthly]

    Completed PHASE3

    Status: Recruiting → Completed

  13. Sep 2017 — Dec 2017 [monthly]

    Recruiting PHASE3

  14. Feb 2017 — Sep 2017 [monthly]

    Recruiting PHASE3

  15. Jan 2017 — Feb 2017 [monthly]

    Recruiting PHASE3

    First recorded

Dec 2010

Trial started

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

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • CEL-SCI Corporation
  • Orient Europharma Co., Ltd.
  • Teva Branded Pharmaceutical Products R&D, Inc.
Data source: CEL-SCI Corporation

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

Study Locations

Amravati, India , Ankara, Turkey (Türkiye) , Aurangabad, India , Banja Luka, Bosnia and Herzegovina , Barcelona, Spain , Belgrade, Serbia , Bialystok, Poland , Budapest, Hungary , Chang-hua, Taiwan , Charleston, United States and 74 more locations