Clinical trial · Interventional
Efficacy and Safety Study of Leukocyte Interleukin,Injection (LI) to Treat Cancer of the Oral Cavity
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
NCT01265849CI-TRIAL-00060438IT-MATTERScompletedPhase 3Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this study was to determine whether LI administered in combination with cyclophosphamide, indomethacin and zinc in a multivitamin (CIZ) combination prior to standard of care therapy (surgery followed by radiotherapy or concurrent radiochemotherapy) is safe and will increase the overall survival of subjects with previously untreated locally advanced primary squamous cell carcinoma of the oral cavity or soft palate at a median of 3 to 5 years
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Squamous Cell Carcinoma of the Oral Cavity | Oral Cavity Squamous Cell Carcinoma | ALIAS | 0.90 |
| Squamous Cell Carcinoma of the Soft Palate | Soft Palate Squamous Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (7)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cisplatin | Drug | Cisplatin | ALIAS |
| Cyclophosphamide | Drug | Cyclophosphamide | ALIAS |
| Indomethacin | Drug | — | UNRESOLVED |
| LI | Biological | — | UNRESOLVED |
| Radiotherapy | Radiation | — | UNRESOLVED |
| Surgery | Procedure | — | UNRESOLVED |
| Zinc | Dietary Supplement | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- LI + CIZ + SOC
- description
- LI plus CIZ (cyclophosphamide, indomethacin and zinc-multivitamins) was given as neoadjuvant therapy prior to standard of care (SOC).
- interventionNames
- Biological: LI
- Drug: Cyclophosphamide
- Drug: Indomethacin
- Dietary Supplement: Zinc
- Procedure: Surgery
- Drug: Cisplatin
- Radiation: Radiotherapy
- type
- ACTIVE_COMPARATOR
- label
- Standard of Care (SOC) only
- description
- SOC for previously untreated SCCHN patients is currently surgery (with curative intent) followed by either radiotherapy or combined radiochemotherapy depending on the patient's risk status for recurrence as determined at surgery.
- interventionNames
- Procedure: Surgery
- Drug: Cisplatin
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria (main): * Untreated SCCHN of oral cavity (anterior tongue, floor of mouth, cheek)/soft palate, categories T1N1-2M0,T2N1-2M0,T3N0-2M0,T4N0-2M0 (T4 allowed only if invasion of mandible is negligible i. e. 5mm or less) scheduled for SOC * Primary tumor and any positive node(s) measurable in 2 dimensions * Normal immune function * No immunosuppressives with 1 year of entry * KPS\>70/100 * Age\>18 * Male or Female (non-pregnant) * Life expectancy \>6 months * Able to take oral medication * Able to provide informed consent Exclusion Criteria (main): * Subjects to be treated with other than SOC * Tumor invasion of bone (also see inclusion criteria) * Tumor classifications T1N0, T2N0, T4N3, any TN classification with M1 * Tumors in locations other than those specified in inclusion criteria * Active peptic ulcer (or on full-dose therapeutic anti-coagulants) * Prior resection of jugular nodes ipsilateral to tumor * Acute or chronic viral, bacterial immune or other disease associated with abnormal immune function * Subjects on hemodialysis or peritoneal dialysis; or having a history of * History of asthma, allergy to fluoroquinolone antibiotics, congestive heart failure, or on hemodialysis or peritoneal dialysis * Any condition that in the opinion of the investigator would cause the subject to be unable to participate or tolerate the protocol regimen * Failure to meet inclusion criteria
References
Publications (2)
- DERIVEDTalor E, Lavin P, Cipriano J, Markovic D, Ladanyi A, Timar J; IT-MATTERS Investigators. A novel neoadjuvant immunotherapy confers improved overall survival in oral cancer patients with low tumor PD-L1 expression The IT-MATTERS Clinical trial - Prognostic role of tumor PD-L1 expression. Oral Oncol. 2026 Jul 31;181:108092. doi: 10.1016/j.oraloncology.2026.108092. Online ahead of print. PMID 42537452
- DERIVEDTalor E, Timar J, Lavin P, Cipriano J, Markovic D, Ladanyi A, Karpenko A, Bondarenko I, Stosic S, Sobat H, Zhukavets A, Imamovic N, Chien CY, Bankowska-Wozniak M, Kisely M, Jovic R, Young JEM, Hao SP. Neoadjuvant leukocyte interleukin injection immunotherapy improves overall survival in low-risk locally advanced head and neck squamous cell carcinoma -the IT-MATTERS study. Pathol Oncol Res. 2025 Mar 21;31:1612084. doi: 10.3389/pore.2025.1612084. eCollection 2025. PMID 40191245