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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 (IT-MATTERS)
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
Details
| Lead sponsor | CEL-SCI Corporation |
|---|---|
| Phase | Phase 3 |
| Status | COMPLETED |
| Enrolment | 928 |
| Start date | 2010-12 |
| Completion | 2020-12-04 |
Conditions
- Squamous Cell Carcinoma of the Oral Cavity
- Squamous Cell Carcinoma of the Soft Palate
Interventions
- LI
- Cyclophosphamide
- Indomethacin
- Zinc
- Surgery
- Cisplatin
- Radiotherapy
Primary outcomes
- Overall Survival (OS) — From the date of treatment assignment to death or the last follow-up date. Maximum follow-up was approximately 113 months.
OS was assessed using Kaplan-Meier life-table using a log rank test and confirmed further with tumor stage, tumor location, and geographic stratified log rank test. Both Stratified and unstratified log rank test are presented with the unstratified log rank test constituting the primary analysis. A two-sided p-value of 0.05 or less was considered statistically significant for comparing the two groups (i.e., Study comparator arms: LI+CIZ+SOC vs. SOC alone). Interim analyses were performed (by the iDMC) periodically throughout the study to assess safety, sample size and futility. - OS in Low Risk Subjects — From the date of treatment assignment to death or the last follow-up date. Maximum follow-up was approximately 113 months.
OS was assessed using Kaplan-Meier life-table using a log rank test and confirmed further with tumor stage, tumor location, and geographic stratified log rank test. Both Stratified and unstratified log rank test are presented with the unstratified log rank test constituting the primary analysis. A two-sided p-value of 0.05 or less was considered statistically significant for comparing the two groups (i.e., Study comparator arms: LI+CIZ+SOC vs. SOC alone). Low-risk assessment and data analysis was never performed during the study and was done only after database lock.
Countries
United States, Austria, Belarus, Bosnia and Herzegovina, Canada, Croatia, France, Hungary, India, Israel, Italy, Malaysia, Poland, Romania, Russia, Serbia, Spain, Sri Lanka, Taiwan, Thailand, Turkey (Türkiye), Ukraine, United Kingdom