Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02609386 | IRX-2 Regimen in Patients With Newly Diagnosed Stage II, III, or IVA Squamous Cell Carcinoma of the Oral Cavity | PHASE2 | COMPLETED | 105 | — | — | Jan 11, 2016 | Feb 28, 2022 | Jan 30, 2024 | 22 | United States, Brazil +2 |
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.
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.
| Arm | Type | Description |
|---|---|---|
| Regimen 1 | EXPERIMENTAL | IRX Regimen with IRX-2, cyclophosphamide, indomethacin, zinc-containing multivitamin, and omeprazole as neoadjuvant and adjuvant therapy. |
| Regimen 2 | ACTIVE_COMPARATOR | Regimen 1 but without IRX-2 |
| Name | Type | Description |
|---|---|---|
| IRX-2 | BIOLOGICAL | Method of Administration: Administered for 10 days as subcutaneous bilateral injections in the upper neck. |
| Cyclophosphamide | DRUG | Method of Administration: Cyclophosphamide is administered once by IV |
| Indomethacin | DRUG | Method of Administration: Indomethacin is administered orally for 21 days. |
| Zinc-containing multivitamin | DIETARY_SUPPLEMENT | Method of Administration: Zinc-containing multivitamin is administered orally for 21 days. |
| Omeprazole | DRUG | Method of Administration: Omeprazole is administered orally for 21 days |
Inclusion Criteria: 1. Pathologically confirmed (histology or cytology) clinical Stage II, III, or IVA squamous cell cancer of the oral cavity (excluding lip). Subjects must be staged using AJCC Cancer Staging Manual Edition 7.0 (appendices 1 and 2). 2. Disease surgically resectable with curative i...