Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
IRX-2 · 2 trials · 2 indications
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.
The frequency of all Adverse Events (greater than 5%) is reported. All Serious Adverse Events were described.
| 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 |
| IRX-2 Regimen | EXPERIMENTAL | The IRX-2 regimen is the combination of a 2-week course of IRX-2 itself, an initial dose of cyclophosphamide, and a 3-week course of indomethacin, zinc supplementation, and omeprazole. |
| 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 |
| Zinc | DRUG | 21 days of zinc gluconate (65 mg) as part of an oral multivitamin |
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...