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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02241369 | Immunotherapy in Subjects With HPV-6 Associated Aerodigestive Precancerous Lesions and Malignancies | PHASE1 | COMPLETED | 3 | — | — | May 1, 2014 | Sep 1, 2018 | Nov 16, 2018 | 1 | United States |
| Arm | Type | Description |
|---|---|---|
| Cohort I | EXPERIMENTAL | 3 mg of INO-3106 (D0); 6 mg of INO-3106 (Wk3); 6 mg of INO-3106 + 1 mg of INO-9012 (Wk6); 6 mg of INO-3106 + 1 mg of INO-9012 (Wk9); |
| Cohort II | EXPERIMENTAL | 6 mg of INO-3106 in combination with 1 mg of INO-9012, or at the MTD determined above at D0, Wk3, Wk6, Wk9 |
| Name | Type | Description |
|---|---|---|
| INO-3106, INO-9012 | BIOLOGICAL | - |
Inclusion Criteria: * Signed and dated written Ethics Committee approved informed consent * Age ≥18 years * Histologically documented HPV-6 positive aerodigestive invasive malignancy (mucosal squamous cell head and neck cancer or lung cancer) who have completed therapies such as radiation/chemoradi...