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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01280552 | A Study of ICT-107 Immunotherapy in Glioblastoma Multiforme (GBM) | PHASE2 | COMPLETED | 124 | — | — | Jan 1, 2011 | Dec 1, 2015 | Mar 20, 2017 | 25 | United States |
The objective is to compare overall survival (OS) in patients when treated with ICT 107 versus Control. OS defined as the time from randomization until date of death or the last date patient known alive (if death is not observed) All randomized patients are included in Intent to Treat analysis
Overall survival in a predefined subpopulation. All randomized patients are included in intent to treat analysis.
| Arm | Type | Description |
|---|---|---|
| ICT-107 | EXPERIMENTAL | Autologous dendritic cells pulsed with immunogenic peptides from tumor antigens |
| Control | PLACEBO_COMPARATOR | Autologous dendritic cells that have not been pulsed with antigens |
| Name | Type | Description |
|---|---|---|
| ICT-107 | BIOLOGICAL | Autologous dendritic cells pulsed with immunogenic antigens |
| Placebo DC | BIOLOGICAL | Autologous dendritic cells (DC) that have not been pulsed with antigens |
Inclusion Criteria: 1. Confirmed, initial diagnosis of GBM. Patients must be newly diagnosed with GBM and not yet received chemoradiation. 2. ≥ 18 years of age 3. HLA-A1 or HLA-A2 positive 4. KPS score of ≥ 70% 5. Baseline hematologic studies and chemistry profiles must meet the following criteria:...