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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00458601 | Phase II Study of Rindopepimut (CDX-110) in Patients With Glioblastoma Multiforme | PHASE2 | COMPLETED | 82 | — | — | Aug 1, 2007 | May 1, 2016 | Jan 16, 2018 | 34 | United States |
| Arm | Type | Description |
|---|---|---|
| CDX-110 with GM-CSF | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| CDX-110 with GM-CSF | DRUG | Three biweekly intradermal injections over four weeks followed by monthly injections until tumor progression. Each dose will be 0.8 mL containing approximately 500 mcg CDX-110 and 150 mcg GM CSF. |
| Temozolomide | DRUG | Maintenance temozolomide will begin after completion of the three initial injections of CDX-110 plus GM-CSF. 150 to 200 mg/m2 for 5 days during each 28-day cycle for a minimum of six cycles or a maximum of 12 cycles, intolerance or progression. |
Inclusion Criteria: * Newly diagnosed de novo GBM with documented EGFRvIII expression in tumor tissue. * Gross total resection followed by conventional chemoradiation therapy without progression of disease. Exclusion Criteria: * Presence of diffuse leptomeningeal disease or gliomatosis cerebri. *...