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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01480479 | Phase III Study of Rindopepimut/GM-CSF in Patients With Newly Diagnosed Glioblastoma | PHASE3 | COMPLETED | 745 | — | — | Nov 1, 2011 | Nov 1, 2016 | Jan 16, 2018 | 223 | United States, Australia +22 |
| NCT01498328 | A Study of Rindopepimut/GM-CSF in Patients With Relapsed EGFRvIII-Positive Glioblastoma | PHASE2 | COMPLETED | 127 | — | — | Dec 1, 2011 | May 17, 2016 | Feb 17, 2020 | 45 | United States |
The primary efficacy endpoint of Overall Survival is defined as the number of months from randomization to the date of death (whatever the cause), and will be censored for patients who remain alive at completion of the study for patients with a gross total resection (\~n=374). The overall survival of patients will be monitored and compared between the two study arms until the end of the study.
Evaluate the antitumor activity of rindopepimut in adult patients with relapsed glioblastoma, as measured by the progression-free survival rate at 6 months post-Day 1 (PFS 6).
Evaluate the anti-tumor activity of rindopepimut in adult patients with relapsed glioblastoma, as measured by the objective response rate (ORR) for patients with measurable disease at study entry.
| Arm | Type | Description |
|---|---|---|
| Rindopepimut/GM-CSF plus Temozolomide | EXPERIMENTAL | - |
| KLH plus Temozolomide | ACTIVE_COMPARATOR | - |
| Group 1a: Bevacizumab Naïve with Bevacizumab + rindopepimut. | EXPERIMENTAL | About half of the patients who have never received treatment with bevacizumab will receive rindopepimut/GM-CSF in a blinded fashion in combination with bevacizumab. |
| Group 1b: Bevacizumab Naïve with Bevacizumab + KLH control | EXPERIMENTAL | About half of the patients who have never received treatment with bevacizumab will receive KLH in a blinded fashion in combination with bevacizumab. |
| Group 2 and 2C: Refractory to Bevacizumab | EXPERIMENTAL | Patients with progressive disease while currently on or within two months after discontinuing bevacizumab will be administered rindopepimut/GM-CSF while continuing (or restarting if they had stopped bevacizumab). |
| Name | Type | Description |
|---|---|---|
| Rindopepimut (CDX-110) with GM-CSF | DRUG | Two intradermal injections two weeks apart, followed by monthly injections until tumor progression or intolerance. Each dose will be 0.8 mL containing approximately 500 mcg CDX-110 and 150 mcg GM CSF. |
| Temozolomide | DRUG | 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, or until intolerance or progression. |
| KLH | DRUG | Two intradermal injections two weeks apart, followed by monthly injections until tumor progression or intolerance. Each dose will be 0.8mL containing approximately 100mcg of KLH. |
| Bevacizumab | DRUG | A vascular endothelial growth factor (VEGF)-specific humanized monoclonal antibody angiogenesis inhibitor. Infusions of 10 mg/kg of bevacizumab will begin on day 1 and will be administered every two weeks until progression of disease or intolerance during the treatment period. |
Inclusion Criteria- Among other criteria, patients must meet the following conditions to be eligible for the study: 1. Adult patients, ≥ 18 years old 2. Newly diagnosed glioblastoma 3. Attempted surgical resection followed by conventional chemoradiation 4. Documented EGFRvIII positive tumor status...