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Rindopepimut with GM-CSF · 2 trials · 7 indications
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...
Rindopepimut with GM-CSF is an investigational therapeutic vaccine being developed for glioblastoma, an aggressive form of brain cancer. It combines rindopepimut, a vaccine antigen, with GM-CSF as an immune stimulant. The regimen is designed to target tumor cells expressing the EGFRvIII mutation. It is not yet approved for any indication.
Rindopepimut with GM-CSF is being studied for the treatment of glioblastoma, including newly diagnosed and relapsed cases. Clinical trials have enrolled patients with EGFRvIII-positive glioblastoma and related subtypes such as gliosarcoma and giant cell glioblastoma. It remains an investigational therapy and is not approved for clinical use.
Rindopepimut with GM-CSF targets EGFR, specifically the EGFRvIII mutant form of the epidermal growth factor receptor. Rindopepimut is a vaccine antigen that directs an immune response against EGFRvIII-expressing tumor cells, while GM-CSF is included as an immune adjuvant to enhance that response.
Rindopepimut with GM-CSF is being developed by Celldex Therapeutics, Inc., which trades on the Nasdaq under the ticker CLDX. The company has sponsored the clinical trials evaluating this vaccine regimen in glioblastoma.
Rindopepimut with GM-CSF has been evaluated in Phase 3 clinical development. The Phase 3 trial, along with a Phase 2 trial, has been completed. The drug is investigational and has not been approved by the FDA for any indication.
Rindopepimut with GM-CSF has been studied in two completed clinical trials. NCT01480479 was a Phase 3 study in newly diagnosed glioblastoma with 745 patients. NCT01498328 was a Phase 2 study in relapsed EGFRvIII-positive glioblastoma with 127 patients. Both trials are completed and no trials are currently active.