Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
CDX-110 with GM-CSF · 1 trial · 1 indication
| 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. *...
CDX-110 with GM-CSF is used for the treatment of malignant glioma, a type of brain tumor. It is an investigational therapy being studied in patients with glioblastoma multiforme, the most aggressive form of malignant glioma. The drug is administered to stimulate an immune response against the tumor.
CDX-110 with GM-CSF targets the epidermal growth factor receptor variant III (EGFRvIII), a tumor-specific mutation found in a subset of glioblastoma patients. The drug is a peptide vaccine designed to elicit an immune response against cancer cells expressing this mutation, while GM-CSF serves as an adjuvant to boost the immune response.
CDX-110 with GM-CSF is being developed by Celldex Therapeutics, Inc., a biopharmaceutical company traded on NASDAQ under the ticker symbol CLDX. The company is focused on developing targeted immunotherapies for cancer and other diseases.
CDX-110 with GM-CSF is in Phase 2 clinical development. It has completed a Phase 2 study in patients with glioblastoma multiforme, and it remains an investigational drug that has not been approved by regulatory authorities. Further clinical development would be required before any potential approval.
CDX-110 with GM-CSF has been studied in one completed Phase 2 clinical trial, identified by the National Clinical Trial number NCT00458601. This trial, titled 'Phase II Study of Rindopepimut (CDX-110) in Patients With Glioblastoma Multiforme,' enrolled 82 participants in the United States and was completed.
Yes, CDX-110 with GM-CSF is also known as Rindopepimut. The clinical trial NCT00458601 refers to the drug as Rindopepimut (CDX-110), confirming that these names refer to the same investigational therapy being developed by Celldex Therapeutics for malignant glioma.