Rindopepimut, is an immunotherapy that targets the tumor specific oncogene called EGFRvIII, an activated mutation of the epidermal growth factor receptor (EGFR), a protein that has been well validated as a target for cancer therapy. This 2-arm, randomized, Phase 3 study will investigate the efficacy and safety of the addition of rindopepimut to the current standard of care, temozolomide, in patients with recently diagnosed EGFRvIII positive glioblastoma. All patients will be administered temozolomide. Patients will be randomly assigned to receive rindopepimut (given along with GM-CSF as a vaccine adjuvant) and half the patients will be randomly assigned to receive a keyhole limpet hemocyanin (KLH). Patients will be treated until disease progression or intolerance to therapy and all patients will be followed for survival.
The formal name of this study is Phase III Study of Rindopepimut/GM-CSF in Patients With Newly Diagnosed Glioblastoma.
- Adult patients, ≥ 18 years old
- At least partial surgical resection followed by conventional chemoradiation
- EGFRvIII positive tumor documented by a central Celldex-designated laboratory
- No evidence of progressive disease from the post-operative period to the post-chemoradiation period
- Systemic corticosteroid therapy at ≤2 mg of dexamethasone or equivalent per day for at least 3 days prior to randomization
WHO-ECOG Performance Status ≤ 2