A Study of Rindopepimut/GM-CSF in Patients With Relapsed EGFRvIII-Positive Glioblastoma

Inclusion Criteria

• •Among other criteria, patients must meet the following conditions to be eligible for the study:
• •1. Age ≥18 years of age.
• •2. Histologic diagnosis of glioblastoma (WHO Grade IV).
• •3. Documented EGFRvlll positive tumor status (central lab confirmation).
• •4. First or second relapse of de novo glioblastoma or first diagnosis or first relapse of secondary glioblastoma.
• •5. Previous treatment must include surgery, conventional radiation therapy and temozolomide (TMZ).
• •6. Screening MRI must be obtained at least 4 weeks after any salvage surgery, and at least 12 weeks after radiation therapy.
• •7. KPS of ≥ 70%.
• •8. If applicable, systemic corticosteroid therapy must be at a dose of ≤ 4 mg of dexamethasone or equivalent per day during the week prior to Day 1.
• •9. Evaluable disease in Groups 1 and 2; measurable disease in Group 2C
• •10. Life expectancy \> 12 weeks.
• •11. Patients in Group 2 and 2C must have had disease progression while receiving bevacizumab or within 2 months of treatment with bevacizumab.