Phase III Study of Rindopepimut/GM-CSF in Patients With Newly Diagnosed Glioblastoma
Status:
Completed
Trial end date:
2016-11-01
Target enrollment:
Participant gender:
Summary
This 2-arm, randomized, phase III study will investigate the efficacy and safety of the
addition of rindopepimut (an experimental cancer vaccine that may act to promote anti-cancer
effects in patients who have tumors that express the EGFRvIII protein) to the current
standard of care (temozolomide) in patients with recently diagnosed glioblastoma, a type of
brain cancer.
All patients will be administered temozolomide, the standard treatment for glioblastoma. Half
the patients will be randomly assigned to receive rindopepimut and half the patients will be
randomly assigned to receive a control called keyhole limpet hemocyanin.
Patients will be treated in a blinded fashion (neither the patient or the doctor will know
which arm of the study the patient is on). Patients will be treated until disease progression
or intolerance to therapy and all patients will be followed for survival.