An International, Randomized, Double-Blind, Controlled Study of Rindopepimut/GM-CSF with Adjuvant Temozolomide in Patients with Newly Diagnosed, Surgically Resected, EGFRvIII-positive Glioblastoma (The ACT IV Study)
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
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.
View more details from ClinicalTrials.gov.
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