An International, Randomized, Double-Blind, Controlled Study of Rindopepimut/GM-CSF with Adjuvant Temozolomide in Patients with Newly Diagnosed, Surgically Resected, EGFRvIII-positive Glioblastoma
What is the purpose of this trial?
The purpose of this research study is to find out whether adding treatment with rindopepimut (also known as CDX-110) to the commonly used chemotherapy drug called temozolomide helps to shrink brain tumors or prevents brain tumors from growing and helps patients with brain tumors live longer than treatment with temozolomide alone. Temozolomide is a standard treatment for glioblastoma and all patients in this study will be administered temozolomide according to routine practice. The study will also see how treatment affects your quality of life. Additional studies may be performed to see how your body’s immune system (the system your body uses to fight cancer, infections and “foreign bodies”) is reacting to the treatment. The study will also see what side effects there are when injections of rindopepimut are given along with the commonly used temozolomide chemotherapy. Patients assigned to receive temozolomide alone will be given Keyhole Limpet Hemocyanin (KLH) as a “placebo” injection. A placebo injection is a shot that is given without any expected therapeutic benefit. The purpose of the placebo is to disguise which treatment you are receiving from you and your doctor. KLH is one of the components (or parts) of the rindopepimut vaccine as well. This is a Phase 3 study. A phase 3 study is a study that is designed to confirm the results seen in earlier studies with the investigational agent. About half of the patients will receive rindopepimut and half will receive KLH. The study treatments will be blinded, which means that neither you nor your study doctor will know whether you are receiving rindopepimut or KLH. This kind of study is called a “randomized, double-blind, controlled study,” and it is the best way to determine the effect of rindopepimut on newly diagnosed glioblastoma. Rindopepimut is an investigational medication. An investigational medication is one that is not approved by the U.S. Food and Drug Administration (FDA) for use by the general public. Because this is a research study, rindopepimut will be given to you only during this study and not after the study is over.
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