The purpose of this study is to determine the safety and effectiveness of an experimental immunotherapy called TVI-Brain-1 for the treatment of newly diagnosed glioblastomas (a form of brain cancer) when combined with standard-of-care surgery, radiotherapy, and chemotherapy. Study procedures include collection and testing of cancer tissue samples after surgery and chemoradiation therapy (radiation and temozolomide). Patients will be randomly assigned to 1 of 2 groups: the standard-of-care treatment group or the TVI-Brain-1 group. Participants will have a 50% chance of being in the standard treatment alone or in the group receiving standard treatment and the study drug. After surgery, patients assigned to the TVI-Brain-1 group will receive vaccinations to induce an immune response to produce white blood cells. A sample of the patient’s white blood cells (T-cells) will be drawn and used to create an anti-cancer drug that is administered after the completion of radiotherapy and chemotherapy. Temozolomide is approved by the U.S. Food and Drug Administration (FDA) as a treatment for adult glioblastomas.
What is the full name of this clinical trial?
TVI-AST-008: RANDOMIZED PHASE 2B STUDY OF SAFETY AND EFFICACY OF TVI-BRAIN-1 COMBINED WITH CONFORMAL RADIOTHERAPY AND TEMOZOLOMIDE VERSUS STANDARD THERAPY IN NEWLY DIAGNOSED O6-METHYLGUANINE METHYLTRANSFERASE NEGATIVE GLIOBLASTOMA MULTIFORME