This is a clinical trial for adults under the age of 70 years of age, who have been diagnosed with a brain tumor called a glioblastoma (GBM).
   
The purpose of this study is to see how safe the study drug IGV-001 is when given with standard of care therapy and to see if it works in slowing glioblastoma tumor regrowth. Additionally, the study will compare how well IGV-001 + SOC therapy works compared to a placebo + standard of care therapy.   

IGV-001 is a personalized, cell-based, whole tumor immunotherapeutic product that is made using a participant's own GBM tumor cells collected during brain surgery. GBM tumor cells are combined with IMV-001, a genetic material that works against a protein that is involved in the creation of glioblastomas. The mixture is then put inside biodiffusion chambers, which are dime-sized containers that are inserted into the belly area for approximately 48 hours. While the biodiffusion chambers are inside the body, it is believed that the body will react by creating special fighter cells (cancer antigen presentation cells, dendritic cells and T-cells) to attack the GBM tumor cells. This is called an immune response. It is believed that the body will “remember” the GBM tumor cells and know how to fight them if more tumor cells are identified inside the body. 

IGV-001 is considered investigational which means it has not yet been approved by the United States Food and Drug Administration (FDA). The combination of IGV-001 with standard of care therapy is also not approved by the FDA and is considered investigational.

The standard of care therapy that will be given to all participants during the study will be a combination of radiation therapy (also called radiotherapy) and temozolomide. Radiotherapy involves using a machine to aim beams of powerful energy at specific parts of human body to kill cancer cells. Temozolomide is a medicine taken by mouth and is approved by the FDA for the treatment of brain cancer.

Participants will be randomly assigned by chance, like rolling a pair of dice, to receive either IGV-001 or placebo that will be placed into biodiffusion chambers and surgically implanted in their belly for approximately 48 hours and then removed. A placebo looks like the study medicine but does not contain any medication or active ingredients. Neither participants nor the study doctor will know to which of these study medicine groups they are assigned. 

Participants will be in the study for approximately 3 years with around 9 months of active participation and then a follow-up period.