Glioblastoma study ACT IV Study

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 quality of life. Additional studies may be performed to see how the body’s immune system (the system the 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 “control” injection. A control injection is a shot that is given without any expected therapeutic benefit. The purpose of the control 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. Study Contacts:

Dr. Shakeeb Yunus (Principal Investigator) (508) 334-45539

Kathryn Clark (Senior Research Nurse) (774) 823-4465

Meera Sreedhara (Clinical Research Coordinator) (508) 856-2023