Summary:
Diagnosed with Glioblastoma? Learn more about the ACT IV study.
About the study
The ACT IV study is a Phase III study to investigate the effect rindopepimut has on the survival rate, time to disease progression, and quality of life of patients with newly diagnosed glioblastoma.
Only people whose tumors test positive for a particular mutation called Epidermal Growth Factor Receptor variant III (EGFRvIII) can participate. The EGFRvIII mutation is present in approximately one-third of glioblastomas and appears to promote the growth of glioblastoma tumor cells.
Approximately 440 people are expected to participate in the study, which is being conducted at nearly 200 locations around the world.
What are the study medications?
Patients will be randomly assigned to receive either vaccination with rindopepimut plus standard temozolomide chemotherapy or a “control” injection of KLH plus standard temozolomide chemotherapy. ACT IV is “double-blind” study, meaning neither study participants nor the study doctor know whether participants are receiving rindopepimut or the control injection. About one-half of the patients will be assigned to receive each regimen.
Rindopepimut is an investigational cancer vaccine being developed to treat EGFRvIII-positive glioblastoma. Investigational means that it is not yet approved by regulatory authorities (e.g., the FDA in the United States; Health Canada in Canada) for use by the general public. Rindopepimut is designed to activate and “train” the immune system to recognize the EGFRvIII mutation and kill the cancer cells. Rindopepimut is given with a low dose of GM-CSF (Leukine®, sargramostim), a man-made version of a substance naturally produced by your body that activates the immune system.
Keyhole Limpet Hemocyanin (KLH) is the control injection for patients assigned to receive standard temozolomide without the investigational vaccine.
Temozolomide is the standard chemotherapy drug used to treat brain cancer. All ACT IV study participants will receive temozolomide as part of their treatment.
What will happen during the study?
Participation in the ACT IV study is expected to last for up to five years but could be longer. The study has three phases:
Screening — For potential study participants, tumor tissue saved from their prior surgery will be shipped to a laboratory to see if it contains the EGFRvIII mutation. Other tests and procedures, including blood tests, physical examinations, vital signs, and brain MRIs, will be performed to determine if the participant can be in the study. Potential participants may be receiving chemotherapy and radiation while being evaluated for the study.
Treatment Phase — There are two possible treatment regimens (injections of rindopepimut plus the standard treatment temozolomide or injections of KLH control plus the standard treatment temozolomide). Eligible participants will have an equal chance of receiving either treatment regimen. Neither the patient nor the doctor will know which treatment the patient is receiving. Throughout the study treatment phase, study visits will occur twice per month, and the tests and procedures described above will be routinely repeated. Participants will be closely monitored by the study doctor and staff.
Post-treatment Follow up — Participants will be contacted every three months to assess their health and to see what additional treatments are being used to treat their glioblastoma.
Who can participate?
You may be eligible for ACT IV if you:
- Are 18 years of age or older
- Have newly diagnosed glioblastoma
- Had or are scheduled to have surgery to remove the tumor
- Had or are scheduled to have post-surgery standard radiation and chemotherapy with temozolomide, without growth of the tumor during this time
- Have not received other treatments for glioblastoma
All participants must be enrolled into the study within 2 weeks of completing standard of care chemoradiation therapy. Therefore, it is important to complete the pre-study evaluations prior to finishing chemoradiation.
There are other eligibility criteria that the study doctor will review with you.
Where is the study taking place?
Click here for an updated list of study locations.