Phase 3 Study of Optune Concomitant With Temozolomide Plus Pembrolizumab in Newly Diagnosed Glioblastoma (EF-41)

This study is looking at new treatment options for people with newly diagnosed Glioblastoma after they have already completed initial therapy such as surgery and radiation. All participants will continue standard maintenance treatment with the chemotherapy drug temozolomide and use the Optune device, which is worn on the scalp and delivers electrical fields to help slow tumor growth. Patients will then be randomly assigned to receive either the immunotherapy drug Pembrolizumab or a placebo. The study will compare these two groups to see if adding immunotherapy can help improve outcomes.

• Adults 18+ years of age
• Newly diagnosed Glioblastoma who have completed initial standard treatment, including surgery and radiation with temozolomide, and are eligible to start maintenance therapy
• Confirmed diagnosis based on tumor tissue
• Adequate recovery from prior treatment-related side effects
• Stable or acceptable blood, liver, and kidney function
• Must be able to use the Optune device as part of their treatment plan and be well enough to carry out daily activities with minimal assistance

• Receiving maintenance therapy with temozolomide and the Optune device, plus either the immunotherapy drug Pembrolizumab or a placebo
• Attending regular clinic visits, magnetic resonance imaging (MRI) scans, and safety checks to monitor treatment response and side effects.