Phase 3 Study of Optune with Temozolomide and Pembrolizumab for Newly Diagnosed Glioblastoma

Inclusion Criteria

• Must be 18 years or older.
• Have a new diagnosis of glioblastoma, a type of brain cancer.
• Have recovered from surgery to remove as much of the tumor as possible.
• Have completed standard radiation and chemotherapy treatment.
• Be able to use the Optune device along with Temozolomide chemotherapy.
• Have a good overall health status, with minimal symptoms affecting daily activities.
• If taking steroids, the dose must be stable or decreasing.

Exclusion Criteria

• Have previously received certain types of immunotherapy treatments.
• Need more than 2 mg of the steroid dexamethasone daily due to brain swelling.
• Have had other cancer treatments or experimental drugs within the last 4 weeks.
• Have received a live vaccine within 30 days before starting the study treatment.
• Are currently in another clinical trial or have used an experimental device recently.
• Have an immune system deficiency or are on high-dose steroids or other immune-suppressing treatments.
• Have another active cancer that has needed treatment in the last 3 years.
• Have a history of lung disease that required steroids.
• Have early progression of the disease after initial treatment.
• Have certain types of brain or spinal cord disease.