EF-41/KEYNOTE D58: Phase 3 Study of Optune Concomitant With Temozolomide Plus Pembrolizumab in Newly Diagnosed Glioblastoma

To be considered for this study, you need to be at least 18 years old and have been recently diagnosed with glioblastoma. You must have had surgery for your glioblastoma and completed your standard radiotherapy and chemotherapy (with temozolomide).

It's important that you are generally well enough to take part, meaning you can look after yourself and do most daily activities. You also need to be able to use the Optune device and continue with temozolomide chemotherapy. If you are taking steroids, their dose should be stable or reducing.

There are also some reasons why you might not be able to join. For example, if you've already had certain types of immunotherapy drugs, or if you require high doses of steroids because of swelling in your brain. You also can't have had other experimental treatments recently, or received certain vaccines within the last month.

Taking part in this study means you would be randomly assigned to one of two treatment groups, like flipping a coin. You'd receive either the study drug (pembrolizumab) or a dummy drug (placebo), along with the Optune device and temozolomide chemotherapy. You and your doctors won't know which one you are receiving. Participation involves regular visits for health checks, blood tests, and scans to monitor your condition and the effects of the treatment. The total duration of your participation, including follow-up, would be discussed in detail by the study team, but typically these types of studies involve ongoing treatment and monitoring for a significant period. You are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.