A Study Comparing Niraparib With Temozolomide in Adult Participants With Newly-diagnosed, MGMT Unmethylated Glioblastoma

This study is for adults, aged 18 or older, who have been recently diagnosed with a specific type of brain tumour called glioblastoma. Importantly, your tumour must have a particular characteristic known as 'MGMT unmethylated'. This is something your doctor can test for.

To join, you must be well enough for standard radiotherapy, and you shouldn't have had any other treatment for glioblastoma before your surgery or biopsy. Doctors will also need enough of your tumour tissue to be checked by experts.

For women, you cannot be pregnant, planning to become pregnant, or breastfeeding during the study. If you could become pregnant, you'll need to use very effective contraception. For men, you’ll need to agree not to donate sperm and either avoid sexual activity or use a condom with effective contraception for your partner during and after the study.

If you decide to take part, you'll be randomly assigned to one of two groups: one will receive niraparib, and the other will receive temozolomide. It's like flipping a coin – neither you nor the doctors choose which group you're in. Both medications are taken daily, usually as pills, at the same time as you receive your standard radiotherapy, which typically lasts 6 to 7 weeks.

After radiotherapy, you might continue taking the study medication for several months, or until the doctors decide the cancer is getting worse, or you complete six cycles if you are on temozolomide. You'll have regular hospital visits for check-ups and to see how you're responding to the treatment. You'll also need to keep a simple daily diary to record when you take your medication. The study will involve around 450 people in total.