Study Comparing Niraparib and Temozolomide for Newly Diagnosed Glioblastoma Patients

Inclusion Criteria

• Must have a confirmed diagnosis of newly diagnosed glioblastoma based on specific medical guidelines.
• Be 18 years or older.
• Have enough tumor tissue available for further analysis.
• Have a specific genetic marker (unmethylated MGMT) determined by a local test.
• Be suitable for standard radiation therapy as judged by the doctor.
• Have not received any prior treatment for glioblastoma, except for surgery or biopsy.
• Female participants must not be pregnant or breastfeeding and must use effective birth control if of childbearing potential.
• Male participants must agree to use birth control and not donate sperm during the study and for 90 days after.
• Be able to provide informed consent and follow study requirements.
• Have a performance status score of 70 or higher, indicating the ability to care for oneself.
• Have adequate organ function and controlled blood pressure.
• Be on a stable or reduced dose of dexamethasone, a steroid medication.
• Be able to swallow pills.

Exclusion Criteria

• Have cancer that has spread to other parts of the body or the brain's lining.
• Have a history of lung inflammation requiring treatment.
• Have a high risk of bleeding due to recent major injuries or surgery.
• Have significant digestive issues affecting medication absorption.
• Have severe liver disease or unstable liver conditions.
• Have HIV unless under control with treatment.
• Have a history of certain blood disorders or other cancers within the last 2 years, except for specific non-threatening types.
• Have a history of certain brain conditions.
• Have any condition that may interfere with study participation.
• Be unable to undergo MRI scans with contrast.
• Have had surgery more than 6 weeks before starting radiation therapy.
• Have unresolved surgical wound issues.
• Have allergies to study drugs or their components.
• Have used PARP inhibitors for cancer treatment before.
• Have received a live vaccine within 30 days before starting the study.
• Have had recent blood transfusions or growth factor treatments.
• Be participating in another clinical trial or using investigational drugs.
• Have used tumor treating fields for glioblastoma.
• Have certain genetic mutations (IDH or H3 mutations).
• Have a previous diagnosis of lower-grade glioma.