protocolSection identificationModule nctId: NCT06388733, orgStudyIdInfo id: IVY P3-24-021, briefTitle: A Study Comparing Niraparib With Temozolomide in Adult Participants With Newly-diagnosed, MGMT Unmethylated Glioblastoma, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06, primaryCompletionDateStruct date: 2027-12, completionDateStruct date: 2028-03, studyFirstPostDateStruct date: 2024-04-29, lastUpdatePostDateStruct date: 2024-04-29, sponsorCollaboratorsModule leadSponsor name: Ivy Brain Tumor Center, class: OTHER, collaborators name: GlaxoSmithKline, descriptionModule briefSummary: The goal of this Phase 3 clinical trial is to compare the efficacy of niraparib versus temozolomide (TMZ) in adult participants with newly-diagnosed, MGMT unmethylated glioblastoma multiforme (GBM). The main questions it aims to answer are:Does niraparib improve progression-free survival (PFS) compared to TMZ?Does niraparib improve overall survival (OS) compared to TMZ?Participants will be randomly assigned to one of two treatment arms: niraparib or TMZ.* study drug (Niraparib) or* comparator drug (Temozolomide - which is the standard approved treatment for MGMT unmethylated glioblastoma).The study medication will be taken daily while receiving standard of care radiation therapy (RT) for 6-7 weeks.Participants may continue to take the niraparib or TMZ adjuvantly as long as the cancer does not get worse or completion of 6 cycles of treatment (TMZ). A total of 450 participants will be enrolled in the study.Participants' tasks will include:* Complete study visits as scheduled* Complete a diary to record study medication, conditionsModule conditions: Glioblastoma, conditions: GBM, conditions: Brain Neoplasms, Adult, Malignant, conditions: Brain Tumor, designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, maskingDescription: Blinded Independent Central Review is composed of independent radiologists and will be utilized to assess progression of disease, enrollmentInfo count: 450, type: ESTIMATED, armsInterventionsModule interventions name: Niraparib, interventions name: Temozolomide, outcomesModule primaryOutcomes measure: Progression-free survival (PFS) assessed by Blinded Independent Central Review (BICR), primaryOutcomes measure: Overall survival, secondaryOutcomes measure: Overall response rate, secondaryOutcomes measure: Compare symptoms, function, and Health-related quality of life (HRQoL) and symptoms by EORTC QLQ-C30-item Core module (EORTC QLQ-C30) (Scores on a scale), secondaryOutcomes measure: Compare symptoms, function, and Health-related quality of life (HRQoL) and symptoms by EORTC QLQ-BN20-item Core module (EORTC QLQ-BN20) (Scores on a scale), secondaryOutcomes measure: Changes from baseline in neurocognitive function assessed by Hopkins Verbal Learning Test, secondaryOutcomes measure: Changes from baseline in neurocognitive function assessed by Controlled Oral Word Association, secondaryOutcomes measure: Changes from baseline in neurocognitive function assessed by Trail Making Test Parts A and B, secondaryOutcomes measure: Number of participants with adverse events (AEs), serious adverse events (SAEs) and adverse events of special interest (AESIs), secondaryOutcomes measure: Number of treatment discontinuations, dose interruptions, and dose reductions due to AEs, SAEs, or AESIs, changes in Karnofsky performance status, changes in clinical laboratory results, and vital sign measurements, secondaryOutcomes measure: Frequency and severity of symptomatic AEs based on PRO-CTCAE, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False