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 question it aims to answer is: 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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
450
Participants will receive niraparib 200 mg orally once daily starting on Day 1 of RT. Following completion of RT, participants will continue niraparib adjuvant therapy orally once daily on Days 1 to 28 of each 28-day cycle until progression by BICR
Participants randomized to the comparator arm (Arm B) will receive SOC TMZ 75 mg/m2 orally once daily with RT starting on Day 1 of RT. Following completion of RT, participants will complete a 4-week rest period, and then receive adjuvant TMZ 150 to 200 mg/m2 orally once daily on Days 1 to 5 of each 28-day cycle until progression by BICR or for a maximum of 6 cycles.
University of Alabama at Birmingham
Birmingham, Alabama, United States
RECRUITINGIvy Brain Tumor Center
Phoenix, Arizona, United States
RECRUITINGScripps Cancer Center
La Jolla, California, United States
RECRUITINGMoores UCSD Cancer Center
La Jolla, California, United States
Overall survival
Overall survival, defined as the time from the date of randomization to the date of death due to any cause.
Time frame: 24 months
Progression-free survival (PFS) assessed by Blinded Independent Central Review (BICR)
Progression-free survival, defined as the time from the date of randomization to the date of first disease progression per RANO 2.0 by BICR assessment or death from any cause, whichever occurs first.
Time frame: 24 months
Overall response rate
Percentage of patients who achieved confirmed complete response or confirmed partial response to treatment evaluated using RANO 2.0 by BICR.
Time frame: 24 months
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)
EORTC QLQ-C30 is a validated questionnaire to assess overall health-related quality of life in participants with cancer.
Time frame: on Day 1 pre-dose or up to 7 days prior, on any day during the 6th week of RT, and on days of MRI at 4- and 12- weeks after RT, every 16 weeks thereafter on days of MRI
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)
EORTC QLQ-BN20 is a clinically valid and useful tool for assessing disease- and treatment-specific symptoms in brain neoplasm participants.
Time frame: on Day 1 pre-dose or up to 7 days prior, on any day during the 6th week of RT, and on days of MRI at 4- and 12- weeks after RT, every 16 weeks thereafter on days of MRI
Compare symptoms, function, and Health-related quality of life (HRQoL) and symptoms by EQ-5D-3L
The EQ-5D-3L descriptive system comprises the following five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression.
Time frame: on Day 1 pre-dose or up to 7 days prior, on any day during the 6th week of RT, and on days of MRI at 4- and 12- weeks after RT, every 16 weeks thereafter on days of MRI
Changes from baseline in neurocognitive function assessed by Hopkins Verbal Learning test
The Hopkins Verbal Learning Test is designed to evaluate memory. It requires participants to memorize a list of 12 items for 3 consecutive tests (recall), to identify the same 12 items from a list of semantically related or unrelated items (recognition), and to recall the same 12 items after a 15-minute delay (delayed recall).
Time frame: on Day 1 pre-dose or up to 7 days prior, on any day during the 6th week of RT, and on days of MRI at 4- and 12- weeks after RT, every 16 weeks thereafter on days of MRI
Changes from baseline in neurocognitive function assessed by Controlled Oral Word Association
The Controlled Oral Word Association Test is designed to evaluate verbal fluency. It requires participants to name words beginning with a specific letter with increasing associated activity, in 3 one-minute periods.
Time frame: on Day 1 pre-dose or up to 7 days prior, on any day during the 6th week of RT, and on days of MRI at 4- and 12- weeks after RT, every 16 weeks thereafter on days of MRI
Changes from baseline in neurocognitive function assessed by Trail Making Test Parts A and B
The Trail Making Test Part A is designed to evaluate visual motor scanning speed, and the Trail Making Test Part B is designed to evaluate executive function. These tests require participants to connect circles in numerical (Part A) or alternating numerical and alphabetical sequence (Part B) within a timed interval of less than 5 minutes for each test.
Time frame: on Day 1 pre-dose or up to 7 days prior, on any day during the 6th week of RT, and on days of MRI at 4- and 12- weeks after RT, every 16 weeks thereafter on days of MRI
Incidence of participants with adverse events (AEs), serious adverse events (SAEs) and adverse events of special interest (AESIs)
AEs, SAEs and AESIs will be collected
Time frame: 24 months
Incidence 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
Treatment discontinuations, dose interruptions, and dose reductions
Time frame: 24 months
Frequency and severity of symptomatic AEs based on PRO-CTCAE
The PRO-CTCAE is a patient-reported outcome measure developed to evaluate symptomatic toxicity in patients on cancer clinical trials.
Time frame: 24 months
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Indiana University
Indianapolis, Indiana, United States
RECRUITINGThe NeuroMedical Center
Baton Rouge, Louisiana, United States
RECRUITINGMaineHealth Maine Medical Center Care
South Portland, Maine, United States
RECRUITINGTufts Medical Center
Boston, Massachusetts, United States
RECRUITINGUniversity of Michigan Rogel Cancer Center
Ann Arbor, Michigan, United States
RECRUITINGAllina Health
Minneapolis, Minnesota, United States
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