OncoMatch/Clinical Trials/NCT06388733
A Study Comparing Niraparib With Temozolomide in Adult Participants With Newly-diagnosed, MGMT Unmethylated Glioblastoma
Is NCT06388733 recruiting? Yes, currently enrolling (May 2026). This Phase 3 trial studies multiple treatments including Niraparib and Temozolomide for glioblastoma.
Treatment: Niraparib · Temozolomide — 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
Check if I qualifyExtracted eligibility criteria
Cancer type
Glioblastoma
Biomarker criteria
Required: MGMT unmethylated promoter
Unmethylated MGMT promoter region determined locally by a validated PSQ or qMS-PCR assay
Excluded: IDH1 mutation
Presence of known isocitrate dehydrogenase (IDH) mutation.
Excluded: IDH2 mutation
Presence of known isocitrate dehydrogenase (IDH) mutation.
Excluded: H3F3A (H3 K27M) mutation
Presence of known H3 mutation.
Excluded: HIST1H3B mutation
Presence of known H3 mutation.
Prior therapy
Must have received: surgical resection or biopsy
No prior treatment for GBM (including brachytherapy or BCNU wafers), other than surgical resection or biopsy.
Cannot have received: PARP inhibitor
Prior therapy with PARP inhibitors for systemic cancer.
Cannot have received: tumor treating fields (Optune)
Treatment with tumor treating fields (e.g., Optune) for GBM.
Cannot have received: brachytherapy
No prior treatment for GBM (including brachytherapy or BCNU wafers), other than surgical resection or biopsy.
Cannot have received: BCNU wafer
No prior treatment for GBM (including brachytherapy or BCNU wafers), other than surgical resection or biopsy.
Lab requirements
Blood counts
Kidney function
Liver function
Adequate organ function
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- University of Alabama at Birmingham · Birmingham, Alabama
- Ivy Brain Tumor Center · Phoenix, Arizona
- Scripps Cancer Center · La Jolla, California
- Moores UCSD Cancer Center · La Jolla, California
- Indiana University · Indianapolis, Indiana
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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