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

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

Trial Details

NCT ID
NCT06388733
Phase
PHASE3
Sponsor
Ivy Brain Tumor Center
Status
RECRUITING
Cancer Type
Glioblastoma (GBM) Brain Cancer
Interventions
  • Niraparib
  • Temozolomide
Locations (sample)
  • Birmingham, Alabama, United States|33.52066,-86.80249
  • Phoenix, Arizona, United States|33.44838,-112.07404
  • La Jolla, California, United States|32.84727,-117.2742
  • Guilford, Connecticut, United States|41.28899,-72.68176
  • Indianapolis, Indiana, United States|39.76838,-86.15804

Key Eligibility Criteria

  • 1\. Histologic documentation of a newly-diagnosed intracranial GBM, per 2021 WHO classification guidelines through local pathology review.
  • 2\. Age ≥18 years at the time of signing informed consent.
  • 3\. Sufficient tissue available for retrospective central pathology review, retrospective central confirmation of MGMT promoter methylation status …
  • 4\. Unmethylated MGMT promoter region determined locally by a validated PSQ or qMS-PCR assay compliant to local regulations. Numerical cut-off for …

For full eligibility, visit ClinicalTrials.gov.

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