What is niraparib studying for glioblastoma multiforme (GBM)?

Niraparib is being studied to see if it can improve overall survival compared to the standard drug temozolomide in adults with newly diagnosed GBM that has unmethylated MGMT. This research helps understand if niraparib offers a new option for treating this aggressive brain tumor. The trial is sponsored by the Ivy Brain Tumor Center.

Who may be eligible for this glioblastoma clinical trial?

Adults aged 18 years or older with newly diagnosed glioblastoma multiforme and an unmethylated MGMT promoter may be eligible. Both male and female participants can join if they meet health criteria, including good organ function and ability to take oral medications. Please review eligibility criteria for more details.

Is there any cost to participate in this glioblastoma clinical trial?

Study-related care, including the study drugs and all trial visits, is provided at no cost. However, personal travel expenses to attend study visits may vary and are not guaranteed to be covered by the trial.

Actively Recruiting

Phase 3

Age: 18Years +

All Genders

ID06388733

A Phase 3 Study Comparing Niraparib With Temozolomide in Adults With Newly-diagnosed, MGMT Unmethylated Glioblastoma

Led by Ivy Brain Tumor Center · Updated on 2026-04-01

450

Participants Needed

Research Sites

13 weeks

Total Duration

AI-Summary

What this Trial Is About

Researchers are comparing two treatments, niraparib and temozolomide TMZ, in adults with newly diagnosed glioblastoma multiforme GBM that has an unmethylated MGMT promoter. This Phase 3 trial aims to find out if niraparib can improve overall survival compared to the current standard treatment, TMZ. The trial will enroll 450 adult participants and is sponsored by the Ivy Brain Tumor Center. Participants will be randomly assigned to receive either niraparib or TMZ. Niraparib is taken orally once daily starting with radiation therapy RT for 6 to 7 weeks and continued as an adjuvant treatment until cancer progression or discontinuation. The TMZ group receives the drug daily during RT, followed by a rest period and then up to 6 cycles of adjuvant TMZ. Radiation therapy is given as standard care to 60 Gy in 30 fractions. During the study, participants will complete scheduled visits and keep a diary to record medication use. Researchers will monitor overall survival over 24 months as the primary outcome. Secondary measures include progression-free survival, response rates, quality of life assessments, neurocognitive function tests, and tracking of adverse events. Safety and treatment effects will be closely observed throughout the trial period, which continues until March 2028.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years +

All Genders

Eligibility Criteria

You may qualify if you...

Histologic confirmation of newly diagnosed intracranial glioblastoma multiforme (GBM) per 2021 WHO guidelines
Age 18 years or older at time of consent
Sufficient tissue available for pathology review and MGMT methylation testing
MGMT promoter unmethylated status confirmed by validated local test
Suitable for standard radiation therapy to 60 Gy in 30 fractions
No prior GBM treatment except surgical resection or biopsy
For females, not pregnant, breastfeeding, or planning pregnancy and using effective contraception if childbearing potential
For males, agree to sperm donation restrictions and contraception use during and 6 months after study treatment
Able to provide informed consent and comply with study requirements
Karnofsky performance status of 70 or higher
Adequate organ function
Normal or controlled blood pressure
Stable or reduced dexamethasone dose (5 mg daily or less) within 7 days before randomization
Ability to swallow oral medications whole

You will not qualify if you...

Presence of metastatic or predominant leptomeningeal disease
Active or recent pneumonitis requiring steroids or immunomodulators within 90 days
Increased bleeding risk due to recent major injury or surgery (except tumor resection)
Significant gastrointestinal abnormalities affecting absorption
Cirrhosis or unstable liver/biliary disease
HIV infection unless controlled with specific criteria
History or features of MDS/AML
Other malignancies within 2 years except certain treated skin or bladder cancers
Prior posterior reversible encephalopathy syndrome (PRES)
Conditions hindering compliance with study or follow-up
Inability to undergo MRI with contrast
Biopsy or resection more than 6 weeks before planned radiation start
Surgical wound complications at enrollment
Known allergy to niraparib, temozolomide, or related compounds
Prior PARP inhibitor therapy
Recent live vaccine within 30 days before study intervention
Recent blood transfusion or colony-stimulating factors within 4 weeks
Recent treatment with other investigational drugs within 5 half-lives
Prior use of tumor treating fields for GBM
Known IDH or H3 mutation
Previous diagnosis of WHO Grade 2 or 3 glioma

Research Team

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