A Study Comparing Niraparib With Temozolomide in Adult Participants With Newly-diagnosed, MGMT Unmethylated Glioblastoma (NCT06388733)
A Phase 3, Open-label, Randomized 2-arm Study Comparing the Clinical Efficacy and Safety of Niraparib With Temozolomide in Adult Participants With Newly-diagnosed, MGMT Unmethylated Glioblastoma
🩺 Plain-English Summary (8th-Grade Level)
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
Who can join: Review the eligibility criteria below.
Location: University of Alabama at Birmingham — Birmingham, Alabama
Age range: 18 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (95 Sites)
Showing the first 25 of 95 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
- Smilow Cancer Hospital at Yale New Haven — Guilford, Connecticut
- Indiana University — Indianapolis, Indiana
- The NeuroMedical Center — Baton Rouge, Louisiana
- MaineHealth Maine Medical Center Care — South Portland, Maine
- Tufts Medical Center — Boston, Massachusetts
- University of Michigan Rogel Cancer Center — Ann Arbor, Michigan
- Allina Health — Minneapolis, Minnesota
- University of Minnesota Health Clinics and Surgery Center, Minneapolis — Minneapolis, Minnesota
- Saint Lukes Neuro Oncology — Kansas City, Missouri
- Washington University, School of Medicine — St Louis, Missouri
- Jersey Shore University Medical Center — Neptune City, New Jersey
- Atlantic Health System — Summit, New Jersey
- Northwell Health — New Hyde Park, New York
- New York University Ambulatory Care Center — New York, New York
- Montefiore Medical Center — The Bronx, New York
- Duke Cancer Center Brain Tumor Clinic — Durham, North Carolina
- Wake Forest Baptist Health — Winston-Salem, North Carolina
- University of Cincinnati Cancer Institute — Cincinnati, Ohio
- The Cleveland Clinic Foundation — Cleveland, Ohio
- The Ohio State University — Columbus, Ohio
- Providence Portland Medical Center — Portland, Oregon
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Glioblastoma
- Analyzing Pulsed Reduced Dose Radiotherapy in Upfront Glioblastoma — Milwaukee, Wisconsin
- A Dose Finding Study of [177Lu]Lu-DOTA-TATE in Newly Diagnosed Glioblastoma in Combination With Standard of Care and in Recurrent Glioblastoma as a Single Agent. — New York, New York
- A Phase 1-2 Study of ST101 in Patients With Advanced Solid Tumors — San Francisco, California
- Trial of Niraparib in Participants With Newly-diagnosed Glioblastoma and Recurrent Glioma — Phoenix, Arizona
- Testing the Addition of the Chemotherapy Drug Lomustine (Gleostine) to the Usual Treatment (Temozolomide and Radiation Therapy) for Newly Diagnosed MGMT Methylated Glioblastoma — Fairbanks, Alaska
Explore by condition: All Glioblastoma clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Review the official NIH record below to find the coordinating site.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.