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New hope for glioblastoma: phase 3 trial pits niraparib against standard chemo

NCT ID NCT06388733

Disease control Sponsor: Ivy Brain Tumor Center Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jul 02, 2026 · Updated 2 times

Summary

This Phase 3 trial compares the drug niraparib to the standard chemo temozolomide in 450 adults with newly diagnosed, aggressive glioblastoma that has a specific genetic marker (MGMT unmethylated). Participants take the assigned drug daily during radiation, then continue until the cancer worsens or for up to 6 cycles. The main goal is to see if niraparib helps people live longer.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
niraparib (Zejula)
What this could lead to
If niraparib works better than temozolomide, it could become a new standard treatment for this aggressive brain cancer, potentially extending survival.
What could go wrong
This is a large Phase 3 trial, but glioblastoma is very hard to treat. Niraparib may not improve survival over the current drug, and side effects are possible.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 450 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jun 2024

Expected to finish

Mar 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion 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 and genomic analysis. If insufficient tissue is available,pproval may be granted on a case-by-case basis after a review. * 4\. Unmethylated MGMT promoter region determined locally by a validated PSQ or qMS-PCR assay compliant to local regulations. Numerical cut-off for an MGMT unmethylated tumor will be defined in the protocol. * 5\. Suitability for SOC RT to 60 Gy in 30 fractions using ESTRO-EANO 'single phase' targeting approach \[Niyazi, 2023\], per investigator's judgment. * 6\. No prior treatment for GBM (including brachytherapy or BCNU wafers), other than surgical resection or biopsy. * 7\. Female participants: Not pregnant, planning to get pregnant, or breastfeeding and one of the following conditions apply: is of nonchildbearing potential or is of childbearing potential AND using a contraceptive method that is highly effective (with a failure rate of \<1% per year) from screening through at least 180 days after the last dose of study intervention. Breastfeeding is contraindicated during the study and for one month after the last dose of study intervention. * 8\. Male participants: Must agree to the following during the study intervention period and for at least 6 months after the last dose of study intervention: refrain from donation sperm PLUS be abstinent from heterosexual activity or agree to use a male condom and be advised of the benefit for a female partner to use a contraceptive method that is highly effective (with a failure rate of \<1% per year). * 9\. The participant must be capable of providing signed informed consent, including compliance with the requirements and restrictions listed in the ICF and in this protocol. * 10\. Karnofsky performance status of ≥70. * 11\. Adequate organ function * 12\. Normal blood pressure (BP) or adequately treated and controlled hypertension (defined as systolic BP ≤140 mmHg and diastolic BP ≤90 mmHg). * 13\. Stable or decreased dose of dexamethasone, requiring no more than 5 mg daily equivalent dose, within 7 days before randomization. * 14\. Ability to swallow oral medications whole. Exclusion Criteria: * 1\. Presence of metastatic or predominant leptomeningeal disease. * 2\. Current active pneumonitis or any history of pneumonitis requiring steroids (any dose) or immunomodulatory treatment within 90 days of planned start of the study. * 3\. Participant is at an increased bleeding risk due to concurrent conditions (e.g., major injuries or major surgery within the past 28 days prior to start of study treatment with the exception of tumor resection). * 4\. Any clinically significant gastrointestinal abnormalities that may alter absorption such as malabsorption syndrome or major resection of the stomach and/or bowels. * 5\. Has cirrhosis or current unstable liver or biliary disease per investigator assessment defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminemia, esophageal/gastric varices, or persistent jaundice. NOTE: Stable noncirrhotic chronic liver disease (including Gilbert's syndrome or asymptomatic gallstones), hepatobiliary involvement of malignancy, or chronic stable HBV infection (in a participant for whom HDV infection has been excluded) or chronic HCV infection is acceptable if the participant otherwise meets entry criteria. * 6\. Known human immunodeficiency virus (HIV) unless participants meet all of the following criteria: * Cluster of differentiation 4 ≥350/µL and viral load \<400 copies/mL. * No history of acquired immunodeficiency syndrome-defining opportunistic infections within 12 months prior to enrollment. * No history of HIV-associated malignancy for the past 5 years. * Concurrent antiretroviral therapy as per the most current National Institutes of Health (NIH) Guidelines for the Use of Antiretroviral Agents in Adults and Adolescents Living with HIV \[NIH, 2021\] started \>4 weeks prior to study enrollment. * 7\. MDS/AML or with features suggestive of MDS/AML. * 8\. History of another malignancy within 2 years prior to registration. Participants with a past history of adequately treated carcinoma-in-situ, basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or superficial transitional cell carcinoma of the bladder are eligible. Participants with a history of other malignancies are eligible if they have been treated with curative intent or continuously disease free for at least 2 years after definitive primary treatment. * 9\. Prior history of posterior reversible encephalopathy syndrome (PRES). * 10\. Any psychological, familial, sociological, or geographical condition potentially hampering compliance with the study requirements and/or follow-up procedures. * 11\. Inability to undergo MRI brain with IV contrast. * 12\. Biopsy and/or resection (whichever is later) occurring \>6 weeks prior to planned RT start date. * 13\. Surgical wound complication recovery at the time of enrollment. * 14\. Known hypersensitivity to the components of niraparib, TMZ, or their formulation excipients. * 15\. Known hypersensitivity to dacarbazine (DTIC). * 16\. Prior therapy with PARP inhibitors for systemic cancer. * 17\. Received a live vaccine within 30 days before the planned start of study intervention. Coronavirus disease 2019 (COVID-19) vaccines that do not contain live viruses are allowed. Note: mRNA and adenoviral-based COVID-19 vaccines are considered non-live. * 18\. Received a transfusion (platelets or red blood cells) or colony-stimulating factors (e.g., granulocyte macrophage colony-stimulating factor or recombinant erythropoietin) within 4 weeks of the planned start of study intervention. * 19\. Treatment with another investigational drug or other intervention within 5 half-lives of the investigational product. * 20\. Treatment with tumor treating fields (e.g., Optune) for GBM. * 21\. Presence of known isocitrate dehydrogenase (IDH) mutation. * 22\. Presence of known H3 mutation. * 23\. Previous diagnosis of WHO Grade 2 or 3 glioma.

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Conditions

The condition(s) this trial relates to.

brain cancer brain neoplasm glioblastoma glioma susceptibility 1

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Brain neoplasms, adult, malignant Brain tumor GBM Glioblastoma

Contacts and locations

Locations

  • A.S.L. Napoli 1 Centro Ospedale del Mare

    Naples, Napoli, 80147, Italy

  • Addenbrooke's Hospital

    Cambridge, Cambridgeshire, CB2 0QQ, United Kingdom

  • Allina Health

    Minneapolis, Minnesota, 55407, United States

  • Atlantic Health System

    Summit, New Jersey, 07901, United States

  • Austin Health

    Heidelberg, Victoria, 3084, Australia

  • Azienda Ospedaliera Universitaria Careggi

    Florence, Firenze, 50134, Italy

  • Azienda Ospedaliera Universitaria Policlinico Umberto I - Università di Roma La Sapienza

    Rome, Roma, 00161, Italy

  • Azienda Ospedaliero-Universitaria Città della Salute e della Scienza di Torino

    Torino, Torino, 10124, Italy

  • BC Cancer - Vancouver

    Vancouver, British Columbia, V5Z 4E6, Canada

  • Baylor Scott & White Health

    Temple, Texas, 76508, United States

  • Bayside Health (formerly The Alfred Hospital)

    Melbourne, Victoria, 3004, Australia

  • Beatson West of Scotland Cancer Centre

    Glasgow, Strathclyde, G12 0YN, United Kingdom

  • Bristol Haematology and Oncology Centre

    Bristol, Avon, BS2 8ED, United Kingdom

  • CHU Amiens-Picardie - Site Sud

    Amiens, Somme, 80054, France

  • CHU Nice - Hôpital Pasteur

    Nice, Alpes Maritimes, 06001, France

  • CHUM (Centre hospitalier de l'Université de Montréal)

    Montreal, Quebec, H2X 0C1, Canada

  • CRLCC Eugene Marquis

    Rennes, Ille et Vilaine, 35000, France

  • Centre Georges François Leclerc

    Dijon, 21079, France

  • Centre Hospitalier Universitaire de Lyon-Hospices Civils de Lyon-Hopital Pierre Wertheimer

    Bron, Rhone, 69500, France

  • Centre Hospitalier Universitaire de Sherbrooke

    Sherbrooke, Quebec, J1H 5N4, Canada

  • Centre Leon Berard

    Lyon, Rhone, 69008, France

  • Clinica Universidad de Navarra

    Pamplona, Navarre, 31008, Spain

  • Duke Cancer Center Brain Tumor Clinic

    Durham, North Carolina, 27710, United States

  • Ente Ospedaliero Cantonale

    Bellinzona, 6500, Switzerland

  • Fondazione IRCCS Istituto Neurologico Carlo Besta

    Milan, Milano, 20133, Italy

  • Groupe Hospitalier Pitie-Salpetriere

    Paris, Paris, 75013, France

  • Guy's Hospital

    London, SE1 9RT, United Kingdom

  • Hospital Clinic de Barcelona

    Barcelona, Barcelona, 08036, Spain

  • Hospital Clinico Universitario de Salamanca

    Salamanca, Salamanca, 37370, Spain

  • Hospital Universitari Vall d'Hebron

    Barcelona, Barcelona, 08035, Spain

  • Hospital Universitario 12 de Octubre

    Madrid, Madrid, 28041, Spain

  • Hospital Universitario HM Madrid Sanchinarro

    Madrid, Madrid, 28050, Spain

  • Hospital Universitario Ramon y Cajal

    Madrid, Madrid, 28034, Spain

  • Hospital Universitario Reina Sofia

    Córdoba, Córdoba, 14004, Spain

  • Hospital Universitario Virgen del Rocio

    Seville, Sevilla, 41013, Spain

  • Hospital del Mar

    Barcelona, Barcelona, 08003, Spain

  • Hôpital de la Timone

    Marseille, Bouches-du-Rhône, 13385, France

  • ICO - Site René Gauducheau

    Saint-Herblain, Loire Atlantique, 44800, France

  • ICO Girona - Hospital Universitari de Girona Dr Josep Trueta

    Girona, Girona, 17007, Spain

  • ICO l'Hospitalet - Hospital Duran i Reynals

    Barcelona, 08906, Spain

  • IOV - Istituto Oncologico Veneto IRCCS

    Padova, Padova, 35128, Italy

  • IRCCS Istituto delle Scienze Neurologiche di Bologna

    Bologna, Bologna, 40139, Italy

  • Indiana University

    Indianapolis, Indiana, 46202, United States

  • Inselspital - Universitaetsspital Bern

    Bern, 3010, Switzerland

  • Institut du Cancer de Montpellier

    Montpellier, Herault, 34298, France

  • Istituto Clinico Humanitas

    Rozzano, Milano, 20089, Italy

  • Ivy Brain Tumor Center

    Phoenix, Arizona, 85013, United States

  • Jersey Shore University Medical Center

    Neptune City, New Jersey, 07753, United States

  • Klinikum Chemnitz gGmbH

    Chemnitz, Saxony, 09116, Germany

  • Maastricht UMC

    Maastricht, 6229 HX, Netherlands

  • MaineHealth Maine Medical Center Care

    South Portland, Maine, 04106, United States

  • Medical University of South Carolina - Department of Neurosurgery

    Charleston, South Carolina, 29425, United States

  • Montefiore Medical Center

    The Bronx, New York, 10461, United States

  • Moores UCSD Cancer Center

    La Jolla, California, 92093, United States

  • New York University Ambulatory Care Center

    New York, New York, 10016, United States

  • Northwell Health

    New Hyde Park, New York, 11042, United States

  • Oslo Universitetssykehus HF, Radiumhospitalet

    Oslo, 0379, Norway

  • Peter MacCallum Cancer Centre

    Melbourne, Victoria, 3000, Australia

  • Providence Portland Medical Center

    Portland, Oregon, 97213, United States

  • Queen Elizabeth Hospital

    Birmingham, West Midlands, B15 2TH, United Kingdom

  • Saint Lukes Neuro Oncology

    Kansas City, Missouri, 64111, United States

  • Scripps Cancer Center

    La Jolla, California, 92037, United States

  • Smilow Cancer Hospital at Yale New Haven

    Guilford, Connecticut, 06437, United States

  • St Vincent's Hospital Melbourne

    Fitzroy, Victoria, 3065, Australia

  • St. Olavs Hospital Hf, Universitetssykehuset i Trondheim

    Trondheim, 7030, Norway

  • Sunnybrook Health Sciences Centre

    Toronto, Ontario, M4N 3M5, Canada

  • The Christie Hospital

    Manchester, Greater Manchester, M20 4BX, United Kingdom

  • The Clatterbridge Cancer Centre

    Metropolitan Borough of Wirral, Merseyside, CH63 4JY, United Kingdom

  • The Cleveland Clinic Foundation

    Cleveland, Ohio, 44195, United States

  • The NeuroMedical Center

    Baton Rouge, Louisiana, 70809, United States

  • The Ohio State University

    Columbus, Ohio, 43210, United States

  • The University of Vermont Medical Center

    Burlington, Vermont, 05401, United States

  • Thomas Jefferson University

    Philadelphia, Pennsylvania, 19107, United States

  • Tufts Medical Center

    Boston, Massachusetts, 02111, United States

  • UMC Utrecht

    Utrecht, 3584 CX, Netherlands

  • Universitaetsklinikum Bonn AoeR

    Bonn, North Rhine-Westphalia, 53127, Germany

  • Universitaetsklinikum Heidelberg

    Heidelberg, Baden-Wurttemberg, 69120, Germany

  • Universitaetsklinikum Leipzig

    Leipzig, Saxony, 04103, Germany

  • Universitaetsklinikum Regensburg

    Regensburg, Bavaria, 93053, Germany

  • Universitaetsklinikum Tuebingen

    Tübingen, Baden-Wurttemberg, 72076, Germany

  • Universitaetsmedizin Mannheim

    Mannheim, Baden-Wurttemberg, 68167, Germany

  • Universitaetsspital Basel

    Basel, 4031, Switzerland

  • Universitaetsspital Zürich

    Zurich, 8091, Switzerland

  • University Health Network - Princess Margaret Cancer Centre

    Toronto, Ontario, M5G 2M9, Canada

  • University of Alabama at Birmingham

    Birmingham, Alabama, 35233, United States

  • University of Cincinnati Cancer Institute

    Cincinnati, Ohio, 45267, United States

  • University of Michigan Rogel Cancer Center

    Ann Arbor, Michigan, 48109, United States

  • University of Minnesota Health Clinics and Surgery Center, Minneapolis

    Minneapolis, Minnesota, 55455, United States

  • University of Pittsburgh Medical Center Health System

    Pittsburgh, Pennsylvania, 15232, United States

  • University of Washington Medical Center

    Seattle, Washington, 98109, United States

  • University of Wisconsin Cancer Center

    Madison, Wisconsin, 53706, United States

  • Velindre Cancer Centre

    Cardiff, South Glamorgan, CF14 2TL, United Kingdom

  • Vivantes Klinikum Neukoelln

    Berlin, State of Berlin, 12351, Germany

  • Wake Forest Baptist Health

    Winston-Salem, North Carolina, 27157, United States

  • Washington University, School of Medicine

    St Louis, Missouri, 63110, United States

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