TrialPath
← Back to searchRecruiting

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

NCT06388733 · NeuroTrials, LLC
In plain English

Click the button to translate this study into plain language — what it is, who qualifies, and what participation looks like.

Official title
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
About this study
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
Eligibility criteria
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.
Study design
Enrollment target: 450 participants
Allocation: randomized
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2024-06-19
Estimated completion: 2028-03
Last updated: 2026-04-01
Interventions
Drug: NiraparibDrug: Temozolomide
Primary outcomes
  • Overall survival (24 months)
Sponsor
Ivy Brain Tumor Center · other
With: GlaxoSmithKline
Contacts & investigators
ContactStudy Navigator · contact · research@ivybraintumorcenter.org · 602-406-8605
InvestigatorNader Sanai, MD · study_chair, Ivy Brain Tumor Center
All locations (95)
University of Alabama at BirminghamRecruiting
Birmingham, Alabama, United States
Ivy Brain Tumor CenterRecruiting
Phoenix, Arizona, United States
Scripps Cancer CenterRecruiting
La Jolla, California, United States
Moores UCSD Cancer CenterRecruiting
La Jolla, California, United States
Smilow Cancer Hospital at Yale New HavenRecruiting
Guilford, Connecticut, United States
Indiana UniversityRecruiting
Indianapolis, Indiana, United States
The NeuroMedical CenterRecruiting
Baton Rouge, Louisiana, United States
MaineHealth Maine Medical Center CareRecruiting
South Portland, Maine, United States
Tufts Medical CenterRecruiting
Boston, Massachusetts, United States
University of Michigan Rogel Cancer CenterRecruiting
Ann Arbor, Michigan, United States
Allina HealthRecruiting
Minneapolis, Minnesota, United States
University of Minnesota Health Clinics and Surgery Center, MinneapolisRecruiting
Minneapolis, Minnesota, United States
Saint Lukes Neuro OncologyRecruiting
Kansas City, Missouri, United States
Washington University, School of MedicineRecruiting
St Louis, Missouri, United States
Jersey Shore University Medical CenterRecruiting
Neptune City, New Jersey, United States
Atlantic Health SystemRecruiting
Summit, New Jersey, United States
Northwell HealthRecruiting
New Hyde Park, New York, United States
New York University Ambulatory Care CenterRecruiting
New York, New York, United States
Montefiore Medical CenterRecruiting
The Bronx, New York, United States
Duke Cancer Center Brain Tumor ClinicRecruiting
Durham, North Carolina, United States
Wake Forest Baptist HealthRecruiting
Winston-Salem, North Carolina, United States
University of Cincinnati Cancer InstituteRecruiting
Cincinnati, Ohio, United States
The Cleveland Clinic FoundationRecruiting
Cleveland, Ohio, United States
The Ohio State UniversityRecruiting
Columbus, Ohio, United States
Providence Portland Medical CenterRecruiting
Portland, Oregon, United States
Thomas Jefferson UniversityRecruiting
Philadelphia, Pennsylvania, United States
University of Pittsburgh Medical Center Health SystemRecruiting
Pittsburgh, Pennsylvania, United States
Medical University of South Carolina - Department of NeurosurgeryRecruiting
Charleston, South Carolina, United States
Baylor Scott & White HealthRecruiting
Temple, Texas, United States
The University of Vermont Medical CenterRecruiting
Burlington, Vermont, United States
University of Washington Medical CenterRecruiting
Seattle, Washington, United States
University of Wisconsin Cancer CenterRecruiting
Madison, Wisconsin, United States
St Vincent's Hospital MelbourneRecruiting
Fitzroy, Victoria, Australia
Austin HealthRecruiting
Heidelberg, Victoria, Australia
Peter MacCallum Cancer CentreRecruiting
Melbourne, Victoria, Australia
Bayside Health (formerly The Alfred Hospital)Recruiting
Melbourne, Victoria, Australia
BC Cancer - VancouverRecruiting
Vancouver, British Columbia, Canada
Sunnybrook Health Sciences CentreRecruiting
Toronto, Ontario, Canada
University Health Network - Princess Margaret Cancer CentreRecruiting
Toronto, Ontario, Canada
CHUM (Centre hospitalier de l'Université de Montréal)Recruiting
Montreal, Quebec, Canada
Centre Hospitalier Universitaire de SherbrookeRecruiting
Sherbrooke, Quebec, Canada
CHU Nice - Hôpital PasteurRecruiting
Nice, Alpes Maritimes, France
Hôpital de la TimoneRecruiting
Marseille, Bouches-du-Rhône, France
Institut du Cancer de MontpellierRecruiting
Montpellier, Herault, France
CRLCC Eugene MarquisRecruiting
Rennes, Ille et Vilaine, France
ICO - Site René GauducheauRecruiting
Saint-Herblain, Loire Atlantique, France
Groupe Hospitalier Pitie-SalpetriereRecruiting
Paris, Paris, France
Centre Hospitalier Universitaire de Lyon-Hospices Civils de Lyon-Hopital Pierre WertheimerRecruiting
Bron, Rhone, France
Centre Leon BerardRecruiting
Lyon, Rhone, France
CHU Amiens-Picardie - Site SudRecruiting
Amiens, Somme, France
Centre Georges François LeclercRecruiting
Dijon, France
Universitaetsklinikum HeidelbergRecruiting
Heidelberg, Baden-Wurttemberg, Germany
Universitaetsmedizin MannheimRecruiting
Mannheim, Baden-Wurttemberg, Germany
Universitaetsklinikum TuebingenRecruiting
Tübingen, Baden-Wurttemberg, Germany
Universitaetsklinikum RegensburgRecruiting
Regensburg, Bavaria, Germany
Universitaetsklinikum Bonn AoeRRecruiting
Bonn, North Rhine-Westphalia, Germany
Klinikum Chemnitz gGmbHRecruiting
Chemnitz, Saxony, Germany
Universitaetsklinikum LeipzigRecruiting
Leipzig, Saxony, Germany
Vivantes Klinikum NeukoellnRecruiting
Berlin, State of Berlin, Germany
IRCCS Istituto delle Scienze Neurologiche di BolognaRecruiting
Bologna, Bologna, Italy
Azienda Ospedaliera Universitaria CareggiRecruiting
Florence, Firenze, Italy
Fondazione IRCCS Istituto Neurologico Carlo BestaRecruiting
Milan, Milano, Italy
Istituto Clinico HumanitasRecruiting
Rozzano, Milano, Italy
A.S.L. Napoli 1 Centro Ospedale del MareRecruiting
Naples, Napoli, Italy
IOV - Istituto Oncologico Veneto IRCCSRecruiting
Padova, Padova, Italy
Azienda Ospedaliera Universitaria Policlinico Umberto I - Università di Roma La SapienzaRecruiting
Rome, Roma, Italy
Azienda Ospedaliero-Universitaria Città della Salute e della Scienza di TorinoRecruiting
Torino, Torino, Italy
Maastricht UMCRecruiting
Maastricht, Netherlands
UMC UtrechtRecruiting
Utrecht, Netherlands
Oslo Universitetssykehus HF, RadiumhospitaletRecruiting
Oslo, Norway
St. Olavs Hospital Hf, Universitetssykehuset i TrondheimRecruiting
Trondheim, Norway
Hospital del MarRecruiting
Barcelona, Barcelona, Spain
Hospital Universitari Vall d'HebronRecruiting
Barcelona, Barcelona, Spain
Hospital Clinic de BarcelonaRecruiting
Barcelona, Barcelona, Spain
Hospital Universitario Reina SofiaRecruiting
Córdoba, Córdoba, Spain
ICO Girona - Hospital Universitari de Girona Dr Josep TruetaRecruiting
Girona, Girona, Spain
Hospital Universitario Ramon y CajalRecruiting
Madrid, Madrid, Spain
Hospital Universitario 12 de OctubreRecruiting
Madrid, Madrid, Spain
Hospital Universitario HM Madrid SanchinarroRecruiting
Madrid, Madrid, Spain
Clinica Universidad de NavarraRecruiting
Pamplona, Navarre, Spain
Hospital Clinico Universitario de SalamancaRecruiting
Salamanca, Salamanca, Spain
Hospital Universitario Virgen del RocioRecruiting
Seville, Sevilla, Spain
ICO l'Hospitalet - Hospital Duran i ReynalsRecruiting
Barcelona, Spain
Universitaetsspital BaselRecruiting
Basel, Switzerland
Ente Ospedaliero CantonaleRecruiting
Bellinzona, Switzerland
Inselspital - Universitaetsspital BernRecruiting
Bern, Switzerland
Universitaetsspital ZürichRecruiting
Zurich, Switzerland
Bristol Haematology and Oncology CentreRecruiting
Bristol, Avon, United Kingdom
Addenbrooke's HospitalRecruiting
Cambridge, Cambridgeshire, United Kingdom
The Christie HospitalRecruiting
Manchester, Greater Manchester, United Kingdom
The Clatterbridge Cancer CentreRecruiting
Metropolitan Borough of Wirral, Merseyside, United Kingdom
Velindre Cancer CentreRecruiting
Cardiff, South Glamorgan, United Kingdom
Beatson West of Scotland Cancer CentreRecruiting
Glasgow, Strathclyde, United Kingdom
Queen Elizabeth HospitalRecruiting
Birmingham, West Midlands, United Kingdom
Guy's HospitalRecruiting
London, United Kingdom
A Study Comparing Niraparib With Temozolomide in Adult Participants With Newly-diagnosed, MGMT Unmethylated Glioblastoma · TrialPath