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

March 31, 2026 updated by: Ivy Brain Tumor Center

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

450

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Australia
    • Victoria
      • Fitzroy, Victoria, Australia, 3065
        • Recruiting
        • St Vincent's Hospital Melbourne
        • Contact:
        • Principal Investigator:
          • Anthony Dowling, MBBS, DMedSc, FRACP
      • Heidelberg, Victoria, Australia, 3084
        • Recruiting
        • Austin Health
        • Contact:
        • Principal Investigator:
          • Hui Gan, hui.gan@austin.org.au
      • Melbourne, Victoria, Australia, 3000
        • Recruiting
        • Peter MacCallum Cancer Centre
        • Contact:
        • Principal Investigator:
          • James Whittle, MD, PhD
      • Melbourne, Victoria, Australia, 3004
        • Recruiting
        • Bayside Health (formerly The Alfred Hospital)
        • Contact:
        • Principal Investigator:
          • Malaka Ameratunga, MBBS, FRACP
  • Canada
    • British Columbia
      • Vancouver, British Columbia, Canada, V5Z 4E6
        • Recruiting
        • BC Cancer - Vancouver
        • Contact:
        • Principal Investigator:
          • Manik Chahal, MD, PhD, FRCPC
    • Ontario
      • Toronto, Ontario, Canada, M4N 3M5
        • Recruiting
        • Sunnybrook Health Sciences Centre
        • Principal Investigator:
          • Mary Jane Lim-Fat, MD, MSc, FRCPC
      • Toronto, Ontario, Canada, M5G 2M9
        • Recruiting
        • University Health Network - Princess Margaret Cancer Centre
        • Principal Investigator:
          • Warren Mason, MD
    • Quebec
      • Montreal, Quebec, Canada, H2X 0C1
        • Recruiting
        • CHUM (Centre hospitalier de l'Université de Montréal)
        • Contact:
        • Principal Investigator:
          • Sarah Lapointe, MD
      • Sherbrooke, Quebec, Canada, J1H 5N4
        • Recruiting
        • Centre Hospitalier Universitaire de Sherbrooke
        • Principal Investigator:
          • David Mathieu, MD, FRCS(C)
  • France
      • Dijon, France, 21079
        • Recruiting
        • Centre Georges François Leclerc
        • Principal Investigator:
          • Francois Ghiringhelli, MD, PhD
        • Contact:
    • Alpes Maritimes
      • Nice, Alpes Maritimes, France, 06001
        • Recruiting
        • CHU Nice - Hôpital Pasteur
        • Principal Investigator:
          • Veronique Bourg, MD
        • Contact:
    • Bouches-du-Rhône
      • Marseille, Bouches-du-Rhône, France, 13385
        • Recruiting
        • Hopital de la Timone
        • Contact:
        • Principal Investigator:
          • Emeline Tabouret, MD, PhD
    • Herault
      • Montpellier, Herault, France, 34298
        • Recruiting
        • Institut du Cancer de Montpellier
        • Contact:
        • Principal Investigator:
          • Amélie Darlix, MD, PhD
    • Ille et Vilaine
      • Rennes, Ille et Vilaine, France, 35000
        • Recruiting
        • CRLCC Eugene Marquis
        • Principal Investigator:
          • Elodie Vauleon, MD
    • Loire Atlantique
      • Saint-Herblain, Loire Atlantique, France, 44800
        • Recruiting
        • ICO - Site René Gauducheau
        • Principal Investigator:
          • Carole Gourmelon, MD
        • Contact:
    • Paris
      • Paris, Paris, France, 75013
        • Recruiting
        • Groupe Hospitalier Pitie-Salpetriere
        • Principal Investigator:
          • Mehdi Touat, MD, PhD, MCU-PH
        • Contact:
    • Rhone
      • Bron, Rhone, France, 69500
        • Recruiting
        • Centre Hospitalier Universitaire de Lyon-Hospices Civils de Lyon-Hopital Pierre Wertheimer
        • Principal Investigator:
          • Francois Ducray, MD
        • Contact:
      • Lyon, Rhone, France, 69008
        • Recruiting
        • Centre Leon Berard
        • Contact:
        • Principal Investigator:
          • Aurelien Maureille, MD
    • Somme
      • Amiens, Somme, France, 80054
        • Recruiting
        • Chu Amiens-Picardie - Site Sud
        • Principal Investigator:
          • Mathieu Boone, MD
        • Contact:
  • Germany
    • Baden-Wurttemberg
      • Heidelberg, Baden-Wurttemberg, Germany, 69120
        • Recruiting
        • Universitaetsklinikum Heidelberg
        • Principal Investigator:
          • Antje Wick, MD
        • Contact:
      • Mannheim, Baden-Wurttemberg, Germany, 68167
        • Recruiting
        • Universitaetsmedizin Mannheim
        • Principal Investigator:
          • Lukas Bunse, MD
        • Contact:
      • Tübingen, Baden-Wurttemberg, Germany, 72076
        • Recruiting
        • Universitaetsklinikum Tuebingen
        • Principal Investigator:
          • Ghazaleh Tabatabai, MD
        • Contact:
    • Bavaria
      • Regensburg, Bavaria, Germany, 93053
        • Recruiting
        • Universitaetsklinikum Regensburg
        • Principal Investigator:
          • Peter Hau, MD
        • Contact:
    • North Rhine-Westphalia
      • Bonn, North Rhine-Westphalia, Germany, 53127
        • Recruiting
        • Universitaetsklinikum Bonn AoeR
        • Principal Investigator:
          • Ulrich Herrlinger, MD
        • Contact:
    • Saxony
      • Chemnitz, Saxony, Germany, 09116
        • Recruiting
        • Klinikum Chemnitz gGmbH
        • Contact:
        • Principal Investigator:
          • Sven-Axel May, MD
      • Leipzig, Saxony, Germany, 04103
        • Recruiting
        • Universitaetsklinikum Leipzig
        • Principal Investigator:
          • Clemens Seidel, MD
    • State of Berlin
      • Berlin, State of Berlin, Germany, 12351
        • Recruiting
        • Vivantes Klinikum Neukoelln
        • Principal Investigator:
          • Maike de Wit, MD
        • Contact:
  • Italy
    • Bologna
      • Bologna, Bologna, Italy, 40139
        • Recruiting
        • IRCCS Istituto delle Scienze Neurologiche di Bologna
        • Principal Investigator:
          • Enrico Franceschi, MD
        • Contact:
    • Firenze
      • Florence, Firenze, Italy, 50134
        • Recruiting
        • Azienda Ospedaliera Universitaria Careggi
        • Principal Investigator:
          • Lorenzo Livi, MD
        • Contact:
    • Milano
      • Milan, Milano, Italy, 20133
        • Recruiting
        • Fondazione IRCCS Istituto Neurologico Carlo Besta
        • Principal Investigator:
          • Antonio Silvani, MD
        • Contact:
      • Rozzano, Milano, Italy, 20089
        • Recruiting
        • Istituto Clinico Humanitas
        • Principal Investigator:
          • Matteo Simonelli, MD
        • Contact:
    • Napoli
      • Naples, Napoli, Italy, 80147
        • Recruiting
        • A.S.L. Napoli 1 Centro Ospedale del Mare
        • Principal Investigator:
          • Bruno Danielle, MD
    • Padova
      • Padua, Padova, Italy, 35128
        • Recruiting
        • Iov - Istituto Oncologico Veneto Irccs
        • Principal Investigator:
          • Giuseppe Lombardi, MD
    • Roma
      • Rome, Roma, Italy, 00161
        • Recruiting
        • Azienda Ospedaliera Universitaria Policlinico Umberto I - Università di Roma La Sapienza
        • Principal Investigator:
          • Giuseppe Minniti, MD
        • Contact:
    • Torino
      • Torino, Torino, Italy, 10124
        • Recruiting
        • Azienda Ospedaliero-Universitaria Città della Salute e della Scienza di Torino
        • Principal Investigator:
          • Roberta Rudà, MD
        • Contact:
  • Netherlands
      • Maastricht, Netherlands, 6229 HX
        • Recruiting
        • Maastricht UMC
        • Principal Investigator:
          • Ann Hoeben, MD
      • Utrecht, Netherlands, 3584 CX
        • Recruiting
        • UMC Utrecht
        • Contact:
        • Principal Investigator:
          • Filip De Vos, MD, PhD
  • Norway
      • Oslo, Norway, 0379
        • Recruiting
        • Oslo Universitetssykehus HF, Radiumhospitalet
        • Contact:
        • Principal Investigator:
          • Petter Brandal, MD
      • Trondheim, Norway, 7030
        • Recruiting
        • St. Olavs Hospital Hf, Universitetssykehuset i Trondheim
        • Principal Investigator:
          • Tora Solheim, MD
  • Spain
      • Barcelona, Spain, 08906
        • Recruiting
        • ICO L'Hospitalet - Hospital Duran i Reynals
        • Principal Investigator:
          • Noelia Vilarino Quintela, MD
    • Barcelona
      • Barcelona, Barcelona, Spain, 08036
        • Recruiting
        • Hospital Clinic de Barcelona
        • Principal Investigator:
          • Estela Pineda Losada, MD
        • Contact:
      • Barcelona, Barcelona, Spain, 08003
        • Recruiting
        • Hospital del Mar
        • Contact:
        • Principal Investigator:
          • Maria Martinez Garcia, MD, PhD
      • Barcelona, Barcelona, Spain, 08035
        • Recruiting
        • Hospital Universitari Vall d'Hebron
        • Principal Investigator:
          • Maria Vieito Villar, MD
        • Contact:
    • Córdoba
      • Córdoba, Córdoba, Spain, 14004
        • Recruiting
        • Hospital Universitario Reina Sofia
        • Contact:
        • Principal Investigator:
          • Juan Solivera Vela, MD
    • Girona
      • Girona, Girona, Spain, 17007
        • Recruiting
        • ICO Girona - Hospital Universitari de Girona Dr Josep Trueta
        • Principal Investigator:
          • Sonia Del Barco Berron, MD
    • Madrid
      • Madrid, Madrid, Spain, 28034
        • Recruiting
        • Hospital Universitario Ramón y Cajal
        • Principal Investigator:
          • Maria Angeles Vaz Salgado, MD
        • Contact:
      • Madrid, Madrid, Spain, 28041
        • Recruiting
        • Hospital Universitario 12 de Octubre
        • Principal Investigator:
          • Juan Manuel Sepulveda Sanchez, MD, PhD
        • Contact:
      • Madrid, Madrid, Spain, 28050
        • Recruiting
        • Hospital Universitario Hm Madrid Sanchinarro
        • Contact:
        • Principal Investigator:
          • Angela Santiago Gomez, MD
    • Navarre
      • Pamplona, Navarre, Spain, 31008
        • Recruiting
        • Clinica Universidad de Navarra
        • Principal Investigator:
          • Jaime Gallego Perez de Larraya
        • Contact:
    • Salamanca
      • Salamanca, Salamanca, Spain, 37370
        • Recruiting
        • Hospital Clínico Universitario de Salamanca
        • Principal Investigator:
          • Luis Miguel Navarro Martín, MD
    • Sevilla
      • Seville, Sevilla, Spain, 41013
        • Recruiting
        • Hospital Universitario Virgen del Rocio
        • Principal Investigator:
          • Miriam Alonso Garcia, MD
        • Contact:
  • Switzerland
      • Basel, Switzerland, 4031
        • Recruiting
        • Universitaetsspital Basel
        • Contact:
        • Principal Investigator:
          • Benjamin Thiele, MD
      • Bellinzona, Switzerland, 6500
        • Recruiting
        • Ente Ospedaliero Cantonale
        • Contact:
        • Principal Investigator:
          • Barbara Muoio, MD
      • Bern, Switzerland, 3010
        • Recruiting
        • Inselspital - Universitaetsspital Bern
        • Principal Investigator:
          • Dennis Hoch, MD
      • Zurich, Switzerland, 8091
        • Recruiting
        • UniversitaetsSpital Zurich
        • Contact:
        • Principal Investigator:
          • Dorothee Gramatzki, MD
  • United Kingdom
      • London, United Kingdom, SE1 9RT
        • Recruiting
        • Guy's Hospital
        • Principal Investigator:
          • Lucy Brazil, BSc, MBBS, MRCP, FRCP, MD
    • Avon
      • Bristol, Avon, United Kingdom, BS2 8ED
        • Recruiting
        • Bristol Haematology and Oncology Centre
        • Contact:
        • Principal Investigator:
          • Katherine Falconer, MB BS
    • Cambridgeshire
      • Cambridge, Cambridgeshire, United Kingdom, CB2 0QQ
        • Recruiting
        • Addenbrooke's Hospital
        • Contact:
        • Principal Investigator:
          • Fiona Harris, MB ChB
    • Greater Manchester
      • Manchester, Greater Manchester, United Kingdom, M20 4BX
        • Recruiting
        • The Christie Hospital
        • Contact:
        • Principal Investigator:
          • Catherine McBain, MB ChB, MRCP, FRCR, MD
    • Merseyside
      • Metropolitan Borough of Wirral, Merseyside, United Kingdom, CH63 4JY
        • Recruiting
        • The Clatterbridge Cancer Centre
        • Contact:
        • Principal Investigator:
          • Shaveta Mehta, MD
    • South Glamorgan
      • Cardiff, South Glamorgan, United Kingdom, CF14 2TL
        • Recruiting
        • Velindre Cancer Centre
        • Contact:
        • Principal Investigator:
          • Jillian Maclean, MB ChB
    • Strathclyde
      • Glasgow, Strathclyde, United Kingdom, G12 0YN
        • Recruiting
        • Beatson West Of Scotland Cancer Centre
        • Principal Investigator:
          • Stefan Nowicki, MB BChir
    • West Midlands
      • Birmingham, West Midlands, United Kingdom, B15 2TH
        • Recruiting
        • Queen Elizabeth Hospital
        • Principal Investigator:
          • Helen Benghiat, MB ChB
        • Contact:
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35233
        • Recruiting
        • University of Alabama at Birmingham
        • Principal Investigator:
          • Louis Nabors, MD
    • Arizona
      • Phoenix, Arizona, United States, 85013
        • Recruiting
        • Ivy Brain Tumor Center
        • Contact:
        • Principal Investigator:
          • Yoshie Umemura, MD
    • California
      • La Jolla, California, United States, 92093
        • Recruiting
        • Moores UCSD Cancer Center
        • Principal Investigator:
          • David Piccioni, MD
        • Contact:
      • La Jolla, California, United States, 92037
        • Recruiting
        • Scripps Cancer Center
        • Principal Investigator:
          • Tresa McGranahan, MD
    • Connecticut
      • Guilford, Connecticut, United States, 06437
        • Recruiting
        • Smilow Cancer Hospital at Yale New Haven
        • Principal Investigator:
          • Sylvia Kurz, MD, PhD
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Recruiting
        • Indiana University
        • Principal Investigator:
          • Kathryn Nevel, MD
    • Louisiana
      • Baton Rouge, Louisiana, United States, 70809
        • Recruiting
        • The Neuromedical Center
        • Principal Investigator:
          • Jon Olson, MD
        • Contact:
    • Maine
      • South Portland, Maine, United States, 04106
        • Recruiting
        • MaineHealth Maine Medical Center Care
        • Principal Investigator:
          • Christine Lu-Emerson, MD
        • Contact:
    • Massachusetts
      • Boston, Massachusetts, United States, 02111
        • Recruiting
        • Tufts Medical Center
        • Principal Investigator:
          • Suriya Jeyapalan, MD
        • Contact:
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • Recruiting
        • University of Michigan Rogel Cancer Center
        • Principal Investigator:
          • Nathan Clarke, MD
    • Minnesota
      • Minneapolis, Minnesota, United States, 55407
        • Recruiting
        • Allina Health
        • Contact:
        • Principal Investigator:
          • Andrea Wasilewski, MD, PhD
      • Minneapolis, Minnesota, United States, 55455
        • Recruiting
        • University of Minnesota Health Clinics and Surgery Center, Minneapolis
        • Principal Investigator:
          • Elizabeth Neil, MD
    • Missouri
      • Kansas City, Missouri, United States, 64111
        • Recruiting
        • Saint Lukes Neuro Oncology
        • Principal Investigator:
          • Samuel Goldlust, MD
      • St Louis, Missouri, United States, 63110
        • Recruiting
        • Washington University, School of Medicine
        • Principal Investigator:
          • Omar Butt, MD, PhD
    • New Jersey
      • Neptune City, New Jersey, United States, 07753
        • Recruiting
        • Jersey Shore University Medical Center
        • Principal Investigator:
          • Carlos Silva Correia, MD
      • Summit, New Jersey, United States, 07901
        • Recruiting
        • Atlantic Health System
        • Principal Investigator:
          • Robert Aiken, MD
    • New York
      • New Hyde Park, New York, United States, 11042
        • Recruiting
        • Northwell Health
        • Principal Investigator:
          • Michael Schulder, MD
      • New York, New York, United States, 10016
        • Recruiting
        • New York University Ambulatory Care Center
        • Principal Investigator:
          • Alexandra Miller, MD, PhD
      • The Bronx, New York, United States, 10461
        • Recruiting
        • Montefiore Medical Center
        • Principal Investigator:
          • Adilia Hormigo, MD, PhD
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Recruiting
        • Duke Cancer Center Brain Tumor Clinic
        • Principal Investigator:
          • Mustafa Khasraw, MD, FRACP, MRCP
      • Winston-Salem, North Carolina, United States, 27157
        • Recruiting
        • Wake Forest Baptist Health
        • Principal Investigator:
          • Glenn Lesser, MD
        • Contact:
    • Ohio
      • Cincinnati, Ohio, United States, 45267
        • Recruiting
        • University of Cincinnati Cancer Institute
        • Principal Investigator:
          • Lalanthica Yogendran, MD
      • Cleveland, Ohio, United States, 44195
        • Recruiting
        • The Cleveland Clinic Foundation
        • Principal Investigator:
          • David Peereboom, MD
      • Columbus, Ohio, United States, 43210
        • Recruiting
        • The Ohio State University
        • Principal Investigator:
          • Pierre Vinay Giglio, MD
    • Oregon
      • Portland, Oregon, United States, 97213
        • Recruiting
        • Providence Portland Medical Center
        • Principal Investigator:
          • Prakash Ambady, MD
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19107
        • Recruiting
        • Thomas Jefferson University
        • Principal Investigator:
          • Iyad Alnahhas, MD
        • Contact:
      • Pittsburgh, Pennsylvania, United States, 15232
        • Recruiting
        • University of Pittsburgh Medical Center Health System
        • Principal Investigator:
          • Serah Choi, MD, PhD
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Recruiting
        • Medical University of South Carolina - Department of Neurosurgery
        • Principal Investigator:
          • Alicia Zukas, MD
    • Texas
      • Temple, Texas, United States, 76508
        • Recruiting
        • Baylor Scott & White Health
        • Principal Investigator:
          • Jennifer Murillo, DO
    • Vermont
      • Burlington, Vermont, United States, 05401
        • Recruiting
        • The University of Vermont Medical Center
        • Principal Investigator:
          • Alissa Thomas, MD
        • Contact:
    • Washington
      • Seattle, Washington, United States, 98109
        • Recruiting
        • University of Washington Medical Center
        • Contact:
        • Principal Investigator:
          • Vyshak Venur, MD
    • Wisconsin
      • Madison, Wisconsin, United States, 53706
        • Recruiting
        • University of Wisconsin Cancer Center
        • Principal Investigator:
          • Ankush Bhatia, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Arm A: Niraparib
Drug: Niraparib
Participants will receive niraparib 200 mg orally once daily starting on Day 1 of RT. Following completion of RT, participants will continue niraparib adjuvant therapy orally once daily on Days 1 to 28 of each 28-day cycle until progression by BICR
Other Names:
  • Zejula
Active Comparator: Arm B: Temozolomide
Drug: Temozolomide
Participants randomized to the comparator arm (Arm B) will receive SOC TMZ 75 mg/m2 orally once daily with RT starting on Day 1 of RT. Following completion of RT, participants will complete a 4-week rest period, and then receive adjuvant TMZ 150 to 200 mg/m2 orally once daily on Days 1 to 5 of each 28-day cycle until progression by BICR or for a maximum of 6 cycles.
Other Names:
  • Temodar
  • TMZ

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall survival
Time Frame: 24 months
Overall survival, defined as the time from the date of randomization to the date of death due to any cause.
24 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression-free survival (PFS) assessed by Blinded Independent Central Review (BICR)
Time Frame: 24 months
Progression-free survival, defined as the time from the date of randomization to the date of first disease progression per RANO 2.0 by BICR assessment or death from any cause, whichever occurs first.
24 months
Overall response rate
Time Frame: 24 months
Percentage of patients who achieved confirmed complete response or confirmed partial response to treatment evaluated using RANO 2.0 by BICR.
24 months
Compare symptoms, function, and Health-related quality of life (HRQoL) and symptoms by EORTC QLQ-C30-item Core module (EORTC QLQ-C30) (Scores on a scale)
Time Frame: on Day 1 pre-dose or up to 7 days prior, on any day during the 6th week of RT, and on days of MRI at 4- and 12- weeks after RT, every 16 weeks thereafter on days of MRI
EORTC QLQ-C30 is a validated questionnaire to assess overall health-related quality of life in participants with cancer.
on Day 1 pre-dose or up to 7 days prior, on any day during the 6th week of RT, and on days of MRI at 4- and 12- weeks after RT, every 16 weeks thereafter on days of MRI
Compare symptoms, function, and Health-related quality of life (HRQoL) and symptoms by EORTC QLQ-BN20-item Core module (EORTC QLQ-BN20) (Scores on a scale)
Time Frame: on Day 1 pre-dose or up to 7 days prior, on any day during the 6th week of RT, and on days of MRI at 4- and 12- weeks after RT, every 16 weeks thereafter on days of MRI
EORTC QLQ-BN20 is a clinically valid and useful tool for assessing disease- and treatment-specific symptoms in brain neoplasm participants.
on Day 1 pre-dose or up to 7 days prior, on any day during the 6th week of RT, and on days of MRI at 4- and 12- weeks after RT, every 16 weeks thereafter on days of MRI
Changes from baseline in neurocognitive function assessed by Controlled Oral Word Association
Time Frame: on Day 1 pre-dose or up to 7 days prior, on any day during the 6th week of RT, and on days of MRI at 4- and 12- weeks after RT, every 16 weeks thereafter on days of MRI
The Controlled Oral Word Association Test is designed to evaluate verbal fluency. It requires participants to name words beginning with a specific letter with increasing associated activity, in 3 one-minute periods.
on Day 1 pre-dose or up to 7 days prior, on any day during the 6th week of RT, and on days of MRI at 4- and 12- weeks after RT, every 16 weeks thereafter on days of MRI
Changes from baseline in neurocognitive function assessed by Trail Making Test Parts A and B
Time Frame: on Day 1 pre-dose or up to 7 days prior, on any day during the 6th week of RT, and on days of MRI at 4- and 12- weeks after RT, every 16 weeks thereafter on days of MRI
The Trail Making Test Part A is designed to evaluate visual motor scanning speed, and the Trail Making Test Part B is designed to evaluate executive function. These tests require participants to connect circles in numerical (Part A) or alternating numerical and alphabetical sequence (Part B) within a timed interval of less than 5 minutes for each test.
on Day 1 pre-dose or up to 7 days prior, on any day during the 6th week of RT, and on days of MRI at 4- and 12- weeks after RT, every 16 weeks thereafter on days of MRI
Frequency and severity of symptomatic AEs based on PRO-CTCAE
Time Frame: 24 months
The PRO-CTCAE is a patient-reported outcome measure developed to evaluate symptomatic toxicity in patients on cancer clinical trials.
24 months
Compare symptoms, function, and Health-related quality of life (HRQoL) and symptoms by EQ-5D-3L
Time Frame: on Day 1 pre-dose or up to 7 days prior, on any day during the 6th week of RT, and on days of MRI at 4- and 12- weeks after RT, every 16 weeks thereafter on days of MRI
The EQ-5D-3L descriptive system comprises the following five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression.
on Day 1 pre-dose or up to 7 days prior, on any day during the 6th week of RT, and on days of MRI at 4- and 12- weeks after RT, every 16 weeks thereafter on days of MRI
Changes from baseline in neurocognitive function assessed by Hopkins Verbal Learning test
Time Frame: on Day 1 pre-dose or up to 7 days prior, on any day during the 6th week of RT, and on days of MRI at 4- and 12- weeks after RT, every 16 weeks thereafter on days of MRI
The Hopkins Verbal Learning Test is designed to evaluate memory. It requires participants to memorize a list of 12 items for 3 consecutive tests (recall), to identify the same 12 items from a list of semantically related or unrelated items (recognition), and to recall the same 12 items after a 15-minute delay (delayed recall).
on Day 1 pre-dose or up to 7 days prior, on any day during the 6th week of RT, and on days of MRI at 4- and 12- weeks after RT, every 16 weeks thereafter on days of MRI
Incidence of participants with adverse events (AEs), serious adverse events (SAEs) and adverse events of special interest (AESIs)
Time Frame: 24 months
AEs, SAEs and AESIs will be collected
24 months
Incidence of treatment discontinuations, dose interruptions, and dose reductions due to AEs, SAEs, or AESIs, changes in Karnofsky performance status, changes in clinical laboratory results, and vital sign measurements
Time Frame: 24 months
Treatment discontinuations, dose interruptions, and dose reductions
24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ivy Brain Tumor Center

Collaborators

GlaxoSmithKline

Investigators

  • Study Chair: Nader Sanai, MD, Ivy Brain Tumor Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 19, 2024

Primary Completion (Estimated)

December 1, 2027

Study Completion (Estimated)

March 1, 2028

Study Registration Dates

First Submitted

April 24, 2024

First Submitted That Met QC Criteria

April 24, 2024

First Posted (Actual)

April 29, 2024

Study Record Updates

Last Update Posted (Actual)

April 1, 2026

Last Update Submitted That Met QC Criteria

March 31, 2026

Last Verified

August 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IVY P3-24-021

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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