Actively Recruiting
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
95
Research Sites
13 weeks
Total Duration
On this page
Sponsors
I
Ivy Brain Tumor Center
Lead Sponsor
G
GlaxoSmithKline
Collaborating Sponsor
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
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
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 6 months or until disease progression
Participants receive either niraparib or temozolomide along with radiation therapy, followed by adjuvant therapy until disease progression or treatment completion.
Daily oral medication during radiation therapy and adjuvant cycles with regular visits for assessments and MRI scans
Duration - Up to 24 months
Participants are monitored for overall survival, progression, symptoms, quality of life, neurocognitive function, and adverse events after treatment ends.
Visits on days of MRI at 4 and 12 weeks after radiation therapy and every 16 weeks thereafter
Trial Site Locations
Total: 95 locations
1
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35233
Actively Recruiting
2
Ivy Brain Tumor Center
Phoenix, Arizona, United States, 85013
Actively Recruiting
3
Scripps Cancer Center
La Jolla, California, United States, 92037
Actively Recruiting
4
Moores UCSD Cancer Center
La Jolla, California, United States, 92093
Actively Recruiting
5
Smilow Cancer Hospital at Yale New Haven
Guilford, Connecticut, United States, 06437
Actively Recruiting
6
Indiana University
Indianapolis, Indiana, United States, 46202
Actively Recruiting
7
The NeuroMedical Center
Baton Rouge, Louisiana, United States, 70809
Actively Recruiting
8
MaineHealth Maine Medical Center Care
South Portland, Maine, United States, 04106
Actively Recruiting
9
Tufts Medical Center
Boston, Massachusetts, United States, 02111
Actively Recruiting
10
University of Michigan Rogel Cancer Center
Ann Arbor, Michigan, United States, 48109
Actively Recruiting
11
Allina Health
Minneapolis, Minnesota, United States, 55407
Actively Recruiting
12
University of Minnesota Health Clinics and Surgery Center, Minneapolis
Minneapolis, Minnesota, United States, 55455
Actively Recruiting
13
Saint Lukes Neuro Oncology
Kansas City, Missouri, United States, 64111
Actively Recruiting
14
Washington University, School of Medicine
St Louis, Missouri, United States, 63110
Actively Recruiting
15
Jersey Shore University Medical Center
Neptune City, New Jersey, United States, 07753
Actively Recruiting
16
Atlantic Health System
Summit, New Jersey, United States, 07901
Actively Recruiting
17
Northwell Health
New Hyde Park, New York, United States, 11042
Actively Recruiting
18
New York University Ambulatory Care Center
New York, New York, United States, 10016
Actively Recruiting
19
Montefiore Medical Center
The Bronx, New York, United States, 10461
Actively Recruiting
20
Duke Cancer Center Brain Tumor Clinic
Durham, North Carolina, United States, 27710
Actively Recruiting
21
Wake Forest Baptist Health
Winston-Salem, North Carolina, United States, 27157
Actively Recruiting
22
University of Cincinnati Cancer Institute
Cincinnati, Ohio, United States, 45267
Actively Recruiting
23
The Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44195
Actively Recruiting
24
The Ohio State University
Columbus, Ohio, United States, 43210
Actively Recruiting
25
Providence Portland Medical Center
Portland, Oregon, United States, 97213
Actively Recruiting
26
Thomas Jefferson University
Philadelphia, Pennsylvania, United States, 19107
Actively Recruiting
27
University of Pittsburgh Medical Center Health System
Pittsburgh, Pennsylvania, United States, 15232
Actively Recruiting
28
Medical University of South Carolina - Department of Neurosurgery
Charleston, South Carolina, United States, 29425
Actively Recruiting
29
Baylor Scott & White Health
Temple, Texas, United States, 76508
Actively Recruiting
30
The University of Vermont Medical Center
Burlington, Vermont, United States, 05401
Actively Recruiting
31
University of Washington Medical Center
Seattle, Washington, United States, 98109
Actively Recruiting
32
University of Wisconsin Cancer Center
Madison, Wisconsin, United States, 53706
Actively Recruiting
33
St Vincent's Hospital Melbourne
Fitzroy, Victoria, Australia, 3065
Actively Recruiting
34
Austin Health
Heidelberg, Victoria, Australia, 3084
Actively Recruiting
35
Peter MacCallum Cancer Centre
Melbourne, Victoria, Australia, 3000
Actively Recruiting
36
Bayside Health (formerly The Alfred Hospital)
Melbourne, Victoria, Australia, 3004
Actively Recruiting
37
BC Cancer - Vancouver
Vancouver, British Columbia, Canada, V5Z 4E6
Actively Recruiting
38
Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada, M4N 3M5
Actively Recruiting
39
University Health Network - Princess Margaret Cancer Centre
Toronto, Ontario, Canada, M5G 2M9
Actively Recruiting
40
CHUM (Centre hospitalier de l'Université de Montréal)
Montreal, Quebec, Canada, H2X 0C1
Actively Recruiting
41
Centre Hospitalier Universitaire de Sherbrooke
Sherbrooke, Quebec, Canada, J1H 5N4
Actively Recruiting
42
CHU Nice - Hôpital Pasteur
Nice, Alpes Maritimes, France, 06001
Actively Recruiting
43
Hôpital de la Timone
Marseille, Bouches-du-Rhône, France, 13385
Actively Recruiting
44
Institut du Cancer de Montpellier
Montpellier, Herault, France, 34298
Actively Recruiting
45
CRLCC Eugene Marquis
Rennes, Ille et Vilaine, France, 35000
Actively Recruiting
46
ICO - Site René Gauducheau
Saint-Herblain, Loire Atlantique, France, 44800
Actively Recruiting
47
Groupe Hospitalier Pitie-Salpetriere
Paris, Paris, France, 75013
Actively Recruiting
48
Centre Hospitalier Universitaire de Lyon-Hospices Civils de Lyon-Hopital Pierre Wertheimer
Bron, Rhone, France, 69500
Actively Recruiting
49
Centre Leon Berard
Lyon, Rhone, France, 69008
Actively Recruiting
50
CHU Amiens-Picardie - Site Sud
Amiens, Somme, France, 80054
Actively Recruiting
51
Centre Georges François Leclerc
Dijon, France, 21079
Actively Recruiting
52
Universitaetsklinikum Heidelberg
Heidelberg, Baden-Wurttemberg, Germany, 69120
Actively Recruiting
53
Universitaetsmedizin Mannheim
Mannheim, Baden-Wurttemberg, Germany, 68167
Actively Recruiting
54
Universitaetsklinikum Tuebingen
Tübingen, Baden-Wurttemberg, Germany, 72076
Actively Recruiting
55
Universitaetsklinikum Regensburg
Regensburg, Bavaria, Germany, 93053
Actively Recruiting
56
Universitaetsklinikum Bonn AoeR
Bonn, North Rhine-Westphalia, Germany, 53127
Actively Recruiting
57
Klinikum Chemnitz gGmbH
Chemnitz, Saxony, Germany, 09116
Actively Recruiting
58
Universitaetsklinikum Leipzig
Leipzig, Saxony, Germany, 04103
Actively Recruiting
59
Vivantes Klinikum Neukoelln
Berlin, State of Berlin, Germany, 12351
Actively Recruiting
60
IRCCS Istituto delle Scienze Neurologiche di Bologna
Bologna, Bologna, Italy, 40139
Actively Recruiting
61
Azienda Ospedaliera Universitaria Careggi
Florence, Firenze, Italy, 50134
Actively Recruiting
62
Fondazione IRCCS Istituto Neurologico Carlo Besta
Milan, Milano, Italy, 20133
Actively Recruiting
63
Istituto Clinico Humanitas
Rozzano, Milano, Italy, 20089
Actively Recruiting
64
A.S.L. Napoli 1 Centro Ospedale del Mare
Naples, Napoli, Italy, 80147
Actively Recruiting
65
IOV - Istituto Oncologico Veneto IRCCS
Padova, Padova, Italy, 35128
Actively Recruiting
66
Azienda Ospedaliera Universitaria Policlinico Umberto I - Università di Roma La Sapienza
Rome, Roma, Italy, 00161
Actively Recruiting
67
Azienda Ospedaliero-Universitaria Città della Salute e della Scienza di Torino
Torino, Torino, Italy, 10124
Actively Recruiting
68
Maastricht UMC
Maastricht, Netherlands, 6229 HX
Actively Recruiting
69
UMC Utrecht
Utrecht, Netherlands, 3584 CX
Actively Recruiting
70
Oslo Universitetssykehus HF, Radiumhospitalet
Oslo, Norway, 0379
Actively Recruiting
71
St. Olavs Hospital Hf, Universitetssykehuset i Trondheim
Trondheim, Norway, 7030
Actively Recruiting
72
Hospital del Mar
Barcelona, Barcelona, Spain, 08003
Actively Recruiting
73
Hospital Universitari Vall d'Hebron
Barcelona, Barcelona, Spain, 08035
Actively Recruiting
74
Hospital Clinic de Barcelona
Barcelona, Barcelona, Spain, 08036
Actively Recruiting
75
Hospital Universitario Reina Sofia
Córdoba, Córdoba, Spain, 14004
Actively Recruiting
76
ICO Girona - Hospital Universitari de Girona Dr Josep Trueta
Girona, Girona, Spain, 17007
Actively Recruiting
77
Hospital Universitario Ramon y Cajal
Madrid, Madrid, Spain, 28034
Actively Recruiting
78
Hospital Universitario 12 de Octubre
Madrid, Madrid, Spain, 28041
Actively Recruiting
79
Hospital Universitario HM Madrid Sanchinarro
Madrid, Madrid, Spain, 28050
Actively Recruiting
80
Clinica Universidad de Navarra
Pamplona, Navarre, Spain, 31008
Actively Recruiting
81
Hospital Clinico Universitario de Salamanca
Salamanca, Salamanca, Spain, 37370
Actively Recruiting
82
Hospital Universitario Virgen del Rocio
Seville, Sevilla, Spain, 41013
Actively Recruiting
83
ICO l'Hospitalet - Hospital Duran i Reynals
Barcelona, Spain, 08906
Actively Recruiting
84
Universitaetsspital Basel
Basel, Switzerland, 4031
Actively Recruiting
85
Ente Ospedaliero Cantonale
Bellinzona, Switzerland, 6500
Actively Recruiting
86
Inselspital - Universitaetsspital Bern
Bern, Switzerland, 3010
Actively Recruiting
87
Universitaetsspital Zürich
Zurich, Switzerland, 8091
Actively Recruiting
88
Bristol Haematology and Oncology Centre
Bristol, Avon, United Kingdom, BS2 8ED
Actively Recruiting
89
Addenbrooke's Hospital
Cambridge, Cambridgeshire, United Kingdom, CB2 0QQ
Actively Recruiting
90
The Christie Hospital
Manchester, Greater Manchester, United Kingdom, M20 4BX
Actively Recruiting
91
The Clatterbridge Cancer Centre
Metropolitan Borough of Wirral, Merseyside, United Kingdom, CH63 4JY
Actively Recruiting
92
Velindre Cancer Centre
Cardiff, South Glamorgan, United Kingdom, CF14 2TL
Actively Recruiting
93
Beatson West of Scotland Cancer Centre
Glasgow, Strathclyde, United Kingdom, G12 0YN
Actively Recruiting
94
Queen Elizabeth Hospital
Birmingham, West Midlands, United Kingdom, B15 2TH
Actively Recruiting
95
Guy's Hospital
London, United Kingdom, SE1 9RT
Actively Recruiting
Research Team
S
Study Navigator
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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