ClinicalTrials.gg
CompletedNCT03345095MIRAGEUpdated Jul 1, 2025Results posted

A Phase III Trial of With Marizomib in Patients With Newly Diagnosed Glioblastoma

A Phase 3 interventional study of Marizomib and Temozolomide in Newly Diagnosed Glioblastoma, sponsored by European Organisation for Research and Treatment of Cancer - EORTC. Completed at 82 sites in 12 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-07-01.

Sponsored by European Organisation for Research and Treatment of Cancer - EORTC · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
749
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 20 studies in Glioblastoma by European Organisation for Research and Treatment of Cancer - EORTC — 1 open to participants now, 1 under way, 1 of them phase 3. Glioblastoma · European Organisation for Research and Treatment of Cancer - EORTC.

Enrollment
Largest of 18
749 · median 55
Started
2018
with 1 other
Phase 3
5 of 20
1 open now
Registered
17th of 20
by date

Among the 20 studies in Glioblastoma by European Organisation for Research and Treatment of Cancer - EORTC, this one has the largest enrollment of the 18 interventional ones that give a count, is one of 2 that started in 2018, is one of 5 in phase 3, and was the 17th registered.

Glioblastoma

2,132 studies on the registry are indexed under Glioblastoma; 464 are open to participants now.

Browse Glioblastoma studies →

Open to participants now

1 of the 20 studies in Glioblastoma by European Organisation for Research and Treatment of Cancer - EORTC is open now, in 11 countries. Recruiting first, the newest first:

By country, each count listing its studies:

Who these studies take

Of the 339 Glioblastoma studies recruiting now, 234 (69%) set no upper age limit and 65 (19%) stop at 75 or younger; 27 take children under 18; 13 take healthy volunteers.

This study: 18 Years and older · all sexes · no healthy volunteers.

The full table on the hub →

This tab as a report to print or save as PDF → With an account.

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 20 studies in Glioblastoma by European Organisation for Research and Treatment of Cancer - EORTC, or all of them as a file.
02

Study summary

The standard of care for newly diagnosed glioblastoma includes surgery, involved-field radiotherapy, and concomitant and six cycles of maintenance temozolomide chemotherapy, however the prognosis remains dismal. Marizomib has been tested in patients with newly diagnosed and recurrent glioblastoma in phase I and phase II studies. In patients with recurrent glioblastoma, marizomib was administered as a single agent or in combination with bevacizumab (NCT02330562). Based on encouraging observations, a phase I/II trial of marizomib in combination with Temozolomide+Radiotherapy(TMZ/RT) followed by Temozolomide (TMZ) in newly diagnosed glioblastoma has been launched (NCT02903069) which explores safety and tolerability of this triple combination and which shall help to determine the dose for further clinical trials in glioblastoma. In this context, given that marizomib has been established as a safe addition to the standard TMZ/RT -->TMZ, a phase III study is considered essential to establishing its impact on overall survival.

03

Conditions studied

  • Newly Diagnosed Glioblastoma

Browse trials for

Keywords

  • Marizomib
  • Temozolomide
  • Glioblastoma
  • Phase III
04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

Inclusion Criteria:

  • confirmed newly diagnosed glioblastoma (WHO grade IV)
  • Tumor resection (gross total or partial), or only
  • Availability of formalin-fixed paraffin-embedded (FFPE) tumor block or 24 unstained slides for o6-methylguanine-DNA-methyltransferase (MGMT) analysis
  • Patient must be eligible for standard TMZ/RT + TMZ
  • performance score (KPS) ≥ 70
  • Recovered from effects of surgery, postoperative infection and other complications of surgery (if any)
  • The patient is at least 18 years of age on day of signing
  • Stable or decreasing dose of for at least 1 week prior to inclusion
  • The patient has a of at least 3 months
  • Patient has undergone a brain MRI within 14 days of randomization but after intervention (resection or biopsy)
  • The patient shows adequate organ functions as assessed by the specified laboratory values within 2 weeks prior to randomization defined as adequate bone marrow, renal and hepatic function within the following ranges:

    • white blood cell count (WBC) ≥ 3×10*9/L
    • (ANC) ≥ 1.5×10*9/L
    • count of ≥ 100×10*9/L independent of transfusion
    • ≥ 10 g/dl
    • Total ≤ 1.5 (ULN)
    • (ALT), aspartate aminotransferase (AST), alkaline phosphatase (ALP) ≤ 2.5 × ULN
    • Serum creatinine \< 1.5 x ULN or (CrCl) > 30 mL/min(using the Cockcroft-Gault formula)
  • Women of child bearing potential () must have a negative urine or serum pregnancy test within 7 days prior to the first dose of study treatment.
  • Patients of childbearing / must agree to use adequate measures, as defined by the investigator, during the study treatment period and for at least 6 months after the last study treatment. A highly effective method of birth control is defined as those which result in low failure rate (i.e. less than 1 percent per year) when used consistently and correctly. Patients must also agree not to donate sperm during the study and for 6 months after receiving the last dose of study treatment.
  • Women who are breast feeding must agree to discontinue nursing prior to the first dose of study treatment and until 6 months after the last study treatment.
  • Ability to take oral medication
  • Ability to understand the requirements of the study, provide written informed consent and authorization of use and disclosure of protected health information, and agree to abide by the study restrictions and return for the required assessments.
  • Before patient registration/randomization, written informed consent must be given according to International Council for Harmonisation (ICH) / Good clinical practice (GCP), and national/local regulations.
Terms in these criteria, in plain language(16)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Histologically or cytologically confirmed

The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).

Your pathology report is the document that shows this.

Biopsy and archival tissue

A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.

Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.

Karnofsky performance status (KPS)

A 0–100 scale of how well someone can carry out everyday activities. 100 is no complaints and no signs of illness; 70 is able to look after yourself but not to work or keep up normal activity; 50 is needing considerable help and frequent medical care.

Studies often ask for 60 or 70 and above. Your doctor gives the score.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

Life expectancy

The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.

Absolute neutrophil count (ANC)

The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.

It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.

Platelets

Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.

Hemoglobin (Hb)

The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).

Bilirubin

A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.

Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.

ULN (upper limit of normal)

The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.

“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.

ALT and AST (liver enzymes)

Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.

Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.

Creatinine clearance (CrCl)

How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.

Childbearing potential

Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).

Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.

Reproductive potential

Able to have children. For women this usually means from the first period until menopause, unless permanently unable to through surgery; for men, unless permanently sterile. Read who the line is about — participants, women, men, or their partners.

Criteria about it usually ask for contraception during the study and for a time after it.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
749 participants (actual)

Study arms

  • Experimental
    Experimental Arm

    Radiotherapy + Temozolomide + Marizomib followed by adjuvant Temozolomide + Marizomib

    Drug: Marizomib · Drug: Temozolomide · Radiation: radiotherapy

  • Active comparator
    Standard Arm

    Radiotherapy + Temozolomide followed by adjuvant Temozolomide

    Drug: Temozolomide · Radiation: radiotherapy

Interventions

  • Intravenous administration of Marizomib

  • Oral Administration of Temozolomide

    Also known as: TMZ

  • Radiationradiotherapy

    60 Gy in 30 fractions over 6 weeks

    Also known as: RT

06

What researchers measure

Primary outcomes

  1. Overall Survival (OS)

    Overall Survival (OS): OS is defined as the number of days from date of randomization to the date of death due to any cause. If a patient has not died, the data will be censored at the last date documented to be alive.

    Time frame: From the date of randomization up to the date of death, assessed up to 49 months

Secondary outcomes

  1. Progression Free Survival (PFS)

    PFS is defined as the number of days from date of randomization to the date of earliest disease progression based on Response Assessment in Neuro-Oncology criteria (by investigator) or to the date of death due to any cause, if disease progression does not occur. Patients for whom neither death nor progression have been documented were censored on the date of the last radiological assessment that the patient was progression-free. If a patient with no post-baseline radiological assessment then the data were censored at the date of randomization. Patients with two or more missing response assessments prior to a visit with documented disease progression (or death) were censored at the last visit where the patient was documented to be progression free. Patients who received new anti-cancer therapy or cancer-related surgery prior to progression or death were not censored at the last assessment where the patient was documented as progression free prior to the new therapy.

    Time frame: From the date of randomization until the date of first objective progression or the date of patient's death whichever occurs first, assessed up to 49 months

  2. Health-related Quality of Life (HRQol)

    HRQoL was assessed with the EORTC Quality of Life Questionnaire (QLQ-C30) version 3. The primary HRQol score is Physical Functioning. It is reported at week 16 during the Temozolomide (TMZ) maintenance phase. Physical functioning score is ranging 0 to 100. A large scores indicate a good physical functioning. A negative difference indicates a worsening physical functioning.

    Time frame: From randomization until progression or death which ever occurs first, reported at week 16 by the mean difference from baseline assessment.

  3. Mini Mental State Examination (MMSE)

    MMSE is a brief, standardized tool to grade patients' neurocognitive function. It is an 11-question measure that tests five areas of neurocognitive function: orientation, registration, attention and calculation, recall, and language. A large MMSE score indicates a good cognitive functioning. The maximum MMSE score is 30 which corresponds to the best neurocognitive function and minimum MMSE score is 0 the worst neurocognitive function.The patient's neurocognitive function are considered 'impaired' if MMSE is 26 or less and 'normal' if it is 27 or more. MMSE has been validated and extensively used in both clinical practice and research. It is reported at week 16 during the Temozolomide (TMZ) maintenance phase. A negative difference indicates a worsening cognitive functioning. Difference range reported in the data table is min -19 and max 10. The mean difference is reported with 95% confidence interval (CI). A CI which excludes 0 indicates a significant mean MMSE score change.

    Time frame: From the date of randomization until end of treatment. It is reported at week 16 by the mean difference from baseline assessment.

07

Results

Posted Jan 31, 2024

Participant flow

Patient registration was accepted from authorized investigators. Patients were registered on the Electronic Data Capture system. To access it, the investigator needed a user name and a password which were provided by the EORTC Headquarters. In case of problems investigators could contact the EORTC Clinical Data Manager. A Subject Identifier was allocated to the patient. This number allowed the identification of the patient in the Electronic Data Capture.

Participant flow — Overall Study
MilestoneExperimental ArmStandard Arm
Started374375
Completed1258
Not completed249367
Withdrew: Lack of efficacy184156
Withdrew: Adverse event36118
Withdrew: Withdrawal by subject2259
Withdrew: Physician decision318
Withdrew: Death24
Withdrew: Other reasons211
Withdrew: Protocol violation01

Outcome measures

PrimaryOverall Survival (OS)

Overall Survival (OS): OS is defined as the number of days from date of randomization to the date of death due to any cause. If a patient has not died, the data will be censored at the last date documented to be alive.

Time frame:
From the date of randomization up to the date of death, assessed up to 49 months
Reported as:
Median · Months
Overall Survival (OS)
MonthsExperimental ArmStandard Arm
Overall Survival (OS)16.13 (14.92 to 17.77)15.08 (13.73 to 16.99)
SecondaryProgression Free Survival (PFS)

PFS is defined as the number of days from date of randomization to the date of earliest disease progression based on Response Assessment in Neuro-Oncology criteria (by investigator) or to the date of death due to any cause, if disease progression does not occur. Patients for whom neither death nor progression have been documented were censored on the date of the last radiological assessment that the patient was progression-free. If a patient with no post-baseline radiological assessment then the data were censored at the date of randomization. Patients with two or more missing response assessments prior to a visit with documented disease progression (or death) were censored at the last visit where the patient was documented to be progression free. Patients who received new anti-cancer therapy or cancer-related surgery prior to progression or death were not censored at the last assessment where the patient was documented as progression free prior to the new therapy.

Time frame:
From the date of randomization until the date of first objective progression or the date of patient's death whichever occurs first, assessed up to 49 months
Reported as:
Median · Months
Progression Free Survival (PFS)
MonthsExperimental ArmStandard Arm
Progression Free Survival (PFS)6.34 (5.82 to 7.85)6.11 (4.93 to 7.29)
SecondaryHealth-related Quality of Life (HRQol)

HRQoL was assessed with the EORTC Quality of Life Questionnaire (QLQ-C30) version 3. The primary HRQol score is Physical Functioning. It is reported at week 16 during the Temozolomide (TMZ) maintenance phase. Physical functioning score is ranging 0 to 100. A large scores indicate a good physical functioning. A negative difference indicates a worsening physical functioning.

Time frame:
From randomization until progression or death which ever occurs first, reported at week 16 by the mean difference from baseline assessment.
Reported as:
Mean · score on a scale
Health-related Quality of Life (HRQol)
score on a scaleExperimental ArmStandard Arm
Health-related Quality of Life (HRQol)-11.8 (-15.0 to -8.7)-5.4 (-8.0 to -2.9)
Statistical analysis
  • Experimental Arm vs Standard Arm · Wilcoxon (Mann-Whitney) · p = 0.0004 · Mean difference (net): -6.4 · 95% CI -8.6 to -2.5
SecondaryMini Mental State Examination (MMSE)

MMSE is a brief, standardized tool to grade patients' neurocognitive function. It is an 11-question measure that tests five areas of neurocognitive function: orientation, registration, attention and calculation, recall, and language. A large MMSE score indicates a good cognitive functioning. The maximum MMSE score is 30 which corresponds to the best neurocognitive function and minimum MMSE score is 0 the worst neurocognitive function.The patient's neurocognitive function are considered 'impaired' if MMSE is 26 or less and 'normal' if it is 27 or more. MMSE has been validated and extensively used in both clinical practice and research. It is reported at week 16 during the Temozolomide (TMZ) maintenance phase. A negative difference indicates a worsening cognitive functioning. Difference range reported in the data table is min -19 and max 10. The mean difference is reported with 95% confidence interval (CI). A CI which excludes 0 indicates a significant mean MMSE score change.

Time frame:
From the date of randomization until end of treatment. It is reported at week 16 by the mean difference from baseline assessment.
Reported as:
Mean · score on a scale
Mini Mental State Examination (MMSE)
score on a scaleExperimental ArmStandard Arm
Mini Mental State Examination (MMSE)-0.95 (-1.51 to -0.38)-0.39 (-0.82 to 0.04)
Statistical analysis
  • Experimental Arm vs Standard Arm · Wilcoxon (Mann-Whitney) · p = 0.15 · Mean difference (net): -0.55 · 95% CI -1.27 to 0.16

Adverse events

Collected over Adverse Events (AEs) were collected from first dose of radiotherapy up to 49 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 49 months after patient enrolment in the study.. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Experimental Arm55/309 (17.8%)114/305 (37.4%)300/305 (98.4%)
Standard Arm57/307 (18.6%)80/297 (26.9%)283/297 (95.3%)
Most frequent serious events
Showing 10 of 153
Most frequent serious events
EventExperimental ArmStandard Arm
SeizureNervous system disorders15/30514/297
Brain OedemaNervous system disorders8/3058/297
Malignant Neoplasm ProgressionNeoplasms benign, malignant and unspecified (incl cysts and polyps)8/3055/297
Platelet Count DecreasedInvestigations2/3057/297
ThrombocytopeniaBlood and lymphatic system disorders7/3051/297
NauseaGastrointestinal disorders7/3051/297
Confusional StatePsychiatric disorders7/3053/297
HallucinationPsychiatric disorders7/3050/297
HeadacheNervous system disorders6/3052/297
General Physical Health DeteriorationGeneral disorders4/3055/297
Most frequent other events
Showing 10 of 642
Most frequent other events
EventExperimental ArmStandard Arm
NauseaGastrointestinal disorders205/305122/297
FatigueGeneral disorders188/305170/297
HeadacheNervous system disorders163/30592/297
VomitingGastrointestinal disorders158/30553/297
ConstipationGastrointestinal disorders126/30597/297
HallucinationPsychiatric disorders115/3051/297
AlopeciaSkin and subcutaneous tissue disorders73/30599/297
InsomniaPsychiatric disorders87/30536/297
Gait DisturbanceGeneral disorders72/30515/297
DizzinessNervous system disorders71/30531/297

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)Experimental ArmStandard ArmTotal
<=18 years000
Between 18 and 65 years287276563
>=65 years8799186
Age, Continuous
Age, Continuous(years)Experimental ArmStandard ArmTotal
Median58.5 (21 to 79)58.0 (20 to 79)58.0 (20 to 79)
Sex: Female, Male
Sex: Female, Male(Participants)Experimental ArmStandard ArmTotal
Female119142261
Male255233488
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Experimental ArmStandard ArmTotal
American Indian or Alaska Native011
Asian7512
Native Hawaiian or Other Pacific Islander101
Black or African American202
White279290569
More than one race000
Unknown or Not Reported8579164
Region of Enrollment
Region of Enrollment(participants)Experimental ArmStandard ArmTotal
Canada104108212
Austria6713
Netherlands454489
Belgium303262
United States211940
Norway448
Denmark91019
United Kingdom8715
France5554109
Switzerland202444
Germany383775
Spain342963
Karnofsky Performance Status
Karnofsky Performance Status(Participants)Experimental ArmStandard ArmTotal
70/80126123249
90/100248252500
Extent of surgery
Extent of surgery(Participants)Experimental ArmStandard ArmTotal
Gross total192192384
Partial/biopsy182183365
08

Study locations

82 sites
  • Mayo Clinic Scottsdale
    Scottsdale, Arizona 85259, United States
  • University of California at Irvine
    Orange, California 92868, United States
  • University of California
    San Francisco, California 94143-0372, United States
  • John Wayne Cancer Institute
    Santa Monica, California 90404, United States
  • University of Florida
    Gainesville, Florida 32610, United States
  • Mayo Clinic
    Jacksonville, Florida 32224-9980, United States
  • Mayo Clinic
    Rochester, Minnesota 55905, United States
  • Ohio State University Comprehensive Cancer Center
    Columbus, Ohio 43210, United States
  • Penn State College of Medicine, Hershey Medical Center-Penn State Neuroscience Institute
    Hershey, Pennsylvania 17033, United States
  • Innsbruck Universitaetsklinik
    Innsbruck, 6020, Austria
  • Kepler University Hospital
    Linz, 4020, Austria
  • Medical University Vienna - General Hospital AKH
    Vienna, 1090, Austria
  • Onze Lieve Vrouw Ziekenhuis
    Aalst, 9300, Belgium
  • GasthuisZusters Antwerpen - Sint-Augustinus
    Antwerp, Belgium
  • Hopitaux Universitaires Bordet-Erasme - Hopital Universitaire Erasme
    Brussels, 1070, Belgium
  • Cliniques Universitaires Saint-Luc
    Brussels, Belgium
  • Grand Hopital de Charleroi - Grand Hôpital de Charleroi - Site Notre Dame
    Charleroi, Belgium
  • Universitair Ziekenhuis Gent
    Ghent, 9000, Belgium
  • C.H.U. Sart-Tilman
    Liège, Belgium
  • Saint John Regional Hospital
    Saint John, New Brunswick E2L 4L2, Canada
  • London Regional Cancer Center
    London, Ontario N6A 4L6, Canada
  • Ottawa Health Research Institute
    Ottawa, Ontario K1Y 4K7, Canada
  • Windsor Regional Cancer Centre
    Windsor, Ontario, Canada
  • Centre Hospitalier Universitaire de Sherbrooke-Fleurimont
    Sherbrooke, Quebec J1H 5N4, Canada
  • BCCA - Abbotsford Centre
    Abbotsford British Columbia, Canada
  • Tom Baker Cancer Centre
    Calgary, AB T2N 4N2, Canada
  • Regional Cancer Program of Hopital Reg. de Sudbury Reg. Hospital
    Greater Sudbury, Canada
  • QEII Health Sciences Centre-Capital District Health Authority
    Halifax, CA B3H 1V7, Canada
  • Hamilton Health Sciences, Juravinski Cancer Centre
    Hamilton, Canada
  • Kingston Health Sciences Centre
    Kingston, CA K7L 2V7, Canada
  • Montreal Neurological Institute and Hospital McGill University
    Montreal, H3A 2B4, Canada
  • CHUM - Centre Hospitalier de l'Université de Montreal - Hopital Notre-Dame
    Montreal, Canada
  • Hopital Du Sacre-Coeur De Montreal
    Montreal, Canada
  • CHU de Quebec-Hopital l'Enfant-Jesus (HEJ)
    Québec, Canada
  • Allan Blair Cancer Centre
    Regina, Canada
  • Sault Area Hospital
    Sault Ste. Marie, Canada
  • Odette Cancer Centre - Sunnybrook Health Sciences Centre
    Toronto, Canada
  • University Health Network - Oci / Princess Margaret Hospital
    Toronto, Canada
  • Centre hospitalier regional de Trois-Rivieres
    Trois-Rivières, Canada
  • BC Cancer Agency
    Vancouver, V5Z4E9, Canada
  • Bcca - Vancouver Island Cancer Centre
    Victoria, BC V8R 6V5, Canada
  • Cancercare Manitoba
    Winnipeg, Canada
  • Aarhus University Hospitals - Aarhus University Hospital
    Aarhus, 8000, Denmark
  • University Hospitals Copenhagen - Rigshospitalet
    Copenhagen, 2100, Denmark
  • Centre Hospitalier Departemental Vendée
    La Roche-sur-Yon, Vendee 85925, France
  • CHU de Lyon - CHU Lyon - Hopital neurologique Pierre Wertheimer
    Bron, 69677, France
  • CHRU de Lille
    Lille, France
  • Institut de Cancerologie de l'Ouest
    Nantes, France
  • Assistance Publique - Hopitaux de Paris - La Pitie Salpetriere
    Paris, France
  • Gustave Roussy
    Villejuif, France
  • Universitaetsklinikum Bonn
    Bonn, 53105, Germany
  • Universitaetsklinik Erlangen-Neurologische Klinik
    Erlangen, 91054, Germany
  • Klinikum Der J.W. Goethe Universitaet-Klinik und Poliklinik fur Neurochirurgie
    Frankfurt, 60528, Germany
  • UniversitaetsKlinikum Heidelberg - Head Hospital
    Heidelberg, 69120, Germany
  • Universitaetsklinikum Leipzig-Klinik für Strahlentherapie und Radioonkologie
    Leipzig, 04103, Germany
  • Johannes Gutenberg Universitaetskliniken - Mainz University Medical Center
    Mainz, 55131, Germany
  • UniversitaetsMedizin Mannheim
    Mannheim, 68167, Germany
  • Technische Universitaet Muenchen - Klinikum Rechts Der Isar
    München, 81675, Germany
  • Universitaetskliniken Regensburg
    Regensburg, 93053, Germany
  • Universitaetsklinikum Tuebingen- Crona Kliniken
    Tübingen, 72076, Germany
  • Catharina Ziekenhuis
    Eindhoven, North Brabant 5602, Netherlands
  • Spaarne Gasthuis - Vrije Universiteit Medisch Centrum
    Amsterdam, Netherlands
  • The Netherlands Cancer Institute-Antoni Van Leeuwenhoekziekenhuis
    Amsterdam, Netherlands
  • University Medical Center Groningen
    Groningen, Netherlands
  • Academisch Ziekenhuis Maastricht
    Maastricht, 6202, Netherlands
  • Radboud University Medical Center Nijmegen
    Nijmegen, 6525, Netherlands
  • Erasmus MC
    Rotterdam, Netherlands
  • Medisch Centrum Haaglanden - Westeinde
    The Hague, 2501, Netherlands
  • Universitair Medisch Centrum - Academisch Ziekenhuis
    Utrecht, 3584, Netherlands
  • Oslo University Hospital - Radiumhospitalet
    Oslo, Norway
  • Institut Catala d'Oncologia - ICO Badalona - Hospital Germans Trias i Pujol (Institut Catala D'Oncologia)
    Badalona, Spain
  • Hospital Clinic Universitari de Barcelona
    Barcelona, 08036, Spain
  • Institut Catala D'Oncologia
    L'Hospitalet de Llobregat, 08908, Spain
  • Hospital Universitario 12 De Octubre
    Madrid, 28041, Spain
  • Clinica Universidad de Navarra - Clinica Universitaria De Navarra
    Pamplona, Spain
  • University Hospital of Geneva
    Geneva, Switzerland
  • Centre Hospitalier Universitaire Vaudois
    Lausanne, Switzerland
  • Kantonsspital
    Sankt Gallen, Switzerland
  • UniversitaetsSpital
    Zurich, Switzerland
  • NHS Lothian - Western General Hospital
    Edinburgh, EH4 2XU, United Kingdom
  • Guy's and St Thomas' NHS - Guy s and St Thomas' NHS - Guy's Hospital
    London, United Kingdom
  • Sheffield Teaching Hospitals NHS Foundation Trust - Weston Park Hospital
    Sheffield, S10 2SJ, United Kingdom
09

References and documents

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

10

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Jul 2018 to primary completion in Aug 2022, 48 months.

Results were first posted in Jan 2024, 1 year 5 months after primary completion.

Of 43 phase 3 interventional studies under Glioblastoma, half reached primary completion within 48 months of starting (the median), counting those still running; a quarter within 44 and three quarters within 87. This study's 48 months is close to that.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 7, 2017
First posted
Nov 17, 2017
StartActual
Jul 26, 2018
Primary completionActual
Aug 23, 2022
CompletionActual
Jun 30, 2023
Results first posted
Jan 31, 2024
Last update
Jul 1, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 1, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT03345095
Collaborators
Celgene, Canadian Cancer Trials Group
Responsible party
Sponsor
First posted
Nov 17, 2017
Start date
Jul 26, 2018
Primary completion
Aug 23, 2022
Completion
Jun 30, 2023
Results posted
Jan 31, 2024
Last update
Jul 1, 2025

Study contacts

Patrick Roth
principal investigator · EORTC Study Coordinator

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jun 2025. You cannot join it, but the record below documents what was studied.

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Discussion

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Studies of the drug tested here: Marizomib

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