ClinicalTrials.gg
RecruitingNCT06809322VIGORUpdated Oct 7, 2026

Vorasidenib Maintenance for IDH Mutant Astrocytoma

A Phase 3 interventional study of Vorasidenib and Vorasidenib Placebo in IDH-mutant Grade 2 or 3 Astrocytoma, sponsored by European Organisation for Research and Treatment of Cancer - EORTC. Recruiting at 59 sites in 12 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-07.

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

From the registry’s dates

  • Started Jan 2026; still recruiting 9 months later.
Updated Oct 7, 2026Site recruiting status changedGo to Updates ↓
Phase
Phase 3
Study type
Interventional
Enrollment
468
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

The main goal of VIGOR is to demonstrate that vorasidenib maintenance therapy improves locally assessed progression-free survival (PFS) from enrolment compared to placebo in patients with IDH-mutant, CNS5 WHO Grade 2 or 3 astrocytoma following the completion of first-line chemoradiotherapy.

The primary endpoint is Progression-free survival (PFS), as assessed locally from the date of enrolment using the RANO 2.0 criteria.

In this a comparative, randomized (1:1), triple blinded, multicentre phase III superiority trial with one stopping rule for efficacy and futility after end of enrolment, participants in the experimental arm will receive vorasidenib orally once daily at a dose of 40 mg in continuous 28-day cycles while participants in the control arm will receive a matched oral placebo once daily in continuous 28-day cycles

Read the detailed description

Diffuse gliomas are the most common primary brain tumors in adults and are associated with high morbidity and mortality. Approximately 25% of diffuse gliomas harbour mutations in the isocitrate dehydrogenase (IDH) 1 or 2 genes. Among IDH-mutated gliomas, IDH-mutant astrocytoma is the most common diagnosis and occurs mainly in adults in their thirties or forties. Most cases correspond to CNS5 WHO grade 2 and 3, while grade 4 tumors are rare. The prognosis of grade 2 and 3 tumors is significantly better (median overall survival times up to 10 years) than that of grade 4 tumors (median overall survival times around 3-7 years).

According to international guidelines and based on randomized clinical trials, treatment options for IDH-mutated astrocytoma after maximum safe neurosurgical resection include active surveillance or radiotherapy followed by chemotherapy with procarbazine, lomustine and vincristine (PCV) or temozolomide. An active surveillance strategy, however, can be recommended for patients with oligodendroglioma grade 2 or astrocytoma grade 2 with particularly favourable prognostic factors, such as absence of neurological deficits and limited tumor burden. Despite this multimodal treatment, IDH-mutant astrocytomas recur and ultimately lead to patient death, with median progression-free survival times around 7 years and overall survival times of approximately 9-11 years. Novel treatment strategies are needed to extend the survival of these patients.

Recently, the international randomized placebo-controlled phase III INDIGO trial has shown considerable efficacy on progression free survival of the mutant IDH inhibitor vorasidenib in patients with IDH-mutant diffuse grade 2 gliomas that were considered candidates for an active surveillance strategy by the treating physician. Vorasidenib (AG881) is an orally available brain-penetrant dual inhibitor of mutant IDH1 and IDH2 proteins. INDIGO enrolled patients with residual or recurrent non-enhancing grade 2 IDH-mutant glioma who had not received prior radiotherapy or chemotherapy. Participants received either vorasidenib (40 mg once daily) or a matched placebo, given continuously in 28-day cycles. From January 2020 through February 2022, a total of 331 participants were randomly assigned to receive vorasidenib (168 participants) or placebo (163 participants ). The image-based progression-free survival was significantly longer for participants in the vorasidenib group than in the placebo group: 27.7 months (95% CI, 17.0 to non-estimable) vs 11.1 months (95% CI, 11.0-13.7), with a hazard-ratio for disease progression or death of 0.39 (95% CI, 0.27-0.56, p\<0.001). Additionally, time to next intervention was significantly delayed in the vorasidenib group as compared to the placebo group with a hazard ratio of 0.26 (95% CI, 0.15-0.43, p\<0.001). Adverse events leading to treatment interruption occurred in 3.6% of the vorasidenib group and 1.2% of the placebo group. An increased alanine amino transferase level of grade 3 or higher occurred in 9.6% of participants receiving vorasidenib and in none of the participants receiving placebo. Overall, based on the INDIGO trial data, registrational approval by the FDA was granted in August 2024 and EMA approval is expected. Vorasidenib is likely to enter routine clinical practice for patients with IDH-mutant gliomas that do not require immediate chemoradiotherapy.

In the current trial, the investigator will evaluate whether adding vorasidenib as maintenance therapy after completion of standard chemoradiotherapy in patients with astrocytoma, IDH-mutant, CNS5 WHO Grade 2 or 3 prolongs progression-free survival compared to placebo. This trial will also explore the effect of vorasidenib maintenance treatment on overall survival, response rate, time to next intervention, toxicity, health-related quality of life, neurological symptoms, and neurocognitive function. Additionally, this trial will enable translational research through the analysis of tissue samples, liquid biopsies (blood samples), and neuroimaging data.

Overall, VIGOR aims to establish a new standard of care for IDH-mutated, CNS5 WHO Grade 2 or 3 astrocytoma by incorporating maintenance targeted therapy with vorasidenib into the current standard of care chemoradiotherapy.

02

Conditions studied

  • IDH-mutant Grade 2 or 3 Astrocytoma

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Keywords

  • Astrocytoma
  • IDH-mutant grade 2 or 3
  • Vorasidenib
  • Placebo- controlled
  • Triple-blinded
  • Phase III study
03

In context

Astrocytoma

688 studies on the registry are indexed under Astrocytoma; 80 are open to participants now.

This study's planned enrollment of 468 is above the median of 31 across 531 interventional studies indexed under Astrocytoma.

Browse Astrocytoma studies →

Lead sponsor

European Organisation for Research and Treatment of Cancer - EORTC is the lead sponsor of 352 studies on the registry; 23 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Before participant's enrolment, written must be given according to ICH/GCP, and national/local regulations.
  • Age ≥ 18 years
  • Integrated diagnosis of astrocytoma, IDH-mutant, WHO CNS5 grade 2 or 3, per local assessment
  • Documented IDH1 or IDH2 mutation based on local testing of tumour tissue
  • At least 1 prior surgery for glioma (, partial resection, gross-total resection)
  • Completed standard of care radiotherapy (minimum 50.4 Gy, photons or protons allowed) followed by SoC chemotherapy (i.e., either 4-12 cycles of temozolomide or 2-6 cycles of PCV).
  • Adequate bone marrow function: ≥ 1.5 x 109/L, ≥ 9 g/dL, 100 x 109/ L.
  • Adequate renal function: serum creatinine ≤ 2.0 x , or creatine clearance > 40 mL/min, as calculated based on 2021 formula.
  • Adequate hepatic function:

    • Total ≤ 1.5 × ULN (except for patients with Gilbert's syndrome who are excluded if total bilirubin > 3.0 × ULN or direct bilirubin ≥1.5 × ULN)
    • (ALT) and aspartate aminotransferase (AST) ≤ 1.5 x ULN.
    • Alkaline phosphatase (ALP) ≤ 2.5 x ULN.
  • Recovered from any toxicity of the previous chemoradiotherapy cycle unless stable and manageable per investigator´s judgement
  • 0-2
  • Stable or decreasing dose, or no use of corticoids, for at least 7 days prior to enrollment.
  • Baseline brain MRI available, as defined in the schedule of assessments
  • Available FFPE tumour tissue from prior neurosurgery for central biobanking and translational research
  • Women of (WOCBP) must have a negative serum pregnancy test within two weeks prior to enrolment.
  • Participants of childbearing / should use two adequate methods of , including a highly effective method and a barrier method during the study treatment period and for at least 90 days after the last dose of treatment.

Exclusion criteria

Exclusion Criteria:

  • Presence of 1p19q co-deletion, per local assessment.
  • Tumour recurrence or progression per RANO 2.0 criteria between first day of radiotherapy and enrolment, per local assessment
  • Last chemotherapy dose of chemoradiotherapy less than 6 weeks or more than 12 weeks before enrolment
  • Prior therapy with an IDH inhibitor or IDH vaccine
  • Any prior or concurrent whose natural history or treatment has the potential to interfere with the safety or efficacy assessment of the regimen.
  • Integrated diagnosis of astrocytoma, IDH-mutated, CNS5 WHO grade 4
  • Pregnancy or breastfeeding
  • Significant known active cardiac disease within 6 months before enrollment, including Class III or IV congestive heart failure, myocardial infarction, unstable angina, and/or stroke.
  • Known to any of the components of vorasidenib.
  • Ongoing use of medications that are CYP2C8, CYP2C9, CYP2C19, or substrates with a narrow therapeutic index. Participants must be transferred to other medications before receiving the first dose of study drug.
  • Known active virus (HBV) or virus (HCV) infection, known positive antibody results, or AIDS-related illness.

Participants with a sustained viral response to HCV treatment or immunity to prior HBV infection will be permitted. Participants with chronic HBV that is adequately suppressed by institutional practice will be permitted.

  • Known active inflammatory gastrointestinal disease, chronic diarrhea, previous gastric resection or lap band dysphagia, short-gut syndrome, gastroparesis, or other condition that limits the gastrointestinal absorption of drugs administered orally.

Gastroesophageal reflux disease under medical treatment is allowed (assuming no drug interaction potential).

  • Inability or known to undergo contrast media MRI.
  • Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be assessed and discussed with the patient before the enrolment in the trial.
Terms in these criteria, in plain language(26)

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.

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.

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.

Line of therapy

A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.

“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.

Adjuvant and neoadjuvant

Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.

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.

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).

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.

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.

GFR and eGFR (kidney filtering)

GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².

Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.

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.

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.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

ECOG performance status

A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.

0
Fully active, no restrictions.
1
Limited in strenuous activity, but walking and able to do light work, such as housework or office work.
2
Walking and able to look after yourself, but unable to work; up and about more than half of waking hours.
3
Able to look after yourself only in part; in bed or a chair more than half of waking hours.
4
Unable to look after yourself at all; in bed or a chair all day.

Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.

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.

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.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

NYHA class (heart failure)

The New York Heart Association’s four classes of how much heart failure limits physical activity.

I
No limits: ordinary activity causes no undue tiredness or breathlessness.
II
Slight limits: comfortable at rest, ordinary activity causes symptoms.
III
Marked limits: comfortable at rest, less than ordinary activity causes symptoms.
IV
Symptoms even at rest; any activity makes them worse.

Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

CYP3A (CYP3A4) inhibitors and inducers

CYP3A is a group of enzymes, mainly CYP3A4, in the liver and gut that break down many medicines. Some medicines, supplements and foods (grapefruit, St John’s wort) slow them down or speed them up, which changes how much of a study drug stays in the body.

Studies list them so they can be avoided or switched; bring a list of everything you take, including supplements.

Hepatitis B tests

Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.

Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.

Hepatitis C tests

Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.

After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
468 participants (estimated)

Study arms

  • Experimental
    Experimental arm

    Participants will receive vorasidenib orally once daily at a dose of 40 mg in continuous 28-day cycles up to 5 years or until disease progression, unacceptable toxicity, or withdrawal of patient consent.

    Drug: Vorasidenib

  • Placebo comparator
    Control arm

    Participants will receive a matched oral vorasidenib placebo once daily in continuous 28-day cycles until disease progression, unacceptable toxicity, or withdrawal of patient consent for up to 5 years.

    Drug: Vorasidenib Placebo

Interventions

  • Vorasidinib will be administered orally once daily at a dose of 40 mg in continuous 28-day cycles

  • DrugVorasidenib Placebo

    Matched oral vorasidenib placebo will be administered once daily in continuous 28-day cycles

06

What researchers measure

Primary outcomes

  1. Progression-free survival (PFS) by local assessment

    Progression-free survival (PFS) will be defined as the number of days from date of enrolment to the date of earliest disease progression based on Response Assessment (RANO 2.0) or to the date of death due to any cause, if disease progression did not occur (the date of progression or death or censoring - date of enrolment + 1). Patients who received new anti-cancer therapy or cancer-related surgery or radiotherapy prior to progression or death will not be censored at the last assessment where the patient was documented as progression free prior to the new anti-cancer therapy or cancer-related surgery or radiotherapy, instead progression after start of new therapy or surgery will be considered a valid event for PFS.

    Time frame: ~7.7 years and 10.5 years from first patient in

Secondary outcomes

  1. PFS by local assessment

    Progression-free survival (PFS) will be defined as the number of days from date of enrolment to the date of earliest disease progression based on Response Assessment (RANO 2.0) or to the date of death due to any cause, if disease progression did not occur (the date of progression or death or censoring - date of enrolment + 1). Patients who received new anti-cancer therapy or cancer-related surgery or radiotherapy prior to progression or death will not be censored at the last assessment where the patient was documented as progression free prior to the new anti-cancer therapy or cancer-related surgery or radiotherapy, instead progression after start of new therapy or surgery will be considered a valid event for PFS.

    Time frame: ~7.7 years and 10.5 years from first patient in

  2. Progression-free survival (PFS) from the start of radiotherapy

    Progression-free survival from the start of radiotherapy will be defined as the number of days from date of start of radiotherapy till progression or censoring with the same rules as for PFS.

    Time frame: ~7.7 years and 10.5 years from first patient in

  3. Overall Survival

    Overall survival (OS) will be defined as the number of days from date of enrolment to the date of death due to any cause (the date of death or censoring - date of enrolment +1). If a subject has not died, the data will be censored at the last date documented to be alive. Patients still alive (or not known to have died before the cutoff date) or lost to follow-up are censored at the last date known to be alive.

    Time frame: ~7.7 years and 10.5 years from first patient in

  4. Overall Response

    All patients included in the study must be assessed for their overall response treatment based on RANO 2.0 criteria at each assessment of the disease, from the start of study treatment until disease progression , even if there is a major protocol treatment deviation, if they are ineligible, or not followed/ /re-evaluated. Each patient will be assigned one of the following categories: complete response (CR), partial response (PR), minor response (MR, applicable only to non-enhancing disease), stable disease (SD), Equivocal progressive disease (EqPD), progressive disease (PD), early death (ED) or not evaluable (NE). Early death is defined as any death occurring before the first per protocol time point of tumour re-evaluation.

    Time frame: ~7.7 years and 10.5 years from first patient in

  5. Time to next intervention

    Time to next intervention (TTNI) will be defined as the number of days calculated from the date of enrolment until the commencement of further anticancer treatment following vorasidenib or placebo discontinuation (including surgery or radiotherapy), irrespective of whether progression was documented. If a patient does not initiate further anticancer therapy TTNI will be censored at the date of death or last known alive date.

    Time frame: ~7.7 years and 10.5 years from first patient in

  6. Adverse events

    All adverse events (AEs) will be recorded; the investigator will assess whether those events are drug related (reasonable possibility, no reasonable possibility) and this assessment will be recorded in the database for all AEs. The collection period for all AEs will start up to 4 weeks prior to enrolment and until 30 days after the end of treatment. After those 30 days, only SAEs related to study drug or study participation have to be collected. All AEs must be followed until resolution or stabilization.

    Time frame: ~7.7 years from first patient in

  7. Health-related Quality of Life QLQ-C30.

    Health related quality of life (HRQoL) will be measured using a questionnaire which will be completed by the patient: EORTC QLQ-C30

    Time frame: ~7.7 years from first patient in

  8. Health-related Quality of Life QLQ-BN20.

    Health related quality of life (HRQoL) will be measured using a questionnaire which will be completed by the patient: EORTC QLQ-BN20.

    Time frame: ~7.7 years from first patient in

  9. Health-related Quality of Life IADL-BN32

    Health related quality of life (HRQoL) will be measured using a questionnaire which will be completed by the patient: IADL-BN32

    Time frame: ~7.7 years from first patient in

  10. Health-related Quality of Life item list 46 (IL46)

    Health related quality of life (HRQoL) will be measured using a questionnaire which will be completed by the patient: item list 46 (IL46)

    Time frame: ~7.7 years from first patient in

  11. Neurocognitive function HVLT-R - Part A Free recall

    Neurocognitive function will be measured using a questionnaire which will be completed by the patient: HVLT-R - Part A Free recall

    Time frame: ~7.7 years from first patient in

  12. Neurocognitive function TMT - Part A

    Neurocognitive function will be measured using a questionnaire which will be completed by the patient: TMT - Part A

    Time frame: ~7.7 years from first patient in

  13. Neurocognitive function TMT - Part B

    Neurocognitive function will be measured using a questionnaire which will be completed by the patient: TMT - Part B

    Time frame: ~7.7 years from first patient in

  14. Neurocognitive function COWA

    Neurocognitive function will be measured using a questionnaire which will be completed by the patient: COWA

    Time frame: ~7.7 years from first patient in

  15. Neurocognitive function MOS scale

    Neurocognitive function will be measured using a questionnaire which will be completed by the patient: MOS scale

    Time frame: ~7.7 years from first patient in

  16. Neurocognitive function HVLT-R - Part B Delayed recall HVLT-R - Part C Delayed recognition

    Neurocognitive function will be measured using a questionnaire which will be completed by the patient: HVLT-R - Part B Delayed recall HVLT-R - Part C Delayed recognition

    Time frame: ~7.7 years from first patient in

  17. Seizure activity

    Seizure activity will be measured using will be measured using a questionnaire which will be completed by the physician: Seizure Control Composite Score Index

    Time frame: ~7.7 years from first patient in

07

Study locations

35 of 59 sites recruiting
08

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Jan 2026 (actual). Primary completion is estimated for Apr 2035, 110 months after the start.

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

Registered
Jan 22, 2025
First posted
Feb 5, 2025
StartActual
Jan 16, 2026
Primary completionEst.
Apr 13, 2035
CompletionEst.
May 31, 2037
Last update
Oct 7, 2026
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.
Sites
3 sites changed recruiting status (3 now recruiting)
Show 3 sites
  • Odette Cancer Centre Sunnybrook Health Sciences Centre · Toronto, CanadaNot yet recruiting→Recruiting
  • University Health Network Princess Margaret Cancer Centre · Toronto, CanadaNot yet recruiting→Recruiting
  • Clatterbridge Cancer Centre · Metropolitan Borough of Wirral, United KingdomNot yet recruiting→Recruiting
Oct 7, 2026
Show all 1 update
  1. Oct 7, 2026
    3 sites changed recruiting status (3 now recruiting)
    Show 3 sites
    • Odette Cancer Centre Sunnybrook Health Sciences Centre · Toronto, CanadaNot yet recruiting→Recruiting
    • University Health Network Princess Margaret Cancer Centre · Toronto, CanadaNot yet recruiting→Recruiting
    • Clatterbridge Cancer Centre · Metropolitan Borough of Wirral, United KingdomNot yet recruiting→Recruiting
    + 1 other change: verification date

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

09

Registry details

Key details

Study ID
NCT06809322
Collaborators
Canadian Cancer Trials Group, Olivia Newton-John Cancer Research Institute
Responsible party
Sponsor
First posted
Feb 5, 2025
Start date
Jan 16, 2026
Primary completion
Apr 13, 2035 (estimated)
Completion
May 31, 2037 (estimated)
Last update
Oct 7, 2026

Study contacts

EORTC HQ
Contact
eortc@eortc.org
+32 2 774611
Matthias Preusser
study chair · Universitaetsklinikum Wien - AKH uniklinieken, Vienna, Austria.
Marjolein Geurts
study chair · Brain Tumour Center, Erasmus MC Cancer Institute, Rotterdam, the Netherlands.

Oversight

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

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Studies of the drug tested here: Vorasidenib

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