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Vorasidenib with Lomustine for Recurrent IDH-Mutant Glioma

This study is testing a combination of two drugs, vorasidenib and lomustine, for adults with recurrent (returned) brain cancer called IDH-mutant glioma. Vorasidenib is an oral targeted therapy for IDH1- or IDH2-mutant brain tumors, and lomustine is a chemotherapy drug. To join, you must be at least 18 years old, have a Karnofsky performance status score of 60% or higher (meaning you can mostly care for yourself), and be willing to sign an informed consent form. The main goal of this study is to find the safest and most tolerable dose of vorasidenib when given with lomustine. This will help researchers plan a future study to see how well this combination treats the cancer. The current recruitment status is unclear.

Study design
This interventional study plans to enroll 24 participants. It uses a dose de-escalation design to find the right dose of vorasidenib in combination with lomustine.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The Recommended Combination Dose will be measured for up to 48 months.

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NCT07629089

VorAsidenib With Lomustine In Patients With rEcurrent IDH-mutaNT Glioma Harboring IDH1 and/or IDH2 Mutations

Not Yet Recruiting
PHASE1Ages 18+InterventionalTreatment
Megan Mantica
~24 participants
Updated 2026-06-05 on ClinicalTrials.gov
What's tested:VorasidenibLomustine

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Recommended Combination Dose (RCD)
Measured over Up to 48 months

Conditions

Brain Cancer

Explore related trials

AstrocytomaOligodendrogliomaIDH1 GeneIDH2 Gene

Where it's being run

1 sites across 1 states
Pennsylvania1

Study leadership

  • Megan Mantica, MD · PRINCIPAL_INVESTIGATOR · UPMC Hillman Cancer Center

Who to contact

Linda Elias, RN, BSN
[email protected]
(412) 623-6037
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Hemoglobin ≥ 9.0 g/dL
Absolute neutrophil count ≥ 1,500/mcL
Platelet count ≥ 100,000/mcL
Serum total bilirubin ≤1.5 × upper limit of reference range (ULN); if \>1.5 × ULN and due to Gilbert syndrome, total bilirubin ≤3×ULN with direct bilirubin ≤ULN
Aspartate aminotransferase (AST) at or below ULN
Alanine aminotransferase (ALT) at or below ULN
Alkaline phosphatase (ALP) ≤2.5 X institutional ULN
Serum creatinine ≤ 2.0 × ULN, OR Creatinine clearance \> 40 mL/min based on the Cockcroft-Gault glomerular filtration rate estimation: (140 - Age) × (Weight in kg) × (0.85 if female) / 72 × Serum Creatinine 14. Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, patients should be class II or better. 15. Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within six (6) months are eligible for this trial. 16. For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated. 17. Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load.

Exclusion

Brainstem involvement either as primary location or by tumor extension
Clinically relevant functional or neurocognitive deficits due to the tumor in the opinion of the Investigator (deficits resulting from surgery are allowed)
Uncontrolled seizures (defined as persistent seizures interfering with activities of daily life AND failed 3 lines of antiepileptic drug regimens including at least 1 combination regimen). 6. Concurrent active malignancy except for:
Curatively resected non-melanoma skin cancer
Curatively treated carcinoma in situ.
Note: Subjects with previously treated malignancies are eligible provided they have been disease-free for 3 years at Screening. 7. Are pregnant or breastfeeding. 8. Patients with uncontrolled intercurrent illness or any other significant condition(s) that would make participation in this protocol unreasonably hazardous. 9. Have a known hypersensitivity to any of the components of vorasidenib or lomustine. 10. Have a heart-rate corrected QT interval using Fridericia's formula (QTcF) ≥450 msec or other factors that increase the risk of QT prolongation or arrhythmic events (eg, heart failure, hypokalemia, family history of long QT interval syndrome).

What this trial measures

  • Recommended Combination Dose (RCD)Up to 48 months

    Recommended combination dose (RCD) of vorasidenib in combination with lomustine in patients with recurrent Grades 2-4 oligodendroglioma and astrocytoma with an IDH1 or IDH2 mutation, determined using 3x3 dose de-escalation design with 3 dosing levels of vorasidenib. Initially, 3 patients are treated at Level 0. If # DLT≤1/3, treat 3 more patients at Level 0. If # DLT≤1/6, start the dose expansion part at Level 0. If # DLT≥2/6, treat 3-6 patients at dose Level -1. If # DLT≤1/6, start the dose expansion part at Level -1. If # DLT≥2/6, then 3-6 patients will be treated at dose Level -2. If #DLT≤1/6, start the dose expansion part at Level -2.