VorAsidenib With Lomustine In Patients With rEcurrent IDH-mutaNT Glioma Harboring IDH1 and/or IDH… (NCT07629089) | Clinical Trial Compass
Not Yet RecruitingPhase 1
VorAsidenib With Lomustine In Patients With rEcurrent IDH-mutaNT Glioma Harboring IDH1 and/or IDH2 Mutations
United States24 participantsStarted 2026-06-30
Plain-language summary
This study will test the hypothesis that vorasidenib in combination with lomustine will be safe and tolerable. The overall goal of this study is to identify the optimal vorasidenib dose that can be tested in a subsequent phase 2 study to determine the efficacy of vorasidenib in combination with lomustine in patients with recurrent IDH mutant gliomas.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Age ≥18 years.
. Karnofsky performance status score of ≥ 60%.
. Be able to understand and willing to sign informed consent or assent as determined by local requirements.
. Be willing to comply with scheduled visits, treatment plans, and laboratory tests, including serial peripheral blood sampling and during the study.
. Must have recurrent IDH-mutant oligodendroglioma or astrocytoma grade 2-4 harboring IDH1 and/or IDH2 mutation per WHO 2021 criteria (Louis et al, 2021).
. Must have IDH1 (IDH1 R132H/C/G/S/L mutation variants tested) and/or IDH2 (IDH2 R172K/M/W/S/G mutation variants tested) mutation(s) as determined by standard of care local testing.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. Must have available 1p/19q and tumor O-6-methylguanine-deoxyribonucleic acid (DNA) methyltransferase (MGMT) status available from a pathological report as per standard of care local testing.
. Have presence of measurable disease based on RANO2.0 criteria AND imaging review meeting definition of progression of disease as per RANO2.0 criteria (see Section 10.1.1 for more information).
Exclusion criteria
. Patients who have not recovered to grade 0 or 1 or pre-treatment baseline from adverse events due to prior anti-cancer therapy (i.e., have residual toxicities \> grade 1) with the exception of alopecia.
. Presence of extracranial metastatic or leptomeningeal disease.
. Have had any prior anticancer therapy within 28-days of treatment other than surgery (biopsy, sub-total resection, gross- total resection) for treatment of glioma including systemic chemotherapy, radiotherapy, vaccines, small-molecules, IDH inhibitors, investigational agents, laser ablation, etc.
. Early progression prior to 3 months from completion of radiotherapy.
. Have features assessed as high-risk by the Investigator, including:
. Concurrent active malignancy except for:
. Are pregnant or breastfeeding.
. Patients with uncontrolled intercurrent illness or any other significant condition(s) that would make participation in this protocol unreasonably hazardous.