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NCT07215910 · ClinicalTrials.gov registry record · Phase 3
Testing Addition of an Anti-cancer Drug, Vorasidenib to Temozolomide, After Radiation for Advanced Brain Cancer
A Phase 3 study, sponsored by Alliance for Clinical Trials in Oncology.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 408
- Enrollment target
NCT07215910: Recruiting Phase 3 study, sponsored by Alliance for Clinical Trials in Oncology.
NCT07215910 is a Phase 3 study that is actively recruiting participants, run by Alliance for Clinical Trials in Oncology. The registered enrollment target is 408 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (47% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07215910, a Phase 3 study, is actively recruiting participants, sponsored by Alliance for Clinical Trials in Oncology.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 408 participants
- Enrollment target
Study Summary
This phase III trial compares the effect of vorasidenib to placebo in combination with usual treatment, temozolomide, in treating patients with newly diagnosed grade 3 astrocytoma after radiation. Temozolomide is in a class of medications called alkylating agents. It works by damaging the cell's deoxyribonucleic acid and may kill tumor cells and slow down or stop tumor growth. Vorasidenib citrate blocks the proteins made by the mutated IDH1 and IDH2 genes, which may help keep tumor cells from growing. It is a type of enzyme inhibitor and a type of targeted therapy. Adding vorasidenib to the usual treatment, temozolomide, may be more effective than temozolomide alone in treating patients with newly diagnosed grade 3 astrocytoma after radiation therapy.
Primary Outcome
This is defined as the time from randomization to the time of documented disease progression, as determined by BICR using the Response Assessment in Neuro-Oncology (RANO) 2.0 criteria or death due to any cause. PFS distributions will be evaluated for each arm and will be graphically and quantitatively compared using Kaplan-Meier methods. These methods will be used to estimate the median PFS as well as 2-, 3-, and 5-year estimates for PFS by treatment arm along with corresponding 95% confidence i
Interventions
- DRUG Temozolomide
- RADIATION Intensity-Modulated Radiation Therapy
- PROCEDURE Intensity-Modulated Proton Therapy
- RADIATION Volume Modulated Arc Therapy
- RADIATION Pencil Beam Scanning
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 408 participants |
| Start Date | 2026-07-20 |
| Est. Completion | 2040-01 |
| Phase | Phase 3 |
What NCT07215910 shows while recruiting
NCT07215910 is an interventional study that assigns participants to a tested intervention. The registered 408 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (47% lower).
The record links to 0 conditions, and to 5 interventions - of which Temozolomide is the first listed.
NCT07215910 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT07215910 about?
NCT07215910 is a clinical study titled "Testing Addition of an Anti-cancer Drug, Vorasidenib to Temozolomide, After Radiation for Advanced Brain Cancer". This phase III trial compares the effect of vorasidenib to placebo in combination with usual treatment, temozolomide, in treating patients with newly diagnosed grade 3 astrocytoma after radiation. Temozolomide is in a class of medications called alkylating agents. It works by damaging the cell's deo...
What is the current status of trial NCT07215910?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 408 participants. The study started on 2026-07-20. Estimated completion is 2040-01.
What interventions are being tested in trial NCT07215910?
The interventions under investigation include: Temozolomide (DRUG), Intensity-Modulated Radiation Therapy (RADIATION), Intensity-Modulated Proton Therapy (PROCEDURE), Volume Modulated Arc Therapy (RADIATION), Pencil Beam Scanning (RADIATION).
Who is sponsoring clinical trial NCT07215910?
This trial is sponsored by Alliance for Clinical Trials in Oncology, which has 446 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT07215910's enrollment target sits among peer trials
408 911th of 2000 higher than 1,088 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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