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NCT07326566 · ClinicalTrials.gov registry record · Phase 2
Study of Silevertinib With Temozolomide for the Treatment of Newly Diagnosed GBM With Unmethylated MGMT and EGFRvIII
A Phase 2 study of Glioma and Brain Cancer, sponsored by Black Diamond Therapeutics.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 162
- Enrollment target
- 1
- Study location
NCT07326566: Recruiting Phase 2 study of Glioma and Brain Cancer, sponsored by Black Diamond Therapeutics.
NCT07326566 is a Phase 2 study of Glioma and Brain Cancer that is actively recruiting participants, run by Black Diamond Therapeutics. The registered enrollment target is 162 participants, below the 208-participant average among 87 other Glioma trials with a reported enrollment target (22% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07326566, a Phase 2 study of Glioma and Brain Cancer, is actively recruiting participants, sponsored by Black Diamond Therapeutics.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 162 participants
- Enrollment target
- 1
- Study location
Study Summary
The purpose of this study is to see if combining silevertinib with temozolomide after surgery and radiotherapy helps treat newly diagnosed glioblastoma (GBM) better than using temozolomide alone in the maintenance setting. Specifically, this study is being done to find answers to the following questions: * How much of the study drugs (silevertinib combined with temozolomide) should be given to participants with GBM? * What are the side effects participants have when taking the study drug (silevertinib combined with temozolomide)? * Can the study drug (silevertinib combined with temozolomide) help participants with GBM live longer without disease progression compared to treatment with temozolomide alone?
Primary Outcome
Progression-free survival, defined as the time from the date of randomization to the date of first disease progression per RANO 2.0 by BICR assessment or death from any cause, whichever occurs first.
Conditions Studied
Interventions
- DRUG silevertinib in combination with temozolomide
- DRUG temozolomide (TMZ)
Study Locations (1)
New York
- Columbia University Irving Medical Center - New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 162 participants |
| Start Date | 2026-04 |
| Est. Completion | 2029-03 |
| Phase | Phase 2 |
What NCT07326566 shows while recruiting
NCT07326566 is an interventional study that assigns participants to a tested intervention. The registered 162 participants enrollment target is mid-sized for trials with a published cap, below the 208-participant average among 87 other Glioma trials with a reported enrollment target (22% lower).
The record links to 7 conditions, with Glioma appearing as the primary indexed condition, and to 2 interventions - of which silevertinib in combination with temozolomide is the first listed.
NCT07326566 reports a single indexed study location in New York.
Frequently Asked Questions
What is clinical trial NCT07326566 about?
NCT07326566 is a clinical study titled "Study of Silevertinib With Temozolomide for the Treatment of Newly Diagnosed GBM With Unmethylated MGMT and EGFRvIII". The purpose of this study is to see if combining silevertinib with temozolomide after surgery and radiotherapy helps treat newly diagnosed glioblastoma (GBM) better than using temozolomide alone in the maintenance setting. Specifically, this study is being done to find answers to the following ques...
What is the current status of trial NCT07326566?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 162 participants. The study started on 2026-04. Estimated completion is 2029-03.
What conditions does trial NCT07326566 study?
This clinical trial studies the following conditions: Glioma, Brain Cancer, GBM, Central Nervous System Diseases, Glioblastoma (GBM).
What interventions are being tested in trial NCT07326566?
The interventions under investigation include: silevertinib in combination with temozolomide (DRUG), temozolomide (TMZ) (DRUG).
Who is sponsoring clinical trial NCT07326566?
This trial is sponsored by Black Diamond Therapeutics, which has 3 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT07326566 being conducted?
This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT07326566's enrollment target sits among peer trials
162 10th of 87 higher than 78 of 87 other Glioma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Glioma 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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