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Silevertinib with Temozolomide for Newly Diagnosed Glioblastoma

This study is looking at a new way to treat newly diagnosed glioblastoma (GBM), a type of brain cancer, after surgery and radiation. It combines silevertinib with temozolomide, a standard chemotherapy. Silevertinib is designed to block a growth signal in cancer cells that have changes in a protein called EGFR. You may be able to join if you have newly diagnosed GBM, are at least 18 years old, and your tumor has a positive EGFR status. The study aims to see if this combination helps you live longer without your disease progressing compared to temozolomide alone. The study's current status is unclear.

Study design
This is an interventional study with an estimated 162 participants. It has two parts: a safety lead-in to find the best dose, followed by a randomized part where participants receive either silevertinib plus temozolomide or temozolomide alone.
What's involved
You would receive silevertinib and/or temozolomide orally on specific days of a 28-day cycle for up to 6 cycles. The study does not specify other visits, procedures, or tests.
Compensation
Not stated in the trial record.
Follow-up
Your progression-free survival will be assessed at 12 months after treatment.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07326566

Study of Silevertinib With Temozolomide for the Treatment of Newly Diagnosed GBM With Unmethylated MGMT and EGFRvIII

Recruiting
PHASE2Ages 18+InterventionalTreatment
Black Diamond Therapeutics, Inc.
~162 participants
Updated 2026-08-28 on ClinicalTrials.gov
What's tested:silevertinib in combination with temozolomidetemozolomide (TMZ)

At a glance

Recruiting sites
28 of 28 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Progression-free survival (PFS) assessed by Blinded Independent Central Review (BICR)
Measured over 12 months

Conditions

Glioblastoma (GBM)
Newly Diagnosed Glioblastoma
GBM
Glioblastoma Multiforme (GBM)
Glioma
Central Nervous System Diseases
Brain Cancer

Explore related trials

GlioblastomaMGMT Gene

Where it's being run

28 sites across 18 states
Massachusetts3
New Jersey3
New York3
California2
Florida2
Pennsylvania2
Virginia2
Alabama1

Who to contact

Black Diamond Therapeutics Clinical Trial Navigation Service
[email protected]
(866) 955-4397
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Newly diagnosed histologically confirmed glioblastoma that is isocitrate dehydrogenase wild type (IDH-WT).
Positive EGFR status in the brain tumor as determined by a commercially available test or validated laboratory assay (CLIA or comparable certification).
For Part 1 (Safety Lead-in) ONLY: EGFR alterations.
For Part 2 (Randomized, Controlled Trial) ONLY: EGFRvIII.
For Part 2 (Randomized, Controlled Trial) ONLY: Unmethylated MGMT promoter tumor status based on a validated assay.
No treatment for newly diagnosed GBM other than surgery followed by standard-of-care adjuvant postoperative radiation (54 to 60 Gy) and TMZ chemotherapy.
At least 4 weeks since completion of radiation therapy, with a post-radiation MRI showing no progression.

Exclusion

Recurrent multifocal disease, metastatic, leptomeningeal, or extracranial GBM, or gliomatosis cerebri.
Progression of GBM prior to Enrollment, Screening, or Randomization.
Biopsy-only/no resectional surgery.
Prior or concomitant treatment for GBM with an EGFR-targeting agent, including silevertinib, bevacizumab, cytotoxic chemotherapy, immunotherapy, experimental therapies, Gliadel wafers, GammaTile®, or other intratumoral or intracavitary antineoplastic therapy.
Intent to use Optune® (TTF).
Significant other uncontrolled health conditions or other malignancies.

What this trial measures

  • Progression-free survival (PFS) assessed by Blinded Independent Central Review (BICR)12 months

    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.