NCT07326566From ClinicalTrials.govRecruiting

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

A Phase 2 Randomized, Multicenter Study to Evaluate the Efficacy and Safety of Silevertinib, an Oral EGFR Inhibitor, in Combination With Temozolomide in Patients With Newly Diagnosed Glioblastoma With Unmethylated MGMT Promoter and EGFRvIII

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

At a glance

Phase: Phase 2
Study type: Interventional
Sponsor: Black Diamond Therapeutics, Inc.
Enrolment target: 162
Started: 5 May 2026
Main results due: November 2028
Study sites: 31
Registry updated: 28 September 2026

Can you take part?

Aged 18 years and over.
Open to any sex.
You need the condition being studied — healthy volunteers are not accepted.

These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.

Read the full eligibility criteria

Key Inclusion Criteria:

* 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.

Key Exclusion Criteria:

* 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 study is about

In the sponsor’s own words, from the registry.

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?

Study sites(31)

University of Alabama at Birmingham O'Neal Comprehensive Cancer Center
Birmingham, Alabama, United States
Recruiting
Highlands Oncology Group
Springdale, Arkansas, United States
Recruiting
UCSD Moores Cancer Center
La Jolla, California, United States
Recruiting
Cedars-Sinai Medical Center
Los Angeles, California, United States
Recruiting
Stanford University
Palo Alto, California, United States
Recruiting
Yale Cancer Center
New Haven, Connecticut, United States
Recruiting
Johns Hopkins Sibley Memorial Hospital
Washington D.C., District of Columbia, United States
Recruiting
Miami Cancer Institute
Miami, Florida, United States
Recruiting
Moffitt Cancer Center
Tampa, Florida, United States
Recruiting
Piedmont Oncology Research
Atlanta, Georgia, United States
Recruiting
Johns Hopkins Sidney Kimmel Cancer Center - Baltimore
Baltimore, Maryland, United States
Recruiting
Massachusetts General Hospital
Boston, Massachusetts, United States
Recruiting
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
Recruiting
Dana Farber Cancer Institute
Boston, Massachusetts, United States
Recruiting
Henry Ford Cancer- Detroit
Detroit, Michigan, United States
Recruiting
Washington University School of Medicine Siteman Cancer Center
St Louis, Missouri, United States
Recruiting
University of Nebraska Medical Center
Omaha, Nebraska, United States
Recruiting
John Theurer Cancer Center at Hackensack University Medical Center
Hackensack, New Jersey, United States
Recruiting
Rutgers Cancer Institute
New Brunswick, New Jersey, United States
Recruiting
Atlantic Health
Summit, New Jersey, United States
Recruiting
Northwell Health Center for Advanced Medicine - Brain Tumor Center
Lake Success, New York, United States
Recruiting
Columbia University Irving Medical Center
New York, New York, United States
Recruiting
Montefiore Medical Center
The Bronx, New York, United States
Recruiting
Cleveland Clinic Taussig Cancer Center
Cleveland, Ohio, United States
Recruiting
Ohio State University
Columbus, Ohio, United States
Recruiting
Thomas Jefferson University, Sidney Kimmel Comprehensive Cancer Center
Philadelphia, Pennsylvania, United States
Recruiting
UPMC Hillman Cancer Center
Pittsburgh, Pennsylvania, United States
Recruiting
Prisma Health
Greenville, South Carolina, United States
Recruiting
Huntsman Cancer Institute, University of Utah
Salt Lake City, Utah, United States
Recruiting
Inova Schar Cancer Institute
Fairfax, Virginia, United States
Recruiting
VCU Massey Comprehensive Cancer Center
Richmond, Virginia, United States
Recruiting

Showing 31 of 31 sites. 31 of the 31 sites on this study are recruiting right now — a site can stop enrolling while the study as a whole is still open.

Source: ClinicalTrials.gov record NCT07326566. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.

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