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NCT07326566RecruitingPhase 2

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

Source: ClinicalTrials.gov · Last updated 2 Nov 2026

Brief summary (registry, in English)

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?

Status (registry)
Recruiting
Phase (registry)
Phase 2
Study type
Interventional
Enrollment
162 (estimated)
First submitted
7 Jan 2026
Start date
5 May 2026
Primary completion date
Nov 2028
Lead sponsor
Black Diamond Therapeutics, Inc.
Diseases
Glioblastoma
NCT number
NCT07326566

What you commit to

  • Study type: Interventional · Phase 2
  • Planned participants: 162
  • From 5 May 2026 to the primary completion date, Nov 2028
  • 38 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Progression of GBM prior to Enrollment, Screening, or Randomization.
  • Biopsy-only/no resectional surgery.

Other illness

  • Recurrent multifocal disease, metastatic, leptomeningeal, or extracranial GBM, or gliomatosis cerebri.
  • Significant other uncontrolled health conditions or other malignancies.

Lab values

  • 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.

Other

  • Intent to use Optune® (TTF).

Who the study is looking for

  • 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.

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (38)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
University of Michigan
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Ann ArborUnited StatesRecruiting
Piedmont Oncology Research
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AtlantaUnited StatesRecruiting
Johns Hopkins Sidney Kimmel Cancer Center - Baltimore
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BaltimoreUnited StatesRecruiting
University of Alabama at Birmingham O'Neal Comprehensive Cancer Center
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BirminghamUnited StatesRecruiting
Dana-Farber Cancer Institute
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BostonUnited StatesRecruiting
Massachusetts General Hospital
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BostonUnited StatesRecruiting
Beth Israel Deaconess Medical Center
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BostonUnited StatesRecruiting
Cleveland Clinic Taussig Cancer Center
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ClevelandUnited StatesRecruiting
Ohio State University
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ColumbusUnited StatesRecruiting
Henry Ford Cancer- Detroit
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DetroitUnited StatesRecruiting
Inova Schar Cancer Institute
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FairfaxUnited StatesRecruiting
Prisma Health
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GreenvilleUnited StatesRecruiting
John Theurer Cancer Center at Hackensack University Medical Center
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HackensackUnited StatesRecruiting
UT MD Anderson Cancer Center
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HoustonUnited StatesRecruiting
UCSD Moores Cancer Center
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La JollaUnited StatesRecruiting
Northwell Health Center for Advanced Medicine - Brain Tumor Center
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Lake SuccessUnited StatesRecruiting
Cedars-Sinai Medical Center
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Los AngelesUnited StatesRecruiting
University of Wisconsin Carbone Cancer Center
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MadisonUnited StatesRecruiting
Miami Cancer Institute
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MiamiUnited StatesRecruiting
Atrium Health Levine Cancer Institute
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MinneapolisUnited StatesRecruiting
Rutgers Cancer Institute
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New BrunswickUnited StatesRecruiting
Yale Cancer Center
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New HavenUnited StatesRecruiting
Columbia University Irving Medical Center
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New YorkUnited StatesRecruiting
University of Nebraska Medical Center
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OmahaUnited StatesRecruiting
UC Irvine Health
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OrangeUnited StatesRecruiting
Stanford University
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Palo AltoUnited StatesRecruiting
Thomas Jefferson University, Sidney Kimmel Comprehensive Cancer Center
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PhiladelphiaUnited StatesRecruiting
UPMC Hillman Cancer Center
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PittsburghUnited StatesRecruiting
VCU Massey Comprehensive Cancer Center
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RichmondUnited StatesRecruiting
Huntsman Cancer Institute/University of Utah
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Salt Lake CityUnited StatesRecruiting
Maine Health Cancer Care and Blood Disorders - Scarborough
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ScarboroughUnited StatesRecruiting
Highlands Oncology Group
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SpringdaleUnited StatesRecruiting
Washington University School of Medicine - Siteman Cancer Center
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St LouisUnited StatesRecruiting
Atlantic Health
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SummitUnited StatesRecruiting
Moffitt Cancer Center
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TampaUnited StatesRecruiting
Montefiore Medical Center
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The BronxUnited StatesRecruiting
Johns Hopkins Sibley Memorial Hospital
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Washington D.C.United StatesRecruiting
Atrium Health Wake Forest Baptist
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Winston-SalemUnited StatesRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.