RecruitingPhase IIEN originalGlioma (brain cancer)

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

⚠️

This is not medical advice. AI-assisted translation — inaccuracies may occur. Always verify the original and consult your oncologist before taking any steps.

About the trial

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?

Original English text from ClinicalTrials.gov

Who can (and can't) join

✓ Qualifies

  • Nowo rozpoznany glejak mózgu (potwierdzony badaniem), określonego typu genetycznego
  • Obecność specjalnego markera EGFR w komórkach nowotworu
  • Specjalny typ zmian genetycznych EGFR (dla drugiej fazy badania)
  • Specjalny stan promotora MGMT w nowotworze (dla drugiej fazy badania)
  • Operacja usunięcia nowotworu, następnie standardowe leczenie (promieniowanie i chemioterapia)
  • Co najmniej 4 tygodnie od zakończenia radioterapii, bez objawów pogorszenia się nowotworu

✗ Disqualifies

  • Nowotwór przerzutowy, w wielu miejscach, lub rozprzestrzeniający się po oponach mózgowych
  • Pogorszenie się nowotworu przed włączeniem do badania
  • Operacja była tylko biopsja, bez usunięcia nowotworu
  • Wcześniejsze leczenie lekami na EGFR, bevacizumabem, innymi chemioterapiami lub immunoterapiami
  • Planowane użycie urządzenia Optune (TTF)
  • Niekontrolowane poważne choroby współistniejące lub inne nowotwory

Simplified criteria — AI translation

Trial details

Minimum age
18 Years
Last updated (source)
July 23, 2026
Sex
No restrictions

Therapies / drugs in trial

Locations (22)

University of Alabama at Birmingham O'Neal Comprehensive Cancer Center

Birmingham, United States

Highlands Oncology Group

Springdale, United States

Cedars-Sinai Medical Center

Los Angeles, United States

Yale Cancer Center

New Haven, United States

Johns Hopkins Sibley Memorial Hospital

Washington D.C., United States

Miami Cancer Institute

Miami, United States

Moffitt Cancer Center

Tampa, United States

Johns Hopkins Sidney Kimmel Cancer Center - Baltimore

Baltimore, United States

Massachusetts General Hospital

Boston, United States

Beth Israel Deaconess Medical Center

Boston, United States

Dana Farber Cancer Institute

Boston, United States

Henry Ford Cancer- Detroit

Detroit, United States

Washington University School of Medicine Siteman Cancer Center

St Louis, United States

John Theurer Cancer Center at Hackensack University Medical Center

Hackensack, United States

Rutgers Cancer Institute

New Brunswick, United States

Atlantic Health

Summit, United States

Northwell Health Center for Advanced Medicine - Brain Tumor Center

Lake Success, United States

Columbia University Irving Medical Center

New York, United States

Montefiore Medical Center

The Bronx, United States

Thomas Jefferson University, Sidney Kimmel Comprehensive Cancer Center

Philadelphia, United States

UPMC Hillman Cancer Center

Pittsburgh, United States

Prisma Health

Greenville, United States

Trial contact

Black Diamond Therapeutics Clinical Trial Navigation Service

Contact information from ClinicalTrials.gov. Contact in English.

Share this trial

Data from ClinicalTrials.gov. AI-assisted translation, last sync: 7/10/2026.

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