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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