Study of Silevertinib With Temozolomide for the Treatment of Newly Diagnosed GBM With Unmethylated MGMT and EGFRvIII
Recruiting now · Phase 2
Conditions studied: Glioblastoma (GBM), Newly Diagnosed Glioblastoma, GBM, Glioblastoma Multiforme (GBM), Glioma, Central Nervous System Diseases, Brain Cancer
In brief
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?
Key facts
- Study ID
- NCT07326566
- Run by
- Black Diamond Therapeutics, Inc.
- People needed
- 162
- Starts
- 2026-05-05
- Expected to finish
- 2029-03-01
- Last updated by the study team
- 2026-08-06
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
Where it is running
- University of Alabama at Birmingham O'Neal Comprehensive Cancer Center — Birmingham, Alabama, United States (enrolling)
- Highlands Oncology Group — Springdale, Arkansas, United States (enrolling)
- Cedars-Sinai Medical Center — Los Angeles, California, United States (enrolling)
- Stanford University — Palo Alto, California, United States (enrolling)
- Yale Cancer Center — New Haven, Connecticut, United States (enrolling)
- Johns Hopkins Sibley Memorial Hospital — Washington D.C., District of Columbia, United States (enrolling)
- Miami Cancer Institute — Miami, Florida, United States (enrolling)
- Moffitt Cancer Center — Tampa, Florida, United States (enrolling)
- Johns Hopkins Sidney Kimmel Cancer Center - Baltimore — Baltimore, Maryland, United States (enrolling)
- Massachusetts General Hospital — Boston, Massachusetts, United States (enrolling)
- Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States (enrolling)
- Dana Farber Cancer Institute — Boston, Massachusetts, United States (enrolling)
- Henry Ford Cancer- Detroit — Detroit, Michigan, United States (enrolling)
- Washington University School of Medicine Siteman Cancer Center — St Louis, Missouri, United States (enrolling)
- John Theurer Cancer Center at Hackensack University Medical Center — Hackensack, New Jersey, United States (enrolling)
- Rutgers Cancer Institute — New Brunswick, New Jersey, United States (enrolling)
- Atlantic Health — Summit, New Jersey, United States (enrolling)
- Northwell Health Center for Advanced Medicine - Brain Tumor Center — Lake Success, New York, United States (enrolling)
- Columbia University Irving Medical Center — New York, New York, United States (enrolling)
- Montefiore Medical Center — The Bronx, New York, United States (enrolling)
- Thomas Jefferson University, Sidney Kimmel Comprehensive Cancer Center — Philadelphia, Pennsylvania, United States (enrolling)
- UPMC Hillman Cancer Center — Pittsburgh, Pennsylvania, United States (enrolling)
- Prisma Health — Greenville, South Carolina, United States (enrolling)
- Huntsman Cancer Institute, University of Utah — Salt Lake City, Utah, United States (enrolling)
Full record on ClinicalTrials.gov
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