Study of Silevertinib With Temozolomide for the Treatment of Newly Diagnosed GBM With Unmethylated MGMT and EGFRvIII (NCT07326566)
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
🩺 Plain-English Summary (8th-Grade Level)
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?
Who can join: Review the eligibility criteria below.
Location: University of Alabama at Birmingham O'Neal Comprehensive Cancer Center — Birmingham, Alabama
Age range: 18 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (28 Sites)
Showing the first 25 of 28 sites.
- University of Alabama at Birmingham O'Neal Comprehensive Cancer Center — Birmingham, Alabama
- Highlands Oncology Group — Springdale, Arkansas
- Cedars-Sinai Medical Center — Los Angeles, California
- Stanford University — Palo Alto, California
- Yale Cancer Center — New Haven, Connecticut
- Johns Hopkins Sibley Memorial Hospital — Washington D.C., District of Columbia
- Miami Cancer Institute — Miami, Florida
- Moffitt Cancer Center — Tampa, Florida
- Johns Hopkins Sidney Kimmel Cancer Center - Baltimore — Baltimore, Maryland
- Massachusetts General Hospital — Boston, Massachusetts
- Beth Israel Deaconess Medical Center — Boston, Massachusetts
- Dana Farber Cancer Institute — Boston, Massachusetts
- Henry Ford Cancer- Detroit — Detroit, Michigan
- Washington University School of Medicine Siteman Cancer Center — St Louis, Missouri
- University of Nebraska Medical Center — Omaha, Nebraska
- John Theurer Cancer Center at Hackensack University Medical Center — Hackensack, New Jersey
- Rutgers Cancer Institute — New Brunswick, New Jersey
- Atlantic Health — Summit, New Jersey
- Northwell Health Center for Advanced Medicine - Brain Tumor Center — Lake Success, New York
- Columbia University Irving Medical Center — New York, New York
- Montefiore Medical Center — The Bronx, New York
- Ohio State University — Columbus, Ohio
- Thomas Jefferson University, Sidney Kimmel Comprehensive Cancer Center — Philadelphia, Pennsylvania
- UPMC Hillman Cancer Center — Pittsburgh, Pennsylvania
- Prisma Health — Greenville, South Carolina
📞 Contact the Study Coordinator
Phone: (866) 955-4397
Email: blackdiamondtx@careboxhealth.com
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
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Explore by condition: All Glioblastoma (GBM) clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.