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
Status: Recruiting
Location: See all (29) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY
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?
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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.
Locations
United States
Alabama
University of Alabama at Birmingham O'Neal Comprehensive Cancer Center
RECRUITING
Birmingham
Arkansas
Highlands Oncology Group
RECRUITING
Springdale
California
Cedars-Sinai Medical Center
RECRUITING
Los Angeles
Stanford University
RECRUITING
Palo Alto
Connecticut
Yale Cancer Center
RECRUITING
New Haven
Washington, D.c.
Johns Hopkins Sibley Memorial Hospital
RECRUITING
Washington D.c.
Florida
Miami Cancer Institute
RECRUITING
Miami
Moffitt Cancer Center
RECRUITING
Tampa
Georgia
Piedmont Oncology Research
RECRUITING
Atlanta
Massachusetts
Beth Israel Deaconess Medical Center
RECRUITING
Boston
Dana Farber Cancer Institute
RECRUITING
Boston
Massachusetts General Hospital
RECRUITING
Boston
Maryland
Johns Hopkins Sidney Kimmel Cancer Center - Baltimore
RECRUITING
Baltimore
Michigan
Henry Ford Cancer- Detroit
RECRUITING
Detroit
Missouri
Washington University School of Medicine Siteman Cancer Center
RECRUITING
St Louis
Nebraska
University of Nebraska Medical Center
RECRUITING
Omaha
New Jersey
John Theurer Cancer Center at Hackensack University Medical Center
RECRUITING
Hackensack
Rutgers Cancer Institute
RECRUITING
New Brunswick
Atlantic Health
RECRUITING
Summit
New York
Northwell Health Center for Advanced Medicine - Brain Tumor Center
RECRUITING
Lake Success
Columbia University Irving Medical Center
RECRUITING
New York
Montefiore Medical Center
RECRUITING
The Bronx
Ohio
Ohio State University
RECRUITING
Columbus
Pennsylvania
Thomas Jefferson University, Sidney Kimmel Comprehensive Cancer Center
RECRUITING
Philadelphia
UPMC Hillman Cancer Center
RECRUITING
Pittsburgh
South Carolina
Prisma Health
RECRUITING
Greenville
Utah
Huntsman Cancer Institute, University of Utah
RECRUITING
Salt Lake City
Virginia
Inova Schar Cancer Institute
RECRUITING
Fairfax
VCU Massey Comprehensive Cancer Center
RECRUITING
Richmond
Contact Information
Primary
Black Diamond Therapeutics Clinical Trial Navigation Service
blackdiamondtx@careboxhealth.com
(866) 955-4397
Time Frame
Start Date:2026-05-05
Estimated Completion Date:2029-03
Participants
Target number of participants:162
Treatments
Experimental: silevertinib and temozolomide
silevertinib at dose determined in Part 1 until disease progression in combination with temozolomide 150-200 mg/m2 orally once daily on Days 1 to 5 of each 28-day cycle for maximum of 6 cycles
Active_comparator: temozolomide
temozolomide 150-200 mg/m2 orally once daily on Days 1 to 5 of each 28-day cycle for maximum of 6 cycles