Actively Recruiting
Study of Silevertinib With Temozolomide for the Treatment of Newly Diagnosed GBM With Unmethylated MGMT and EGFRvIII
Led by Black Diamond Therapeutics, Inc. · Updated on 2026-05-11
162
Participants Needed
5
Research Sites
147 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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?
CONDITIONS
Official Title
Study of Silevertinib With Temozolomide for the Treatment of Newly Diagnosed GBM With Unmethylated MGMT and EGFRvIII
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Newly diagnosed glioblastoma confirmed to be isocitrate dehydrogenase wild type (IDH-WT)
- Positive EGFR status in the brain tumor by validated test
- For Part 1: EGFR alterations required
- For Part 2: EGFRvIII mutation and unmethylated MGMT promoter tumor status based on validated assays
- No prior GBM treatment except surgery followed by standard adjuvant radiation and temozolomide chemotherapy
- At least 4 weeks since completing radiation therapy with a post-radiation MRI showing no disease progression
You will not qualify if you...
- Recurrent multifocal, metastatic, leptomeningeal, extracranial GBM, or gliomatosis cerebri
- GBM progression before enrollment, screening, or randomization
- Only biopsy without tumor resection surgery
- Prior or current treatment with EGFR-targeting agents, bevacizumab, cytotoxic chemotherapy, immunotherapy, experimental therapies, Gliadel wafers, GammaTile®, or other intratumoral/intracavitary treatments
- Planned use of Optune® (Tumor Treating Fields)
- Significant uncontrolled health conditions or other cancers
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 5 locations
1
Highlands Oncology Group
Springdale, Arkansas, United States, 72762
Actively Recruiting
2
Cedars-Sinai Medical Center
Los Angeles, California, United States, 90048
Actively Recruiting
3
Atlantic Health
Summit, New Jersey, United States, 07901
Actively Recruiting
4
Columbia University Irving Medical Center
New York, New York, United States, 10032
Actively Recruiting
5
UPMC Hillman Cancer Center
Pittsburgh, Pennsylvania, United States, 15232
Actively Recruiting
Research Team
B
Black Diamond Therapeutics Clinical Trial Navigation Service
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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