Actively Recruiting
Study to Evaluate Silevertinib Combined With Temozolomide in Adults With Newly Diagnosed Glioblastoma With Unmethylated MGMT Promoter and EGFRvIII
Led by Black Diamond Therapeutics, Inc. · Updated on 2026-06-05
162
Participants Needed
10
Research Sites
17 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating whether adding silevertinib to temozolomide after surgery and radiotherapy improves treatment for adults with newly diagnosed glioblastoma (GBM) compared to temozolomide alone. This Phase 2 study focuses on patients with GBM that shows specific genetic features, including unmethylated MGMT promoter and EGFRvIII alterations. The trial aims to find the best dose of silevertinib, assess side effects, and see if this combination helps patients live longer without their disease worsening. The study has two parts: Part 1 tests the safety and optimal dose of silevertinib combined with temozolomide in about 12 participants. Part 2 randomizes around 150 participants to receive either silevertinib plus temozolomide or temozolomide alone. Treatments are given in 28-day cycles, with silevertinib taken daily until disease progression and temozolomide taken orally for the first 5 days of each cycle for up to 6 cycles. Participants will take the study drugs as directed and attend regular clinic visits for health monitoring, brain imaging, and lab tests to check their GBM status. They will also keep a paper diary at home to record when they take their medication. The main outcome measured is progression-free survival over 12 months, with overall survival also monitored for 18 months. The study will continue until March 2029.
CONDITIONS
Brief 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...
- Adults aged 18 years or older
- Newly diagnosed glioblastoma confirmed by tissue diagnosis
- Isocitrate dehydrogenase wild type (IDH-WT) glioblastoma
- Positive EGFR status confirmed by a validated test
- For Part 1: presence of EGFR alterations
- For Part 2: presence of EGFRvIII and unmethylated MGMT promoter tumor status
- Completed surgery followed by standard radiation therapy (54 to 60 Gy) and temozolomide chemotherapy
- At least 4 weeks since finishing radiation with no tumor progression on post-radiation MRI
You will not qualify if you...
- Multifocal, metastatic, leptomeningeal, extracranial GBM, or gliomatosis cerebri
- GBM progression before enrollment or randomization
- Biopsy only without tumor resection surgery
- Prior or current treatment with EGFR-targeting agents including silevertinib or bevacizumab
- Prior cytotoxic chemotherapy, immunotherapy, experimental therapies, Gliadel wafers, GammaTile®, or other intratumoral 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
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 6 cycles of 28 days each
Participants receive cycles of study treatment with silevertinib combined with temozolomide or temozolomide alone to fight brain cancer.
Cycle visits every 28 days during treatment
Duration - Up to 18 months
Participants return for frequent clinic visits to monitor overall health and tumor status after treatment ends.
Regular clinic visits and imaging assessments
Trial Site Locations
Total: 10 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
Yale Cancer Center
New Haven, Connecticut, United States, 06510
Actively Recruiting
4
Moffitt Cancer Center
Tampa, Florida, United States, 33612
Actively Recruiting
5
Washington University School of Medicine Siteman Cancer Center
St Louis, Missouri, United States, 63108
Actively Recruiting
6
Atlantic Health
Summit, New Jersey, United States, 07901
Actively Recruiting
7
Northwell Health Center for Advanced Medicine - Brain Tumor Center
Lake Success, New York, United States, 11042
Actively Recruiting
8
Columbia University Irving Medical Center
New York, New York, United States, 10032
Actively Recruiting
9
UPMC Hillman Cancer Center
Pittsburgh, Pennsylvania, United States, 15232
Actively Recruiting
10
Prisma Health
Greenville, South Carolina, United States, 29605
Actively Recruiting
Research Team
B
Black Diamond Therapeutics Clinical Trial Navigation Service
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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