Study of Silevertinib and Temozolomide for Treating Newly Diagnosed Glioblastoma with Specific Genetic Features
Sponsor: Black Diamond Therapeutics, Inc.
ClinicalTrials ID:NCT07326566
This clinical trial is testing whether adding the drug silevertinib to the standard treatment of temozolomide can improve outcomes for patients with newly diagnosed glioblastoma (GBM) that has specific genetic characteristics.
Patient Parameters
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Program Overview
The aim of this study is to find out if combining silevertinib with temozolomide after surgery and radiotherapy can treat newly diagnosed glioblastoma (GBM) more effectively than using temozolomide alone. The study will explore the right dosage of silevertinib, the side effects of the combination, and whether it helps patients live longer without the disease getting worse compared to temozolomide alone.
Description
Silevertinib is a drug designed to block signals that help some tumors grow, especially those with changes in a protein called EGFR. Temozolomide is a standard cancer treatment that works by damaging the DNA of cancer cells, which can lead to their death. This study involves two parts:
In Part 1, called the Safety Lead-in, about 12 participants will receive silevertinib with temozolomide to check if the combination is safe and to find the best dose.
In Part 2, around 150 participants will be randomly assigned to one of two groups:
- Group 1 will receive silevertinib and temozolomide.
- Group 2 will receive temozolomide only.
Both parts of the study will involve treatment cycles lasting 28 days each. Silevertinib will be taken daily, and temozolomide will be taken for the first 5 days of each cycle, up to 6 cycles. Participants will need to:
- Take the study drugs as directed.
- Attend regular clinic visits to monitor their health and the status of their GBM.
- Undergo imaging and lab tests to check the status of their GBM.
- Keep a diary at home to record when they take the study drugs.
Eligibility Criteria
Inclusion Criteria
- Newly diagnosed glioblastoma confirmed by lab tests, with specific genetic features (IDH-WT and positive EGFR status).
- For Part 1: Must have EGFR alterations.
- For Part 2: Must have EGFRvIII and unmethylated MGMT promoter status.
- No prior treatment for GBM other than surgery and standard radiation and temozolomide.
- At least 4 weeks since finishing radiation therapy, with no disease progression on a post-radiation MRI.
Exclusion Criteria
- Recurrent or widespread GBM, or GBM that has spread beyond the brain.
- Disease progression before joining the study.
- Only had a biopsy, not full surgery.
- Previous or current treatment with EGFR-targeting drugs or other specific therapies for GBM.
- Planning to use Optune® (TTF).
- Other uncontrolled health conditions or other cancers.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Highlands Oncology Group | 72762 | Springdale | Arkansas |
| Cedars-Sinai Medical Center | 90048 | Los Angeles | California |
| Yale Cancer Center | 06510 | New Haven | Connecticut |
| Washington University School of Medicine Siteman Cancer Center | 63108 | St Louis | Missouri |
| Atlantic Health | 07901 | Summit | New Jersey |
| Columbia University Irving Medical Center | 10032 | New York | New York |
| UPMC Hillman Cancer Center | 15232 | Pittsburgh | Pennsylvania |
| Prisma Health | 29605 | Greenville | South Carolina |
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