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Study of Silevertinib With Temozolomide for the Treatment of Newly Diagnosed GBM With Unmethylated MGMT and EGFRvIII

Exploring Silevertinib and Temozolomide for new GBM treatment options.

Recruiting
18 years and older
All
Phase 2

This study looks at combining two drugs, silevertinib and temozolomide, to treat newly diagnosed glioblastoma (GBM), a type of brain cancer. **Silevertinib** is designed to block signals that help cancer grow. **Temozolomide** damages the cancer cell's DNA, which can stop the growth of tumors. The study wants to know if using both together is better than temozolomide alone.

The study has two parts. In Part 1, 12 people will try both drugs to find the best dose and check safety. In Part 2, 150 people will be randomly chosen to receive either both drugs or just temozolomide. The treatment is given in 28-day cycles, with temozolomide taken for the first 5 days of each cycle.

If you join, you will need to visit the clinic often for check-ups and tests. You will also keep a diary at home to track when you take the medicine.

  • The study lasts for several months with frequent clinic visits.
  • Participants will take the drugs orally and record their intake.
  • Eligibility includes having GBM and completing surgery and radiation.
Study details
    Glioblastoma (GBM)
    Newly Diagnosed Glioblastoma
    GBM
    Glioblastoma Multiforme (GBM)
    Glioma
    Central Nervous System Diseases
    Brain Cancer

NCT07326566

Black Diamond Therapeutics, Inc.

17 October 2026

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FAQs

Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

How long does a clinical trial take place?

The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

Do I get compensated for taking part in clinical trials?

Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

How safe are clinical trials?

Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
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