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New treatment option for Glioblastoma (GBM)
Official title Study of Silevertinib With Temozolomide for the Treatment of Newly Diagnosed GBM With Unmethylated MGMT and EGFRvIII
ClinicalTrials.gov ID: NCT07326566
What this study is testing
What is silevertinib in combination with temozolomide?
silevertinib in combination with temozolomide is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for glioblastoma (gbm).
Also referred to as BDTX-1535, Temodar.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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?
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- For Part 1 (Safety Lead-in) ONLY: EGFR alterations.
- For Part 2 (assigned by chance, Controlled Trial) ONLY: EGFRvIII.
- For Part 2 (assigned by chance, Controlled Trial) ONLY: Unmethylated MGMT promoter tumor status based on a validated assay.
You likely can't join if
- Recurrent multifocal disease, metastatic, leptomeningeal, or extracranial GBM, or gliomatosis cerebri.
- Progression of GBM prior to Enrollment, Screening, or Randomization.
- Biopsy-only/no resectional surgery.
- Prior or concomitant treatment for GBM with an EGFR-targeting agent, including silevertinib, bevacizumab, cytotoxic chemotherapy, immunotherapy...
- Intent to use Optune® (TTF).
- Significant other uncontrolled health conditions or other malignancies.
See the full eligibility criteria
- 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 (assigned by chance, Controlled Trial) ONLY: EGFRvIII.
- For Part 2 (assigned by chance, 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. Key
- Recurrent multifocal disease, metastatic, leptomeningeal, or extracranial GBM, or gliomatosis cerebri.
- Progression of GBM prior to Enrollment, Screening, or Randomization.
- Biopsy-only/no resectional surgery.
- Prior or concomitant treatment for GBM with an EGFR-targeting agent, including silevertinib, bevacizumab, cytotoxic chemotherapy, immunotherapy, experimental therapies, Gliadel wafers, GammaTile®, or other intratumoral...
- Intent to use Optune® (TTF).
- Significant other uncontrolled health conditions or other malignancies.
The study team makes the final eligibility decision.
Where it's taking place
- Springdale, Arkansas, United States
- Los Angeles, California, United States
- New Haven, Connecticut, United States
- Washington D.C., District of Columbia, United States
- Miami, Florida, United States
- Tampa, Florida, United States
- Baltimore, Maryland, United States
- Boston, Massachusetts, United States
- Detroit, Michigan, United States
- St Louis, Missouri, United States
- Hackensack, New Jersey, United States
- New Brunswick, New Jersey, United States
- Summit, New Jersey, United States
- Lake Success, New York, United States
- New York, New York, United States
- The Bronx, New York, United States
- Philadelphia, Pennsylvania, United States
- Pittsburgh, Pennsylvania, United States
- Greenville, South Carolina, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Springdale, Arkansas, United States; Los Angeles, California, United States; New Haven, Connecticut, United States; Washington D.C., District of Columbia, United States; Miami, Florida, United States; Tampa, Florida, United States and 13 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.