OncoMatch/Clinical Trials/NCT07326566
Study of Silevertinib With Temozolomide for the Treatment of Newly Diagnosed GBM With Unmethylated MGMT and EGFRvIII
Is NCT07326566 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including silevertinib in combination with temozolomide and temozolomide (TMZ) for glioblastoma (gbm).
Treatment: silevertinib in combination with temozolomide · temozolomide (TMZ) — 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?
Check if I qualifyExtracted eligibility criteria
Cancer type
Glioblastoma
Biomarker criteria
Required: IDH1 wild-type
isocitrate dehydrogenase wild type (IDH-WT)
Required: EGFR positive status
Positive EGFR status in the brain tumor as determined by a commercially available test or validated laboratory assay (CLIA or comparable certification)
Required: EGFR EGFRvIII
For Part 2 (Randomized, Controlled Trial) ONLY: EGFRvIII
Required: MGMT unmethylated promoter
Unmethylated MGMT promoter tumor status based on a validated assay
Prior therapy
Must have received: surgery — newly diagnosed
No treatment for newly diagnosed GBM other than surgery followed by standard-of-care adjuvant postoperative radiation (54 to 60 Gy) and TMZ chemotherapy
Must have received: radiation therapy — adjuvant postoperative
No treatment for newly diagnosed GBM other than surgery followed by standard-of-care adjuvant postoperative radiation (54 to 60 Gy) and TMZ chemotherapy
Must have received: temozolomide (temozolomide) — adjuvant postoperative
No treatment for newly diagnosed GBM other than surgery followed by standard-of-care adjuvant postoperative radiation (54 to 60 Gy) and TMZ chemotherapy
Cannot have received: EGFR-targeting agent (silevertinib, bevacizumab)
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 or intracavitary antineoplastic therapy
Cannot have received: cytotoxic chemotherapy
Exception: except standard-of-care adjuvant temozolomide
Prior or concomitant treatment for GBM with...cytotoxic chemotherapy
Cannot have received: immunotherapy
Prior or concomitant treatment for GBM with...immunotherapy
Cannot have received: experimental therapy
Prior or concomitant treatment for GBM with...experimental therapies
Cannot have received: intratumoral or intracavitary antineoplastic therapy (Gliadel wafers, GammaTile)
Prior or concomitant treatment for GBM with...Gliadel wafers, GammaTile®, or other intratumoral or intracavitary antineoplastic therapy
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Highlands Oncology Group · Springdale, Arkansas
- Columbia University Irving Medical Center · New York, New York
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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