NCT07326566Phase 2Recruiting

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

Study sponsor: Black Diamond Therapeutics, Inc. · BDTX

Compare the available registry edits below. Primary completion is the date data collection ends for the main study measures; it does not tell you when results will be published.

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Primary completion2028-11Estimated

Enrollment · participants162Estimated

Source updated2026-09-28Last update listed in the registry record

Version history

Changes to this trial

Last 12 months

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Posted 2026-03-19 · 1 field changed

Recruitment status changed

− Before

~~Not yet recruiting~~

+ After

Recruiting

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Study details

Conditions studied

Glioblastoma (GBM); Newly Diagnosed Glioblastoma; GBM; Glioblastoma Multiforme (GBM); Glioma; Central Nervous System Diseases; Brain Cancer

Treatments or interventions studied

silevertinib in combination with temozolomideDrugAlso known as BDTX-1535, Temodar, TMZ
temozolomide (TMZ)DrugAlso known as TMZ, Temodar

Primary outcomes · main study measures

measure: Progression-free survival (PFS) assessed by Blinded Independent Central Review (BICR); description: Progression-free survival, defined as the time from the date of randomization to the date of first disease progression per RANO 2.0 by BICR assessment or death from any cause, whichever occurs first.; timeFrame: 12 months

History coverage

Research sample: selected versions from May 2023 onward plus a preceding baseline where available. Only selected fields were retained; endpoint measures were truncated to 300 characters. This is not complete trial or sponsor history. Daily snapshots begin when collection starts.

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