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

Conditions

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

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• silevertinib in combination with temozolomide — DRUG
  Participants enrolled into Part 1 (Safety Lead-In) or randomized to Arm A in Part 2 will receive silevertinib at dose determined in Part 1 until disease progression in combination with temozolomide 150-200 mg/m2 orally once daily on Days 1 to 5 of each 28-day cycle for maximum of 6 cycles.
• temozolomide (TMZ) — DRUG
  Participants randomized to Arm B will receive temozolomide 150-200 mg/m2 orally once daily on Days 1 to 5 of each 28-day cycle for maximum of 6 cycles

Study Details

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?

Key Dates

Start date

May 5, 2026

Status verified

May 2026

Primary completion

Nov 30, 2028

Completion

Mar 31, 2029

Study Design

Enrollment

162 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: silevertinib and temozolomide
  silevertinib at dose determined in Part 1 until disease progression in combination with temozolomide 150-200 mg/m2 orally once daily on Days 1 to 5 of each 28-day cycle for maximum of 6 cycles
• Active Comparator: temozolomide
  temozolomide 150-200 mg/m2 orally once daily on Days 1 to 5 of each 28-day cycle for maximum of 6 cycles

Primary Outcome Measure

Progression-free survival (PFS) assessed by Blinded Independent Central Review (BICR) [ Time Frame: 12 months ]

Central Contacts

• Black Diamond Therapeutics Clinical Trial Navigation Service
  (866) 955-4397
  [email protected]

Locations (12)

Find similar trials in Springdale, AR

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