A Phase II Randomized, Multicenter Study to Evaluate the Efficacy and Safety of Silevertinib, an Oral EGFR Inhibitor, in Combination With Temozolomide in Patients With Newly Diagnosed Glioblastoma With Unmethylated MGMT Promoter and EGFRvIII
Categories (click each to see list of all clinical trials associated with that category): Brain/Neuro (ONC), FPBCC CTO Studies
Current Status: Open
Phase: II
Principal Investigator: Muir, Kate-Lynn
Contact Information:
Michaela Savine
misavine@unmc.edu
Eligibility: https://clinicaltrials.gov/study/NCT07326566?term=NCT07326566&viewType=Card&rank=1#participation-criteria
Summary
PRIMARY OBJECTIVES
I. To compare the PFS of patients with newly diagnosed GBM with unmethylated MGMT promoter and EGFRvIII treated with silevertinib and TMZ or TMZ alone, administered as maintenance therapy post-adjuvant chemoradiation.
SECONDARY OBJECTIVES
I. To compare the OS of patients with newly diagnosed GBM with unmethylated MGMT promoter and EGFRvIII treated with silevertinib and TMZ or TMZ alone, administered as maintenance therapy post-adjuvant chemoradiation.
II. Part 1 Only: To determine a RP2CD of silevertinib and TMZ to study in a randomized trial.
III. To assess the safety and tolerability of the combination of silevertinib and TMZ.
IV. To characterize the PK of the combination of silevertinib and TMZ.