The objective of N²M² is the improvement of overall survival of patients with glioblastoma with an unmethylated MGMT promoter based on molecular characterization and use of targeted compounds in a modern trial design. The progression-free survival rate at six months (PFS-6) will be used to make decisions.
Description: defined as the proportion of patients free of progression at 6 months after study entry. PFS will be calculated from study entry until clinical or radiographic progression or death, whichever comes first.Progression will be evaluated according to Response Assessment in Neurooncology (RANO) criteria or Immunotherapy Response Assessment in Neurooncology (iRANO) criteria.Measure: PFS-6 rate Time: 6 months
Description: Toxic effects will be graded according to CTCAE v5.0.Measure: Incidence of Treatment-Emergent Adverse Events (AE) Time: 6 months
Description: defined as the time from first administration of the investigational medicinal product (IMP) to time of death from any cause.Measure: Overall survival (OS) Time: 6 months
There is one SNP
BRAF V600E mutation and a distinct treatment or some others, but it is expected that these linear relations will be replaced in a learning system by relations that take upstream and downstream target alterations and also parallel signaling pathways into account and may therefore already predict a certain likelihood of resistance development. --- V600E ---