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.
Name: APG101
Description: weekly i.v.Type: DrugSubtrial A: APG101
Name: Alectinib
Description: twice dailyType: DrugSubtrial B: Alectinib
Name: Idasanutlin
Description: on 5 days of a 28 days cycleType: DrugSubtrial C: Idasanutlin
Name: Atezolizumab
Description: i.v. every 3 weeksType: DrugSubtrial D: Atezolizumab
Name: Vismodegib
Description: daily orallyType: DrugSubtrial E: Vismodegib
Name: Temsirolimus
Description: weekly i.v.Type: DrugSubtrial G: Temsirolimus
Name: Palbociclib
Description: orally on 21 days of a 28 days cycleType: DrugSubtrial F: Palbociclib
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 monthsDescription: Toxic effects will be graded according to CTCAE v4.03.
Measure: Incidence of Treatment-Emergent Adverse Events (AE) Time: 6 monthsDescription: 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 monthsAllocation: Non-Randomized
Parallel Assignment
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 ---