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Report for Clinical Trial NCT03158389

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

Umbrella Protocol for Phase I/IIa Trials of Molecularly Matched Targeted Therapies Plus Radiotherapy in Patients With Newly Diagnosed Glioblastoma Without MGMT Promoter Methylation: NCT Neuro Master Match - N²M² (NOA-20)

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.

NCT03158389 Glioblastoma, Adult
HPO:Glioblastoma multiforme

7 Interventions

Name: APG101

Description: weekly i.v.
Type: Drug
Group Labels: 1

Subtrial A: APG101

Name: Alectinib

Description: twice daily (oral)
Type: Drug
Group Labels: 1

Subtrial B: Alectinib

Name: Idasanutlin

Description: orally on 5 days of a 28 days cycle
Type: Drug
Group Labels: 1

Subtrial C: Idasanutlin

Name: Atezolizumab

Description: i.v. every 3 weeks
Type: Drug
Group Labels: 1

Subtrial D: Atezolizumab

Name: Vismodegib

Description: daily orally
Type: Drug
Group Labels: 1

Subtrial E: Vismodegib

Name: Temsirolimus

Description: weekly i.v.
Type: Drug
Group Labels: 1

Subtrial G: Temsirolimus

Name: Palbociclib

Description: orally on 21 days of a 28 days cycle
Type: Drug
Group Labels: 1

Subtrial F: Palbociclib

Primary Outcomes

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

Secondary Outcomes

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

Purpose: Treatment

Allocation: Non-Randomized

Parallel Assignment

There is one SNP


1 V600E

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 ---

HPO Nodes