NCT Neuro Master Match - N²M² (NOA-20)

Sponsor
University Hospital Heidelberg
Study ID
NCT03158389
Phase
PHASE1/PHASE2
Status
Completed

Conditions

  • Glioblastoma, Adult

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • APG101 — DRUG
    weekly i.v.
  • Alectinib — DRUG
    twice daily (oral)
  • Idasanutlin — DRUG
    orally on 5 days of a 28 days cycle
  • Atezolizumab — DRUG
    i.v. every 3 weeks
  • Vismodegib — DRUG
    daily orally
  • Temsirolimus — DRUG
    weekly i.v.
  • Palbociclib — DRUG
    orally on 21 days of a 28 days cycle

Study Details

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.

Key Dates

Start date
May 7, 2018
Status verified
Sep 2023
Primary completion
Feb 22, 2023
Completion
Feb 22, 2023

Study Design

Enrollment
228 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Subtrial A: APG101
    * weekly application of 800 mg i.v. for 6 months or until progression * in conjunction with radiotherapy (at 60 Gy in 2 Gy fractions) for the first 6 weeks
  • Experimental: Subtrial B: Alectinib
    * 600 mg orally twice daily (bid) for 6 months or until progression * in conjunction with radiotherapy (at 60 Gy in 2 Gy fractions) for the first 6 weeks
  • Experimental: Subtrial C: Idasanutlin
    * at escalating doses from 100 mg until maximum tolerated dose daily administered (orally) on five consecutive days of a 28-day cycle for 6 months or until progression * in conjunction with radiotherapy (at 60 Gy in 2 Gy fractions) for the first 6 weeks
  • Experimental: Subtrial D: Atezolizumab
    * application of 1200 mg i.v. every three weeks for 6 months or until progression * in conjunction with radiotherapy (at 60 Gy in 2 Gy fractions) for the first 6 weeks
  • Experimental: Subtrial E: Vismodegib
    * daily application of 150 mg orally for 6 months or until progression * in conjunction with radiotherapy (at 60 Gy in 2 Gy fractions) for the first 6 weeks
  • Experimental: Subtrial F: Palbociclib
    * 75/100/125 mg orally once daily on 21/28 days * in conjunction with radiotherapy (at 60 Gy in 2 Gy fractions) for the first 6 weeks * followed by a 4 weeks break (after last dose of 2nd cycle) * and with maintenance therapy with palbociclib at 125 mg daily for 6 months or until progression
  • Experimental: Subtrial G: Temsirolimus
    * weekly application of 25 mg i.v. for 6 months or until progression * in conjunction with radiotherapy (at 60 Gy in 2 Gy fractions) for the first 6 weeks

Primary Outcome Measure

PFS-6 rate [ Time Frame: 6 months ]

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