Glioblastoma
Conditions
Brief summary
• Safety (adverse events)
Detailed description
Dose Escalation Cohorts und Expansion Group Arms A-C:, • PFS at 6 months (PFS-6), • Median progression-free survival (mPFS), • Median overall survival (mOS), • Tumor vascularization as per vascular MRI scans at baseline and 2, 4, and 6 months, • Topography of recurrence, • Determination of maximum tolerated dose (MTD), • Definition of recommended Phase 2 dose (RP2D), • Olaptesed plasma levels at steady state, • NANO assessment, • Quality of Life, Expansion Group Arms D-H:, • PFS at 6 months (PFS-6), • Median progression-free survival (mPFS), • Median overall survival (mOS), • Landmark overall survival at 18 months (OS18), • Overall response rate (ORR), • Olaptesed plasma levels at steady state, • Quality of Life
Interventions
DRUGKEYTRUDA 25 mg/mL concentrate for solution for infusion
DRUGNOX-A12
DRUGAvastin 25 mg/ml concentrate for solution for infusion.
Sponsors
TME Pharma AG
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| • Safety (adverse events) | — |
Secondary
| Measure | Time frame |
|---|---|
| Dose Escalation Cohorts und Expansion Group Arms A-C:, • PFS at 6 months (PFS-6), • Median progression-free survival (mPFS), • Median overall survival (mOS), • Tumor vascularization as per vascular MRI scans at baseline and 2, 4, and 6 months, • Topography of recurrence, • Determination of maximum tolerated dose (MTD), • Definition of recommended Phase 2 dose (RP2D), • Olaptesed plasma levels at steady state, • NANO assessment, • Quality of Life, Expansion Group Arms D-H:, • PFS at 6 months (PFS-6), • Median progression-free survival (mPFS), • Median overall survival (mOS), • Landmark overall survival at 18 months (OS18), • Overall response rate (ORR), • Olaptesed plasma levels at steady state, • Quality of Life | — |
Countries
Germany
Outcome results
None listed