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Rindopepimut with Temozolomide in EGFRvIII-positive Glioblastoma
NCT01480479Phase 3
Key facts
- Status
- Completed
- Start
- Nov 2011
- Primary completion
- Nov 2016
- Countries
- 24
- Sponsor
- Celldex Therapeutics
- Modality
- Peptides, Vaccines & Immunotherapeutics
- Drugs
- rindopepimut
- Conditions
- glioblastoma (GBM)
01
Overview
Phase 3, randomised, double-blind trial of rindopepimut in glioblastoma (GBM) (2 arms), sponsored by Celldex Therapeutics. Primary endpoint: Overall Survival at 5 years. Started Nov 2011; status: completed.
02
Design
2 arms- Study design
- RandomizedDouble-blind
Rindopepimut/GM-CSF + Temozolomide
Rindopepimut (CDX-110) with GM-CSF + Temozolomide
KLH + Temozolomide
KLH + Temozolomide
03
Who it enrols
Adult patients with newly diagnosed, surgically resected EGFRvIII-positive glioblastoma who have completed standard chemoradiation without progression.
04
Endpoints
Primary
Overall Survival
Secondary
Progression-free survival
Safety and Tolerability
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