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ERC1671 plus Bevacizumab in Recurrent Glioblastoma
NCT01903330Phase 2
Key facts
- Status
- Active, not recruiting
- Start
- Mar 2014
- Primary completion
- Mar 2026
- Countries
- 1
- Modality
- Prophylactic Vaccines, Cell Therapies, Therapeutic Vaccines
- Drugs
- Sitoiganap
- Conditions
- glioblastoma (GBM)Gliosarcoma (GS)
01
Overview
Phase 2, randomised, double-blind trial in glioblastoma (GBM) and Gliosarcoma (GS) comparing ERC1671 + GM-CSF + Cyclophosphamide + Bevacizumab with Placebo + Bevacizumab (2 arms). Primary endpoint: Overall Survival at 12 months. Started Mar 2014; status: active, not recruiting.
02
Design
2 arms- Study design
- RandomizedDouble-blind
ERC1671 + GM-CSF + Cyclophosphamide + Bevacizumab
ERC1671 and GM-CSF intradermal, Cyclophosphamide oral, Bevacizumab IV
Placebo + Bevacizumab
Placebo Injection/Pill + Bevacizumab IV
03
Endpoints
Primary
Overall Survival
Secondary
Progression-Free Survival
Immune Response
Percentage of Grade 3-5 Adverse Events
Rate of Radiographic Response
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