This phase II clinical trial studies how well ERC1671 plus Granulocyte-macrophage
colony-stimulating factor (GM-CSF) plus Cyclophosphamide with Bevacizumab works compared to
Placebo Injection plus Placebo Pill with Bevacizumab in treating patients with
recurrent/progressive, bevacizumab nave glioblastoma multiforme and gliosarcoma (World
Health Organization (WHO) grade IV malignant gliomas, GBM).
This is a blinded Phase II study of ERC1671 in combination with bevacizumab in patients with
relapsed, bevacizumab naive glioblastoma. The patients who will be randomized (in a 1:1
ratio) to receive either ERC 1671 in combination with GM-CSF and cyclophosphamide or a
placebo control, in combination with bevacizumab. The study will be double blinded.
ERC1671/GM-CSF will be intradermally administered, while cyclophosphamide is orally
administered. GM-CSF dose is 500mcg fixed dose and cyclophosphamide dose is 50 mg/day.
Bevacizumab or approved bevacizumab biosimilars are administered as standard of care at 10
mg/kg every 2 weeks.
If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.
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