Glioblastoma Clinical Trial
Official title:
A Phase I Trial of Actively Personalized Peptide Vaccinations Plus Immunomodulators in Patients With Newly Diagnosed Glioblastoma Concurrent to First Line Temozolomide Maintenance Therapy
The primary objective of this study is to assess the safety and tolerability, feasibility and biological activity (immunogenicity) of the actively personalized vaccination (APVAC) concept in newly diagnosed glioblastoma (GB) patients.
This is a multicenter, open-label, single arm, first-in-man phase I trial to investigate the
safety, feasibility and immunogenicity of the novel APVAC approach in patients with newly
diagnosed GB.
Primary Endpoints:
- Safety: Determine the safety and tolerability profile of patient-tailored APVAC vaccines
when administered with immunomodulators concurrent to maintenance temozolomide (TMZ)
cycles.
- Feasibility: Determine duration and success rates for APVAC1 and APVAC2 processes and
for vaccinations with APVAC drug products.
- Biological activity: Descriptive analysis of induced T-cell responses after vaccinations
with APVAC1 and APVAC2 drug products plus immunomodulators.
Secondary Study Objectives:
- Identification of biomarkers putatively predictive for immunological response and/or
associated with clinical success or failure. Analyzed biomarkers may include
non-cellular parameters measured from tumor, plasma or serum, and cellular parameters
measured from peripheral blood mononuclear cells (PBMCs), leukapheresis samples or
isolated tumor-infiltrating lymphocytes (TILs).
- Description of potential clinical activity of the APVAC drug products. Descriptive
analysis of clinical outcome in patients will be reported including OS and PFS.
Correlation analysis of these parameters with immune response data may provide first
hints on clinical activity of the vaccine.
After the standard chemoradiotherapy with TMZ has been completed and as soon as the start of
the first maintenance TMZ cycle the vaccination phase begins. It starts with the first APVAC1
vaccination, followed by additional APVAC2 vaccinations at a later time point and ends with
the Last Endpoint Evaluation Visit (LEEV) of a patient.
Single vaccinations with APVAC vaccines consist of an intradermal (i.d.) injection of the
personalized APVAC drug product into the skin of the thigh, shoulder or abdomen followed by
subcutaneous (s.c.) injection of 1.5 mg poly-ICLC (Hiltonol®) in close proximity to the
vaccination site. The second immunomodulator GM-CSF (75 μg) will be applied i.d. to the APVAC
vaccination site 10-30 min before injection of the APVACs.
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