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Report for Clinical Trial NCT02754362

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

A Toll-like Receptor Agonist as an Adjuvant to Tumor Associated Antigens (TAA) Mixed With Montanide ISA-51 VG With Bevacizumab for Patients With Recurrent Glioblastoma

This is a phase II study to determine the immunogenicity and efficacy of a vaccine composed of tumor associated long synthetic peptides mixed with Montanide ISA-51 VG administered with polyinosinic-polycytidylic acid - poly-L-lysine carboxymethylcellulose (Poly-ICLC) and bevacizumab in adults with recurrent glioblastoma.

NCT02754362 Glioblastoma Glioma
HPO:Glioblastoma multiforme

4 Interventions

Name: Bevacizumab

Description: Bevacizumab is a humanized monoclonal antibody that targets vascular endothelial growth factor (VEGF), a proangiogenic factor which aids in tumor vessel formation.
Type: Drug
Group Labels: 3

Block 1 Block 2 Block 3

Name: Peptide Vaccine

Description: Vaccine of long synthetic peptides encoding T cell epitopes in tumor associated antigens. Vaccine Consists of: EGFRvIII peptide 100 mcg IL13Ralpha peptide 100 mcg EphA2 peptide 100 mcg Her2/neu peptide 100 mcg YKL-40 peptide 100 mcg
Type: Biological
Group Labels: 2

Block 2 Block 3

Name: Poly-ICLC as immune adjuvant

Description: Poly-ICLC is a toll like receptor 3 agonist which directly activates dendritic cells and triggers natural killer cells to kill tumor cells.
Type: Drug
Group Labels: 2

Block 2 Block 3

Name: Keyhole limpet hemocyanin (KLH)

Description: Potent Immunogen used in vaccine approaches for a number of diseases including cancer, AIDS, and infectious diseases
Type: Drug
Group Labels: 1

Block 2

Primary Outcomes

Measure: Assays to determine immunity to the vaccine's antigen

Time: 9 Weeks

Measure: Measure of Humoral Immune Responses measured by ELISA

Time: 9 Weeks

Description: Measured either ex-vivo (assayed directly from thawed PBMCs) or following in-vitro pre-sensitization.

Measure: Antigen specific CD4+ and CD8+ T-cell reactivity to the peptide antigens measured by intracellular cytokine staining

Time: 9 Weeks

Measure: CD4+ and CD8+ T cell reactivity to KLH measured by T cell proliferation quantified by tritiated thymidine incorporation

Time: 9 Weeks

Measure: Measure of Tumor Responses measured by the Response Evaluation Criteria in Solid Tumors (RECIST).

Time: 1 Day

Purpose: Treatment

Allocation: Non-Randomized

Crossover Assignment

There is one SNP


1 G20210A

- Patients must not have a known thrombophilic condition (i.e. protein S, protein C or antithrombin III deficiency, Factor V Leiden, Factor II G20210A mutation, homocysteinemia or antiphospholipid antibody syndrome). --- G20210A ---

HPO Nodes