This proof of concept study is designed to test the safety and tolerability of PGV001-based personalized multi-peptide vaccines in combination with CDX-301 in subjects with a history of aggressive prostate cancer, in the tumor free adjuvant setting.
This proof of concept study is designed to test the safety and tolerability of PGV001-based personalized multi-peptide vaccines in combination with CDX-301 in subjects with a history of aggressive prostate cancer, in the tumor free adjuvant setting. This study will also assess the capacity of PGV001-based a multi-peptide therapeutic vaccines to produce a robust tumor antigen-specific T lymphocytic response in the peripheral circulation when combined with CDX-301, and it will expand the collective body of knowledge regarding the identification, selection and use of mutation-derived tumor antigens for personalized immunotherapy in prostate cancer patients. The purpose of the proposed trial will be to assess the following hypothesis: Mutation-derived tumor antigens (MTA) may arise as a result of somatic non-synonymous variations-including nucleotide substitutions, as well as small insertions and deletions-which occur during tumorigenesis. Somatic mutations may be characterized through the use of high-throughput sequencing technologies, and the resulting sequence data used to identify TSA. Sequence data can inform the design of patient-specific immune-based therapies, which may be capable of inducing quantitative changes in the concentration of circulating antigen-specific T lymphocytes directed against TSA, which may in-turn lead to immune-mediated elimination of residual malignant cells.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
27
Icahn School of Medicine at Mount Sinai (ISMMS)
New York, New York, United States
Number of adverse events
Adverse events will be measured by severity of Adverse events with toxicity grading defined by Cancer Therapy Evaluation Program's (CTEP) v5.0 of National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) scale .
Time frame: 37 days
Number of adverse events
Adverse events will be measured by severity of Adverse events with toxicity grading defined by Cancer Therapy Evaluation Program's (CTEP) v5.0 of National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) scale .
Time frame: 191 days
Change in immune cell subsets
Changes in immune cell subsets to compare immune responses at baseline to prostate antigens and viruses with immune responses obtained after treatment with the vaccine combination
Time frame: 37 days
Change in immune cell subsets
Changes in immune cell subsets to compare immune responses at baseline to prostate antigens and viruses with immune responses obtained after treatment with the vaccine combination
Time frame: 191 days
Change in immune cell subsets
Changes in immune cell subsets to compare immune responses at baseline to prostate antigens and viruses with immune responses obtained after treatment with the vaccine combination
Time frame: 365 days
Change in the frequency of vaccine epitope-specific T lymphocyte populations
Change in the frequency of vaccine epitope-specific T lymphocyte populations in post-treatment peripheral blood compared to peripheral blood obtained prior to the start of vaccination.
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Time frame: 37 days
Change in the frequency of vaccine epitope-specific T lymphocyte populations
Change in the frequency of vaccine epitope-specific T lymphocyte populations in post-treatment peripheral blood compared to peripheral blood obtained prior to the start of vaccination.
Time frame: 191 days
Change in the frequency of vaccine epitope-specific T lymphocyte populations
Change in the frequency of vaccine epitope-specific T lymphocyte populations in post-treatment peripheral blood compared to peripheral blood obtained prior to the start of vaccination.
Time frame: 365 days
Radiographic free survival
Radiographic free survival (RFS) by Kaplan-Meier (KM) method.
Time frame: 10 years