This research study is evaluating a new type of Kidney Cancer vaccine called "Personalized
NeoAntigen Cancer Vaccine"as a possible treatment for Kidney Cancer.
The following intervention will be involved in this study:
Personalized Neoantigen Vaccine
This research study is a Phase I clinical trial, which tests the safety of an investigational
kidney cancer vaccine and also tries to define the appropriate dose of the investigational
kidney cancer vaccine to use for further studies. "Investigational" means that the kidney
cancer vaccine, in this case the Personalized Neoantigen Cancer Vaccine, is being studied. It
also means that the FDA (the U.S. Food and Drug Administration) has not approved the
Personalized Cancer Vaccine for any use in patients, including people with kidney cancer.
Poly-ICLC (also called Hiltonol) is an experimental "viral mimic" and an activator of
immunity. Poly-ICLC is an investigational drug, meaning the FDA has not approved it as a
treatment for any disease.
Personalized NeoAntigen Cancer Vaccine: The purpose of this study is to determine if it is
possible to make and administer safely a vaccine against kidney cancer by using information
gained from specific characteristics of the participant's own kidney cancer. It is known that
kidney cancers have mutations (changes in genetic material) that are specific to an
individual patient and tumor. These mutations can cause the tumor cells to produce proteins
that appear very different from the body's own cells. It is possible that these proteins used
in a vaccine may induce strong immune responses, which may help the participant's body fight
any tumor cells that could cause the kidney cancer to come back in the future. The study will
examine the safety of the vaccine when given at several different time points and will
examine the participant's blood cells for signs that the vaccine induced an immune response.
Ipilimumab (Yervoy™) is an antibody that has been approved by the United States Food and Drug
Administration (FDA) for the treatment of melanoma.
In this research study, the investigators are looking at the safety and tolerability of the
Personalized NeoAntigen Cancer Vaccine combined with Ipilimumab as well as the body's immune
response to the vaccine. Ipilimumab will be delivered as an injection given underneath the
skin rather than injected in the vein in proximity to each vaccination site in order to 1)
direct anti-CTLA4 activity to the vaccine-draining lymph nodes and 2) limit potential toxic
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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