A Phase II Clinical Trial of GVAX Pancreas Vaccine (with Cyclophosphamide) in Combination with Nivolumab and Stereotactic Body Radiation Therapy (SBRT) Followed by Definitive Resection for Patients with Borderline Resectable Pancreatic Adenocarcinoma

Protocol No
JH-J1756-IRB00130075-GVAX
Principal Investigator
Ben George
Phase
II
Summary
This research is being done to determine the safety and effectiveness (anti-tumor activity) of the GVAX pancreas vaccine, cyclophosphamide, nivolumab, and stereotactic body radiation therapy (SBRT) in people with borderline resectable pancreatic cancer (pancreatic cancer that the surgeons are not sure if can be removed). Other goals of the study are to learn more about how the immune system responds and how a tumor might respond to the drugs given in the study. What is the GVAX pancreas vaccine? GVAX pancreas vaccine is made from other patients' pancreatic cancer cells. The cells were changed in a laboratory to make a protein called GM-CSF (Granulocyte-Macrophage ColonyStimulating Factor). This is done by putting the GM-CSF gene into the pancreatic cancer cells. A gene is a piece of DNA with a message on it that tells a cell to make something. In this case, the message is to make more GM-CSF than it would normally make. GM-CSF helps to activate a person’s own immune system cells to recognize and attack their cancer cells. Because a gene was inserted into the cells of the other patients' cancer cells to make this vaccine, it is called gene therapy. This gene therapy is investigational. The word "investigational" means that GVAX pancreas vaccine is not approved for marketing by the Food and Drug Administration (FDA). The FDA is allowing the use of GVAX pancreas vaccine in this study. The pancreatic cancer cells are also specially treated with radiation in the laboratory so they do not grow or divide into more cells. GVAX pancreas vaccine is given with a low-dose chemotherapy called cyclophosphamide. What is cyclophosphamide (Cy)? Cyclophosphamide (Cy) is a drug approved at certain doses by the Food and Drug Administration (FDA) to treat a variety of cancer diseases. However, it is not approved to treat pancreatic cancer, and is still considered investigational when a low-dose form of Cy is combined with the pancreas cancer vaccine. Cy given before the pancreas cancer vaccine may help the immune system respond better to treatment with the vaccine. What is nivolumab (OPDIVO®)? Nivolumab (BMS-936558; (OPDIVO®)) is a human monoclonal antibody made in a laboratory. Antibodies exist normally in the body. An antibody is a type of protein normally made by immune cells that helps protect the body against foreign matter, such as bacteria and viruses. These antibodies attach, or bind to, foreign matter in a very specific way, and this binding helps the body clear the infection. Nivolumab works by attaching to and blocking a protein called PD-1. PD-1 is present on different types of cells in the immune system and can shut down the immune cells so that they do not effectively fight disease. Antibodies that block the PD-1 protein on these immune cells can potentially stop PD-1 from shutting down the immune cells, thus allowing the cells to recognize and help the body destroy the cancer cells. Nivolumab is approved by the FDA for the treatment of certain types of cancer. It is not approved for use in combination with Cy and GVAX. The FDA is allowing the use of nivolumab in this research study. Bristol-Myers Squibb is providing Nivolumab for use in this study. What is SBRT? SBRT is a form of radiation therapy that can be used to treat cancer. SBRT uses multiple beams of high energy x-ray radiation to concentrate the radiation within the tumor in a very accurate way over a short time period. Each of the study drugs has been tested individually in humans in clinical trials. However, they have not been tested in combination, which is the regimen for this study. People with borderline resectable pancreatic cancer who have not received any treatment for their cancer can join this study. We don't know if this study will help you. Your condition may get better but it could stay the same or even get worse. We hope the information from this study will help us develop a better treatment for pancreatic cancer.
Description
GVAX Pancreas Vaccine (With CY) in Combination With Nivolumab and SBRT for Patients With Borderline Resectable Pancreatic Cancer
Participating Institutions
Froedtert Hospital
Status
OPEN TO ACCRUAL
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