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Phase I/IIa Study of an Autologous Tumor/DC Vaccine in Metastatic Melanoma

This study includes patients that have been treated for metastatic melanoma with one of the FDA-approved checkpoint inhibitors (CPI) but the melanoma has not gone away or is slowly getting worse. There will be approximately 45 people volunteering for this study from approximately 4-8 hospitals across the United States.

The purpose of this study is to (1) produce and test a vaccine that is made from the patient’s tumor cells and white blood cells to determine if it can be used in addition to the CPI to help fight melanoma by producing a stronger immune response against cancer; (2) to look at the safety of the combination of the vaccine and CPI (what side effects are caused); and (3) to look at the immune system’s response to this combination of the vaccine and CPI.

The vaccine is given by injections into the patient’s skin to see if it will cause the patient to develop an immune response (a positive response) against the tumor. The immune response may enable the patient’s body to slow or stop the tumor(s) from growing. The vaccine is an investigational drug, meaning it is not approved by the FDA. This study is designed to find out its safety and effectiveness in the treatment of melanoma.

During participation in this study, the patient will be asked to make approximately 10 out-patient clinic visits over the period of 12 months. The mandatory clinic visits will last approximately 1 hour (60 minutes). In addition, the patient will be followed with periodic visits approximately every 3 months by their treating physician to monitor for the status of metastatic melanoma. These visits are standard of care but the information gained during these visits will also be collected as a part of this study.

ClinicalTrials.gov Identifier: NCT02678741