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Protocol: A prospective, randomized, blinded, placebo-controlled, phase 2b trial of an autologous tumor lysate (TL) + yeast cell wall particles (YCWP) + dendritic cells (DC) vaccine versus unloaded YCWP + DC in stage III and stage IV (resected) melanoma to prevent recurrence

This study includes patients that have been treated for stage III or stage IV melanoma, that has been surgically removed (resected) and are at high risk for melanoma coming back (recurrence). There will be approximately 120 people volunteering for this study from approximately 10-12 hospitals across the United States.

The purpose of this study is to (1) produce and test a vaccine that is made from a patient’s tumor cells and white blood cells to determine if it can prevent melanoma recurrence; (2) to look at the safety of the vaccine (what side effects it has); and (3) to look at the immune system’s response to this vaccine.

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 their tumor. The immune response may enable the patient’s body to slow or stop any recurrence of the tumor. The vaccine is an investigational drug, meaning it is not approved by the United States Food and Drug Administration (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 36 months. In addition, the patient will be followed with periodic visits every 3-6 months by their treating physician to monitor for recurrence of your melanoma. These visits are not study-specific, but the information gained during these visits will be collected as a part of this study.


The map above depicts the locations where the clinical trial is taking place across the United States.

For more detailed criteria, eligibility, and trial specifics at, please click here. Identifier: NCT02301611