The goal of this clinical research study is to learn how ipilimumab in combination with Lupron (leuprolide acetate) affects the body's own defense (immune) system before having surgery to remove prostate cancer. The safety of the drug combination will also be studied.
Primary Outcome Measures:
- Longitudinal Peripheral Blood Values [ Time Frame: Weekly for 8 weeks ]
- Five immunological variables measured on peripheral blood (pb) samples and tumor tissue samples: (i) effector to regulatory T cell ratio (measured in blood and tumor), (ii) CD4+ICOS+ T cells (measured in blood and tumor), (iii) CD8+ICOS+ T cells (measured in blood and tumor), (iv) NY-ESO-1 antibodies (measured only in blood, not tumor), and (v) absolute lymphocyte count (measured only in blood, not tumor). Measurements based on pb samples weeks 0, 1, 4, 7, and measurements from tumor tissue at week 8.
|Date last updated at source||2016-08-18|
|Study start date||2010-09-01|
|Estimated primary completion date||2015-10-01|