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Clinical trial

Neoadjuvant Ipilimumab in Prostate Cancer

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Last updated:1st Sep 2010
Source: Clinical Trials
Identifier: NCT01194271

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.
Category Value
Date last updated at source 2016-08-18
Study type(s) Interventional
Expected enrolment 19
Study start date 2010-09-01
Estimated primary completion date 2015-10-01

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