A Phase II Study of CTLA Blockade by Ipilimumab plus Androgen Suppression Therapy in Patients with an Incomplete Response to AST Alone for Metastatic Prostate Cancer

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A Phase II Study of CTLA Blockade by Ipilimumab plus Androgen Suppression Therapy in Patients with an Incomplete Response to AST Alone for Metastatic Prostate Cancer

Primary endpoint: the proportion of patients who achieve an undetectable PSA (less than 0.2 ng/ml) after initiation of ipilimumab therapy.
Secondary endpoints: include time to progression, time to disease progression by any measure, time to death from any cause, maximum percentage of PSA reduction in each patient, response in measurable disease by RECIST criteria, measure of T cell response by flow cytometry, number of patients with immune related Adverse Events (IRAEs)and correlation between IRAEs and clinical outcomes. The effect of treatment on the ratio of T regulatory cells to T effetor cells and additional measures of immune response will also be determined. To examine correlative biomarkers and their relatioship to clinical outcomes. Potential biomarkers include, but are not limited to CRP, IGF-1 and -2, or FSH.

Protocol Number081213
Principal InvestigatorMark Stein
PhasePhase II
ScopeNational
Applicable Disease SitesProstate
Therapies InvolvedImmunotherapy
Drugs InvolvedIPILIMUMAB (MDX-010)
Participating InstitutionsRutgers Cancer Institute of New Jersey

For further information on this clinical trial, please contact us at 732-235-8675 or cinjclinicaltrials@umdnj.edu.