drugset / Trial / NCT01530984

Ipilimumab and GMCSF Immunotherapy for Prostate Cancer

NCT01530984 ↗

RandomizedParallel-groupOpen-labelTreatment

Summary

This is an open-label randomized phase II study. Patients are randomized so as to achieve uniform patient cohorts treated on each regimen. Twenty-seven patients will be required per treatment arm, and a total of 54 prostate cancer patients will be required to complete this study. The study will assess for clinical activity by Prostate Specific Antigen (PSA) response, of both single agent ipilimumab and the combination of GM-CSF and ipilimumab in chemotherapy-naïve patients with metastatic castrate resistant prostate cancer.

Timeline

Start
2015-06
Primary completion
2017-12
Completion
2018-12

Outcome

Outcome not reported

Stopped: “Unable to execute contract”

Drugs

EvaluationDrugModalityDoseRoute
Subject GM-CSF Protein / enzyme biologic 250 ug/m2 Subcutaneous
Subject Ipilimumab Monoclonal antibody 3 mg/kg Intravenous

Indications