drugset / Trial / NCT01498978

Ipilimumab in Combination With Androgen Suppression Therapy in Treating Patients With Metastatic Hormone-Resistant Prostate Cancer

NCT01498978 ↗

NaSingle-groupOpen-labelTreatment

Summary

This phase II trial studies how well ipilimumab works when given together with androgen suppression therapy in treating patients with hormone-resistant prostate cancer that has spread to other parts of the body. Monoclonal antibodies, such as ipilimumab, can block tumor growth in different ways. Some block the ability of tumors to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Androgen can cause the growth of prostate cancer. Androgen deprivation therapy may stop the adrenal glands from making androgen. Giving ipilimumab together with androgen suppression therapy may kill more tumor cells.

Timeline

Start
2012-02-06
Primary completion
2017-02-28
Completion
2019-01-19

Outcome

Missed primary endpoint

paper The study was halted at the interim analysis as none of the 10 patients achieved the primary endpoint PMID 32850444 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Ipilimumab Monoclonal antibody 10 mg/kg Intravenous