Safety and Efficacy Study of Ipilimumab 3 mg/kg Versus Ipilimumab 10 mg/kg in Subjects With Metastatic Castration Resistant Prostate Cancer Who Are Chemotherapy Naive

• Status: Completed
• Trial end date: 2016-12-15
• Target enrollment: 0
• Participant gender: Male

Summary

The purpose of this study is to examine the safety and effectiveness (how well the drug works) of two different doses (3 mg/kg and 10 mg/kg) of Ipilimumab (Yervoy™) in patients with metastatic castration resistant prostate cancer.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bristol-Myers Squibb
• Treatments: Antibodies, Monoclonal; Ipilimumab

Criteria

For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

• Prostate cancer with metastases

• Prostate cancer should be castration resistant

• Progression during hormonal therapy

Exclusion Criteria:

• Visceral metastases (eg liver, lung or brain metastases)

• Prior treatment with any immunotherapy for prostate cancer

• Prior or ongoing cytotoxic therapy for prostate cancer

• Autoimmune disease

• Inadequate hematologic, renal, or hepatic function