Status:
COMPLETED
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
Lead Sponsor:
Bristol-Myers Squibb
Conditions:
Prostate Cancer
Eligibility:
MALE
18+ years
Phase:
PHASE2
Brief 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 castrat...
Detailed Description
Prostate Cancer Clinical Trials Working Group 2 (PCWG2) Response Evaluation Criteria In Solid Tumors (RECIST)
Eligibility Criteria
Inclusion
- For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com
- Prostate cancer with metastases
- Prostate cancer should be castration resistant
- Progression during hormonal therapy
Exclusion
- 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
Key Trial Info
Start Date :
December 2 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 15 2016
Estimated Enrollment :
82 Patients enrolled
Trial Details
Trial ID
NCT02279862
Start Date
December 2 2014
End Date
December 15 2016
Last Update
August 28 2019
Active Locations (43)
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1
San Francisco Oncology Associates
San Francisco, California, United States, 94115
2
George Washington University Medical Center
Washington D.C., District of Columbia, United States, 20037
3
Baptist Cancer Institute
Jacksonville, Florida, United States, 32207
4
Cancer Center Of Kansas
Wichita, Kansas, United States, 67214