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:	Terminated
Conditions:	Prostate Cancer, Cancer
Therapuetic Areas:	Oncology
Healthy:	No
Age Range:	18 - Any
Updated:	7/21/2018
Start Date:	December 2, 2014
End Date:	December 15, 2016

A Phase 2, Randomized, Double-Blind Study of Ipilimumab Administered at 3 mg/kg vs 10 mg/kg in Adult Subjects With Metastatic Chemotherapy-Naïve Castration Resistant Prostate Cancer Who Are Asymptomatic or Minimally Symptomatic

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.

Prostate Cancer Clinical Trials Working Group 2 (PCWG2)

Response Evaluation Criteria In Solid Tumors (RECIST)

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

We found this trial at

sites

Providence Portland Medical Center

4805 Northeast Glisan Street
Portland, Oregon 97213

(503) 215-1111