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.
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)
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
12
sites
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4805 Northeast Glisan Street
Portland, Oregon 97213
Portland, Oregon 97213
(503) 215-1111
Providence Portland Medical Center We strive to give those we serve exceptional, compassionate health care...
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5115 Centre Avenue
Pittsburgh, Pennsylvania 15232
Pittsburgh, Pennsylvania 15232
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Cancer Center of Kansas The physicians of Cancer Center are hematologists and oncologists. The staff...
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