A Study to Evaluate Preliminary Safety and Efficacy of Nivolumab Plus Ipilimumab in Men With Metastatic Castration-Resistant Prostate Cancer
Status: | Active, not recruiting |
---|---|
Conditions: | Prostate Cancer, Cancer |
Therapuetic Areas: | Oncology |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 1/16/2019 |
Start Date: | March 17, 2017 |
End Date: | March 24, 2022 |
A Phase 2 Trial of Nivolumab Plus Ipilimumab in Men With Metastatic Castration-Resistant Prostate Cancer
The purpose of this study is to determine whether nivolumab plus ipilimumab has preliminary
evidence of safety and effectiveness in treatment of metastatic castration-resistant prostate
cancer
evidence of safety and effectiveness in treatment of metastatic castration-resistant prostate
cancer
For more information regarding Bristol-Myers Squibb Clinical Trial participation, please
visit www.BMSStudyConnect.com
Inclusion Criteria:
- Metastatic, castrate resistant prostate cancer (M1 by National Comprehensive Cancer
Network (NCCN) criteria)
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1
- Ongoing androgen deprivation therapy (ADT) with a Gonadotropin-releasing hormone
(GnRH) analogue or a surgical/medical castration with testosterone level of
≤1.73nmol/L (50ng/dL)
- Patients with skeletal system symptoms who are already on medications to strengthen
bones are allowed if they were started ˃28 days before study treatment
- Bone-directed radiotherapy to pelvic region for ease of pain from painful bone
metastases is allowed up to 14 days before
Exclusion Criteria:
- Cancer that has spread to the liver or brain
- Active, known, or suspected autoimmune disease or infection
- Prior treatment with any drug that targets T cell co-stimulation pathways(such as
checkpoint inhibitors)
Other protocol defined inclusion/exclusion criteria could apply
We found this trial at
6
sites
Univ of Pennsylvania Penn has a long and proud tradition of intellectual rigor and pursuit...
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University of Chicago One of the world's premier academic and research institutions, the University of...
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Icahn School of Medicine at Mount Sinai Icahn School of Medicine at Mount Sinai is...
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660 S Euclid Ave
Saint Louis, Missouri 63110
Saint Louis, Missouri 63110
(314) 362-5000
Washington University School of Medicine Washington University Physicians is the clinical practice of the School...
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