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

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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


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
3451 Walnut St
Philadelphia, Pennsylvania 19104
1 (215) 898-5000
Univ of Pennsylvania Penn has a long and proud tradition of intellectual rigor and pursuit...
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Philadelphia, PA
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5801 South Ellis Avenue
Chicago, Illinois 60637
 773.702.1234
University of Chicago One of the world's premier academic and research institutions, the University of...
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Chicago, IL
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12 Rue Georges Clemenceau
Clermont-ferrand, 63000
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Clermont-ferrand,
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Houston, Texas 77030
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Houston, TX
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1428 Madison Ave
New York, New York 10029
(212) 241-6500
Icahn School of Medicine at Mount Sinai Icahn School of Medicine at Mount Sinai is...
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New York, NY
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660 S Euclid Ave
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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Saint Louis, MO
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