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
NCT ID: NCT02279862
Last Updated: 2019-08-28
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
82 participants
INTERVENTIONAL
2014-12-02
2016-12-15
Brief Summary
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Detailed Description
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Response Evaluation Criteria In Solid Tumors (RECIST)
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Arm 1: Ipilimumab 3 mg/kg
Ipilimumab 3 mg/kg injection intravenously every 3 weeks for 4 doses in Induction phase. Subjects that are eligible to receive Ipilimumab in the Maintenance phase will be dosed every 12 weeks for a maximum of 3 years since the first induction dose
Ipilimumab
Arm 2: Ipilimumab 10 mg/kg
Ipilimumab 10 mg/kg injection intravenously every 3 weeks for 4 doses in Induction phase. Subjects that are eligible to receive Ipilimumab in the Maintenance phase will be dosed every 12 weeks for a maximum of 3 years since the first induction dose
Ipilimumab
Interventions
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Ipilimumab
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Prostate cancer should be castration resistant
* Progression during hormonal therapy
Exclusion Criteria
* Prior treatment with any immunotherapy for prostate cancer
* Prior or ongoing cytotoxic therapy for prostate cancer
* Autoimmune disease
* Inadequate hematologic, renal, or hepatic function
18 Years
MALE
No
Sponsors
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Bristol-Myers Squibb
INDUSTRY
Responsible Party
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Principal Investigators
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Bristol-Myers Squibb
Role: STUDY_DIRECTOR
Bristol-Myers Squibb
Locations
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San Francisco Oncology Associates
San Francisco, California, United States
George Washington University Medical Center
Washington D.C., District of Columbia, United States
Baptist Cancer Institute
Jacksonville, Florida, United States
Cancer Center Of Kansas
Wichita, Kansas, United States
North Mississippi Med Center
Tupelo, Mississippi, United States
Nebraska Cancer Specialists
Omaha, Nebraska, United States
Providence Portland Medical Center
Portland, Oregon, United States
Northwest Cancer Specialists, Pc
Tualatin, Oregon, United States
University of Pittsburgh Cancer Institute Cancer Services
Pittsburgh, Pennsylvania, United States
Texas Oncology
Houston, Texas, United States
Virginia Cancer Institute
Richmond, Virginia, United States
Local Institution
St Leonards, New South Wales, Australia
Local Institution
Wahroonga, New South Wales, Australia
Local Institution
Parkville, Victoria, Australia
Local Institution
Viña del Mar, Región de Valparaíso, Chile
Local Institution
Recoleta, Santiago de Chile, Chile
Local Institution
Santiago, Santiago Metropolitan, Chile
Local Institution
Clermont-Ferrand, , France
Local Institution
Marseille, , France
Local Institution
Poitiers, , France
Local Institution
Rennes, , France
Local Institution
Saint-Herblain, , France
Local Institution
Villejuif, , France
Universitaetsklinikum Aachen
Aachen, , Germany
Uniklinik Heidelberg
Heidelberg, , Germany
Universitaetsklinikum Jena
Jena, , Germany
Universitaetsklinikum Magdeburg
Magdeburg, , Germany
Universitaetsklinikum Mannheim
Mannheim, , Germany
Local Institution
Marktredwitz, , Germany
Klinikum rechts der Isar der TU
München, , Germany
Urologische Praxis
Rostock, , Germany
Urologische Gemeinschaftspraxis Dres Stammel U. Garcia
Wesel, , Germany
Dgu Urologie
Wuppertal, , Germany
Local Institution
Milan, , Italy
Istituto Nazionale Tumori Fondazione Pascale
Napoli, , Italy
Local Institution
Amsterdam, , Netherlands
Local Institution
Barcelona, , Spain
Local Institution
Hospitalet de Llobregat - Barcelona, , Spain
Local Institution
Seville, , Spain
Local Institution
Valencia, , Spain
Local Institution
Glasgow, Lanarkshire, United Kingdom
Local Institution
Nottingham, Nottinghamshire, United Kingdom
Local Institution
Guildford, Surrey, United Kingdom
Countries
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Related Links
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BMS Clinical Trial Patient Recruiting
Investigator Inquiry Form
Other Identifiers
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2014-002987-34
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CA184-437
Identifier Type: -
Identifier Source: org_study_id
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