An Exploratory Study of the Effects of Nivolumab Combined With Ipilimumab in Patients With Treatment-Naive Stage IV or Recurrent Non-Small Cell Lung Cancer (NSCLC)
NCT ID: NCT03001882
Last Updated: 2024-05-20
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
230 participants
INTERVENTIONAL
2017-03-29
2023-04-24
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Combination therapy
Nivolumab + Ipilimumab
Nivolumab
Specified dose on specified days
Ipilimumab
Specified dose on specified days
Interventions
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Nivolumab
Specified dose on specified days
Ipilimumab
Specified dose on specified days
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Measurable disease by CT or MRI
* Must have full activity or, if limited, must be able to walk and carry out light activities such as light house work or office work
Exclusion Criteria
* Participants with active, known or suspected autoimmune disease
* Prior treatment with any drug that targets T cell co-stimulations pathways (such as checkpoint inhibitors)
18 Years
ALL
No
Sponsors
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Yale University
OTHER
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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Local Institution - 0006
Springdale, Arkansas, United States
Local Institution - 0001
New Haven, Connecticut, United States
Local Institution - 0005
Jacksonville, Florida, United States
Local Institution - 0009
Atlanta, Georgia, United States
Local Institution - 0003
St Louis, Missouri, United States
Local Institution - 0038
The Bronx, New York, United States
Local Institution - 0002
Cleveland, Ohio, United States
Local Institution - 0008
Cleveland, Ohio, United States
Local Institution - 0007
Greenville, South Carolina, United States
Local Institution - 0004
Nashville, Tennessee, United States
Local Institution - 0017
La Louvière, Hainaut, Belgium
Local Institution - 0018
Ghent, , Belgium
Local Institution - 0028
Ghent, , Belgium
Local Institution - 0027
Liège, , Belgium
Local Institution - 0016
Sint-Niklaas, , Belgium
Local Institution - 0036
Paris, , France
Local Institution - 0033
Pierre-Bénite, , France
Local Institution - 0034
Strasbourg, , France
Local Institution - 0039
Toulon, , France
Local Institution - 0015
Essen, , Germany
Local Institution - 0014
Immenstadt im Allgäu, , Germany
Local Institution - 0013
Löwenstein, , Germany
Local Institution - 0012
Stuttgart, , Germany
Local Institution - 0023
Bergamo, , Italy
Local Institution - 0025
Catania, , Italy
Local Institution - 0026
Parma, , Italy
Local Institution - 0024
Perugia, , Italy
Local Institution - 0021
Amsterdam, , Netherlands
Local Institution - 0022
Nijmegen, , Netherlands
Local Institution - 0011
Cluj-Napoca, Cluj, Romania
Local Institution - 0010
Craiova, , Romania
Local Institution - 0031
Barcelona, , Spain
Local Institution - 0029
Madrid, , Spain
Local Institution - 0030
Madrid, , Spain
Local Institution - 0032
Seville, , Spain
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Related Links
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BMS Clinical Trial Information
BMS Clinical Trial Patient Recruiting
Other Identifiers
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2018-000462-11
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CA209-592
Identifier Type: -
Identifier Source: org_study_id
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