An Investigational Immuno-therapy Study of Experimental Medication BMS-986179 Given Alone and in Combination With Nivolumab
NCT ID: NCT02754141
Last Updated: 2023-04-05
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE1/PHASE2
235 participants
INTERVENTIONAL
2016-06-21
2021-10-12
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Arm A-Monotherapy
BMS-986179, dose as specified
BMS-986179
Specified dose on specified days
Arm B- Combination Therapy
BMS-986179 + nivolumab, dose as specified
BMS-986179
Specified dose on specified days
Nivolumab
Specified dose on specified days
Arm C-Combination Therapy
BMS-986179 + rHuPH20, dose as specified
BMS-986179
Specified dose on specified days
rHuPH20
Specified dose on specified days
Interventions
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BMS-986179
Specified dose on specified days
Nivolumab
Specified dose on specified days
rHuPH20
Specified dose on specified days
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Eastern Cooperative Oncology Group (ECOG) 0-1
* Acceptable lab testing results
* Allow biopsies
Exclusion Criteria
* Uncontrolled or significant cardiovascular diseases
* Active or known autoimmune disease
* Organ transplant
18 Years
ALL
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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Local Institution - 0028
Chicago, Illinois, United States
Local Institution - 0001
Baltimore, Maryland, United States
Local Institution - 0022
Boston, Massachusetts, United States
Local Institution - 0023
Buffalo, New York, United States
Local Institution - 0005
New York, New York, United States
Local Institution - 0020
Pittsburgh, Pennsylvania, United States
Local Institution - 0004
Nashville, Tennessee, United States
Local Institution - 0009
Dallas, Texas, United States
Local Institution - 0019
Randwick, New South Wales, Australia
Local Institution - 0017
Sydney, New South Wales, Australia
Local Institution - 0018
Melbourne, Victoria, Australia
Local Institution - 0003
Ottawa, Ontario, Canada
Local Institution - 0002
Toronto, Ontario, Canada
Local Institution - 0024
Montreal, Quebec, Canada
Local Institution - 0014
Montreal, Quebec, Canada
Local Institution - 0033
Marseille, , France
Local Institution - 0021
Marseille, , France
Local Institution - 0008
Toulouse, , France
Local Institution - 0007
Villejuif, , France
Local Institution - 0016
Freiburg im Breisgau, , Germany
Local Institution - 0015
Munich, , Germany
Local Institution - 0012
Napoli, , Italy
Local Institution - 0013
Padua, , Italy
Local Institution - 0006
Amsterdam, , Netherlands
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
FDA Safety Alerts and Recalls
BMS Clinical Trial Patient Recruiting
Other Identifiers
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2016-000603-91
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CA013-004
Identifier Type: -
Identifier Source: org_study_id
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