Study of BMS-986158 in Subjects With Select Advanced Cancers
NCT ID: NCT02419417
Last Updated: 2022-06-16
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE1/PHASE2
83 participants
INTERVENTIONAL
2015-06-19
2021-03-17
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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Monotherapy Treatment
Patients treated at various doses and schedules
BMS-986158
Specified dose on specified days
Combination Therapy
Patients treated at selected doses and schdules
BMS-986158
Specified dose on specified days
Nivolumab
Specified dose on specified days
Interventions
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BMS-986158
Specified dose on specified days
Nivolumab
Specified dose on specified days
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Must have received appropriate standard of care
* At least one measurable lesion at baseline
* Expected to have life expectancy of at least 3 months
* Eastern Cooperative Oncology Group (ECOG) of 0 to 1
Exclusion Criteria
* Uncontrolled or significant cardiovascular disease
* Inadequate bone marrow function
* Chronic gastrointestinal illness
* Prior treatment with Bromodomain and Extra-Terminal (BET) inhibitor
12 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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City Of Hope National Medical Center
Duarte, California, United States
University Of Colorado
Aurora, Colorado, United States
Dana Farber Cancer Institute.
Boston, Massachusetts, United States
Oregon Health & Science University
Portland, Oregon, United States
Univ. Of Pa
Philadelphia, Pennsylvania, United States
Institute for Translational Oncology Research-ITOR
Greenville, South Carolina, United States
Nucleus Network
Melbourne, Victoria, Australia
The Ottawa Hospital Cancer Centre
Ottawa, Ontario, Canada
Local Institution
Lyon, , France
Local Institution
Villejuif, , France
H. Univ. Vall dHebron
Barcelona, , Spain
Centro Integral Oncologico Clara Campal
Madrid, , Spain
Clinica Universidad de Navarra
Pamplona, , Spain
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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BMS Clinical Trial Information
BMS Clinical Trial Patient Recruiting
Investigator Inquiry Form
FDA Safety Alerts and Recalls
Other Identifiers
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2015-000324-29
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CA011-001
Identifier Type: -
Identifier Source: org_study_id
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