A Study of BMS-986253 in Combination With Nivolumab or Nivolumab Plus Ipilimumab in Advanced Cancers
NCT ID: NCT03400332
Last Updated: 2025-07-25
Study Results
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View full resultsBasic Information
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ACTIVE_NOT_RECRUITING
PHASE1/PHASE2
281 participants
INTERVENTIONAL
2018-02-12
2025-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Part 1A: BMS-986253 + nivolumab
BMS-986253
Specified dose on specified days
Nivolumab
Specified dose on specified days
Part 1B: BMS-986253 + nivolumab
BMS-986253
Specified dose on specified days
Nivolumab
Specified dose on specified days
Part 1C: BMS-986253 + nivolumab + ipilimumab
BMS-986253
Specified dose on specified days
Nivolumab
Specified dose on specified days
Ipilimumab
Specified dose on specified days
Part 2A: BMS-986253 + nivolumab + ipilimumab
BMS-986253
Specified dose on specified days
Nivolumab
Specified dose on specified days
Ipilimumab
Specified dose on specified days
Part 2B: Placebo + nivolumab + ipilimumab
Nivolumab
Specified dose on specified days
Ipilimumab
Specified dose on specified days
Placebo
Specified dose on specified days
Interventions
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BMS-986253
Specified dose on specified days
Nivolumab
Specified dose on specified days
Ipilimumab
Specified dose on specified days
Placebo
Specified dose on specified days
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* At least 1 lesion accessible for biopsy
* Eastern Cooperative Oncology Group Performance Status of 0 or 1
Exclusion Criteria
* Participants with active, known or suspected autoimmune disease
* Participants with conditions requiring systemic treatment with either corticosteroids (\> 10mg prednisone equivalents) or other immunosuppressive medications within 14 days of study treatment administration
* Participants with a known history of testing positive for Human Immunodeficiency Virus (HIV) or known Acquired Immunodeficiency Syndrome (AIDS)
* Cytotoxic agents, unless at least 4 weeks have elapsed from last dose of prior anti-cancer therapy and initiation of study therapy
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 - 0059
Springdale, Arkansas, United States
Local Institution - 0099
Los Angeles, California, United States
Local Institution - 0007
Lakewood, Colorado, United States
Local Institution - 0087
Atlanta, Georgia, United States
Local Institution - 0100
Atlanta, Georgia, United States
Local Institution - 0101
Marietta, Georgia, United States
Local Institution - 0012
Columbia, Maryland, United States
Local Institution - 0003
Lutherville, Maryland, United States
Local Institution - 0060
Boston, Massachusetts, United States
Local Institution - 0004
Ann Arbor, Michigan, United States
Local Institution - 0076
Omaha, Nebraska, United States
Comprehensive Cancer Centers Of Nevada
Las Vegas, Nevada, United States
Local Institution - 0005
Hackensack, New Jersey, United States
Local Institution - 0032
New Brunswick, New Jersey, United States
Local Institution - 0025
New York, New York, United States
Local Institution - 0002
New York, New York, United States
Local Institution - 0028
Oklahoma City, Oklahoma, United States
Local Institution - 0017
Eugene, Oregon, United States
Local Institution - 0001
Pittsburgh, Pennsylvania, United States
Local Institution - 0009
Greenville, South Carolina, United States
Local Institution - 0011
Austin, Texas, United States
Local Institution - 0010
Dallas, Texas, United States
Local Institution - 0014
Fort Worth, Texas, United States
Local Institution - 0018
Houston, Texas, United States
Local Institution - 0006
San Antonio, Texas, United States
Local Institution - 0013
Tyler, Texas, United States
Local Institution - 0058
Salt Lake City, Utah, United States
Local Institution - 0015
Fairfax, Virginia, United States
Local Institution - 0008
Norfolk, Virginia, United States
Local Institution - 0088
Wollstonecraft, New South Wales, Australia
Local Institution - 0096
Adelaide, South Australia, Australia
Local Institution - 0090
Melbourne, Victoria, Australia
Local Institution - 0095
Melbourne, Victoria, Australia
Local Institution - 0097
Perth, Western Australia, Australia
Local Institution - 0091
Ballarat Central, , Australia
Local Institution - 0037
Brussels, , Belgium
Local Institution - 0036
Ghent, , Belgium
Local Institution - 0082
Kortrijk, , Belgium
Local Institution - 0030
Edmonton, Alberta, Canada
Local Institution - 0029
Vancouver, British Columbia, Canada
Local Institution - 0078
Victoria, British Columbia, Canada
Local Institution - 0020
Toronto, Ontario, Canada
Local Institution - 0055
Toronto, Ontario, Canada
Local Institution - 0056
Montreal, Quebec, Canada
Local Institution - 0067
Marseille, Bouches-du-Rhône, France
Local Institution - 0085
Nantes, , France
Local Institution - 0068
Paris, , France
Local Institution - 0102
Toulouse, , France
Local Institution - 0069
Villejuif, , France
Local Institution - 0054
Tübingen, Baden-Wurttemberg, Germany
Local Institution - 0052
Mainz, Rhineland-Palatinate, Germany
Local Institution - 0034
Berlin, , Germany
Local Institution - 0053
Hamburg, , Germany
Local Institution - 0043
Forlì, , Italy
Local Institution - 0042
Milan, , Italy
Local Institution - 0027
Napoli, , Italy
Local Institution - 0026
Rozzano-milano, , Italy
Local Institution - 0071
Krakow, , Poland
Local Institution - 0077
Warsaw, , Poland
Local Institution - 0045
Madrid, , Spain
Local Institution - 0022
Madrid, , Spain
Local Institution - 0023
Madrid, , Spain
Local Institution - 0044
Málaga, , Spain
Local Institution - 0021
Pamplona, , Spain
Local Institution - 0047
Santiago de Compostela, , Spain
Local Institution - 0049
Lund, , Sweden
Local Institution - 0040
Lausanne, , Switzerland
Local Institution - 0041
Sankt Gallen, , Switzerland
Local Institution - 0039
Zurich, , Switzerland
Local Institution - 0024
Manchester, Greater Manchester, United Kingdom
Local Institution - 0083
Glasgow, Lanarkshire, United Kingdom
Local Institution - 0019
Birmingham, West Midlands, United Kingdom
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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2023-509061-20
Identifier Type: REGISTRY
Identifier Source: secondary_id
CA027-002
Identifier Type: -
Identifier Source: org_study_id
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