A Study of BMS-986249 Alone and in Combination With Nivolumab in Advanced Solid Tumors
NCT ID: NCT03369223
Last Updated: 2025-11-18
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE1/PHASE2
356 participants
INTERVENTIONAL
2017-12-06
2024-11-07
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
NONE
Study Groups
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Part 1A: BMS-986249
BMS-986249
Specified dose on specified days
Part 1B: BMS-986249 + nivolumab (nivo)
BMS-986249
Specified dose on specified days
Nivolumab
Specified dose on specified days
Part 2A Arm C: BMS-986249 + nivo
Previously untreated unresectable stage III-IV melanoma
BMS-986249
Specified dose on specified days
Nivolumab
Specified dose on specified days
Part 2A Arm D: ipilimumab + nivo then nivo
Previously untreated unresectable stage III-IV melanoma
Nivolumab
Specified dose on specified days
Ipilimumab
Specified dose on specified days
Part 2A Arm F: BMS-986249 + nivo
Previously untreated unresectable stage III-IV melanoma
BMS-986249
Specified dose on specified days
Nivolumab
Specified dose on specified days
Part 2B Cohort 1: BMS-986249 + nivo
Advanced or intermediate hepatocellular carcinoma (HCC)
BMS-986249
Specified dose on specified days
Nivolumab
Specified dose on specified days
Part 2B Cohort 2: BMS-986249 + nivo
Metastatic castration-resistant prostate cancer (CRPC)
BMS-986249
Specified dose on specified days
Nivolumab
Specified dose on specified days
Part 2B Cohort 3: BMS-986249 + nivo
Unresectable locally advanced or metastatic triple-negative breast cancer (TNBC)
BMS-986249
Specified dose on specified days
Nivolumab
Specified dose on specified days
Part 2A Arm A: BMS-986249 + nivo then nivo
* Previously untreated unresectable stage III-IV melanoma
* Enrollment is closed for this Arm
BMS-986249
Specified dose on specified days
Nivolumab
Specified dose on specified days
Part 2A Arm B: BMS-986249 + nivo
* Previously untreated unresectable stage III-IV melanoma
* Enrollment is closed for this Arm
BMS-986249
Specified dose on specified days
Nivolumab
Specified dose on specified days
Part 2A Arm E: Nivo
* Previously untreated unresectable stage III-IV melanoma
* Enrollment is closed for this Arm
Nivolumab
Specified dose on specified days
Interventions
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BMS-986249
Specified dose on specified days
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
* Eastern Cooperative Oncology Group Performance Status of 0 or 1
* Must have received, and then progressed, relapsed, or been intolerant to, at least 1 standard treatment regimen in the advanced or metastatic setting according to tumor type, if such a therapy exists
* Prior anti-cancer treatments such as chemotherapy, radiotherapy, or hormonal are permitted for some participants
* Willing and able to comply with all study procedures
Exclusion Criteria
* Other active malignancy requiring concurrent intervention
* Prior organ allograft
* Active, known, or suspected autoimmune disease
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 - 0005
Aurora, Colorado, United States
Local Institution - 0006
Denver, Colorado, United States
Local Institution - 0017
Miami, Florida, United States
Local Institution - 0024
Baltimore, Maryland, United States
Local Institution - 0001
Hackensack, New Jersey, United States
Local Institution - 0002
New York, New York, United States
Local Institution - 0003
New York, New York, United States
Local Institution - 0029
Cincinnati, Ohio, United States
Local Institution - 0013
Eugene, Oregon, United States
Local Institution - 0004
Philadelphia, Pennsylvania, United States
Local Institution - 0008
Greenville, South Carolina, United States
Local Institution - 0010
Austin, Texas, United States
Local Institution - 0009
Dallas, Texas, United States
Local Institution - 0021
Houston, Texas, United States
Local Institution - 0016
San Antonio, Texas, United States
Local Institution - 0011
Tyler, Texas, United States
Local Institution - 0012
Leesburg, Virginia, United States
Local Institution - 0007
Norfolk, Virginia, United States
Local Institution - 0018
Vancouver, Washington, United States
Local Institution - 0038
Buenos Aires, Distrito Federal, Argentina
Local Institution - 0052
CABA, Distrito Federal, Argentina
Local Institution - 0037
Buenos Aires, , Argentina
Local Institution - 0015
North Sydney, New South Wales, Australia
Local Institution - 0014
Adelaide, South Australia, Australia
Local Institution - 0025
Frankston, Victoria, Australia
Local Institution - 0047
Heidelberg, Victoria, Australia
Local Institution - 0026
Edmonton, Alberta, Canada
Local Institution - 0056
Ottawa, Ontario, Canada
Local Institution - 0036
Santiago, Santiago Metropolitan, Chile
Local Institution - 0039
Helsinki, , Finland
Local Institution - 0030
Essen, , Germany
Local Institution - 0035
Hamburg, , Germany
Local Institution - 0031
Heidelberg, , Germany
Local Institution - 0048
Milan, , Italy
Local Institution - 0020
Napoli, , Italy
Local Institution - 0049
Siena, , Italy
Local Institution - 0040
Warsaw, , Poland
Local Institution - 0045
Bucharest, , Romania
Local Institution - 0041
Craiova, , Romania
Local Institution - 0042
Badalona, Barcelona [Barcelona], Spain
Local Institution - 0022
Madrid, Madrid, Comunidad de, Spain
Local Institution - 0044
Barcelona, , Spain
Local Institution - 0023
Madrid, , Spain
Local Institution - 0050
Madrid, , Spain
Local Institution - 0043
Málaga, , 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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CA030-001
Identifier Type: -
Identifier Source: org_study_id
2018-000416-21
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
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