An Investigational Immuno-therapy Study of BMS-986205 Given in Combination With Nivolumab and in Combination With Both Nivolumab and Ipilimumab in Cancers That Are Advanced or Have Spread
NCT ID: NCT02658890
Last Updated: 2023-08-28
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE1/PHASE2
627 participants
INTERVENTIONAL
2016-04-14
2021-10-26
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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Combination Therapy (Dose Escalation)
BMS 986205 + Nivolumab specified dose at specified intervals.
BMS-986205
Nivolumab
Combination Therapy (Dose Expansion)
BMS 986205 + Nivolumab specified dose at specified intervals.
BMS-986205
Nivolumab
Combination Therapy 2 (Dose Expansion)
BMS 986205 + both Nivolumab and ipilimumab specified dose at specified intervals
BMS-986205
Nivolumab
Ipilimumab
Interventions
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BMS-986205
Nivolumab
Ipilimumab
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* During cohort expansion, subjects with advanced cancer that either have received at least one prior therapy or are treatment naive, depending on the specified tumor type
* Subjects must have measurable disease
* Subject must consent to provide previously collected tumor tissue and a tumor biopsy during screening.
* At least 4 weeks since any previous treatment for cancer
* Must be able to swallow pills or capsules
* Eastern Cooperative Oncology Group(ECOG) Performance Status 0-1
Exclusion Criteria
* Uncontrolled or significant cardiovascular disease
* History of any chronic Hepatitis, active Hepatitis B or C, human immunodeficiency virus (HIV), or acquired immune deficiency syndrome (AIDS)
* Chronic hepatitis: Positive test for Hepatitis B virus surface antigen or Hepatitis C antibody (except for subjects with hepatocellular carcinoma)
* Active central nervous system (CNS) metastases and CNS metastases as the only sites of disease
* Active infection
18 Years
100 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
Tucson, Arizona, United States
Local Institution - 0026
La Jolla, California, United States
Local Institution - 0035
Tampa, Florida, United States
Local Institution - 0005
Atlanta, Georgia, United States
Local Institution - 0048
Atlanta, Georgia, United States
Local Institution - 0027
Chicago, Illinois, United States
Local Institution - 0051
Lutherville, Maryland, United States
Local Institution - 0049
Detroit, Michigan, United States
Local Institution - 0006
St Louis, Missouri, United States
Local Institution - 0033
Hackensack, New Jersey, United States
Local Institution - 0041
New York, New York, United States
Local Institution - 0030
Cleveland, Ohio, United States
Local Institution - 0034
Philadelphia, Pennsylvania, United States
Local Institution - 0057
Pittsburgh, Pennsylvania, United States
Local Institution - 0043
Nashville, Tennessee, United States
Local Institution - 0045
North Sydney, New South Wales, Australia
Local Institution - 0029
Sydney, New South Wales, Australia
Local Institution - 0046
Westmead, New South Wales, Australia
Local Institution - 0044
Brisbane, Queensland, Australia
Local Institution - 0008
Clayton, Victoria, Australia
Local Institution - 0004
Melbourne, Victoria, Australia
Local Institution - 0047
Nedlands, Western Australia, Australia
Local Institution - 0003
Edmonton, Alberta, Canada
Local Institution - 0002
Vancouver, British Columbia, Canada
Local Institution - 0001
Toronto, Ontario, Canada
Local Institution
Greenfield Park, Quebec, Canada
Local Institution - 0036
Montreal, Quebec, Canada
Local Institution - 0059
Helsinki, , Finland
Local Institution - 0040
Lille, , France
Local Institution - 0024
Lyon, , France
Local Institution - 0053
Marseille, , France
Local Institution - 0052
Nantes, , France
Local Institution - 0025
Paris, , France
Local Institution - 0023
Toulouse, , France
Local Institution - 0022
Villejuif, , France
Local Institution - 0019
Essen, , Germany
Local Institution - 0013
Heilbronn, , Germany
Local Institution - 0010
Milan, , Italy
Local Institution - 0011
Milan, , Italy
Local Institution - 0012
Milan, , Italy
Local Institution - 0009
Rozzano MI, , Italy
Local Institution - 0054
Oslo, , Norway
Local Institution - 0042
Warsaw, Masovian Voivodeship, Poland
Local Institution - 0017
Barcelona, , Spain
Local Institution - 0016
Madrid, , Spain
Local Institution - 0018
Madrid, , Spain
Local Institution - 0055
Solna, , Sweden
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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2015-004914-79
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CA017-003
Identifier Type: -
Identifier Source: org_study_id
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