First-In-Human Study of Monoclonal Antibody BMS-986218 by Itself and in Combination With Nivolumab in Participants With Advanced Solid Tumors
NCT ID: NCT03110107
Last Updated: 2025-04-24
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE1/PHASE2
376 participants
INTERVENTIONAL
2017-05-04
2024-04-04
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: Monotherapy (BMS-986218)
BMS-986218
Specified dose on specified days
Part 1B: Combination Therapy (BMS-986218 + Nivolumab)
BMS-986218
Specified dose on specified days
Nivolumab
Specified dose on specified days
Part 2A: Monotherapy (BMS-986218 OR Ipilimumab)
Ipilimumab
Specified dose on specified days
BMS-986218
Specified dose on specified days
Part 2B: Monotherapy (BMS-986218)
BMS-986218
Specified dose on specified days
Part 2C: Expansion Combination Therapy (BMS-986218 + Nivolumab)
BMS-986218
Specified dose on specified days
Nivolumab
Specified dose on specified days
Part 2D: Expansion Combination Therapy (BMS-986218 + Nivolumab)
BMS-986218
Specified dose on specified days
Nivolumab
Specified dose on specified days
Interventions
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Ipilimumab
Specified dose on specified days
BMS-986218
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
* Eastern Cooperative Oncology Group Performance Status of 0 or 1
* Participants must have received, and then progressed, relapsed, or been intolerant to at least 2 standard treatment regimens with proven survival benefit in the advanced or metastatic setting according to tumor type, if such a therapy exists
* Advanced stage cutaneous melanoma who have received standard therapies with proven survival benefit including prior immunotherapy with an anti-programmed cell death 1 (anti-PD-1) or anti-programmed death ligand 1 (anti-PD-L1) (For Part 2A)
* Non-small cell lung cancer (NSCLC) (adenocarcinoma or squamous cell carcinoma) who have received standard therapies with proven survival benefit including prior immunotherapy with an anti-PD-1 or anti-PD-L1 (For Parts 2B \& 2C)
* Microsatellite Stable Colorectal Cancer (MSS CRC) who have received standard therapies with proven survival benefit (Part 2D)
Exclusion Criteria
* Cytotoxic agents, unless at least 4 weeks have elapsed from last dose of prior anti-cancer therapy and initiation of study therapy
* Prior anti-cancer treatments such as chemotherapy, radiotherapy, hormonal, or immunotherapy (including anti-PD-1/PD-L1) are permitted
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 - 0058
Atlanta, Georgia, United States
Local Institution - 0025
Boston, Massachusetts, United States
Local Institution - 0002
Hackensack, New Jersey, United States
Local Institution - 0028
New Brunswick, New Jersey, United States
Local Institution - 0001
New York, New York, United States
Local Institution - 0007
New York, New York, United States
Local Institution - 0015
Monroeville, Pennsylvania, United States
Local Institution - 0004
Philadelphia, Pennsylvania, United States
Local Institution - 0033
Sioux Falls, South Dakota, United States
Local Institution - 0042
Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina
Local Institution - 0053
ABB, Buenos Aires F.D., Argentina
Local Institution - 0057
CABA, Buenos Aires F.D., Argentina
Local Institution - 0062
Córdoba, Córdoba Province, Argentina
Local Institution - 0060
Río Cuarto, Córdoba Province, Argentina
Local Institution - 0047
Villa Siburu, Córdoba Province, Argentina
Local Institution - 0059
Buenos Aires, Distrito Federal, Argentina
Local Institution - 0026
Northmead, New South Wales, Australia
Local Institution - 0006
Wollstonecraft, New South Wales, Australia
Local Institution - 0049
Murdoch, Western Australia, Australia
Local Institution - 0039
Ghent, , Belgium
Local Institution - 0037
Edmonton, Alberta, Canada
Local Institution - 0023
Vancouver, British Columbia, Canada
Local Institution - 0027
Ottawa, Ontario, Canada
Local Institution - 0022
Toronto, Ontario, Canada
Local Institution - 0052
Viña del Mar, Región de Valparaíso, Chile
Local Institution - 0048
Santiago, Santiago Metropolitan, Chile
Local Institution - 0041
Santiago, Santiago Metropolitan, Chile
Local Institution - 0045
Helsinki, , Finland
Local Institution - 0019
Lyon, , France
Local Institution - 0020
Toulouse, , France
Local Institution - 0018
Villejuif, , France
Local Institution - 0009
Dresden, , Germany
Local Institution - 0030
Essen, , Germany
Local Institution - 0029
Haifa, , Israel
Local Institution - 0008
Ramat Gan, , Israel
Local Institution - 0011
Napoli, , Italy
Local Institution - 0061
Rozzano, , Italy
Local Institution - 0010
Siena, , Italy
Local Institution - 0038
Amsterdam, , Netherlands
Local Institution - 0043
Nijmegen, , Netherlands
Local Institution - 0040
Oslo, , Norway
Local Institution - 0036
Warsaw, , Poland
Local Institution - 0034
Cluj-Napoca, , Romania
Local Institution - 0035
Craiova, , Romania
Local Institution - 0014
Barcelona, , Spain
Local Institution - 0056
Madrid, , Spain
Local Institution - 0055
Madrid, , Spain
Local Institution - 0013
Madrid, , Spain
Local Institution - 0054
Málaga, , Spain
Local Institution - 0012
Pamplona, , Spain
Local Institution - 0017
Lausanne, , Switzerland
Local Institution - 0031
Zurich, , Switzerland
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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2017-000597-11
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CA022-001
Identifier Type: -
Identifier Source: org_study_id
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