A Study to Assess BMS-986207 in Combination With Nivolumab and Ipilimumab as First-line Treatment for Participants With Stage IV Non-Small Cell Lung Cancer
NCT ID: NCT05005273
Last Updated: 2024-02-28
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
1 participants
INTERVENTIONAL
2022-10-03
2022-12-27
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
TRIPLE
Study Groups
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Arm A
Nivolumab
Specified dose on specified days
Ipilimumab
Specified dose on specified days
BMS-986207
Specified dose on specified days
Arm B
Nivolumab
Specified dose on specified days
Ipilimumab
Specified dose on specified days
Placebo
Specified dose on specified days
Interventions
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Nivolumab
Specified dose on specified days
Ipilimumab
Specified dose on specified days
BMS-986207
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
* No prior systemic anti-cancer treatment given as primary therapy for advanced or metastatic NSCLC
* Measurable disease as per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
* Eastern Cooperative Oncology Group (ECOG) performance status 0-1
* A formalin-fixed, paraffin-embedded (FFPE) tumor tissue block or a minimum of 20 unstained slides of tumor tissue obtained during screening or prior to enrollment
* Life expectancy of at least 3 months at the time of first dose
Exclusion Criteria
* Participants with known B-rapidly accelerated fibrosarcoma proto-oncogene (BRAF) V600E mutations that are sensitive to available targeted inhibitor therapy. Participants with unknown or indeterminate BRAF mutation status are eligible.
* Untreated central nervous system metastases
* Leptomeningeal metastases (carcinomatous meningitis)
* Concurrent malignancy requiring treatment
* Active, known, or suspected autoimmune disease
* Interstitial lung disease
* Uncontrolled or significant cardiovascular 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 - 0080
Tucson, Arizona, United States
Local Institution - 0051
Fountain Valley, California, United States
Local Institution - 0070
Fort Myers, Florida, United States
Local Institution - 0073
Gainesville, Florida, United States
Local Institution - 0036
Orange City, Florida, United States
Local Institution - 0045
Pensacola, Florida, United States
Local Institution
Port Saint Lucie, Florida, United States
Local Institution - 0068
St. Petersburg, Florida, United States
Local Institution
Tallahassee, Florida, United States
Local Institution
West Palm Beach, Florida, United States
Local Institution - 0081
Boise, Idaho, United States
Local Institution - 0077
Coeur d'Alene, Idaho, United States
Local Institution - 0074
Edgewood, Kentucky, United States
Local Institution - 0002
Ann Arbor, Michigan, United States
Local Institution - 0049
Brooklyn, New York, United States
Local Institution - 0012
Charleston, South Carolina, United States
Local Institution - 0053
Milwaukee, Wisconsin, United States
Local Institution - 0009
Pergamino, Buenos Aires, Argentina
Local Institution - 0054
Rosario, Santa Fe Province, Argentina
Local Institution - 0062
Buenos Aires, , Argentina
Local Institution - 0021
Buenos Aires, , Argentina
Local Institution - 0011
Buenos Aires, , Argentina
Local Institution - 0048
Buenos Aires, , Argentina
Local Institution - 0057
San Juan, , Argentina
Local Institution - 0063
Orange, New South Wales, Australia
Local Institution - 0056
Wahroonga, New South Wales, Australia
Local Institution - 0052
Warrnambool, Victoria, Australia
Local Institution - 0034
Mechelen, Antwerpen, Belgium
Local Institution - 0040
Charleroi, , Belgium
Local Institution - 0043
Mons, , Belgium
Local Institution - 0019
Sint-Niklaas, , Belgium
Local Institution - 0035
Viña del Mar, Región de Valparaíso, Chile
Local Institution - 0015
Viña del Mar, Región de Valparaíso, Chile
Local Institution - 0050
Santiago, Santiago Metropolitan, Chile
Local Institution - 0037
Limoges, , France
Local Institution - 0030
Nantes, , France
Local Institution - 0044
Pessac, , France
Local Institution - 0016
Rouen, , France
Local Institution - 0031
Saint-Priest-en-Jarez, , France
Local Institution - 0013
Suresnes, , France
Local Institution - 0042
Toulon, , France
Local Institution - 0005
Gauting, Bavaria, Germany
Local Institution - 0022
Frankfurt am Main, Hesse, Germany
Local Institution - 0017
Gera, , Germany
Local Institution - 0023
München, , Germany
Local Institution - 0059
Wiesbaden, , Germany
Local Institution - 0064
Haifa, , Israel
Local Institution - 0061
Jerusalem, , Israel
Local Institution - 0078
Jerusalem, , Israel
Local Institution - 0079
Jerusalem, , Israel
Local Institution - 0039
Monza, MB, Italy
Local Institution - 0020
Rozzano, MI, Italy
Local Institution
Milan, , Italy
Local Institution - 0028
Naples, , Italy
Local Institution - 0001
Padua, , Italy
Local Institution - 0024
Bydgoszcz, , Poland
Local Institution - 0003
Lodz, , Poland
Local Institution - 0038
Otwock, , Poland
Local Institution - 0058
Szczecin, , Poland
Local Institution - 0033
Majadahonda, Madrid, Spain
Local Institution - 0041
Alicante, , Spain
Local Institution - 0026
Barcelona, , Spain
Local Institution - 0075
Barcelona, , Spain
Local Institution - 0006
Barcelona, , Spain
Local Institution - 0046
Jaén, , Spain
Local Institution - 0032
Madrid, , Spain
Local Institution - 0076
Istanbul, , Turkey (Türkiye)
Local Institution - 0066
Istanbul, , Turkey (Türkiye)
Local Institution - 0065
Izmir, , Turkey (Türkiye)
Local Institution - 0067
Samsun, , Turkey (Türkiye)
Local Institution - 0072
Yüreğir, , Turkey (Türkiye)
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
FDA Safety Alerts and Recalls
BMS Clinical Trial Patient Recruiting
Other Identifiers
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2021-000039-29
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
U1111-1263-4850
Identifier Type: OTHER
Identifier Source: secondary_id
CA020-016
Identifier Type: -
Identifier Source: org_study_id
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