Study of Nivolumab Combined With Ipilimumab Versus Pemetrexed and Cisplatin or Carboplatin as First Line Therapy in Unresectable Pleural Mesothelioma Patients
NCT ID: NCT02899299
Last Updated: 2024-05-21
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
605 participants
INTERVENTIONAL
2016-11-29
2023-04-28
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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Nivolumab and Ipilimumab
Specified dose on specified days
Nivolumab
Ipilimumab
Pemetrexed and Cisplatin (or Carboplatin)
Specified dose on specified days
Pemetrexed
Cisplatin
Carboplatin
Interventions
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Nivolumab
Ipilimumab
Pemetrexed
Cisplatin
Carboplatin
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Histologically confirmed pleural malignant mesothelioma not eligible for curative surgery
* ECOG Performance status of 0 or 1
* Available tumor sample for testing
* Acceptable blood work
Exclusion Criteria
* Prior chemotherapy for pleural mesothelioma
* Prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2 oranti-CTLA-4 antibody
* History of other malignancy unless the subject has been disease-free for at least 3 years
* Active, untreated central nervous system (CNS) metastasis
18 Years
ALL
No
Sponsors
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Ono Pharmaceutical Co. Ltd
INDUSTRY
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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Ucsf
San Francisco, California, United States
Local Institution - 0014
New Haven, Connecticut, United States
H. Lee Moffitt Cancer Center & Research Inst, Inc
Tampa, Florida, United States
Local Institution - 0002
Chicago, Illinois, United States
Univ Of Maryland Greenbaum Cancer Center
Baltimore, Maryland, United States
Local Institution - 0013
Detroit, Michigan, United States
Cancer & Hematology Centers Of Western Michigan
Grand Rapids, Michigan, United States
Local Institution - 0004
Rochester, Minnesota, United States
Memorial Sloan Kettering Nassau
New York, New York, United States
Local Institution - 0007
Cleveland, Ohio, United States
University Of Pennsylvania
Philadelphia, Pennsylvania, United States
Allegheny Cancer Center
Pittsburgh, Pennsylvania, United States
Local Institution - 0005
Houston, Texas, United States
West Virginia University
Morgantown, West Virginia, United States
Local Institution - 0032
Sydney, New South Wales, Australia
Local Institution - 0031
Birtinya, Queensland, Australia
Local Institution - 0033
Clayton, Victoria, Australia
Local Institution - 0030
Malvern, Victoria, Australia
Local Institution - 0034
Nedlands, Western Australia, Australia
Local Institution - 0089
Brussels, , Belgium
Local Institution - 0086
Edegem, , Belgium
Local Institution - 0087
Liège, , Belgium
Local Institution - 0088
Sint-Niklaas, , Belgium
Local Institution
Barretos, São Paulo, Brazil
Local Institution - 0064
São Paulo, , Brazil
Local Institution - 0018
Santiago, Santiago Metropolitan, Chile
Local Institution - 0133
Harbin, Heilongjiang, China
Local Institution
Changchun, Jilin, China
Local Institution
Shenyang, Liaoning, China
Local Institution - 0124
Kunming, , China
Local Institution - 0120
Shanghai, , China
Local Institution - 0039
Bogotá, , Colombia
Local Institution - 0040
Bogotá, , Colombia
Local Institution - 0057
Caen, , France
Local Institution - 0073
Créteil, , France
Local Institution - 0074
La Tronche, , France
Local Institution - 0067
Lille, , France
Local Institution - 0069
Marseille, , France
Local Institution - 0056
Paris, , France
Local Institution - 0080
Saint-Herblain, , France
Local Institution - 0093
Strasbourg, , France
Local Institution - 0058
Toulon, , France
Local Institution - 0068
Toulouse, , France
Local Institution - 0026
Cologne, , Germany
Local Institution - 0054
Coswig, , Germany
Local Institution - 0038
Essen, , Germany
Local Institution - 0023
Göttingen, , Germany
Local Institution - 0024
Großhansdorf, , Germany
Local Institution - 0027
Hamburg, , Germany
Local Institution - 0037
Heidelberg, , Germany
Local Institution - 0021
Homburg An D. Saar, , Germany
Local Institution - 0022
Immenhausen, , Germany
Local Institution - 0019
Moers, , Germany
Local Institution - 0017
Athens, , Greece
Local Institution - 0016
Thessaloniki, , Greece
Local Institution - 0042
Ravenna, Emilia-Romagna, Italy
Local Institution - 0047
Aviano, , Italy
Local Institution - 0044
Bari, , Italy
Local Institution - 0046
Catania, , Italy
Local Institution - 0045
Genova, , Italy
Local Institution - 0043
Napoli, , Italy
Local Institution - 0048
Rozzano, , Italy
Local Institution - 0041
Siena, , Italy
Local Institution - 0105
Nagoya, Aichi-ken, Japan
Local Institution - 0097
Chiba, Chiba, Japan
Local Institution - 0108
Fukuyama-shi, Hiroshima, Japan
Local Institution - 0114
Hiroshima, Hiroshima, Japan
Local Institution - 0101
Sapporo, Hokkaido, Japan
Local Institution - 0106
Amagasaki-shi, Hyōgo, Japan
Local Institution - 0098
Nishinomiya-shi, Hyōgo, Japan
Local Institution - 0095
Yokohama, Kanagawa, Japan
Local Institution - 0104
Natori-shi, Miyagi, Japan
Local Institution - 0107
Niigata, Niigata, Japan
Local Institution - 0100
Okayama, Okayama-ken, Japan
Local Institution - 0096
Kitaadachi-gun, Saitama, Japan
Local Institution - 0094
Chuo-ku, Tokyo, Japan
Local Institution - 0099
Ube-shi, Yamaguchi, Japan
Local Institution - 0113
Sayama, , Japan
Local Institution - 0051
Guadalajara, Jalisco, Mexico
Local Institution - 0079
Df, Mexico City, Mexico
Local Institution - 0053
Mexico City, Mexico City, Mexico
Local Institution - 0050
Mexico City, Mexico City, Mexico
Local Institution - 0118
Chihuahua City, , Mexico
Local Institution - 0092
Amsterdam, , Netherlands
Local Institution - 0091
Rotterdam, , Netherlands
Local Institution - 0078
Bytom, , Poland
Local Institution - 0076
Krakow, , Poland
Local Institution - 0077
Warsaw, , Poland
Local Institution - 0115
Bucharest, , Romania
Local Institution - 0109
Bucharest, , Romania
Local Institution - 0102
Craiova, , Romania
Local Institution - 0055
Romania, , Romania
Local Institution - 0150
Moscow, , Russia
Local Institution - 0071
Moscow, , Russia
Local Institution - 0072
Saint Petersburg, , Russia
Local Institution - 0060
Pretoria, Gauteng, South Africa
Local Institution - 0059
Cape Town, Western Cape, South Africa
Local Institution - 0049
Bern, , Switzerland
Local Institution - 0036
Lausanne, , Switzerland
Local Institution - 0029
Zurich, , Switzerland
Local Institution - 0111
Diyarbakır, , Turkey (Türkiye)
Local Institution - 0112
Istanbul, , Turkey (Türkiye)
Local Institution - 0110
Seyhan, , Turkey (Türkiye)
Local Institution - 0085
Truro, Cornwall, United Kingdom
Local Institution - 0084
Edinburgh, Midlothian, United Kingdom
Local Institution - 0081
Leicester, , United Kingdom
Local Institution - 0083
London, , United Kingdom
Local Institution - 0116
Manchester, , United Kingdom
Local Institution - 0090
Southampton, , United Kingdom
Countries
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References
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Scherpereel A, Antonia S, Bautista Y, Grossi F, Kowalski D, Zalcman G, Nowak AK, Fujimoto N, Peters S, Tsao AS, Mansfield AS, Popat S, Sun X, Lawrance R, Zhang X, Daumont MJ, Bennett B, McKenna M, Baas P. First-line nivolumab plus ipilimumab versus chemotherapy for the treatment of unresectable malignant pleural mesothelioma: patient-reported outcomes in CheckMate 743. Lung Cancer. 2022 May;167:8-16. doi: 10.1016/j.lungcan.2022.03.012. Epub 2022 Mar 21.
Peters S, Scherpereel A, Cornelissen R, Oulkhouir Y, Greillier L, Kaplan MA, Talbot T, Monnet I, Hiret S, Baas P, Nowak AK, Fujimoto N, Tsao AS, Mansfield AS, Popat S, Zhang X, Hu N, Balli D, Spires T, Zalcman G. First-line nivolumab plus ipilimumab versus chemotherapy in patients with unresectable malignant pleural mesothelioma: 3-year outcomes from CheckMate 743. Ann Oncol. 2022 May;33(5):488-499. doi: 10.1016/j.annonc.2022.01.074. Epub 2022 Feb 3.
Baas P, Scherpereel A, Nowak AK, Fujimoto N, Peters S, Tsao AS, Mansfield AS, Popat S, Jahan T, Antonia S, Oulkhouir Y, Bautista Y, Cornelissen R, Greillier L, Grossi F, Kowalski D, Rodriguez-Cid J, Aanur P, Oukessou A, Baudelet C, Zalcman G. First-line nivolumab plus ipilimumab in unresectable malignant pleural mesothelioma (CheckMate 743): a multicentre, randomised, open-label, phase 3 trial. Lancet. 2021 Jan 30;397(10272):375-386. doi: 10.1016/S0140-6736(20)32714-8. Epub 2021 Jan 21.
Wright K. FDA Approves Nivolumab Plus Ipilimumab for Previously Untreated Unresectable Malignant Pleural Mesothelioma. Oncology (Williston Park). 2020 Nov 12;34(11):502-503. doi: 10.46883/ONC.2020.3411.0502.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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BMS Clinical Trial Information
BMS Clinical Trial Patient Recruiting
Other Identifiers
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2016-001859-43
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CA209-743
Identifier Type: -
Identifier Source: org_study_id
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