Clinical trial NCT02899299: Study of Nivolumab Combined With Ipilimumab Versus Pemetrexed and Cisplatin or Carboplatin as First Line Therapy in Unresectable Pleural Mesothelioma Patients
Official title: A Phase III, Randomized, Open Label Trial of Nivolumab in Combination With Ipilimumab Versus Pemetrexed With Cisplatin or Carboplatin as First Line Therapy in Unresectable Pleural Mesothelioma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Mesothelioma
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
Collaborators: name: Ono Pharmaceutical Co. Ltd
First posted: 2016-09-14
Enrollment: 605
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to test the effectiveness and tolerability of the combination of Nivolumab and Ipilimumab compared to Pemetrexed and Cisplatin or Carboplatin in patients with unresectable pleural mesothelioma.


Eligibility criteria: For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

* Males and Females at least 18 years of age
* 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:

* Primitive peritoneal, pericardial and tunica vaginalis testis mesotheliomas
* 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

Other protocol defined inclusion/exclusion criteria could apply

Primary outcomes:
measure: Overall Survival (OS)
timeFrame: From randomization to the date of death (Up to 40 Months)
Secondary outcomes:
measure: Objective Response Rate (ORR)
timeFrame: From randomization date to the date of objectively documented progression or the date of subsequent anti-cancer therapy, whichever occurs first (Up to 76 months)
measure: Disease Control Rate (DCR)
timeFrame: From randomization date to the date of objectively documented progression or the date of subsequent anti-cancer therapy, whichever occurs first (Up to 76 months
measure: Progression Free Survival (PFS)
timeFrame: From randomization date to the date of first documented tumor progression or death due to any cause, whichever occurs first. (up to 76 months)
measure: Overall Survival (OS) According to PD-L1 Expression Level
timeFrame: From randomization date to the date of death (Up to 76 Months)
measure: Progression Free Survival (PFS) According to PD-L1 Expression Level
timeFrame: From randomization date to the date of first documented tumor progression or death due to any cause, whichever occurs first. (up to 76 months)
measure: Objective Response Rate (ORR) According to PD-L1 Expression Level
timeFrame: From randomization date to the date of objectively documented progression or the date of subsequent anti-cancer therapy, whichever occurs first (Up to 76 months)
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: Ucsf
state: California
city: New Haven
country: United States
facility: Local Institution - 0014
state: Connecticut
city: Tampa
country: United States
facility: H. Lee Moffitt Cancer Center & Research Inst, Inc
state: Florida
city: Chicago
country: United States
facility: Local Institution - 0002
state: Illinois
city: Baltimore
country: United States
facility: Univ Of Maryland Greenbaum Cancer Center
state: Maryland
city: Detroit
country: United States
facility: Local Institution - 0013
state: Michigan
city: Grand Rapids
country: United States
facility: Cancer & Hematology Centers Of Western Michigan
state: Michigan
city: Rochester
country: United States
facility: Local Institution - 0004
state: Minnesota
city: New York
country: United States
facility: Memorial Sloan Kettering Nassau
state: New York
city: Cleveland
country: United States
facility: Local Institution - 0007
state: Ohio
city: Philadelphia
country: United States
facility: University Of Pennsylvania
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Allegheny Cancer Center
state: Pennsylvania
city: Houston
country: United States
facility: Local Institution - 0005
state: Texas
city: Morgantown
country: United States
facility: West Virginia University
state: West Virginia
city: Sydney
country: Australia
facility: Local Institution - 0032
state: New South Wales
city: Birtinya
country: Australia
facility: Local Institution - 0031
state: Queensland
city: Clayton
country: Australia
facility: Local Institution - 0033
state: Victoria
city: Malvern
country: Australia
facility: Local Institution - 0030
state: Victoria
city: Nedlands
country: Australia
facility: Local Institution - 0034
state: Western Australia
city: Brussels
country: Belgium
facility: Local Institution - 0089
city: Edegem
country: Belgium
facility: Local Institution - 0086
city: Liège
country: Belgium
facility: Local Institution - 0087
city: Sint-Niklaas
country: Belgium
facility: Local Institution - 0088
city: Barretos
country: Brazil
facility: Local Institution
state: Sao Paulo
city: Sao Paulo
country: Brazil
facility: Local Institution - 0064
city: Santiago
country: Chile
facility: Local Institution - 0018
state: Metropolitana
city: Harbin Shi
country: China
facility: Local Institution - 0133
state: Heilongjiang
city: Changchun
country: China
facility: Local Institution
state: Jilin
city: Shenyang
country: China
facility: Local Institution
state: Liaoning
city: Kunming
country: China
facility: Local Institution - 0124
city: Shanghai
country: China
facility: Local Institution - 0120
city: Bogota
country: Colombia
facility: Local Institution - 0039
city: Bogota
country: Colombia
facility: Local Institution - 0040
city: Caen
country: France
facility: Local Institution - 0057
city: Creteil
country: France
facility: Local Institution - 0073
city: La Tronche
country: France
facility: Local Institution - 0074
city: Lille Cedex
country: France
facility: Local Institution - 0067
city: Marseille Cedex 20
country: France
facility: Local Institution - 0069
city: Paris
country: France
facility: Local Institution - 0056
city: Saint Herblain
country: France
facility: Local Institution - 0080
city: Strasbourg Cedex
country: France
facility: Local Institution - 0093
city: Toulon Cedex
country: France
facility: Local Institution - 0058
city: Toulouse Cedex 9
country: France
facility: Local Institution - 0068
city: Cologne
country: Germany
facility: Local Institution - 0026
city: Coswig
country: Germany
facility: Local Institution - 0054
city: Essen
country: Germany
facility: Local Institution - 0038
city: Gottingen
country: Germany
facility: Local Institution - 0023
city: Grosshansdorf
country: Germany
facility: Local Institution - 0024
city: Hamburg
country: Germany
facility: Local Institution - 0027
city: Heidelberg
country: Germany
facility: Local Institution - 0037
city: Homburg an d. Saar
country: Germany
facility: Local Institution - 0021
city: Immenhausen
country: Germany
facility: Local Institution - 0022
city: Moers
country: Germany
facility: Local Institution - 0019
city: Athens
country: Greece
facility: Local Institution - 0017
city: Thessaloniki
country: Greece
facility: Local Institution - 0016
city: Ravenna
country: Italy
facility: Local Institution - 0042
state: Emilia-Romagna
city: Aviano
country: Italy
facility: Local Institution - 0047
city: Bari
country: Italy
facility: Local Institution - 0044
city: Catania
country: Italy
facility: Local Institution - 0046
city: Genova
country: Italy
facility: Local Institution - 0045
city: Napoli
country: Italy
facility: Local Institution - 0043
city: Rozzano
country: Italy
facility: Local Institution - 0048
city: Siena
country: Italy
facility: Local Institution - 0041
city: Nagoya-shi
country: Japan
facility: Local Institution - 0105
state: Aichi
city: Chiba-shi
country: Japan
facility: Local Institution - 0097
state: Chiba
city: Fukuyama-shi
country: Japan
facility: Local Institution - 0108
state: Hiroshima
city: Hiroshima-Shi
country: Japan
facility: Local Institution - 0114
state: Hiroshima
city: Sapporo-shi
country: Japan
facility: Local Institution - 0101
state: Hokkaido
city: Amagasaki-shi
country: Japan
facility: Local Institution - 0106
state: Hyogo
city: Nishinomiya-shi
country: Japan
facility: Local Institution - 0098
state: Hyogo
city: Yokohama-shi
country: Japan
facility: Local Institution - 0095
state: Kanagawa
city: Natori-shi
country: Japan
facility: Local Institution - 0104
state: Miyagi
city: Niigata-shi
country: Japan
facility: Local Institution - 0107
state: Niigata
city: Okayama-shi
country: Japan
facility: Local Institution - 0100
state: Okayama
city: Kitaadachi-gun
country: Japan
facility: Local Institution - 0096
state: Saitama
city: Chuo-ku
country: Japan
facility: Local Institution - 0094
state: Tokyo
city: Ube-shi
country: Japan
facility: Local Institution - 0099
state: Yamaguchi
city: Osakasayama-city
country: Japan
facility: Local Institution - 0113
city: Df
country: Mexico
facility: Local Institution - 0079
state: Distrito Federal
city: Mexico
country: Mexico
facility: Local Institution - 0053
state: Distrito Federal
city: Mexico
country: Mexico
facility: Local Institution - 0050
state: Distrito Federal
city: Guadalajara
country: Mexico
facility: Local Institution - 0051
state: Jalisco
city: Chihuahua
country: Mexico
facility: Local Institution - 0118
city: Amsterdam
country: Netherlands
facility: Local Institution - 0092
city: Rotterdam
country: Netherlands
facility: Local Institution - 0091
city: Bytom
country: Poland
facility: Local Institution - 0078
city: Krakow
country: Poland
facility: Local Institution - 0076
city: Warszawa
country: Poland
facility: Local Institution - 0077
city: Bucharest
country: Romania
facility: Local Institution - 0115
city: Bucuresti
country: Romania
facility: Local Institution - 0109
city: Craiova
country: Romania
facility: Local Institution - 0102
city: Romania
country: Romania
facility: Local Institution - 0055
city: Moscow
country: Russian Federation
facility: Local Institution - 0150
city: Moscow
country: Russian Federation
facility: Local Institution - 0071
city: Saint Petersburg
country: Russian Federation
facility: Local Institution - 0072
city: Pretoria
country: South Africa
facility: Local Institution - 0060
state: Gauteng
city: Cape Town
country: South Africa
facility: Local Institution - 0059
state: Western Cape
city: Bern
country: Switzerland
facility: Local Institution - 0049
city: Lausanne
country: Switzerland
facility: Local Institution - 0036
city: Zurich
country: Switzerland
facility: Local Institution - 0029
city: Diyarbakır
country: Turkey
facility: Local Institution - 0111
city: Istanbul
country: Turkey
facility: Local Institution - 0112
city: Seyhan
country: Turkey
facility: Local Institution - 0110
city: Truro
country: United Kingdom
facility: Local Institution - 0085
state: Cornwall
city: Edinburgh
country: United Kingdom
facility: Local Institution - 0084
state: Midlothian
city: Leicester
country: United Kingdom
facility: Local Institution - 0081
city: London
country: United Kingdom
facility: Local Institution - 0083
city: Manchester
country: United Kingdom
facility: Local Institution - 0116
city: Southampton
country: United Kingdom
facility: Local Institution - 0090
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.