Back to resultsStudy of Nivolumab Combined With Ipilimumab Versus Pemetrexed and Cisplatin or Carboplatin as First Line Therapy in Unresectable Pleural Mesothelioma Patients (CheckMate743)
Primary Purpose
Mesothelioma
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Nivolumab
Ipilimumab
Pemetrexed
Cisplatin
Carboplatin
Sponsored by
About this trial
This is an interventional treatment trial for 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
Sites / Locations
- Ucsf
- Local Institution - 0014
- H. Lee Moffitt Cancer Center & Research Inst, Inc
- Local Institution - 0002
- Univ Of Maryland Greenbaum Cancer Center
- Local Institution - 0013
- Cancer & Hematology Centers Of Western Michigan
- Local Institution - 0004
- Memorial Sloan Kettering Nassau
- Local Institution - 0007
- University Of Pennsylvania
- Allegheny Cancer Center
- Local Institution - 0005
- West Virginia University
- Local Institution - 0032
- Local Institution - 0031
- Local Institution - 0033
- Local Institution - 0030
- Local Institution - 0034
- Local Institution - 0089
- Local Institution - 0086
- Local Institution - 0087
- Local Institution - 0088
- Local Institution
- Local Institution - 0064
- Local Institution - 0018
- Local Institution - 0133
- Local Institution
- Local Institution
- Local Institution - 0124
- Local Institution - 0120
- Local Institution - 0039
- Local Institution - 0040
- Local Institution - 0057
- Local Institution - 0073
- Local Institution - 0074
- Local Institution - 0067
- Local Institution - 0069
- Local Institution - 0056
- Local Institution - 0080
- Local Institution - 0093
- Local Institution - 0058
- Local Institution - 0068
- Local Institution - 0026
- Local Institution - 0054
- Local Institution - 0038
- Local Institution
- Local Institution - 0023
- Local Institution - 0024
- Local Institution - 0027
- Local Institution - 0037
- Local Institution - 0021
- Local Institution - 0022
- Local Institution - 0019
- Local Institution - 0017
- Local Institution - 0016
- Local Institution - 0042
- Local Institution - 0047
- Local Institution - 0044
- Local Institution - 0046
- Local Institution - 0045
- Local Institution - 0043
- Local Institution - 0048
- Local Institution - 0041
- Local Institution - 0105
- Local Institution - 0097
- Local Institution - 0108
- Local Institution - 0114
- Local Institution - 0101
- Local Institution - 0106
- Local Institution - 0098
- Local Institution - 0095
- Local Institution - 0104
- Local Institution - 0107
- Local Institution - 0100
- Local Institution - 0096
- Local Institution - 0094
- Local Institution - 0099
- Local Institution - 0113
- Local Institution - 0079
- Local Institution - 0053
- Local Institution - 0050
- Local Institution - 0051
- Local Institution - 0118
- Local Institution - 0092
- Local Institution - 0091
- Local Institution - 0078
- Local Institution - 0076
- Local Institution - 0077
- Local Institution - 0115
- Local Institution - 0109
- Local Institution - 0102
- Local Institution - 0055
- Local Institution - 0150
- Local Institution - 0071
- Local Institution - 0072
- Local Institution - 0060
- Local Institution - 0059
- Local Institution - 0049
- Local Institution - 0036
- Local Institution - 0029
- Local Institution - 0111
- Local Institution - 0112
- Local Institution - 0110
- Local Institution - 0085
- Local Institution - 0084
- Local Institution - 0081
- Local Institution - 0083
- Local Institution - 0116
- Local Institution - 0090
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Nivolumab and Ipilimumab
Pemetrexed and Cisplatin (or Carboplatin)
Arm Description
Specified dose on specified days
Specified dose on specified days
Outcomes
Primary Outcome Measures
Overall Survival (OS)
Overall Survival was defined as the time from randomization to the date of death due to any cause. A participant who has not died was censored at last known date alive.
Secondary Outcome Measures
Objective Response Rate (ORR)
Objective Response Rate is defined as the percentage of randomized participants who achieve a best overall response of complete response or partial response per Blinded Independent Central Review (BICR) assessments (Per adapted m-RECIST for pleural mesothelioma and RECIST 1.1, confirmation of response required).
Disease Control Rate (DCR)
Disease Control Rate is defined as the percentage of all randomized participants whose Best Overall Response was Complete Response, Partial Response, Stable Disease or Non-CR/Non-PD per adapted m-RECIST and RECIST 1.1 as assessed by Blinded Independent Central Review (BICR).
Progression Free Survival (PFS)
Progression Free Survival is defined as the time between the date of randomization and the date of first documented tumor progression per Blinded Independent Central Review (BICR) assessments (using adapted m-RECIST and RECIST 1.1), or death due to any cause, whichever occurs first. Participants who received subsequent anticancer therapy prior to documented progression were censored at the date of the last evaluable tumor assessment conducted on or prior to the date of initiation of the subsequent anticancer therapy.
Overall Survival (OS) According to PD-L1 Expression Level
PD-L1 Expression is defined as the percent of tumor cells membrane staining in a minimum of 100 evaluable tumor cells per validated Dako PD-L1 immunohistochemistry (IHC) assay. This is referred to as quantifiable PD-L1 expression and efficacy is determined by overall survival (OS) analysis.
Progression Free Survival (PFS) According to PD-L1 Expression Level
PD-L1 Expression is defined as the percent of tumor cells membrane staining in a minimum of 100 evaluable tumor cells per validated Dako PD-L1 immunohistochemistry (IHC) assay. This is referred to as quantifiable PD-L1 expression and efficacy is determined by progression free survival (PFS) analysis.
Objective Response Rate (ORR) According to PD-L1 Expression Level
PD-L1 Expression is defined as the percent of tumor cells membrane staining in a minimum of 100 evaluable tumor cells per validated Dako PD-L1 immunohistochemistry (IHC) assay. This is referred to as quantifiable PD-L1 expression and efficacy is determined by objective response rate (ORR) analysis.
Full Information
NCT ID
NCT02899299
First Posted
August 31, 2016
Last Updated
June 29, 2023
Sponsor
Bristol-Myers Squibb
Collaborators
Ono Pharmaceutical Co. Ltd
1. Study Identification
Unique Protocol Identification Number
NCT02899299
Brief Title
Study of Nivolumab Combined With Ipilimumab Versus Pemetrexed and Cisplatin or Carboplatin as First Line Therapy in Unresectable Pleural Mesothelioma Patients
Acronym
CheckMate743
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
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
November 29, 2016 (Actual)
Primary Completion Date
March 25, 2020 (Actual)
Study Completion Date
May 30, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bristol-Myers Squibb
Collaborators
Ono Pharmaceutical Co. Ltd
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mesothelioma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
605 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Nivolumab and Ipilimumab
Arm Type
Experimental
Arm Description
Specified dose on specified days
Arm Title
Pemetrexed and Cisplatin (or Carboplatin)
Arm Type
Active Comparator
Arm Description
Specified dose on specified days
Intervention Type
Biological
Intervention Name(s)
Nivolumab
Other Intervention Name(s)
BMS-936558, Opdivo
Intervention Type
Biological
Intervention Name(s)
Ipilimumab
Other Intervention Name(s)
BMS-734016, Yervoy
Intervention Type
Drug
Intervention Name(s)
Pemetrexed
Intervention Type
Drug
Intervention Name(s)
Cisplatin
Intervention Type
Drug
Intervention Name(s)
Carboplatin
Primary Outcome Measure Information:
Title
Overall Survival (OS)
Description
Overall Survival was defined as the time from randomization to the date of death due to any cause. A participant who has not died was censored at last known date alive.
Time Frame
From randomization to the date of death (Up to 40 Months)
Secondary Outcome Measure Information:
Title
Objective Response Rate (ORR)
Description
Objective Response Rate is defined as the percentage of randomized participants who achieve a best overall response of complete response or partial response per Blinded Independent Central Review (BICR) assessments (Per adapted m-RECIST for pleural mesothelioma and RECIST 1.1, confirmation of response required).
Time Frame
Up to 40 months
Title
Disease Control Rate (DCR)
Description
Disease Control Rate is defined as the percentage of all randomized participants whose Best Overall Response was Complete Response, Partial Response, Stable Disease or Non-CR/Non-PD per adapted m-RECIST and RECIST 1.1 as assessed by Blinded Independent Central Review (BICR).
Time Frame
Up to 40 months
Title
Progression Free Survival (PFS)
Description
Progression Free Survival is defined as the time between the date of randomization and the date of first documented tumor progression per Blinded Independent Central Review (BICR) assessments (using adapted m-RECIST and RECIST 1.1), or death due to any cause, whichever occurs first. Participants who received subsequent anticancer therapy prior to documented progression were censored at the date of the last evaluable tumor assessment conducted on or prior to the date of initiation of the subsequent anticancer therapy.
Time Frame
Up to 40 months
Title
Overall Survival (OS) According to PD-L1 Expression Level
Description
PD-L1 Expression is defined as the percent of tumor cells membrane staining in a minimum of 100 evaluable tumor cells per validated Dako PD-L1 immunohistochemistry (IHC) assay. This is referred to as quantifiable PD-L1 expression and efficacy is determined by overall survival (OS) analysis.
Time Frame
Up to 40 months
Title
Progression Free Survival (PFS) According to PD-L1 Expression Level
Description
PD-L1 Expression is defined as the percent of tumor cells membrane staining in a minimum of 100 evaluable tumor cells per validated Dako PD-L1 immunohistochemistry (IHC) assay. This is referred to as quantifiable PD-L1 expression and efficacy is determined by progression free survival (PFS) analysis.
Time Frame
Up to 40 months
Title
Objective Response Rate (ORR) According to PD-L1 Expression Level
Description
PD-L1 Expression is defined as the percent of tumor cells membrane staining in a minimum of 100 evaluable tumor cells per validated Dako PD-L1 immunohistochemistry (IHC) assay. This is referred to as quantifiable PD-L1 expression and efficacy is determined by objective response rate (ORR) analysis.
Time Frame
Up to 40 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bristol-Myers Squibb
Organizational Affiliation
Bristol-Myers Squibb
Official's Role
Study Director
Facility Information:
Facility Name
Ucsf
City
San Francisco
State/Province
California
ZIP/Postal Code
94143
Country
United States
Facility Name
Local Institution - 0014
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06520
Country
United States
Facility Name
H. Lee Moffitt Cancer Center & Research Inst, Inc
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States
Facility Name
Local Institution - 0002
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Facility Name
Univ Of Maryland Greenbaum Cancer Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Facility Name
Local Institution - 0013
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
Facility Name
Cancer & Hematology Centers Of Western Michigan
City
Grand Rapids
State/Province
Michigan
ZIP/Postal Code
49503
Country
United States
Facility Name
Local Institution - 0004
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
Memorial Sloan Kettering Nassau
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Facility Name
Local Institution - 0007
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
University Of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Allegheny Cancer Center
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15212
Country
United States
Facility Name
Local Institution - 0005
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
West Virginia University
City
Morgantown
State/Province
West Virginia
ZIP/Postal Code
26506
Country
United States
Facility Name
Local Institution - 0032
City
Sydney
State/Province
New South Wales
ZIP/Postal Code
2139
Country
Australia
Facility Name
Local Institution - 0031
City
Birtinya
State/Province
Queensland
ZIP/Postal Code
4575
Country
Australia
Facility Name
Local Institution - 0033
City
Clayton
State/Province
Victoria
ZIP/Postal Code
3168
Country
Australia
Facility Name
Local Institution - 0030
City
Malvern
State/Province
Victoria
ZIP/Postal Code
3144
Country
Australia
Facility Name
Local Institution - 0034
City
Nedlands
State/Province
Western Australia
ZIP/Postal Code
6009
Country
Australia
Facility Name
Local Institution - 0089
City
Brussels
ZIP/Postal Code
1090
Country
Belgium
Facility Name
Local Institution - 0086
City
Edegem
ZIP/Postal Code
2650
Country
Belgium
Facility Name
Local Institution - 0087
City
Liège
ZIP/Postal Code
4000
Country
Belgium
Facility Name
Local Institution - 0088
City
Sint-Niklaas
ZIP/Postal Code
9100
Country
Belgium
Facility Name
Local Institution
City
Barretos
State/Province
Sao Paulo
ZIP/Postal Code
14784-400
Country
Brazil
Facility Name
Local Institution - 0064
City
Sao Paulo
ZIP/Postal Code
05403-010
Country
Brazil
Facility Name
Local Institution - 0018
City
Santiago
State/Province
Metropolitana
ZIP/Postal Code
8420383
Country
Chile
Facility Name
Local Institution - 0133
City
Harbin Shi
State/Province
Heilongjiang
ZIP/Postal Code
150081
Country
China
Facility Name
Local Institution
City
Changchun
State/Province
Jilin
ZIP/Postal Code
130021
Country
China
Facility Name
Local Institution
City
Shenyang
State/Province
Liaoning
Country
China
Facility Name
Local Institution - 0124
City
Kunming
ZIP/Postal Code
0
Country
China
Facility Name
Local Institution - 0120
City
Shanghai
ZIP/Postal Code
200030
Country
China
Facility Name
Local Institution - 0039
City
Bogota
ZIP/Postal Code
0
Country
Colombia
Facility Name
Local Institution - 0040
City
Bogota
ZIP/Postal Code
0
Country
Colombia
Facility Name
Local Institution - 0057
City
Caen
ZIP/Postal Code
14033
Country
France
Facility Name
Local Institution - 0073
City
Creteil
ZIP/Postal Code
94010
Country
France
Facility Name
Local Institution - 0074
City
La Tronche
ZIP/Postal Code
38700
Country
France
Facility Name
Local Institution - 0067
City
Lille Cedex
ZIP/Postal Code
59037
Country
France
Facility Name
Local Institution - 0069
City
Marseille Cedex 20
ZIP/Postal Code
13915
Country
France
Facility Name
Local Institution - 0056
City
Paris
ZIP/Postal Code
75018
Country
France
Facility Name
Local Institution - 0080
City
Saint Herblain
ZIP/Postal Code
44805
Country
France
Facility Name
Local Institution - 0093
City
Strasbourg Cedex
ZIP/Postal Code
67091
Country
France
Facility Name
Local Institution - 0058
City
Toulon Cedex
ZIP/Postal Code
83056
Country
France
Facility Name
Local Institution - 0068
City
Toulouse Cedex 9
ZIP/Postal Code
31059
Country
France
Facility Name
Local Institution - 0026
City
Cologne
ZIP/Postal Code
51109
Country
Germany
Facility Name
Local Institution - 0054
City
Coswig
ZIP/Postal Code
01640
Country
Germany
Facility Name
Local Institution - 0038
City
Essen
ZIP/Postal Code
45147
Country
Germany
Facility Name
Local Institution
City
Essen
ZIP/Postal Code
45147
Country
Germany
Facility Name
Local Institution - 0023
City
Gottingen
ZIP/Postal Code
37075
Country
Germany
Facility Name
Local Institution - 0024
City
Grosshansdorf
ZIP/Postal Code
22927
Country
Germany
Facility Name
Local Institution - 0027
City
Hamburg
ZIP/Postal Code
21075
Country
Germany
Facility Name
Local Institution - 0037
City
Heidelberg
ZIP/Postal Code
69126
Country
Germany
Facility Name
Local Institution - 0021
City
Homburg an d. Saar
ZIP/Postal Code
66421
Country
Germany
Facility Name
Local Institution - 0022
City
Immenhausen
ZIP/Postal Code
34376
Country
Germany
Facility Name
Local Institution - 0019
City
Moers
ZIP/Postal Code
47441
Country
Germany
Facility Name
Local Institution - 0017
City
Athens
ZIP/Postal Code
11527
Country
Greece
Facility Name
Local Institution - 0016
City
Thessaloniki
ZIP/Postal Code
57001
Country
Greece
Facility Name
Local Institution - 0042
City
Ravenna
State/Province
Emilia-Romagna
ZIP/Postal Code
48121
Country
Italy
Facility Name
Local Institution - 0047
City
Aviano
ZIP/Postal Code
33081
Country
Italy
Facility Name
Local Institution - 0044
City
Bari
ZIP/Postal Code
70124
Country
Italy
Facility Name
Local Institution - 0046
City
Catania
ZIP/Postal Code
95124
Country
Italy
Facility Name
Local Institution - 0045
City
Genova
ZIP/Postal Code
16132
Country
Italy
Facility Name
Local Institution - 0043
City
Napoli
ZIP/Postal Code
80131
Country
Italy
Facility Name
Local Institution - 0048
City
Rozzano
ZIP/Postal Code
20089
Country
Italy
Facility Name
Local Institution - 0041
City
Siena
ZIP/Postal Code
53100
Country
Italy
Facility Name
Local Institution - 0105
City
Nagoya-shi
State/Province
Aichi
ZIP/Postal Code
4668560
Country
Japan
Facility Name
Local Institution - 0097
City
Chiba-shi
State/Province
Chiba
ZIP/Postal Code
2608677
Country
Japan
Facility Name
Local Institution - 0108
City
Fukuyama-shi
State/Province
Hiroshima
ZIP/Postal Code
7200001
Country
Japan
Facility Name
Local Institution - 0114
City
Hiroshima-Shi
State/Province
Hiroshima
ZIP/Postal Code
7348551
Country
Japan
Facility Name
Local Institution - 0101
City
Sapporo-shi
State/Province
Hokkaido
ZIP/Postal Code
0030804
Country
Japan
Facility Name
Local Institution - 0106
City
Amagasaki-shi
State/Province
Hyogo
ZIP/Postal Code
6608550
Country
Japan
Facility Name
Local Institution - 0098
City
Nishinomiya-shi
State/Province
Hyogo
ZIP/Postal Code
6638501
Country
Japan
Facility Name
Local Institution - 0095
City
Yokohama-shi
State/Province
Kanagawa
ZIP/Postal Code
2210855
Country
Japan
Facility Name
Local Institution - 0104
City
Natori-shi
State/Province
Miyagi
ZIP/Postal Code
9811293
Country
Japan
Facility Name
Local Institution - 0107
City
Niigata-shi
State/Province
Niigata
ZIP/Postal Code
9518520
Country
Japan
Facility Name
Local Institution - 0100
City
Okayama-shi
State/Province
Okayama
ZIP/Postal Code
7028055
Country
Japan
Facility Name
Local Institution - 0096
City
Kitaadachi-gun
State/Province
Saitama
ZIP/Postal Code
3620806
Country
Japan
Facility Name
Local Institution - 0094
City
Chuo-ku
State/Province
Tokyo
ZIP/Postal Code
1040045
Country
Japan
Facility Name
Local Institution - 0099
City
Ube-shi
State/Province
Yamaguchi
ZIP/Postal Code
7550241
Country
Japan
Facility Name
Local Institution - 0113
City
Osakasayama-city
ZIP/Postal Code
5898511
Country
Japan
Facility Name
Local Institution - 0079
City
Df
State/Province
Distrito Federal
ZIP/Postal Code
06720
Country
Mexico
Facility Name
Local Institution - 0053
City
Mexico
State/Province
Distrito Federal
ZIP/Postal Code
14000
Country
Mexico
Facility Name
Local Institution - 0050
City
Mexico
State/Province
Distrito Federal
ZIP/Postal Code
14050
Country
Mexico
Facility Name
Local Institution - 0051
City
Guadalajara
State/Province
Jalisco
ZIP/Postal Code
44270
Country
Mexico
Facility Name
Local Institution - 0118
City
Chihuahua
ZIP/Postal Code
31000
Country
Mexico
Facility Name
Local Institution - 0092
City
Amsterdam
ZIP/Postal Code
1066 CX
Country
Netherlands
Facility Name
Local Institution - 0091
City
Rotterdam
ZIP/Postal Code
3000 CA
Country
Netherlands
Facility Name
Local Institution - 0078
City
Bytom
ZIP/Postal Code
41-902
Country
Poland
Facility Name
Local Institution - 0076
City
Krakow
ZIP/Postal Code
31-202
Country
Poland
Facility Name
Local Institution - 0077
City
Warszawa
ZIP/Postal Code
02-781
Country
Poland
Facility Name
Local Institution - 0115
City
Bucharest
ZIP/Postal Code
020122
Country
Romania
Facility Name
Local Institution - 0109
City
Bucuresti
ZIP/Postal Code
021389
Country
Romania
Facility Name
Local Institution - 0102
City
Craiova
ZIP/Postal Code
200347
Country
Romania
Facility Name
Local Institution - 0055
City
Romania
ZIP/Postal Code
400015
Country
Romania
Facility Name
Local Institution - 0150
City
Moscow
ZIP/Postal Code
115478
Country
Russian Federation
Facility Name
Local Institution - 0071
City
Moscow
ZIP/Postal Code
121309
Country
Russian Federation
Facility Name
Local Institution - 0072
City
Saint Petersburg
ZIP/Postal Code
197758
Country
Russian Federation
Facility Name
Local Institution - 0060
City
Pretoria
State/Province
Gauteng
ZIP/Postal Code
0075
Country
South Africa
Facility Name
Local Institution - 0059
City
Cape Town
State/Province
Western Cape
ZIP/Postal Code
7570
Country
South Africa
Facility Name
Local Institution - 0049
City
Bern
ZIP/Postal Code
3010
Country
Switzerland
Facility Name
Local Institution - 0036
City
Lausanne
ZIP/Postal Code
1011
Country
Switzerland
Facility Name
Local Institution - 0029
City
Zurich
ZIP/Postal Code
8091
Country
Switzerland
Facility Name
Local Institution - 0111
City
Diyarbakır
ZIP/Postal Code
21280
Country
Turkey
Facility Name
Local Institution - 0112
City
Istanbul
ZIP/Postal Code
34098
Country
Turkey
Facility Name
Local Institution - 0110
City
Seyhan
ZIP/Postal Code
01130
Country
Turkey
Facility Name
Local Institution - 0085
City
Truro
State/Province
Cornwall
ZIP/Postal Code
TR1 3LJ
Country
United Kingdom
Facility Name
Local Institution - 0084
City
Edinburgh
State/Province
Midlothian
ZIP/Postal Code
EH4 2XU
Country
United Kingdom
Facility Name
Local Institution - 0081
City
Leicester
ZIP/Postal Code
LE1 5WW
Country
United Kingdom
Facility Name
Local Institution - 0083
City
London
ZIP/Postal Code
EC1A 7BE
Country
United Kingdom
Facility Name
Local Institution - 0116
City
Manchester
ZIP/Postal Code
M23 9LT
Country
United Kingdom
Facility Name
Local Institution - 0090
City
Southampton
ZIP/Postal Code
SO16 6YD
Country
United Kingdom
12. IPD Sharing Statement
Citations:
PubMed Identifier
35367910
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.
Results Reference
derived
PubMed Identifier
35124183
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.
Results Reference
derived
PubMed Identifier
33485464
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. Erratum In: Lancet. 2021 Feb 20;397(10275):670.
Results Reference
derived
PubMed Identifier
33206991
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.
Results Reference
derived
Links:
URL
https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html
Description
BMS Clinical Trial Information
URL
https://www.bmsstudyconnect.com/s/US/English/USenHome
Description
BMS Clinical Trial Patient Recruiting
URL
https://www.fda.gov/Safety/MedWatch/SafetyInformation/default.htm
Description
FDA Safety Alerts and Recalls
Learn more about this trial
Study of Nivolumab Combined With Ipilimumab Versus Pemetrexed and Cisplatin or Carboplatin as First Line Therapy in Unresectable Pleural Mesothelioma Patients
We'll reach out to this number within 24 hrs