MesotheliomaPhase 3CheckMate743NCT02899299

Study of Nivolumab Combined With Ipilimumab Versus Pemetrexed and Cisplatin or Carboplatin as First Line Therapy in Unresectable Pleural Mesothelioma Patients

A Phase 3 study testing Nivolumab, Ipilimumab and Pemetrexed in people with Mesothelioma, run by Bristol-Myers Squibb at 109 sites in 21 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial 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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Mesothelioma
What is being tested?: Nivolumab, Ipilimumab and Pemetrexed
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 605 participants
Where: 109 sitesin 21 countries
Study dates: 29 Nov 2016to 28 Apr 2023
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

109 sites in 21 countries.

Country

City, postcode or hospital

109 sites in 21 countries

Japan15 sites

Local Institution - 0106
Amagasaki-shi, Hyōgo, 6608550
Local Institution - 0097
Chiba, Chiba, 2608677
Local Institution - 0094
Chuo-ku, Tokyo, 1040045
Local Institution - 0108
Fukuyama-shi, Hiroshima, 7200001
Local Institution - 0114
Hiroshima, Hiroshima, 7348551
Local Institution - 0096
Kitaadachi-gun, Saitama, 3620806
Local Institution - 0105
Nagoya, Aichi-ken, 4668560
Local Institution - 0104
Natori-shi, Miyagi, 9811293
Local Institution - 0107
Niigata, Niigata, 9518520
Local Institution - 0098
Nishinomiya-shi, Hyōgo, 6638501
Local Institution - 0100
Okayama, Okayama-ken, 7028055
Local Institution - 0101
Sapporo, Hokkaido, 0030804
Local Institution - 0113
Sayama, 5898511
Local Institution - 0099
Ube-shi, Yamaguchi, 7550241
Local Institution - 0095
Yokohama, Kanagawa, 2210855

Other trials in Japan

United States14 sites

Univ Of Maryland Greenbaum Cancer Center
Baltimore, Maryland, 21201
Local Institution - 0002
Chicago, Illinois, 60637
Local Institution - 0007
Cleveland, Ohio, 44195
Local Institution - 0013
Detroit, Michigan, 48201
Cancer & Hematology Centers Of Western Michigan
Grand Rapids, Michigan, 49503
Local Institution - 0005
Houston, Texas, 77030
West Virginia University
Morgantown, West Virginia, 26506
Local Institution - 0014
New Haven, Connecticut, 06520
Memorial Sloan Kettering Nassau
New York, New York, 10065
University Of Pennsylvania
Philadelphia, Pennsylvania, 19104
Allegheny Cancer Center
Pittsburgh, Pennsylvania, 15212
Local Institution - 0004
Rochester, Minnesota, 55905
Ucsf
San Francisco, California, 94143
H. Lee Moffitt Cancer Center & Research Inst, Inc
Tampa, Florida, 33612

Other trials in United States

France10 sites

Local Institution - 0057
Caen, 14033
Local Institution - 0073
Créteil, 94010
Local Institution - 0074
La Tronche, 38700
Local Institution - 0067
Lille, 59037
Local Institution - 0069
Marseille, 13915
Local Institution - 0056
Paris, 75018
Local Institution - 0080
Saint-Herblain, 44805
Local Institution - 0093
Strasbourg, 67091
Local Institution - 0058
Toulon, 83056
Local Institution - 0068
Toulouse, 31059

Other trials in France

Germany10 sites

Local Institution - 0026
Cologne, 51109
Local Institution - 0054
Coswig, 01640
Local Institution - 0038
Essen, 45147
Local Institution - 0023
Göttingen, 37075
Local Institution - 0024
Großhansdorf, 22927
Local Institution - 0027
Hamburg, 21075
Local Institution - 0037
Heidelberg, 69126
Local Institution - 0021
Homburg An D. Saar, 66421
Local Institution - 0022
Immenhausen, 34376
Local Institution - 0019
Moers, 47441

Other trials in Germany

Italy8 sites

Local Institution - 0047
Aviano, 33081
Local Institution - 0044
Bari, 70124
Local Institution - 0046
Catania, 95124
Local Institution - 0045
Genova, 16132
Local Institution - 0043
Naples, 80131
Local Institution - 0042
Ravenna, Emilia-Romagna, 48121
Local Institution - 0048
Rozzano, 20089
Local Institution - 0041
Siena, 53100

Other trials in Italy

United Kingdom6 sites

Local Institution - 0084
Edinburgh, Midlothian, EH4 2XU
Local Institution - 0081
Leicester, LE1 5WW
Local Institution - 0083
London, EC1A 7BE
Local Institution - 0116
Manchester, M23 9LT
Local Institution - 0090
Southampton, SO16 6YD
Local Institution - 0085
Truro, Cornwall, TR1 3LJ

Other trials in United Kingdom

Australia5 sites

Local Institution - 0031
Birtinya, Queensland, 4575
Local Institution - 0033
Clayton, Victoria, 3168
Local Institution - 0030
Malvern, Victoria, 3144
Local Institution - 0034
Nedlands, Western Australia, 6009
Local Institution - 0032
Sydney, New South Wales, 2139

Other trials in Australia

China5 sites

Local Institution
Changchun, Jilin, 130021
Local Institution - 0133
Harbin, Heilongjiang, 150081
Local Institution - 0124
Kunming, 0
Local Institution - 0120
Shanghai, 200030
Local Institution
Shenyang, Liaoning

Other trials in China

Mexico5 sites

Local Institution - 0118
Chihuahua City, 31000
Local Institution - 0079
Df, Mexico City, 06720
Local Institution - 0051
Guadalajara, Jalisco, 44270
Local Institution - 0053
Mexico City, Mexico City, 14000
Local Institution - 0050
Mexico City, Mexico City, 14050

Other trials in Mexico

Belgium4 sites

Local Institution - 0089
Brussels, 1090
Local Institution - 0086
Edegem, 2650
Local Institution - 0087
Liège, 4000
Local Institution - 0088
Sint-Niklaas, 9100

Other trials in Belgium

Romania4 sites

Local Institution - 0115
Bucharest, 020122
Local Institution - 0109
Bucharest, 021389
Local Institution - 0102
Craiova, 200347
Local Institution - 0055
Romania, 400015

Other trials in Romania

Poland3 sites

Local Institution - 0078
Bytom, 41-902
Local Institution - 0076
Krakow, 31-202
Local Institution - 0077
Warsaw, 02-781

Other trials in Poland

Russia3 sites

Local Institution - 0150
Moscow, 115478
Local Institution - 0071
Moscow, 121309
Local Institution - 0072
Saint Petersburg, 197758

Other trials in Russia

Switzerland3 sites

Local Institution - 0049
Bern, 3010
Local Institution - 0036
Lausanne, 1011
Local Institution - 0029
Zurich, 8091

Other trials in Switzerland

Turkey (Türkiye)3 sites

Local Institution - 0111
Diyarbakır, 21280
Local Institution - 0112
Istanbul, 34098
Local Institution - 0110
Seyhan, 01130

Other trials in Turkey (Türkiye)

Brazil2 sites

Local Institution
Barretos, São Paulo, 14784-400
Local Institution - 0064
São Paulo, 05403-010

Other trials in Brazil

Colombia2 sites

Local Institution - 0039
Bogotá, 0
Local Institution - 0040
Bogotá, 0

Other trials in Colombia

Greece2 sites

Local Institution - 0017
Athens, 11527
Local Institution - 0016
Thessaloniki, 57001

Other trials in Greece

Netherlands2 sites

Local Institution - 0092
Amsterdam, 1066 CX
Local Institution - 0091
Rotterdam, 3000 CA

Other trials in Netherlands

South Africa2 sites

Local Institution - 0059
Cape Town, Western Cape, 7570
Local Institution - 0060
Pretoria, Gauteng, 0075

Other trials in South Africa

Chile1 site

Local Institution - 0018
Santiago, Santiago Metropolitan, 8420383

Other trials in Chile

About this study

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

Conditions: Mesothelioma
Being tested: Nivolumab, Ipilimumab, Pemetrexed, Cisplatin, Carboplatin
Medical subject headings: Mesothelioma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

NivolumabBiological
Also called BMS-936558, Opdivo
IpilimumabBiological
Also called BMS-734016, Yervoy
PemetrexedDrug
CisplatinDrug
CarboplatinDrug

Study groups in NCT02899299
Study group	Role	What they receive
Nivolumab and Ipilimumab	Experimental	Specified dose on specified days Receives: Biological: Nivolumab; Biological: Ipilimumab
Pemetrexed and Cisplatin (or Carboplatin)	Active comparator	Specified dose on specified days Receives: Drug: Pemetrexed; Drug: Cisplatin; Drug: Carboplatin

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: From randomization to the date of death (Up to 40 Months)

Secondary outcomes (6)

Objective Response Rate (ORR)
Objective Response Rate is defined as the percentage of randomized participants who achieve a best overall response of complete response (CR) or partial response (PR) per Blinded Independent Central Review (BICR) assessments. Per adapted m-RECIST for pleural mesothelioma, each single tumor measurement must be at least 10 mm in length to qualify as measureable disease and contribute to the sum that defines the pleural uni-variate measure. Per RECIST 1.1 for solid tumors, confirmation of response required:
CR=Disappearance of all target lesions; PR=At least a 30% decrease in the sum of the Total Tumor Measurement; Progressive disease (PD)=At least a 20% increase in the sum of the Total Tumor Measurement.
Measured: 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)
Disease Control Rate (DCR)
Disease Control Rate is defined as the percentage of all randomized participants whose Best Overall Response was complete response (CR), partial response (PR), stable disease (SD) or Non-CR/Non-PD as assessed by Blinded Independent Central Review (BICR). Per adapted m-RECIST for pleural mesothelioma, each single tumor measurement must be at least 10 mm in length to qualify as measureable disease and contribute to the sum that defines the pleural uni-variate measure. Per RECIST 1.1 for solid tumors, confirmation of response required:
CR=Disappearance of all target lesions; PR=At least a 30% decrease in the sum of the Total Tumor Measurement; Progressive disease (PD)=At least a 20% increase in the sum of the Total Tumor Measurement; SD=Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD; Non-CR/Non-PD: Persistence of one or more non-target lesion(s).
Measured: 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
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.
Progressive disease (PD)=At least a 20% increase in the sum of the Total Tumor Measurement.
Measured: From randomization date to the date of first documented tumor progression or death due to any cause, whichever occurs first. (up to 76 months)
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. OS 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.
Measured: From randomization date to the date of death (Up to 76 Months)
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. PFS 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.
Progressive disease (PD)=At least a 20% increase in the sum of the Total Tumor Measurement.
Measured: From randomization date to the date of first documented tumor progression or death due to any cause, whichever occurs first. (up to 76 months)
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. ORR is defined as the percentage of participants who achieve a best overall response of complete response (CR) or partial response (PR) per Blinded Independent Central Review (BICR) assessments. Per adapted m-RECIST for pleural mesothelioma, each single tumor measurement must be at least 10 mm in length to qualify as measureable disease and contribute to the sum that defines the pleural uni-variate measure.
per RECIST 1.1 for solid tumors, confirmation of response required: CR=Disappearance of all target lesions; PR=At least a 30% decrease in the sum of the Total Tumor Measurement; Progressive disease (PD)=At least a 20% increase in the sum of the Total Tumor Measurement.
Measured: 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)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

29 Nov 201628 Apr 2023

First posted14 Sep 2016 (estimated)
Study start29 Nov 2016
Primary completion25 Mar 2020
Study completion28 Apr 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (5)Papers the sponsor has linked to this study.
Other trials for MesotheliomaStudies of the same condition, open and under way.
More trials run by Bristol-Myers SquibbThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 605 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02899299
Sponsor's protocol ID: CA209-743
Other IDs: 2016-001859-43, 2016
Acronym: CheckMate743
Status last verified: Apr 2024
First submitted: 31 Aug 2016
Last updated: 21 May 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
Expanded access: Available

Publications

Scherpereel A, Baas P, Nowak AK, Tsao AS, Fujimoto N, Peters S, Mansfield AS, Popat S, Bautista Aragon Y, Talbot T, Grossi F, Kowalski D, Kaplan MA, Cardona AF, Soomro R, Hu N, Lee A, Ip V, Hung YH, Zalcman G. Five-Year Clinical Outcomes With Nivolumab Plus Ipilimumab Versus Chemotherapy as First-Line Treatment for Unresectable Pleural Mesothelioma in CheckMate 743. J Clin Oncol. 2026 Mar 20;44(9):742-749. doi: 10.1200/JCO-25-01328. Epub 2026 Feb 24.
PubMed 41734361
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.
PubMed 35367910
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.
PubMed 35124183
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.
PubMed 33485464
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.
PubMed 33206991

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 21 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT02899299
Acronym / sponsor ID: CheckMate743 / CA209-743
Conditions: Mesothelioma
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 605 participants (actual)
Lead sponsor: Bristol-Myers SquibbIndustry (pharma, biotech, devices)
Collaborators: Ono Pharmaceutical Co., Ltd.
Study start: 29 Nov 2016 (actual)
Primary completion: 25 Mar 2020 (actual)
Study completion: 28 Apr 2023 (actual)
First posted: 14 Sep 2016 (estimated)
Results: Posted 14 Apr 2021

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Nivolumab and Ipilimumab	Experimental	Biological: Nivolumab, Biological: IpilimumabSpecified dose on specified days
Pemetrexed and Cisplatin (or Carboplatin)	Active comparator	Drug: Pemetrexed, Drug: Cisplatin, Drug: CarboplatinSpecified dose on specified days

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

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

Key exclusion criteria (6 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
NivolumabAlso: BMS-936558, Opdivo	Biological	Nivolumab and Ipilimumab
IpilimumabAlso: BMS-734016, Yervoy	Biological	Nivolumab and Ipilimumab
Pemetrexed	Drug	Pemetrexed and Cisplatin (or Carboplatin)
Cisplatin	Drug	Pemetrexed and Cisplatin (or Carboplatin)
Carboplatin	Drug	Pemetrexed and Cisplatin (or Carboplatin)

Primary outcome

Overall Survival (OS)
Time frame: From randomization to the date of death (Up to 40 Months)
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.

6 secondary outcomes

Objective Response Rate (ORR)
Time frame: 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)
Disease Control Rate (DCR)
Time frame: 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
Progression Free Survival (PFS)
Time frame: From randomization date to the date of first documented tumor progression or death due to any cause, whichever occurs first. (up to 76 months)
Overall Survival (OS) According to PD-L1 Expression Level
Time frame: From randomization date to the date of death (Up to 76 Months)
Progression Free Survival (PFS) According to PD-L1 Expression Level
Time frame: From randomization date to the date of first documented tumor progression or death due to any cause, whichever occurs first. (up to 76 months)
Objective Response Rate (ORR) According to PD-L1 Expression Level
Time frame: 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)

Results and safety

Results posted to the registry on 14 Apr 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Treatment A	303	300
Treatment B	302	284

Primary outcome: Overall Survival (OS)

Time frame: From randomization to the date of death (Up to 40 Months). Median (95% Confidence Interval). Unit: Months

Measure	Treatment A n = 303	Treatment B n = 302
Value	18.07 (16.82 to 21.45)	14.09 (12.45 to 16.23)

Treatment A vs Treatment B: Hazard Ratio (HR): 0.74 (96.6% CI 0.60 to 0.91), p = 0.0020, Stratified Log Rank

Population analysed: All Randomized Participants

6 secondary outcomes are reported in the full results.

Adverse events

Time frame: Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months.) SAEs and Other AEs were assessed from first dose to 100 days post the last dose of study therapy (up to approximately 29 months).. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Nivolumab 3mg/kg Plus Ipilimumab 1mg/kg	188 of 300 (62.7%)	277 of 300 (92.3%)	251 of 303
Pemetrexed Plus Cisplatin or Carboplatin	106 of 284 (37.3%)	264 of 284 (93%)	259 of 302

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 41734361Scherpereel A, Baas P, Nowak AK, Tsao AS, Fujimoto N, Peters S, Mansfield AS, Popat S, Bautista Aragon Y, Talbot T, Grossi F, Kowalski D, Kaplan MA, Cardona AF, Soomro R, Hu N, Lee A, Ip V, Hung YH, Zalcman G. Five-Year Clinical Outcomes With Nivolumab Plus Ipilimumab Versus Chemotherapy as First-Line Treatment for Unresectable Pleural Mesothelioma in CheckMate 743. J Clin Oncol. 2026 Mar 20;44(9):742-749. doi: 10.1200/JCO-25-01328. Epub 2026 Feb 24.
Derived from this study: PubMed 35367910Scherpereel 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.
Derived from this study: PubMed 35124183Peters 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.
Derived from this study: PubMed 33485464Baas 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.
Derived from this study: PubMed 33206991Wright 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.
BMS Clinical Trial InformationLink provided by the sponsor.
BMS Clinical Trial Patient RecruitingLink provided by the sponsor.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Bristol-Myers Squibb study director

Bristol-Myers Squibb

109 sites in 21 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Nivolumab, Ipilimumab and Pemetrexed in people with Mesothelioma, run by Bristol-Myers Squibb at 109 sites in 21 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 May 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 109 sites in Japan, United States, France, Germany, Italy and 16 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 14 Apr 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall Survival (OS) (time frame: From randomization to the date of death (Up to 40 Months)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02899299, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 May 2024.