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Study of Nivolumab Combined With Ipilimumab Versus Pemetrexed and Cisplatin or Carboplatin as First Line Therapy in Unresectable Pleural Mesothelioma Patients (CheckMate743)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02899299
Recruitment Status : Active, not recruiting
First Posted : September 14, 2016
Results First Posted : April 14, 2021
Last Update Posted : March 15, 2023
Ono Pharmaceutical Co. Ltd
Information provided by (Responsible Party):
Bristol-Myers Squibb

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.

Condition or disease Intervention/treatment Phase
Mesothelioma Biological: Nivolumab Biological: Ipilimumab Drug: Pemetrexed Drug: Cisplatin Drug: Carboplatin Phase 3

Expanded Access : An investigational treatment associated with this study is no longer available outside the clinical trial.   More info ...

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 605 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : November 29, 2016
Actual Primary Completion Date : March 25, 2020
Estimated Study Completion Date : April 28, 2023

Arm Intervention/treatment
Experimental: Nivolumab and Ipilimumab
Specified dose on specified days
Biological: Nivolumab
Other Names:
  • BMS-936558
  • Opdivo

Biological: Ipilimumab
Other Names:
  • BMS-734016
  • Yervoy

Active Comparator: Pemetrexed and Cisplatin (or Carboplatin)
Specified dose on specified days
Drug: Pemetrexed
Drug: Cisplatin
Drug: Carboplatin

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. Objective Response Rate (ORR) [ Time Frame: Up to 40 months ]
    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).

  2. Disease Control Rate (DCR) [ Time Frame: Up to 40 months ]
    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).

  3. Progression Free Survival (PFS) [ Time Frame: Up to 40 months ]
    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.

  4. Overall Survival (OS) According to PD-L1 Expression Level [ Time Frame: Up to 40 months ]
    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.

  5. Progression Free Survival (PFS) According to PD-L1 Expression Level [ Time Frame: Up to 40 months ]
    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.

  6. Objective Response Rate (ORR) According to PD-L1 Expression Level [ Time Frame: Up to 40 months ]
    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.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02899299

Hide Hide 110 study locations
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United States, California
San Francisco, California, United States, 94143
United States, Connecticut
Local Institution - 0014
New Haven, Connecticut, United States, 06520
United States, Florida
H. Lee Moffitt Cancer Center & Research Inst, Inc
Tampa, Florida, United States, 33612
United States, Illinois
Local Institution - 0002
Chicago, Illinois, United States, 60637
United States, Maryland
Univ Of Maryland Greenbaum Cancer Center
Baltimore, Maryland, United States, 21201
United States, Michigan
Local Institution - 0013
Detroit, Michigan, United States, 48201
Cancer & Hematology Centers Of Western Michigan
Grand Rapids, Michigan, United States, 49503
United States, Minnesota
Local Institution - 0004
Rochester, Minnesota, United States, 55905
United States, New York
Memorial Sloan Kettering Nassau
New York, New York, United States, 10065
United States, Ohio
Local Institution - 0007
Cleveland, Ohio, United States, 44195
United States, Pennsylvania
University Of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Allegheny Cancer Center
Pittsburgh, Pennsylvania, United States, 15212
United States, Texas
Local Institution - 0005
Houston, Texas, United States, 77030
United States, West Virginia
West Virginia University
Morgantown, West Virginia, United States, 26506
Australia, New South Wales
Local Institution - 0032
Sydney, New South Wales, Australia, 2139
Australia, Queensland
Local Institution - 0031
Birtinya, Queensland, Australia, 4575
Australia, Victoria
Local Institution - 0033
Clayton, Victoria, Australia, 3168
Local Institution - 0030
Malvern, Victoria, Australia, 3144
Australia, Western Australia
Local Institution - 0034
Nedlands, Western Australia, Australia, 6009
Local Institution - 0089
Brussels, Belgium, 1090
Local Institution - 0086
Edegem, Belgium, 2650
Local Institution - 0087
Liège, Belgium, 4000
Local Institution - 0088
Sint-Niklaas, Belgium, 9100
Local Institution
Barretos, Sao Paulo, Brazil, 14784-400
Local Institution - 0064
Sao Paulo, Brazil, 05403-010
Local Institution - 0018
Santiago, Metropolitana, Chile, 8420383
China, Heilongjiang
Local Institution - 0133
Harbin Shi, Heilongjiang, China, 150081
China, Jilin
Local Institution
Changchun, Jilin, China, 130021
China, Liaoning
Local Institution
Shenyang, Liaoning, China
Local Institution - 0124
Kunming, China, 0
Local Institution - 0120
Shanghai, China, 200030
Local Institution - 0039
Bogota, Colombia, 0
Local Institution - 0040
Bogota, Colombia, 0
Local Institution - 0057
Caen, France, 14033
Local Institution - 0073
Creteil, France, 94010
Local Institution - 0074
La Tronche, France, 38700
Local Institution - 0067
Lille Cedex, France, 59037
Local Institution - 0069
Marseille Cedex 20, France, 13915
Local Institution - 0056
Paris, France, 75018
Local Institution - 0080
Saint Herblain, France, 44805
Local Institution - 0093
Strasbourg Cedex, France, 67091
Local Institution - 0058
Toulon Cedex, France, 83056
Local Institution - 0068
Toulouse Cedex 9, France, 31059
Local Institution - 0026
Cologne, Germany, 51109
Local Institution - 0054
Coswig, Germany, 01640
Local Institution - 0038
Essen, Germany, 45147
Local Institution
Essen, Germany, 45147
Local Institution - 0023
Gottingen, Germany, 37075
Local Institution - 0024
Grosshansdorf, Germany, 22927
Local Institution - 0027
Hamburg, Germany, 21075
Local Institution - 0037
Heidelberg, Germany, 69126
Local Institution - 0021
Homburg an d. Saar, Germany, 66421
Local Institution - 0022
Immenhausen, Germany, 34376
Local Institution - 0019
Moers, Germany, 47441
Local Institution - 0017
Athens, Greece, 11527
Local Institution - 0016
Thessaloniki, Greece, 57001
Local Institution - 0042
Ravenna, Emilia-Romagna, Italy, 48121
Local Institution - 0047
Aviano, Italy, 33081
Local Institution - 0044
Bari, Italy, 70124
Local Institution - 0046
Catania, Italy, 95124
Local Institution - 0045
Genova, Italy, 16132
Local Institution - 0043
Napoli, Italy, 80131
Local Institution - 0048
Rozzano, Italy, 20089
Local Institution - 0041
Siena, Italy, 53100
Local Institution - 0105
Nagoya-shi, Aichi, Japan, 4668560
Local Institution - 0097
Chiba-shi, Chiba, Japan, 2608677
Local Institution - 0108
Fukuyama-shi, Hiroshima, Japan, 7200001
Local Institution - 0114
Hiroshima-Shi, Hiroshima, Japan, 7348551
Local Institution - 0101
Sapporo-shi, Hokkaido, Japan, 0030804
Local Institution - 0106
Amagasaki-shi, Hyogo, Japan, 6608550
Local Institution - 0098
Nishinomiya-shi, Hyogo, Japan, 6638501
Local Institution - 0095
Yokohama-shi, Kanagawa, Japan, 2210855
Local Institution - 0104
Natori-shi, Miyagi, Japan, 9811293
Local Institution - 0107
Niigata-shi, Niigata, Japan, 9518520
Local Institution - 0100
Okayama-shi, Okayama, Japan, 7028055
Local Institution - 0096
Kitaadachi-gun, Saitama, Japan, 3620806
Local Institution - 0094
Chuo-ku, Tokyo, Japan, 1040045
Local Institution - 0099
Ube-shi, Yamaguchi, Japan, 7550241
Local Institution - 0113
Osakasayama-city, Japan, 5898511
Local Institution - 0079
Df, Distrito Federal, Mexico, 06720
Local Institution - 0053
Mexico, Distrito Federal, Mexico, 14000
Local Institution - 0050
Mexico, Distrito Federal, Mexico, 14050
Local Institution - 0051
Guadalajara, Jalisco, Mexico, 44270
Local Institution - 0118
Chihuahua, Mexico, 31000
Local Institution - 0092
Amsterdam, Netherlands, 1066 CX
Local Institution - 0091
Rotterdam, Netherlands, 3000 CA
Local Institution - 0078
Bytom, Poland, 41-902
Local Institution - 0076
Krakow, Poland, 31-202
Local Institution - 0077
Warszawa, Poland, 02-781
Local Institution - 0115
Bucharest, Romania, 020122
Local Institution - 0109
Bucuresti, Romania, 021389
Local Institution - 0102
Craiova, Romania, 200347
Local Institution - 0055
Romania, Romania, 400015
Russian Federation
Local Institution - 0150
Moscow, Russian Federation, 115478
Local Institution - 0071
Moscow, Russian Federation, 121309
Local Institution - 0072
Saint Petersburg, Russian Federation, 197758
South Africa
Local Institution - 0060
Pretoria, Gauteng, South Africa, 0075
Local Institution - 0059
Cape Town, Western Cape, South Africa, 7570
Local Institution - 0049
Bern, Bern (de), Switzerland, 3010
Local Institution - 0036
Lausanne, Switzerland, 1011
Local Institution - 0029
Zurich, Switzerland, 8091
Local Institution - 0111
Diyarbakır, Turkey, 21280
Local Institution - 0112
Istanbul, Turkey, 34098
Local Institution - 0110
Seyhan, Turkey, 01130
United Kingdom
Local Institution - 0085
Truro, Cornwall, United Kingdom, TR1 3LJ
Local Institution - 0084
Edinburgh, Midlothian, United Kingdom, EH4 2XU
Local Institution - 0081
Leicester, United Kingdom, LE1 5WW
Local Institution - 0083
London, United Kingdom, EC1A 7BE
Local Institution - 0116
Manchester, United Kingdom, M23 9LT
Local Institution - 0090
Southampton, United Kingdom, SO16 6YD
Sponsors and Collaborators
Bristol-Myers Squibb
Ono Pharmaceutical Co. Ltd
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Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  Study Documents (Full-Text)

Documents provided by Bristol-Myers Squibb:
Study Protocol  [PDF] April 25, 2019
Statistical Analysis Plan  [PDF] November 7, 2019

Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):

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Responsible Party: Bristol-Myers Squibb Identifier: NCT02899299    
Other Study ID Numbers: CA209-743
2016-001859-43 ( EudraCT Number )
First Posted: September 14, 2016    Key Record Dates
Results First Posted: April 14, 2021
Last Update Posted: March 15, 2023
Last Verified: February 2023
Additional relevant MeSH terms:
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Mesothelioma, Malignant
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms, Mesothelial
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Pleural Neoplasms
Lung Diseases
Respiratory Tract Diseases
Antineoplastic Agents
Antineoplastic Agents, Immunological
Immune Checkpoint Inhibitors
Molecular Mechanisms of Pharmacological Action
Enzyme Inhibitors
Folic Acid Antagonists
Nucleic Acid Synthesis Inhibitors