Study of Nivolumab Combined With Ipilimumab Versus Pemetrexed and Cisplatin or Carboplatin as First Line Therapy in Unresectable Pleural Mesothelioma Patients (CheckMate743)
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 Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
Study Type
Study Type
Enrollment (Actual)
Enrollment
Phase
Phase
- Phase 3
Expanded Access
Expanded Access
No longer available
- Available: Expanded access is currently available for this investigational treatment, and patients who are not participants in the clinical study may be able to gain access to the drug, biologic, or medical device being studied.
- No longer available: Expanded access was available for this intervention previously but is not currently available and will not be available in the future.
- Temporarily not available: Expanded access is not currently available for this intervention but is expected to be available in the future.
- Approved for marketing: The intervention has been approved by the U.S. Food and Drug Administration for use by the public.
Contacts and Locations
Study Locations
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New South Wales
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Sydney, New South Wales, Australia, 2139
- Local Institution - 0032
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Queensland
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Birtinya, Queensland, Australia, 4575
- Local Institution - 0031
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Victoria
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Clayton, Victoria, Australia, 3168
- Local Institution - 0033
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Malvern, Victoria, Australia, 3144
- Local Institution - 0030
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Western Australia
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Nedlands, Western Australia, Australia, 6009
- Local Institution - 0034
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Brussels, Belgium, 1090
- Local Institution - 0089
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Edegem, Belgium, 2650
- Local Institution - 0086
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Liège, Belgium, 4000
- Local Institution - 0087
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Sint-Niklaas, Belgium, 9100
- Local Institution - 0088
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Sao Paulo, Brazil, 05403-010
- Local Institution - 0064
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Sao Paulo
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Barretos, Sao Paulo, Brazil, 14784-400
- Local Institution
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Metropolitana
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Santiago, Metropolitana, Chile, 8420383
- Local Institution - 0018
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Kunming, China
- Local Institution - 0124
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Shanghai, China, 200030
- Local Institution - 0120
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Heilongjiang
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Harbin Shi, Heilongjiang, China, 150081
- Local Institution - 0133
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Jilin
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Changchun, Jilin, China, 130021
- Local Institution
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Liaoning
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Shenyang, Liaoning, China
- Local Institution
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Bogota, Colombia
- Local Institution - 0039
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Bogota, Colombia
- Local Institution - 0040
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Caen, France, 14033
- Local Institution - 0057
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Creteil, France, 94010
- Local Institution - 0073
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La Tronche, France, 38700
- Local Institution - 0074
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Lille Cedex, France, 59037
- Local Institution - 0067
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Marseille Cedex 20, France, 13915
- Local Institution - 0069
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Paris, France, 75018
- Local Institution - 0056
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Saint Herblain, France, 44805
- Local Institution - 0080
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Strasbourg Cedex, France, 67091
- Local Institution - 0093
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Toulon Cedex, France, 83056
- Local Institution - 0058
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Toulouse Cedex 9, France, 31059
- Local Institution - 0068
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Cologne, Germany, 51109
- Local Institution - 0026
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Coswig, Germany, 01640
- Local Institution - 0054
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Essen, Germany, 45147
- Local Institution - 0038
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Gottingen, Germany, 37075
- Local Institution - 0023
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Grosshansdorf, Germany, 22927
- Local Institution - 0024
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Hamburg, Germany, 21075
- Local Institution - 0027
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Heidelberg, Germany, 69126
- Local Institution - 0037
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Homburg an d. Saar, Germany, 66421
- Local Institution - 0021
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Immenhausen, Germany, 34376
- Local Institution - 0022
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Moers, Germany, 47441
- Local Institution - 0019
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Athens, Greece, 11527
- Local Institution - 0017
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Thessaloniki, Greece, 57001
- Local Institution - 0016
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Aviano, Italy, 33081
- Local Institution - 0047
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Bari, Italy, 70124
- Local Institution - 0044
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Catania, Italy, 95124
- Local Institution - 0046
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Genova, Italy, 16132
- Local Institution - 0045
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Napoli, Italy, 80131
- Local Institution - 0043
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Rozzano, Italy, 20089
- Local Institution - 0048
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Siena, Italy, 53100
- Local Institution - 0041
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Emilia-Romagna
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Ravenna, Emilia-Romagna, Italy, 48121
- Local Institution - 0042
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Osakasayama-city, Japan, 5898511
- Local Institution - 0113
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Aichi
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Nagoya-shi, Aichi, Japan, 4668560
- Local Institution - 0105
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Chiba
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Chiba-shi, Chiba, Japan, 2608677
- Local Institution - 0097
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Hiroshima
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Fukuyama-shi, Hiroshima, Japan, 7200001
- Local Institution - 0108
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Hiroshima-Shi, Hiroshima, Japan, 7348551
- Local Institution - 0114
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Hokkaido
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Sapporo-shi, Hokkaido, Japan, 0030804
- Local Institution - 0101
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Hyogo
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Amagasaki-shi, Hyogo, Japan, 6608550
- Local Institution - 0106
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Nishinomiya-shi, Hyogo, Japan, 6638501
- Local Institution - 0098
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Kanagawa
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Yokohama-shi, Kanagawa, Japan, 2210855
- Local Institution - 0095
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Miyagi
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Natori-shi, Miyagi, Japan, 9811293
- Local Institution - 0104
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Niigata
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Niigata-shi, Niigata, Japan, 9518520
- Local Institution - 0107
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Okayama
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Okayama-shi, Okayama, Japan, 7028055
- Local Institution - 0100
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Saitama
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Kitaadachi-gun, Saitama, Japan, 3620806
- Local Institution - 0096
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Tokyo
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Chuo-ku, Tokyo, Japan, 1040045
- Local Institution - 0094
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Yamaguchi
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Ube-shi, Yamaguchi, Japan, 7550241
- Local Institution - 0099
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Chihuahua, Mexico, 31000
- Local Institution - 0118
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Distrito Federal
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Df, Distrito Federal, Mexico, 06720
- Local Institution - 0079
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Mexico, Distrito Federal, Mexico, 14000
- Local Institution - 0053
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Mexico, Distrito Federal, Mexico, 14050
- Local Institution - 0050
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Jalisco
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Guadalajara, Jalisco, Mexico, 44270
- Local Institution - 0051
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Amsterdam, Netherlands, 1066 CX
- Local Institution - 0092
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Rotterdam, Netherlands, 3000 CA
- Local Institution - 0091
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Bytom, Poland, 41-902
- Local Institution - 0078
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Krakow, Poland, 31-202
- Local Institution - 0076
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Warszawa, Poland, 02-781
- Local Institution - 0077
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Bucharest, Romania, 020122
- Local Institution - 0115
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Bucuresti, Romania, 021389
- Local Institution - 0109
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Craiova, Romania, 200347
- Local Institution - 0102
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Romania, Romania, 400015
- Local Institution - 0055
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Moscow, Russian Federation, 115478
- Local Institution - 0150
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Moscow, Russian Federation, 121309
- Local Institution - 0071
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Saint Petersburg, Russian Federation, 197758
- Local Institution - 0072
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Gauteng
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Pretoria, Gauteng, South Africa, 0075
- Local Institution - 0060
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Western Cape
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Cape Town, Western Cape, South Africa, 7570
- Local Institution - 0059
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Bern, Switzerland, 3010
- Local Institution - 0049
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Lausanne, Switzerland, 1011
- Local Institution - 0036
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Zurich, Switzerland, 8091
- Local Institution - 0029
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Diyarbakır, Turkey, 21280
- Local Institution - 0111
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Istanbul, Turkey, 34098
- Local Institution - 0112
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Seyhan, Turkey, 01130
- Local Institution - 0110
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Leicester, United Kingdom, LE1 5WW
- Local Institution - 0081
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London, United Kingdom, EC1A 7BE
- Local Institution - 0083
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Manchester, United Kingdom, M23 9LT
- Local Institution - 0116
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Southampton, United Kingdom, SO16 6YD
- Local Institution - 0090
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Cornwall
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Truro, Cornwall, United Kingdom, TR1 3LJ
- Local Institution - 0085
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Midlothian
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Edinburgh, Midlothian, United Kingdom, EH4 2XU
- Local Institution - 0084
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California
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San Francisco, California, United States, 94143
- UCSF
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Connecticut
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New Haven, Connecticut, United States, 06520
- Local Institution - 0014
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Florida
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Tampa, Florida, United States, 33612
- H. Lee Moffitt Cancer Center & Research Inst, Inc
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Illinois
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Chicago, Illinois, United States, 60637
- Local Institution - 0002
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Maryland
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Baltimore, Maryland, United States, 21201
- Univ Of Maryland Greenbaum Cancer Center
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Michigan
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Detroit, Michigan, United States, 48201
- Local Institution - 0013
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Grand Rapids, Michigan, United States, 49503
- Cancer & Hematology Centers of Western Michigan
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Minnesota
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Rochester, Minnesota, United States, 55905
- Local Institution - 0004
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New York
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New York, New York, United States, 10065
- Memorial Sloan Kettering Nassau
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Ohio
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Cleveland, Ohio, United States, 44195
- Local Institution - 0007
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Pennsylvania
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Philadelphia, Pennsylvania, United States, 19104
- University of Pennsylvania
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Pittsburgh, Pennsylvania, United States, 15212
- Allegheny Cancer Center
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Texas
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Houston, Texas, United States, 77030
- Local Institution - 0005
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West Virginia
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Morgantown, West Virginia, United States, 26506
- West Virginia University
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Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Number of Arms
Arms and Interventions
Participant Group / ArmParticipant Group / Arm |
Intervention / TreatmentIntervention / Treatment |
|---|---|
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Experimental: Nivolumab and Ipilimumab
Specified dose on specified days
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Other Names:
Other Names:
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Active Comparator: Pemetrexed and Cisplatin (or Carboplatin)
Specified dose on specified days
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What is the study measuring?
Primary Outcome Measures
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Overall Survival (OS)
Time Frame: From randomization to the date of death (Up to 40 Months)
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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.
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From randomization to the date of death (Up to 40 Months)
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Secondary Outcome Measures
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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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)
|
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. |
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)
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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
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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). |
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
|
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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)
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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. |
From randomization date to the date of first documented tumor progression or death due to any cause, whichever occurs first. (up to 76 months)
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Overall Survival (OS) According to PD-L1 Expression Level
Time Frame: From randomization date to the date of death (Up to 76 Months)
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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.
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From randomization date to the date of death (Up to 76 Months)
|
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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)
|
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. |
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)
|
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. |
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)
|
Collaborators and Investigators
Sponsor
Sponsor
Collaborators
Collaborators
Investigators
Investigators
- Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb
Publications and helpful links
General Publications
- 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. Erratum In: Lancet. 2021 Feb 20;397(10275):670.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Study Start
Primary Completion (Actual)
Primary Completion
Study Completion (Actual)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (Estimated)
First Posted
Study Record Updates
Last Update Posted (Actual)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Respiratory Tract Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Lung Diseases
- Neoplasms by Site
- Neoplasms, Glandular and Epithelial
- Respiratory Tract Neoplasms
- Thoracic Neoplasms
- Lung Neoplasms
- Adenoma
- Neoplasms, Mesothelial
- Pleural Neoplasms
- Mesothelioma
- Mesothelioma, Malignant
- Molecular Mechanisms of Pharmacological Action
- Nucleic Acid Synthesis Inhibitors
- Enzyme Inhibitors
- Antineoplastic Agents
- Antineoplastic Agents, Immunological
- Immune Checkpoint Inhibitors
- Folic Acid Antagonists
- Carboplatin
- Nivolumab
- Pemetrexed
- Ipilimumab
Other Study ID Numbers
Other Study ID Numbers
- CA209-743
- 2016-001859-43 (EudraCT Number)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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