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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.
 
ClinicalTrials.gov Identifier: NCT02899299
Recruitment Status : Active, not recruiting
First Posted : September 14, 2016
Results First Posted : April 14, 2021
Last Update Posted : April 14, 2021
Sponsor:
Collaborator:
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

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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

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


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 ClinicalTrials.gov identifier (NCT number): NCT02899299


Locations
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United States, California
University of California San Francisco
San Francisco, California, United States, 94143
United States, Connecticut
Yale University
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
University Of Chicago Medical Center
Chicago, Illinois, United States, 60637
United States, Maryland
Univ Of Maryland Greenbaum Cancer Center
Baltimore, Maryland, United States, 21201
United States, Michigan
Barbara Ann Karmanos Cancer Center
Detroit, Michigan, United States, 48201
Cancer & Hematology Centers Of Western Michigan
Grand Rapids, Michigan, United States, 49503
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
United States, New York
Memorial Sloan Kettering Nassau
New York, New York, United States, 10065
United States, Ohio
Cleveland Clinic
Cleveland, Ohio, United States, 44195
United States, Pennsylvania
Allegheny Cancer Center
Jefferson Hills, Pennsylvania, United States, 15025
University Of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
United States, Texas
The University Of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030
United States, West Virginia
West Virginia University
Morgantown, West Virginia, United States, 26506
Australia, New South Wales
Concord Repatriation General Hospital
Sydney, New South Wales, Australia, 2139
Australia, Queensland
Sunshine Coast University Hospital
Birtinya, Queensland, Australia, 4575
Australia, Victoria
Monash Medical Centre Clayton
Clayton, Victoria, Australia, 3168
Cabrini Hospital
Malvern, Victoria, Australia, 3144
Australia, Western Australia
Sir Charles Gairdner Hospital
Nedlands, Western Australia, Australia, 6009
Belgium
Local Institution
Brussels, Belgium, 1090
Local Institution
Edegem, Belgium, 2650
Local Institution
Liege, Belgium, 4000
Local Institution
Sint-Niklaas, Belgium, 9100
Brazil
Local Institution
Barretos, Sao Paulo, Brazil, 14784-400
Local Institution
Sao Paulo, Brazil, 05403-010
Chile
Centro de Investigacion Clinica Bradford Hill
Santiago, Metropolitana, Chile, 8420383
China, Heilongjiang
Local Institution
Harbin Shi, Heilongjiang, China, 150081
China, Jilin
Local Institution
Changchun, Jilin, China, 130021
China, Liaoning
Local Institution
Shenyang, Liaoning, China
China
Local Institution
Kunming, China
Local Institution
Shanghai, China, 200030
Colombia
Administradora Del Country S.A. - Clinica Del Country
Bogota, Colombia
Hospital Universitario San Ignacio
Bogota, Colombia
France
Local Institution
Caen, France, 14000
Local Institution
Creteil, France, 94010
Hopital Albert Michallon - Chu De Grenoble
La Tronche, France, 38700
CHRU Lille - Hopital Calmette
Lille Cedex, France, 59037
Local Institution
Marseille Cedex 20, France, 13915
Hopital Bichat Claude Bernard
Paris, France, 75018
Institut De Cancerologie De L Ouest
Saint Herblain, France, 44805
Local Institution
Strasbourg Cedex, France, 67091
Local Institution
Toulon Cedex, France, 83056
Local Institution
Toulouse Cedex 9, France, 31059
Germany
Local Institution
Coswig, Germany, 01640
Local Institution
Essen, Germany, 45147
Local Institution
Gottingen, Germany, 37075
Local Institution
Grosshansdorf, Germany, 22927
Local Institution
Hamburg, Germany, 21075
Local Institution
Heidelberg, Germany, 69126
Local Institution
Homburg an d. Saar, Germany, 66421
Local Institution
Immenhausen, Germany, 34376
Local Institution
Koeln, Germany, 51109
Local Institution
Moers, Germany, 47441
Greece
Sotiria General Hospital
Athens, Greece, 11527
Interbalkan European Medical Center
Thessaloniki, Greece, 57001
Italy
Centro Di Riferimento Oncologico
Aviano, Italy, 33081
Istituto Tumori Giovanni Paolo II
Bari, Italy, 70124
Aou Policlinico V. Emanuele Di Catania
Catania, Italy, 95124
Ospedale Policlinico San Martino
Genova, Italy, 16132
Aorn Dei Colli
Napoli, Italy, 80131
Ospedale Santa Maria delle Croci
Ravenna, Italy, 48121
Istituto Clinico Humanitas
Rozzano, Italy, 20089
Azienda Ospedaliera Universitaria Senese
Siena, Italy, 53100
Japan
Local Institution
Nagoya-shi, Aichi, Japan, 4668560
Local Institution
Chiba-shi, Chiba, Japan, 2608677
Local Institution
Fukuyama-shi, Hiroshima, Japan, 7200001
Local Institution
Hiroshima-Shi, Hiroshima, Japan, 7348551
Local Institution
Sapporo-shi, Hokkaido, Japan, 0030804
Local Institution
Amagasaki-shi, Hyogo, Japan, 6608550
Local Institution
Nishinomiya-shi, Hyogo, Japan, 6638501
Local Institution
Yokohama-shi, Kanagawa, Japan, 2210855
Local Institution
Natori-shi, Miyagi, Japan, 9811293
Local Institution
Niigata-shi, Niigata, Japan, 9518520
Local Institution
Okayama-shi, Okayama, Japan, 7028055
Local Institution
Kitaadachi-gun, Saitama, Japan, 3620806
Local Institution
Chuo-ku, Tokyo, Japan, 1040045
Local Institution
Ube-shi, Yamaguchi, Japan, 7550241
Local Institution
Osakasayama-city, Japan, 5898511
Mexico
Local Institution
Df, Distrito Federal, Mexico, 06720
Local Institution
Mexico, Distrito Federal, Mexico, 14000
Medica Sur
Mexico, Distrito Federal, Mexico, 14050
Local Institution
Guadalajara, Jalisco, Mexico, 44270
Centro Estatal de Cancerologia
Chihuahua, Mexico, 31000
Netherlands
Local Institution
Amsterdam, Netherlands, 1066 CX
Local Institution
Rotterdam, Netherlands, 3000 CA
Poland
Local Institution
Bytom, Poland, 41-902
Local Institution
Krakow, Poland, 31-202
Local Institution
Warszawa, Poland, 02-781
Romania
Local Institution
Bucharest, Romania, 020122
Local Institution
Bucuresti, Romania, 021389
Local Institution
Craiova, Romania, 200347
Local Institution
Romania, Romania, 400015
Russian Federation
Local Institution
Moscow, Russian Federation, 115478
Local Institution
Moscow, Russian Federation, 121309
Local Institution
Saint Petersburg, Russian Federation, 197758
South Africa
Local Institution
Pretoria, Gauteng, South Africa, 0075
Local Institution
Cape Town, Western Cape, South Africa, 7570
Switzerland
Local Institution
Bern, Switzerland, 3010
Local Institution
Lausanne, Switzerland, 1011
Local Institution
Zurich, Switzerland, 8091
Turkey
Local Institution
Diyarbakır, Turkey, 21280
Local Institution
Istanbul, Turkey, 34098
Local Institution
Seyhan, Turkey, 01130
United Kingdom
Local Institution
Truro, Cornwall, United Kingdom, TR1 3LJ
Edinburgh Cancer Centre
Edinburgh, Midlothian, United Kingdom, EH4 2XU
Local Institution
Leicester, United Kingdom, LE1 5WW
Local Institution
London, United Kingdom, EC1A 7BE
Local Institution
Manchester, United Kingdom, M23 9LT
Local Institution
Southampton, United Kingdom, SO16 6YD
Sponsors and Collaborators
Bristol-Myers Squibb
Ono Pharmaceutical Co. Ltd
Investigators
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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 ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov 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: April 14, 2021
Last Verified: March 2021
Additional relevant MeSH terms:
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Mesothelioma
Adenoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Mesothelial
Carboplatin
Nivolumab
Pemetrexed
Ipilimumab
Antineoplastic Agents
Antineoplastic Agents, Immunological
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Folic Acid Antagonists
Nucleic Acid Synthesis Inhibitors