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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)

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ClinicalTrials.gov Identifier: NCT02899299
Recruitment Status : Recruiting
First Posted : September 14, 2016
Last Update Posted : June 5, 2018
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

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 600 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 : October 25, 2016
Estimated Primary Completion Date : October 4, 2020
Estimated Study Completion Date : September 28, 2021


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: 3.5 years ]
  2. Progression Free Survival (PFS) [ Time Frame: 3.5 years ]

Secondary Outcome Measures :
  1. Objective Response Rate (ORR) [ Time Frame: 3 years ]
  2. Disease Control Rate (DCR) [ Time Frame: 3 years ]
  3. Composite correlation of PD-L1 expression level and efficacy [ Time Frame: 3 years ]
    Efficacy determined by the ORR, PFS, and OS



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


Contacts
Contact: Recruiting sites have contact information. Please contact the sites directly. If there is no contact information, please email: Clinical.Trials@bms.com
Contact: First line of the email MUST contain NCT# and Site #.

  Hide Study Locations
Locations
United States, California
Ucsf Completed
San Francisco, California, United States, 94143
United States, Connecticut
Yale University Completed
New Haven, Connecticut, United States, 06520
United States, Florida
Local Institution Withdrawn
Fort Myers, Florida, United States, 33901
Local Institution Withdrawn
Saint Petersburg, Florida, United States, 33705
H. Lee Moffitt Cancer Center & Research Inst, Inc Active, not recruiting
Tampa, Florida, United States, 33612
United States, Illinois
University Of Chicago Active, not recruiting
Chicago, Illinois, United States, 60637
United States, Maryland
Univ Of Maryland Greenbaum Cancer Center Active, not recruiting
Baltimore, Maryland, United States, 21201
United States, Michigan
Barbara Ann Karmanos Cancer Center Active, not recruiting
Detroit, Michigan, United States, 48201
Cancer & Hematology Centers Of Western Michigan Completed
Grand Rapids, Michigan, United States, 49503
United States, Minnesota
Mayo Clinic Active, not recruiting
Rochester, Minnesota, United States, 55905
United States, New York
Memorial Sloan Kettering Cancer Center Active, not recruiting
New York, New York, United States, 10065
United States, Ohio
Cleveland Clinic Active, not recruiting
Cleveland, Ohio, United States, 44195
United States, Pennsylvania
Allegheny Cancer Center Active, not recruiting
Jefferson Hills, Pennsylvania, United States, 15025
University Of Pennsylvania Active, not recruiting
Philadelphia, Pennsylvania, United States, 19104
United States, Tennessee
Local Institution Withdrawn
Nashville, Tennessee, United States, 37203
United States, Texas
The University Of Texas MD Anderson Cancer Center Active, not recruiting
Houston, Texas, United States, 77030
United States, West Virginia
West Virginia University Active, not recruiting
Morgantown, West Virginia, United States, 26506
Australia, New South Wales
Concord Repatriation General Hospital Active, not recruiting
Sydney, New South Wales, Australia, 2139
Australia, Queensland
Local Institution Active, not recruiting
Birtinya, Queensland, Australia, 4575
Australia, Victoria
Monash Medical Centre Clayton Active, not recruiting
Clayton, Victoria, Australia, 3168
Cabrini Hospital Active, not recruiting
Malvern, Victoria, Australia, 3144
Australia, Western Australia
Local Institution Active, not recruiting
Nedlands, Western Australia, Australia, 6009
Belgium
Local Institution Active, not recruiting
Brussels, Belgium, 1090
Local Institution Active, not recruiting
Edegem, Belgium, 2650
Local Institution Active, not recruiting
Liege, Belgium, 4000
Local Institution Active, not recruiting
Sint-Niklaas, Belgium, 9100
Brazil
Local Institution Withdrawn
Porto Alegre, RIO Grande DO SUL, Brazil, 90035-903
Local Institution Active, not recruiting
Barretos, SAO Paulo, Brazil, 14784-400
Local Institution Withdrawn
Rio de Janeiro, Brazil, 20230-130
Local Institution Active, not recruiting
Sao Paulo, Brazil, 05403-010
Chile
Centro Internacional de Estudios Clinicos Active, not recruiting
Recoleta, Santiago DE Chile, Chile
China, Beijing
Local Institution Withdrawn
Beijing, Beijing, China, 100032
Local Institution Recruiting
Beijing, Beijing, China, 100142
Contact: Site 0147         
China, Heilongjiang
Local Institution Recruiting
Haerbin, Heilongjiang, China, 150081
Contact: Site 0133         
China, Jiangxi
Local Institution Withdrawn
Nanchang, Jiangxi, China
China, Jilin
Local Institution Withdrawn
Changchun, Jilin, China, 130012
Local Institution Recruiting
Changchun, Jilin, China, 130021
Contact: Site 0151         
China, Liaoning
Local Institution Recruiting
Shenyang, Liaoning, China
Contact: Site 0153         
China, Shaanxi
Local Institution Withdrawn
Xian, Shaanxi, China, 710038
China, Shanghai
Local Institution Withdrawn
Shanghai, Shanghai, China, 200025
China, Zhejiang
Local Institution Withdrawn
Hanghzou, Zhejiang, China
Local Institution Withdrawn
Hangzhou, Zhejiang, China, 310003
Local Institution Withdrawn
Hangzhou, Zhejiang, China, 310022
Local Institution Withdrawn
Wenzhou, Zhejiang, China, 325000
China
Local Institution Withdrawn
Hangzhou, China, 310016
Local Institution Recruiting
Kunming, China
Contact: Site 0124         
Local Institution Recruiting
Shanghai, China, 200030
Contact: Site 0120         
Local Institution Withdrawn
Shanghai, China, 200032
Colombia
Administradora Del Country S.A. - Clinica Del Country Active, not recruiting
Bogota, Colombia
Hospital Universitario San Ignacio Active, not recruiting
Bogota, Colombia
France
Local Institution Active, not recruiting
Caen, France, 14000
Local Institution Active, not recruiting
Creteil, France, 94010
Local Institution Active, not recruiting
La Tronche, France, 38700
Local Institution Active, not recruiting
Lille Cedex, France, 59037
Local Institution Active, not recruiting
Marseille Cedex 20, France, 13915
Local Institution Active, not recruiting
Paris, France, 75018
Local Institution Active, not recruiting
Saint Herblain, France, 44805
Local Institution Active, not recruiting
Strasbourg Cedex, France, 67091
Local Institution Active, not recruiting
Toulon Cedex, France, 83056
Local Institution Active, not recruiting
Toulouse Cedex 9, France, 31059
Germany
Local Institution Active, not recruiting
Coswig, Germany, 01640
Local Institution Active, not recruiting
Essen, Germany, 45147
Local Institution Active, not recruiting
Gottingen, Germany, 37075
Local Institution Active, not recruiting
Grosshansdorf, Germany, 22927
Local Institution Active, not recruiting
Hamburg, Germany, 21075
Local Institution Active, not recruiting
Heidelberg, Germany, 69126
Local Institution Active, not recruiting
Homburg an d. Saar, Germany, 66421
Local Institution Active, not recruiting
Immenhausen, Germany, 34376
Local Institution Active, not recruiting
Koeln, Germany, 51109
Local Institution Active, not recruiting
Moers, Germany, 47441
Greece
Local Institution Active, not recruiting
Athens, Greece, 11527
Local Institution Active, not recruiting
Thessaloniki, Greece, 57001
Italy
Centro Di Riferimento Oncologico Active, not recruiting
Aviano, Italy, 33081
Local Institution Active, not recruiting
Bari, Italy, 70124
Aou Policlinico V. Emanuele Di Catania Active, not recruiting
Catania, Italy, 95124
Ospedale Policlinico San Martino Active, not recruiting
Genova, Italy, 16132
Local Institution Active, not recruiting
Napoli, Italy, 80131
Local Institution Active, not recruiting
Ravenna, Italy, 48121
Istituto Clinico Humanitas Active, not recruiting
Rozzano, Italy, 20089
Azienda Ospedaliera Universitaria Senese Active, not recruiting
Siena, Italy, 53100
Japan
Local Institution Completed
Nagoya-shi, Aichi, Japan, 4668560
Local Institution Active, not recruiting
Chiba-shi, Chiba, Japan, 2608677
Local Institution Active, not recruiting
Fukuyama-shi, Hiroshima, Japan, 7200001
Local Institution Active, not recruiting
Hiroshima-Shi, Hiroshima, Japan, 7348551
Local Institution Active, not recruiting
Sapporo-shi, Hokkaido, Japan, 0030804
Local Institution Active, not recruiting
Amagasaki-shi, Hyogo, Japan, 6608550
Local Institution Active, not recruiting
Nishinomiya-shi, Hyogo, Japan, 6638501
Local Institution Active, not recruiting
Yokohama-shi, Kanagawa, Japan, 2408555
Local Institution Active, not recruiting
Natori-shi, Miyagi, Japan, 9811293
Local Institution Active, not recruiting
Niigata-shi, Niigata, Japan, 9518520
Local Institution Active, not recruiting
Okayama-shi, Okayama, Japan, 7028055
Local Institution Active, not recruiting
Kitaadachi-gun, Saitama, Japan, 3620806
Local Institution Active, not recruiting
Chuo-ku, Tokyo, Japan, 1040045
Local Institution Active, not recruiting
Ube-shi, Yamaguchi, Japan, 7550241
Local Institution Active, not recruiting
Osakasayama-city, Japan, 5898511
Mexico
Local Institution Active, not recruiting
Df, Distrito Federal, Mexico, 06720
Local Institution Active, not recruiting
Mexico, Distrito Federal, Mexico, 14000
Medica Sur Active, not recruiting
Mexico, Distrito Federal, Mexico, 14050
Local Institution Active, not recruiting
Guadalajara, Jalisco, Mexico, 44270
Centro Estatal de Cancerologia Active, not recruiting
Chihuahua, Mexico, 31000
Netherlands
Local Institution Active, not recruiting
Amsterdam, Netherlands, 1066 CX
Local Institution Active, not recruiting
Rotterdam, Netherlands, 3015 CE
Poland
Local Institution Active, not recruiting
Bytom, Poland, 41-902
Local Institution Active, not recruiting
Krakow, Poland, 31-202
Local Institution Active, not recruiting
Warszawa, Poland, 02-781
Romania
Local Institution Active, not recruiting
Bucharest, Romania, 020122
Local Institution Active, not recruiting
Bucuresti, Romania, 021389
Local Institution Active, not recruiting
Craiova, Romania, 200347
Local Institution Active, not recruiting
Romania, Romania, 400015
Russian Federation
Local Institution Active, not recruiting
Moscow, Russian Federation, 115478
Local Institution Active, not recruiting
Moscow, Russian Federation, 121309
Local Institution Active, not recruiting
St.petersburg, Russian Federation, 197758
South Africa
Local Institution Not yet recruiting
Johannesburg, Gauteng, South Africa, 2196
Contact: Site 0061         
Local Institution Not yet recruiting
Parktown, Johannesburg, Gauteng, South Africa, 2193
Contact: Site 0065         
Local Institution Active, not recruiting
Pretoria, Gauteng, South Africa, 0075
Local Institution Active, not recruiting
Cape Town, Western CAPE, South Africa, 7570
Switzerland
Local Institution Active, not recruiting
Bern, Switzerland, 3010
Local Institution Active, not recruiting
Lausanne, Switzerland, 1011
Local Institution Active, not recruiting
Zurich, Switzerland, 8091
Turkey
Local Institution Withdrawn
Ankara, Turkey, 06100
Local Institution Active, not recruiting
Diyarbak?r, Turkey, 21280
Local Institution Active, not recruiting
Istanbul, Turkey, 34098
Local Institution Active, not recruiting
Seyhan, Turkey, 01130
United Kingdom
Local Institution Active, not recruiting
Truro, Cornwall, United Kingdom, TR1 3LJ
Edinburgh Cancer Centre Active, not recruiting
Edinburgh, Midlothian, United Kingdom, EH4 2XU
Local Institution Active, not recruiting
Leicester, United Kingdom, LE1 5WW
Local Institution Completed
London, United Kingdom, EC1A 7BE
Local Institution Active, not recruiting
Manchester, United Kingdom, M23 9LT
Local Institution Active, not recruiting
Southampton, United Kingdom, SO16 6YD
Sponsors and Collaborators
Bristol-Myers Squibb
Ono Pharmaceutical Co. Ltd
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb

Additional Information:
Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT02899299     History of Changes
Other Study ID Numbers: CA209-743
2016-001859-43 ( EudraCT Number )
First Posted: September 14, 2016    Key Record Dates
Last Update Posted: June 5, 2018
Last Verified: June 2018

Additional relevant MeSH terms:
Mesothelioma
Adenoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Mesothelial
Nivolumab
Cisplatin
Carboplatin
Pemetrexed
Antibodies, Monoclonal
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Folic Acid Antagonists
Nucleic Acid Synthesis Inhibitors