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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)

This study is currently recruiting participants.
Verified November 2017 by Bristol-Myers Squibb
Sponsor:
ClinicalTrials.gov Identifier:
NCT02899299
First Posted: September 14, 2016
Last Update Posted: November 8, 2017
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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborator:
Ono Pharmaceutical Co. Ltd
Information provided by (Responsible Party):
Bristol-Myers Squibb
  Purpose
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 Intervention Phase
Mesothelioma Biological: Nivolumab Biological: Ipilimumab Drug: Pemetrexed Drug: Cisplatin Drug: Carboplatin Phase 3

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:
  • Overall Survival (OS) [ Time Frame: 3.5 years ]
  • Progression Free Survival (PFS) [ Time Frame: 3.5 years ]

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


Estimated Enrollment: 600
Actual Study Start Date: October 25, 2016
Estimated Study Completion Date: September 28, 2021
Estimated Primary Completion Date: October 4, 2020 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

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.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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

  Contacts and Locations
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
Local Institution Not yet recruiting
San Francisco, California, United States, 94143
Contact: Site 0001         
United States, Connecticut
Yale University Recruiting
New Haven, Connecticut, United States, 06520
Contact: Sarah Goldberg, Site 0014    203-764-7686      
United States, Florida
Local Institution Not yet recruiting
Fort Myers, Florida, United States, 33901
Contact: Site 0132         
Local Institution Not yet recruiting
Saint Petersburg, Florida, United States, 33705
Contact: Site 0131         
H. Lee Moffitt Cancer Center & Research Inst, Inc Recruiting
Tampa, Florida, United States, 33612
Contact: Scott Antonia, Site 0008         
United States, Illinois
University Of Chicago Recruiting
Chicago, Illinois, United States, 60637
Contact: Hedy Kindler, Site 0002    773-834-1472      
United States, Maryland
Univ Of Maryland Greenbaum Cancer Center Recruiting
Baltimore, Maryland, United States, 21201
Contact: Dan Paul Zandberg, Site 0010    410-328-5009      
United States, Michigan
Barbara Ann Karmanos Cancer Center Recruiting
Detroit, Michigan, United States, 48201
Contact: Antoinette Wozniak, Site 0013    313-576-9767      
Cancer & Hematology Centers Of Western Michigan Recruiting
Grand Rapids, Michigan, United States, 49503
Contact: Yuanbin Chen, Site 0015    616-954-9800      
United States, Minnesota
Local Institution Not yet recruiting
Rochester, Minnesota, United States, 55905
Contact: Site 0004         
United States, New York
Memorial Sloan Kettering Cancer Center Recruiting
New York, New York, United States, 10065
Contact: Marjorie Zauderer, Site 0006    646-888-4656      
United States, Ohio
Cleveland Clinic Recruiting
Cleveland, Ohio, United States, 44195
Contact: James Stevenson, Site 0007    216-444-1739      
United States, Pennsylvania
Allegheny Cancer Center Recruiting
Jefferson Hills, Pennsylvania, United States, 15025
Contact: Amjad Jalil, Site 0011    412-578-4639      
University Of Pennsylvania Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Evan Alley, Site 0009    215-662-9801      
United States, Tennessee
Local Institution Not yet recruiting
Nashville, Tennessee, United States, 37203
Contact: Site 0119         
United States, Texas
The University Of Texas MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Contact: Anne Tsao, Site 0005         
United States, West Virginia
West Virginia University Recruiting
Morgantown, West Virginia, United States, 26506
Contact: Patrick Ma, Site 0012    304-581-1158      
Australia, New South Wales
Concord Repatriation General Hospital Recruiting
Sydney, New South Wales, Australia, 2139
Contact: Anthony Linton, Site 0032    +61297677033      
Australia, Queensland
Local Institution Recruiting
Birtinya, Queensland, Australia, 4575
Contact: Site 0031         
Australia, Victoria
Monash Medical Centre Clayton Recruiting
Clayton, Victoria, Australia, 3168
Contact: Muhammad Alamgeer, Site 0033    +61399288754      
Cabrini Hospital Recruiting
Malvern, Victoria, Australia, 3144
Contact: Benjamin Brady, Site 0030    +61395083421      
Australia, Western Australia
Local Institution Recruiting
Nedlands, Western Australia, Australia, 6009
Contact: Site 0034         
Belgium
Local Institution Recruiting
Brussels, Belgium, 1090
Contact: Site 0089         
Local Institution Recruiting
Edegem, Belgium, 2650
Contact: Site 0086         
Local Institution Recruiting
Liege, Belgium, 4000
Contact: Site 0087         
Local Institution Recruiting
Sint-Niklaas, Belgium, 9100
Contact: Site 0088         
Brazil
Local Institution Not yet recruiting
Porto Alegre, RIO Grande DO SUL, Brazil, 90035-903
Contact: Site 0155         
Local Institution Recruiting
Barretos, SAO Paulo, Brazil, 14784-400
Contact: Site 0062         
Local Institution Not yet recruiting
Rio de Janeiro, Brazil, 20230-130
Contact: Site 0154         
Local Institution Recruiting
Sao Paulo, Brazil, 05403-010
Contact: Site 0064         
Chile
Centro Internacional de Estudios Clinicos Recruiting
Recoleta, Santiago DE Chile, Chile
Contact: Osvaldo Aren Frontera, Site 0018         
China, Beijing
Local Institution Not yet recruiting
Beijing, Beijing, China, 100032
Contact: Site 0121         
Local Institution Not yet recruiting
Beijing, Beijing, China, 100142
Contact: Site 0147         
China, Heilongjiang
Local Institution Not yet recruiting
Haerbin, Heilongjiang, China, 150081
Contact: Site 0133         
China, Jiangxi
Local Institution Not yet recruiting
Nanchang, Jiangxi, China
Contact: Site 0139         
China, Jilin
Local Institution Not yet recruiting
Changchun, Jilin, China, 130012
Contact: Site 0129         
Local Institution Not yet recruiting
Changchun, Jilin, China, 130021
Contact: Site 0151         
China, Liaoning
Local Institution Not yet recruiting
Shenyang, Liaoning, China
Contact: Site 0153         
China, Shaanxi
Local Institution Not yet recruiting
Xian, Shaanxi, China, 710038
Contact: Site 0134         
China, Shanghai
Local Institution Not yet recruiting
Shanghai, Shanghai, China, 200025
Contact: Site 0137         
China, Zhejiang
Local Institution Not yet recruiting
Hanghzou, Zhejiang, China
Contact: Site 0123         
Local Institution Not yet recruiting
Hangzhou, Zhejiang, China, 310003
Contact: Site 0136         
Local Institution Not yet recruiting
Hangzhou, Zhejiang, China, 310022
Contact: Site 0122         
Local Institution Not yet recruiting
Wenzhou, Zhejiang, China, 325000
Contact: Site 0148         
China
Local Institution Not yet recruiting
Hangzhou, China, 310016
Contact: Site 0152         
Local Institution Not yet recruiting
Kunming, China
Contact: Site 0124         
Local Institution Not yet recruiting
Shanghai, China, 200030
Contact: Site 0120         
Local Institution Not yet recruiting
Shanghai, China, 200032
Contact: Site 0141         
Colombia
Administradora Del Country S.A. - Clinica Del Country Recruiting
Bogota, Colombia
Contact: Andres Cardona, Site 0039    57153004702907      
Hospital Universitario San Ignacio Recruiting
Bogota, Colombia
Contact: Ricardo Bruges, Site 0040    57159461612473      
France
Local Institution Recruiting
Caen, France, 14000
Contact: Site 0057         
Local Institution Recruiting
Creteil, France, 94010
Contact: Site 0073         
Local Institution Recruiting
La Tronche, France, 38700
Contact: Site 0074         
Local Institution Recruiting
Lille Cedex, France, 59037
Contact: Site 0067         
Local Institution Recruiting
Marseille Cedex 20, France, 13915
Contact: Site 0069         
Local Institution Recruiting
Paris, France, 75018
Contact: Site 0056         
Local Institution Recruiting
Saint Herblain, France, 44805
Contact: Site 0080         
Local Institution Recruiting
Strasbourg Cedex, France, 67091
Contact: Site 0093         
Local Institution Recruiting
Toulon Cedex, France, 83056
Contact: Site 0058         
Local Institution Recruiting
Toulouse Cedex 9, France, 31059
Contact: Site 0068         
Germany
Local Institution Not yet recruiting
Coswig, Germany, 01640
Contact: Site 0054         
University Hospital Essen Recruiting
Essen, Germany, 45147
Contact: Martin Metzenmacher, Site 0038    +4920172383296      
University Medicine Gottingen Germany Recruiting
Gottingen, Germany, 37075
Contact: Tobias Overbeck, Site 0023    +4955139172396      
Local Institution Recruiting
Grosshansdorf, Germany, 22927
Contact: Site 0024         
Asklepios Klinik Harburg Recruiting
Hamburg, Germany, 21075
Contact: Claas Wesseler, Site 0027    +49401818865008      
Thoraxklinik-Heidelberg Ggmbh Recruiting
Heidelberg, Germany, 69126
Contact: Helge Bischoff, Site 0037    +4962213968304      
Universitaetsklinikum Des Saarlandes Recruiting
Homburg An D. Saar, Germany, 66421
Contact: Thomas Wehler, Site 0021    +4968411621622      
Fachklinik Fuer Lungenkrankheiten Recruiting
Immenhausen, Germany, 34376
Contact: Achim Rittmeyer, Site 0022    +495673501317      
Kliniken Der Stadt Koeln Ggmbh Krankenhaus Mehrheim Recruiting
Koeln, Germany, 51109
Contact: Walburga Engel-Riedel, Site 0026    +49221890713962      
Krankenhaus Bethanien Moers Recruiting
Moers, Germany, 47441
Contact: Kato Kambartel, Site 0019    +4928412002828      
Greece
Local Institution Recruiting
Athens, Greece, 11527
Contact: Site 0017         
Local Institution Recruiting
Thessaloniki, Greece, 57001
Contact: Site 0016         
Italy
Centro Di Riferimento Oncologico Recruiting
Aviano, Italy, 33081
Contact: Alessandra Bearz, Site 0047         
Local Institution Recruiting
Bari, Italy, 70124
Contact: Site 0044         
Aou Policlinico V. Emanuele Di Catania Recruiting
Catania, Italy, 95124
Contact: Hector Jose Soto Parra, Site 0046         
Azienda Ospedaliera Universitaria S. Martino Recruiting
Genova, Italy, 16132
Contact: Francesco Grossi, Site 0045         
Local Institution Recruiting
Napoli, Italy, 80131
Contact: Site 0043         
Local Institution Recruiting
Ravenna, Italy, 48121
Contact: Site 0042         
Istituto Clinico Humanitas Recruiting
Rozzano, Italy, 20089
Contact: Armando Santoro, Site 0048         
Azienda Ospedaliera Universitaria Senese Recruiting
Siena, Italy, 53100
Contact: Michele Maio, Site 0041         
Japan
Local Institution Recruiting
Nagoya-shi, Aichi, Japan, 4668560
Contact: Site 0105         
Local Institution Recruiting
Chiba-shi, Chiba, Japan, 2608677
Contact: Site 0097         
Local Institution Recruiting
Fukuyama-shi, Hiroshima, Japan, 7200001
Contact: Site 0108         
Local Institution Recruiting
Hiroshima-Shi, Hiroshima, Japan, 7348551
Contact: Site 0114         
Local Institution Recruiting
Sapporo-shi, Hokkaido, Japan, 0030804
Contact: Site 0101         
Local Institution Recruiting
Amagasaki-shi, Hyogo, Japan, 6608550
Contact: Site 0106         
Local Institution Recruiting
Nishinomiya-shi, Hyogo, Japan, 6638501
Contact: Site 0098         
Local Institution Recruiting
Yokohama-shi, Kanagawa, Japan, 2408555
Contact: Site 0095         
Local Institution Recruiting
Natori-shi, Miyagi, Japan, 9811293
Contact: Site 0104         
Local Institution Recruiting
Niigata-shi, Niigata, Japan, 9518520
Contact: Site 0107         
Local Institution Recruiting
Okayama-shi, Okayama, Japan, 7028055
Contact: Site 0100         
Local Institution Recruiting
Kitaadachi-gun, Saitama, Japan, 3620806
Contact: Site 0096         
Local Institution Recruiting
Chuo-ku, Tokyo, Japan, 1040045
Contact: Site 0094         
Local Institution Recruiting
Ube-shi, Yamaguchi, Japan, 7550241
Contact: Site 0099         
Local Institution Recruiting
Osakasayama-city, Japan, 5898511
Contact: Site 0113         
Mexico
Local Institution Recruiting
Df, Distrito Federal, Mexico, 06720
Contact: Site 0079         
Local Institution Not yet recruiting
Mexico, Distrito Federal, Mexico, 14000
Contact: Site 0053         
Medica Sur Recruiting
Mexico, Distrito Federal, Mexico, 14050
Contact: Jeronimo Rodriguez Cid, Site 0050    +54871700      
Local Institution Recruiting
Guadalajara, Jalisco, Mexico, 44270
Contact: Site 0051         
Centro Estatal de Cancerologia Recruiting
Chihuahua, Mexico, 31000
Contact: Rene Gonzalez Mendoza, Site 0118    6144106742      
Netherlands
Local Institution Recruiting
Amsterdam, Netherlands, 1066 CX
Contact: Site 0092         
Local Institution Recruiting
Rotterdam, Netherlands, 3015 CE
Contact: Site 0091         
Poland
Local Institution Recruiting
Bytom, Poland, 41-902
Contact: Site 0078         
Local Institution Recruiting
Krakow, Poland, 31-202
Contact: Site 0076         
Local Institution Recruiting
Warszawa, Poland, 02-781
Contact: Site 0077         
Romania
Local Institution Recruiting
Bucharest, Romania, 020122
Contact: Site 0115         
Local Institution Recruiting
Bucuresti, Romania, 021389
Contact: Site 0109         
Local Institution Recruiting
Craiova, Romania, 200347
Contact: Site 0102         
Local Institution Recruiting
Romania, Romania, 400015
Contact: Site 0055         
Russian Federation
Local Institution Recruiting
Moscow, Russian Federation, 115478
Contact: Site 0150         
Local Institution Recruiting
Moscow, Russian Federation, 121309
Contact: Site 0071         
Local Institution Recruiting
St.petersburg, Russian Federation, 197758
Contact: Site 0072         
South Africa
Local Institution Recruiting
Johannesburg, Gauteng, South Africa, 2196
Contact: Site 0061         
Local Institution Recruiting
Pretoria, Gauteng, South Africa, 0075
Contact: Site 0060         
Local Institution Recruiting
Cape Town, Western CAPE, South Africa, 7570
Contact: Site 0059         
Switzerland
Inselspital Bern Recruiting
Bern, Switzerland, 3010
Contact: Amina Scherz, Site 0049         
Centre hospitalier universitaire Vaudois (CHUV) Recruiting
Lausanne, Switzerland, 1011
Contact: Solange Peters, Site 0036         
University Hospital Zurich Recruiting
Zurich, Switzerland, 8091
Contact: Alessandra Curioni Fontecedro, Site 0029    +41442552214      
Turkey
Local Institution Not yet recruiting
Ankara, Turkey, 06100
Contact: Site 0117         
Local Institution Not yet recruiting
Ankara, Turkey, 06100
Contact: Site 0149         
Local Institution Recruiting
Diyarbakır, Turkey, 21280
Contact: Site 0111         
Local Institution Recruiting
Istanbul, Turkey, 34098
Contact: Site 0112         
Local Institution Recruiting
Seyhan, Turkey, 01130
Contact: Site 0110         
United Kingdom
Local Institution Recruiting
Truro, Cornwall, United Kingdom, TR1 3LJ
Contact: Site 0085         
Edinburgh Cancer Centre Recruiting
Edinburgh, Midlothian, United Kingdom, EH4 2XU
Contact: Melanie Mackean, Site 0084         
Local Institution Recruiting
Leicester, United Kingdom, LE1 5WW
Contact: Site 0081         
Local Institution Not yet recruiting
London, United Kingdom, EC1A 7BE
Contact: Site 0083         
Local Institution Recruiting
Manchester, United Kingdom, M23 9LT
Contact: Site 0116         
Local Institution Recruiting
Southampton, United Kingdom, SO16 6YD
Contact: Site 0090         
Sponsors and Collaborators
Bristol-Myers Squibb
Ono Pharmaceutical Co. Ltd
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  More Information

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 Submitted: August 31, 2016
First Posted: September 14, 2016
Last Update Posted: November 8, 2017
Last Verified: November 2017

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