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

NCT02899299 | Completed Phase 3 Results DMC

• 2 other identifiers: CA209-7432016-001859-43
• Study Type: interventional
• Target: 605
• Locations: 21 countries
• Sites: 109

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.

Conditions

Mesothelioma

Outcome Measures

Primary Outcomes (1)

• Overall Survival (OS)

  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.

  From randomization to the date of death (Up to 40 Months)

Secondary Outcomes (6)

• Objective Response Rate (ORR)

  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)

• Disease Control Rate (DCR)

  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

• Progression Free Survival (PFS)

  From randomization date to the date of first documented tumor progression or death due to any cause, whichever occurs first. (up to 76 months)

• Overall Survival (OS) According to PD-L1 Expression Level

  From randomization date to the date of death (Up to 76 Months)

• Progression Free Survival (PFS) According to PD-L1 Expression Level

  From randomization date to the date of first documented tumor progression or death due to any cause, whichever occurs first. (up to 76 months)

Study Arms (2)

Nivolumab and Ipilimumab

EXPERIMENTAL

Specified dose on specified days

Biological: Nivolumab; Biological: Ipilimumab

Pemetrexed and Cisplatin (or Carboplatin)

ACTIVE COMPARATOR

Specified dose on specified days

Drug: Pemetrexed; Drug: Cisplatin; Drug: Carboplatin

Interventions

Nivolumab BIOLOGICAL

Also known as: BMS-936558, Opdivo

Nivolumab and Ipilimumab

Ipilimumab BIOLOGICAL

Also known as: BMS-734016, Yervoy

Nivolumab and Ipilimumab

Pemetrexed DRUG

Pemetrexed and Cisplatin (or Carboplatin)

Cisplatin DRUG

Pemetrexed and Cisplatin (or Carboplatin)

Carboplatin DRUG

Pemetrexed and Cisplatin (or Carboplatin)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bristol-Myers Squibb: lead
• Ono Pharmaceutical Co. Ltd: collaborator

Study Sites (109)

Ucsf

San Francisco, California, 94143, United States

Location

Local Institution - 0014

New Haven, Connecticut, 06520, United States

Location

H. Lee Moffitt Cancer Center & Research Inst, Inc

Tampa, Florida, 33612, United States

Location

Local Institution - 0002

Chicago, Illinois, 60637, United States

Location

Univ Of Maryland Greenbaum Cancer Center

Baltimore, Maryland, 21201, United States

Location

Local Institution - 0013

Detroit, Michigan, 48201, United States

Location

Cancer & Hematology Centers Of Western Michigan

Grand Rapids, Michigan, 49503, United States

Location

Local Institution - 0004

Rochester, Minnesota, 55905, United States

Location

Memorial Sloan Kettering Nassau

New York, New York, 10065, United States

Location

Local Institution - 0007

Cleveland, Ohio, 44195, United States

Location

University Of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Allegheny Cancer Center

Pittsburgh, Pennsylvania, 15212, United States

Location

Local Institution - 0005

Houston, Texas, 77030, United States

Location

West Virginia University

Morgantown, West Virginia, 26506, United States

Location

Local Institution - 0032

Sydney, New South Wales, 2139, Australia

Location

Local Institution - 0031

Birtinya, Queensland, 4575, Australia

Location

Local Institution - 0033

Clayton, Victoria, 3168, Australia

Location

Local Institution - 0030

Malvern, Victoria, 3144, Australia

Location

Local Institution - 0034

Nedlands, Western Australia, 6009, Australia

Location

Local Institution - 0089

Brussels, 1090, Belgium

Location

Local Institution - 0086

Edegem, 2650, Belgium

Location

Local Institution - 0087

Liège, 4000, Belgium

Location

Local Institution - 0088

Sint-Niklaas, 9100, Belgium

Location

Local Institution

Barretos, São Paulo, 14784-400, Brazil

Location

Local Institution - 0064

São Paulo, 05403-010, Brazil

Location

Local Institution - 0018

Santiago, Santiago Metropolitan, 8420383, Chile

Location

Local Institution - 0133

Harbin, Heilongjiang, 150081, China

Location

Local Institution

Changchun, Jilin, 130021, China

Location

Local Institution

Shenyang, Liaoning, China

Location

Local Institution - 0124

Kunming, 0, China

Location

Local Institution - 0120

Shanghai, 200030, China

Location

Local Institution - 0039

Bogotá, 0, Colombia

Location

Local Institution - 0040

Bogotá, 0, Colombia

Location

Local Institution - 0057

Caen, 14033, France

Location

Local Institution - 0073

Créteil, 94010, France

Location

Local Institution - 0074

La Tronche, 38700, France

Location

Local Institution - 0067

Lille, 59037, France

Location

Local Institution - 0069

Marseille, 13915, France

Location

Local Institution - 0056

Paris, 75018, France

Location

Local Institution - 0080

Saint-Herblain, 44805, France

Location

Local Institution - 0093

Strasbourg, 67091, France

Location

Local Institution - 0058

Toulon, 83056, France

Location

Local Institution - 0068

Toulouse, 31059, France

Location

Local Institution - 0026

Cologne, 51109, Germany

Location

Local Institution - 0054

Coswig, 01640, Germany

Location

Local Institution - 0038

Essen, 45147, Germany

Location

Local Institution - 0023

Göttingen, 37075, Germany

Location

Local Institution - 0024

Großhansdorf, 22927, Germany

Location

Local Institution - 0027

Hamburg, 21075, Germany

Location

Local Institution - 0037

Heidelberg, 69126, Germany

Location

Local Institution - 0021

Homburg An D. Saar, 66421, Germany

Location

Local Institution - 0022

Immenhausen, 34376, Germany

Location

Local Institution - 0019

Moers, 47441, Germany

Location

Local Institution - 0017

Athens, 11527, Greece

Location

Local Institution - 0016

Thessaloniki, 57001, Greece

Location

Local Institution - 0042

Ravenna, Emilia-Romagna, 48121, Italy

Location

Local Institution - 0047

Aviano, 33081, Italy

Location

Local Institution - 0044

Bari, 70124, Italy

Location

Local Institution - 0046

Catania, 95124, Italy

Location

Local Institution - 0045

Genova, 16132, Italy

Location

Local Institution - 0043

Napoli, 80131, Italy

Location

Local Institution - 0048

Rozzano, 20089, Italy

Location

Local Institution - 0041

Siena, 53100, Italy

Location

Local Institution - 0105

Nagoya, Aichi-ken, 4668560, Japan

Location

Local Institution - 0097

Chiba, Chiba, 2608677, Japan

Location

Local Institution - 0108

Fukuyama-shi, Hiroshima, 7200001, Japan

Location

Local Institution - 0114

Hiroshima, Hiroshima, 7348551, Japan

Location

Local Institution - 0101

Sapporo, Hokkaido, 0030804, Japan

Location

Local Institution - 0106

Amagasaki-shi, Hyōgo, 6608550, Japan

Location

Local Institution - 0098

Nishinomiya-shi, Hyōgo, 6638501, Japan

Location

Local Institution - 0095

Yokohama, Kanagawa, 2210855, Japan

Location

Local Institution - 0104

Natori-shi, Miyagi, 9811293, Japan

Location

Local Institution - 0107

Niigata, Niigata, 9518520, Japan

Location

Local Institution - 0100

Okayama, Okayama-ken, 7028055, Japan

Location

Local Institution - 0096

Kitaadachi-gun, Saitama, 3620806, Japan

Location

Local Institution - 0094

Chuo-ku, Tokyo, 1040045, Japan

Location

Local Institution - 0099

Ube-shi, Yamaguchi, 7550241, Japan

Location

Local Institution - 0113

Sayama, 5898511, Japan

Location

Local Institution - 0051

Guadalajara, Jalisco, 44270, Mexico

Location

Local Institution - 0079

Df, Mexico City, 06720, Mexico

Location

Local Institution - 0053

Mexico City, Mexico City, 14000, Mexico

Location

Local Institution - 0050

Mexico City, Mexico City, 14050, Mexico

Location

Local Institution - 0118

Chihuahua City, 31000, Mexico

Location

Local Institution - 0092

Amsterdam, 1066 CX, Netherlands

Location

Local Institution - 0091

Rotterdam, 3000 CA, Netherlands

Location

Local Institution - 0078

Bytom, 41-902, Poland

Location

Local Institution - 0076

Krakow, 31-202, Poland

Location

Local Institution - 0077

Warsaw, 02-781, Poland

Location

Local Institution - 0115

Bucharest, 020122, Romania

Location

Local Institution - 0109

Bucharest, 021389, Romania

Location

Local Institution - 0102

Craiova, 200347, Romania

Location

Local Institution - 0055

Romania, 400015, Romania

Location

Local Institution - 0150

Moscow, 115478, Russia

Location

Local Institution - 0071

Moscow, 121309, Russia

Location

Local Institution - 0072

Saint Petersburg, 197758, Russia

Location

Local Institution - 0060

Pretoria, Gauteng, 0075, South Africa

Location

Local Institution - 0059

Cape Town, Western Cape, 7570, South Africa

Location

Local Institution - 0049

Bern, 3010, Switzerland

Location

Local Institution - 0036

Lausanne, 1011, Switzerland

Location

Local Institution - 0029

Zurich, 8091, Switzerland

Location

Local Institution - 0111

Diyarbakır, 21280, Turkey (Türkiye)

Location

Local Institution - 0112

Istanbul, 34098, Turkey (Türkiye)

Location

Local Institution - 0110

Seyhan, 01130, Turkey (Türkiye)

Location

Local Institution - 0085

Truro, Cornwall, TR1 3LJ, United Kingdom

Location

Local Institution - 0084

Edinburgh, Midlothian, EH4 2XU, United Kingdom

Location

Local Institution - 0081

Leicester, LE1 5WW, United Kingdom

Location

Local Institution - 0083

London, EC1A 7BE, United Kingdom

Location

Local Institution - 0116

Manchester, M23 9LT, United Kingdom

Location

Local Institution - 0090

Southampton, SO16 6YD, United Kingdom

Location

Related Publications (4)

• 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.

  PMID: 35367910 DERIVED

• 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.

  PMID: 35124183 DERIVED

• 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.

  PMID: 33485464 DERIVED

• 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.

  PMID: 33206991 DERIVED

Related Links

• BMS Clinical Trial Information
• BMS Clinical Trial Patient Recruiting

MeSH Terms

Conditions

Mesothelioma

Interventions

Nivolumab; Ipilimumab; Pemetrexed; Cisplatin; Carboplatin

Condition Hierarchy (Ancestors)

Adenoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Mesothelial

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Guanine; Hypoxanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Glutamates; Amino Acids, Acidic; Amino Acids; Amino Acids, Dicarboxylic; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Coordination Complexes; Organic Chemicals

Results Point of Contact

• Title: Bristol-Myers Squibb Study Director
• Organization: Bristol-Myers Squibb

Clinical.Trials@bms.com

Please Email:

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR
• Expanded Access: Yes

Study Record Dates

• First Submitted: August 31, 2016
• First Posted: September 14, 2016
• Study Start: November 29, 2016
• Primary Completion: March 25, 2020
• Study Completion: April 28, 2023
• Last Updated: May 21, 2024
• Results First Posted: April 14, 2021

Record last verified: 2024-04

Locations

CN (5); US (14); GB (6); ME (5); CH (3); BE (4); IT (8); RU (3); ZA (2); GR (2); TU (3); AU (5); DE (10); PL (3); RO (4); CO (2); NL (2); JP (15); BR (2); FR (10); CL (1)