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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT02899299
Registration number
NCT02899299
Ethics application status
Date submitted
31/08/2016
Date registered
14/09/2016
Date last updated
21/05/2024
Titles & IDs
Public title
Study of Nivolumab Combined With Ipilimumab Versus Pemetrexed and Cisplatin or Carboplatin as First Line Therapy in Unresectable Pleural Mesothelioma Patients
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Scientific 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
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Secondary ID [1]
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2016-001859-43
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Secondary ID [2]
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CA209-743
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Universal Trial Number (UTN)
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Trial acronym
CheckMate743
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Mesothelioma
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Condition category
Condition code
Cancer
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Lung - Mesothelioma
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Intervention/exposure
Study type
Interventional(has expanded access)
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Description of intervention(s) / exposure
Experimental: Nivolumab and Ipilimumab - Specified dose on specified days
Active comparator: Pemetrexed and Cisplatin (or Carboplatin) - Specified dose on specified days
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Overall Survival (OS)
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Assessment method [1]
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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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Timepoint [1]
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From randomization to the date of death (Up to 40 Months)
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Secondary outcome [1]
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Objective Response Rate (ORR)
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Assessment method [1]
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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.
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Timepoint [1]
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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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Secondary outcome [2]
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Disease Control Rate (DCR)
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Assessment method [2]
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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).
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Timepoint [2]
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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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Secondary outcome [3]
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Progression Free Survival (PFS)
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Assessment method [3]
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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.
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Timepoint [3]
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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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Secondary outcome [4]
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Overall Survival (OS) According to PD-L1 Expression Level
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Assessment method [4]
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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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Timepoint [4]
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From randomization date to the date of death (Up to 76 Months)
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Secondary outcome [5]
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Progression Free Survival (PFS) According to PD-L1 Expression Level
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Assessment method [5]
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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 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.
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Timepoint [5]
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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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Secondary outcome [6]
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Objective Response Rate (ORR) According to PD-L1 Expression Level
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Assessment method [6]
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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 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.
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Timepoint [6]
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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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Eligibility
Key inclusion criteria
For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com
* 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
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key 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
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
29/11/2016
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
28/04/2023
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Sample size
Target
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Accrual to date
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Final
605
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC,WA
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Recruitment hospital [1]
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Local Institution - 0032 - Sydney
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Local Institution - 0031 - Birtinya
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Local Institution - 0033 - Clayton
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Local Institution - 0030 - Malvern
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Local Institution - 0034 - Nedlands
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2139 - Sydney
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4575 - Birtinya
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3168 - Clayton
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3144 - Malvern
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6009 - Nedlands
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Recruitment outside Australia
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Bristol-Myers Squibb
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Address
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Other collaborator category [1]
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Ono Pharmaceutical Co. Ltd
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Ethics approval
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Summary
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.
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Trial website
https://clinicaltrials.gov/study/NCT02899299
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Trial related presentations / 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. doi: 10.1016/S0140-6736(21)00369-X. 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.
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Bristol-Myers Squibb
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Study protocol
https://cdn.clinicaltrials.gov/large-docs/99/NCT02899299/Prot_000.pdf
Statistical analysis plan
https://cdn.clinicaltrials.gov/large-docs/99/NCT02899299/SAP_001.pdf
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https://clinicaltrials.gov/study/NCT02899299
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