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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 : 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

Tracking Information
First Submitted Date  ICMJE August 31, 2016
First Posted Date  ICMJE September 14, 2016
Results First Submitted Date  ICMJE March 24, 2021
Results First Posted Date  ICMJE April 14, 2021
Last Update Posted Date April 14, 2021
Actual Study Start Date  ICMJE November 29, 2016
Actual Primary Completion Date March 25, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 24, 2021)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: September 8, 2016)
  • Overall Survival (OS) [ Time Frame: 3.5 years ]
  • Progression Free Survival (PFS) [ Time Frame: 3.5 years ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 24, 2021)
  • 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).
  • 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).
  • 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.
  • 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.
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: September 8, 2016)
  • 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
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of Nivolumab Combined With Ipilimumab Versus Pemetrexed and Cisplatin or Carboplatin as First Line Therapy in Unresectable Pleural Mesothelioma Patients
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Mesothelioma
Intervention  ICMJE
  • Biological: Nivolumab
    Other Names:
    • BMS-936558
    • Opdivo
  • Biological: Ipilimumab
    Other Names:
    • BMS-734016
    • Yervoy
  • Drug: Pemetrexed
  • Drug: Cisplatin
  • Drug: Carboplatin
Study Arms  ICMJE
  • Experimental: Nivolumab and Ipilimumab
    Specified dose on specified days
    Interventions:
    • Biological: Nivolumab
    • Biological: Ipilimumab
  • Active Comparator: Pemetrexed and Cisplatin (or Carboplatin)
    Specified dose on specified days
    Interventions:
    • Drug: Pemetrexed
    • Drug: Cisplatin
    • Drug: Carboplatin
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: November 2, 2020)
605
Original Estimated Enrollment  ICMJE
 (submitted: September 8, 2016)
600
Estimated Study Completion Date  ICMJE April 28, 2023
Actual Primary Completion Date March 25, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia,   Belgium,   Brazil,   Chile,   China,   Colombia,   France,   Germany,   Greece,   Italy,   Japan,   Mexico,   Netherlands,   Poland,   Romania,   Russian Federation,   South Africa,   Switzerland,   Turkey,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02899299
Other Study ID Numbers  ICMJE CA209-743
2016-001859-43 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Bristol-Myers Squibb
Study Sponsor  ICMJE Bristol-Myers Squibb
Collaborators  ICMJE Ono Pharmaceutical Co. Ltd
Investigators  ICMJE
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
PRS Account Bristol-Myers Squibb
Verification Date March 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP