Study of Nivolumab Combined With Ipilimumab Versus Pemetrexed and Cisplatin or Carboplatin as First Line Therapy in Unresectable Pleural Mesothelioma Patients (CheckMate743)
|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. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02899299|
Recruitment Status : Active, not recruiting
First Posted : September 14, 2016
Results First Posted : April 14, 2021
Last Update Posted : March 15, 2023
- Study Details
- Tabular View
- Study Results
- How to Read a Study Record
|Condition or disease||Intervention/treatment||Phase|
|Mesothelioma||Biological: Nivolumab Biological: Ipilimumab Drug: Pemetrexed Drug: Cisplatin Drug: Carboplatin||Phase 3|
Expanded Access : An investigational treatment associated with this study is no longer available outside the clinical trial. More info ...
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||605 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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 :||November 29, 2016|
|Actual Primary Completion Date :||March 25, 2020|
|Estimated Study Completion Date :||April 28, 2023|
Experimental: Nivolumab and Ipilimumab
Specified dose on specified days
Active Comparator: Pemetrexed and Cisplatin (or Carboplatin)
Specified dose on specified days
- 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.
- 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.
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, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
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
- 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
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
|Study Director:||Bristol-Myers Squibb||Bristol-Myers Squibb|
Documents provided by Bristol-Myers Squibb:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
|Responsible Party:||Bristol-Myers Squibb|
|Other Study ID Numbers:||
2016-001859-43 ( EudraCT Number )
|First Posted:||September 14, 2016 Key Record Dates|
|Results First Posted:||April 14, 2021|
|Last Update Posted:||March 15, 2023|
|Last Verified:||February 2023|
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Respiratory Tract Neoplasms
Neoplasms by Site
Respiratory Tract Diseases
Antineoplastic Agents, Immunological
Immune Checkpoint Inhibitors
Molecular Mechanisms of Pharmacological Action
Folic Acid Antagonists
Nucleic Acid Synthesis Inhibitors