Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Trial Review
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 endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Download to PDF
Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/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
Query!
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
Query!
Secondary ID [1]
0
0
2016-001859-43
Query!
Secondary ID [2]
0
0
CA209-743
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
CheckMate743
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Mesothelioma
0
0
Query!
Condition category
Condition code
Cancer
0
0
0
0
Query!
Lung - Mesothelioma
Query!
Intervention/exposure
Study type
Interventional(has expanded access)
Query!
Description of intervention(s) / exposure
Other interventions - Nivolumab
Other interventions - Ipilimumab
Treatment: Drugs - Pemetrexed
Treatment: Drugs - Cisplatin
Treatment: Drugs - Carboplatin
Experimental: Nivolumab and Ipilimumab - Specified dose on specified days
Active Comparator: Pemetrexed and Cisplatin (or Carboplatin) - Specified dose on specified days
Other interventions: Nivolumab
Other interventions: Ipilimumab
Treatment: Drugs: Pemetrexed
Treatment: Drugs: Cisplatin
Treatment: Drugs: Carboplatin
Query!
Intervention code [1]
0
0
Other interventions
Query!
Intervention code [2]
0
0
Treatment: Drugs
Query!
Comparator / control treatment
Query!
Control group
Query!
Outcomes
Primary outcome [1]
0
0
Overall Survival (OS)
Query!
Assessment method [1]
0
0
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.
Query!
Timepoint [1]
0
0
From randomization to the date of death (Up to 40 Months)
Query!
Secondary outcome [1]
0
0
Objective Response Rate (ORR)
Query!
Assessment method [1]
0
0
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.
Query!
Timepoint [1]
0
0
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)
Query!
Secondary outcome [2]
0
0
Disease Control Rate (DCR)
Query!
Assessment method [2]
0
0
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).
Query!
Timepoint [2]
0
0
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
Query!
Secondary outcome [3]
0
0
Progression Free Survival (PFS)
Query!
Assessment method [3]
0
0
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.
Query!
Timepoint [3]
0
0
From randomization date to the date of first documented tumor progression or death due to any cause, whichever occurs first. (up to 76 months)
Query!
Secondary outcome [4]
0
0
Overall Survival (OS) According to PD-L1 Expression Level
Query!
Assessment method [4]
0
0
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.
Query!
Timepoint [4]
0
0
From randomization date to the date of death (Up to 76 Months)
Query!
Secondary outcome [5]
0
0
Progression Free Survival (PFS) According to PD-L1 Expression Level
Query!
Assessment method [5]
0
0
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.
Query!
Timepoint [5]
0
0
From randomization date to the date of first documented tumor progression or death due to any cause, whichever occurs first. (up to 76 months)
Query!
Secondary outcome [6]
0
0
Objective Response Rate (ORR) According to PD-L1 Expression Level
Query!
Assessment method [6]
0
0
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.
Query!
Timepoint [6]
0
0
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)
Query!
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
Query!
Minimum age
18
Years
Query!
Query!
Maximum age
No limit
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
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
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
Randomised controlled trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Open (masking not used)
Query!
Who is / are masked / blinded?
Query!
Query!
Query!
Query!
Intervention assignment
Parallel
Query!
Other design features
Query!
Phase
Phase 3
Query!
Type of endpoint/s
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Completed
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
29/11/2016
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
Query!
Actual
28/04/2023
Query!
Sample size
Target
Query!
Accrual to date
Query!
Final
605
Query!
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC,WA
Query!
Recruitment hospital [1]
0
0
Local Institution - 0032 - Sydney
Query!
Recruitment hospital [2]
0
0
Local Institution - 0031 - Birtinya
Query!
Recruitment hospital [3]
0
0
Local Institution - 0033 - Clayton
Query!
Recruitment hospital [4]
0
0
Local Institution - 0030 - Malvern
Query!
Recruitment hospital [5]
0
0
Local Institution - 0034 - Nedlands
Query!
Recruitment postcode(s) [1]
0
0
2139 - Sydney
Query!
Recruitment postcode(s) [2]
0
0
4575 - Birtinya
Query!
Recruitment postcode(s) [3]
0
0
3168 - Clayton
Query!
Recruitment postcode(s) [4]
0
0
3144 - Malvern
Query!
Recruitment postcode(s) [5]
0
0
6009 - Nedlands
Query!
Recruitment outside Australia
Country [1]
0
0
United States of America
Query!
State/province [1]
0
0
California
Query!
Country [2]
0
0
United States of America
Query!
State/province [2]
0
0
Connecticut
Query!
Country [3]
0
0
United States of America
Query!
State/province [3]
0
0
Florida
Query!
Country [4]
0
0
United States of America
Query!
State/province [4]
0
0
Illinois
Query!
Country [5]
0
0
United States of America
Query!
State/province [5]
0
0
Maryland
Query!
Country [6]
0
0
United States of America
Query!
State/province [6]
0
0
Michigan
Query!
Country [7]
0
0
United States of America
Query!
State/province [7]
0
0
Minnesota
Query!
Country [8]
0
0
United States of America
Query!
State/province [8]
0
0
New York
Query!
Country [9]
0
0
United States of America
Query!
State/province [9]
0
0
Ohio
Query!
Country [10]
0
0
United States of America
Query!
State/province [10]
0
0
Pennsylvania
Query!
Country [11]
0
0
United States of America
Query!
State/province [11]
0
0
Texas
Query!
Country [12]
0
0
United States of America
Query!
State/province [12]
0
0
West Virginia
Query!
Country [13]
0
0
Belgium
Query!
State/province [13]
0
0
Brussels
Query!
Country [14]
0
0
Belgium
Query!
State/province [14]
0
0
Edegem
Query!
Country [15]
0
0
Belgium
Query!
State/province [15]
0
0
Liège
Query!
Country [16]
0
0
Belgium
Query!
State/province [16]
0
0
Sint-Niklaas
Query!
Country [17]
0
0
Brazil
Query!
State/province [17]
0
0
Sao Paulo
Query!
Country [18]
0
0
Chile
Query!
State/province [18]
0
0
Metropolitana
Query!
Country [19]
0
0
China
Query!
State/province [19]
0
0
Heilongjiang
Query!
Country [20]
0
0
China
Query!
State/province [20]
0
0
Jilin
Query!
Country [21]
0
0
China
Query!
State/province [21]
0
0
Liaoning
Query!
Country [22]
0
0
China
Query!
State/province [22]
0
0
Kunming
Query!
Country [23]
0
0
China
Query!
State/province [23]
0
0
Shanghai
Query!
Country [24]
0
0
Colombia
Query!
State/province [24]
0
0
Bogota
Query!
Country [25]
0
0
France
Query!
State/province [25]
0
0
Caen
Query!
Country [26]
0
0
France
Query!
State/province [26]
0
0
Creteil
Query!
Country [27]
0
0
France
Query!
State/province [27]
0
0
La Tronche
Query!
Country [28]
0
0
France
Query!
State/province [28]
0
0
Lille Cedex
Query!
Country [29]
0
0
France
Query!
State/province [29]
0
0
Marseille Cedex 20
Query!
Country [30]
0
0
France
Query!
State/province [30]
0
0
Paris
Query!
Country [31]
0
0
France
Query!
State/province [31]
0
0
Saint Herblain
Query!
Country [32]
0
0
France
Query!
State/province [32]
0
0
Strasbourg Cedex
Query!
Country [33]
0
0
France
Query!
State/province [33]
0
0
Toulon Cedex
Query!
Country [34]
0
0
France
Query!
State/province [34]
0
0
Toulouse Cedex 9
Query!
Country [35]
0
0
Germany
Query!
State/province [35]
0
0
Cologne
Query!
Country [36]
0
0
Germany
Query!
State/province [36]
0
0
Coswig
Query!
Country [37]
0
0
Germany
Query!
State/province [37]
0
0
Essen
Query!
Country [38]
0
0
Germany
Query!
State/province [38]
0
0
Gottingen
Query!
Country [39]
0
0
Germany
Query!
State/province [39]
0
0
Grosshansdorf
Query!
Country [40]
0
0
Germany
Query!
State/province [40]
0
0
Hamburg
Query!
Country [41]
0
0
Germany
Query!
State/province [41]
0
0
Heidelberg
Query!
Country [42]
0
0
Germany
Query!
State/province [42]
0
0
Homburg an d. Saar
Query!
Country [43]
0
0
Germany
Query!
State/province [43]
0
0
Immenhausen
Query!
Country [44]
0
0
Germany
Query!
State/province [44]
0
0
Moers
Query!
Country [45]
0
0
Greece
Query!
State/province [45]
0
0
Athens
Query!
Country [46]
0
0
Greece
Query!
State/province [46]
0
0
Thessaloniki
Query!
Country [47]
0
0
Italy
Query!
State/province [47]
0
0
Emilia-Romagna
Query!
Country [48]
0
0
Italy
Query!
State/province [48]
0
0
Aviano
Query!
Country [49]
0
0
Italy
Query!
State/province [49]
0
0
Bari
Query!
Country [50]
0
0
Italy
Query!
State/province [50]
0
0
Catania
Query!
Country [51]
0
0
Italy
Query!
State/province [51]
0
0
Genova
Query!
Country [52]
0
0
Italy
Query!
State/province [52]
0
0
Napoli
Query!
Country [53]
0
0
Italy
Query!
State/province [53]
0
0
Rozzano
Query!
Country [54]
0
0
Italy
Query!
State/province [54]
0
0
Siena
Query!
Country [55]
0
0
Japan
Query!
State/province [55]
0
0
Aichi
Query!
Country [56]
0
0
Japan
Query!
State/province [56]
0
0
Chiba
Query!
Country [57]
0
0
Japan
Query!
State/province [57]
0
0
Hiroshima
Query!
Country [58]
0
0
Japan
Query!
State/province [58]
0
0
Hokkaido
Query!
Country [59]
0
0
Japan
Query!
State/province [59]
0
0
Hyogo
Query!
Country [60]
0
0
Japan
Query!
State/province [60]
0
0
Kanagawa
Query!
Country [61]
0
0
Japan
Query!
State/province [61]
0
0
Miyagi
Query!
Country [62]
0
0
Japan
Query!
State/province [62]
0
0
Niigata
Query!
Country [63]
0
0
Japan
Query!
State/province [63]
0
0
Okayama
Query!
Country [64]
0
0
Japan
Query!
State/province [64]
0
0
Saitama
Query!
Country [65]
0
0
Japan
Query!
State/province [65]
0
0
Tokyo
Query!
Country [66]
0
0
Japan
Query!
State/province [66]
0
0
Yamaguchi
Query!
Country [67]
0
0
Japan
Query!
State/province [67]
0
0
Osakasayama-city
Query!
Country [68]
0
0
Mexico
Query!
State/province [68]
0
0
Distrito Federal
Query!
Country [69]
0
0
Mexico
Query!
State/province [69]
0
0
Jalisco
Query!
Country [70]
0
0
Mexico
Query!
State/province [70]
0
0
Chihuahua
Query!
Country [71]
0
0
Netherlands
Query!
State/province [71]
0
0
Amsterdam
Query!
Country [72]
0
0
Netherlands
Query!
State/province [72]
0
0
Rotterdam
Query!
Country [73]
0
0
Poland
Query!
State/province [73]
0
0
Bytom
Query!
Country [74]
0
0
Poland
Query!
State/province [74]
0
0
Krakow
Query!
Country [75]
0
0
Poland
Query!
State/province [75]
0
0
Warszawa
Query!
Country [76]
0
0
Romania
Query!
State/province [76]
0
0
Bucharest
Query!
Country [77]
0
0
Romania
Query!
State/province [77]
0
0
Bucuresti
Query!
Country [78]
0
0
Romania
Query!
State/province [78]
0
0
Craiova
Query!
Country [79]
0
0
Romania
Query!
State/province [79]
0
0
Romania
Query!
Country [80]
0
0
Russian Federation
Query!
State/province [80]
0
0
Moscow
Query!
Country [81]
0
0
Russian Federation
Query!
State/province [81]
0
0
Saint Petersburg
Query!
Country [82]
0
0
South Africa
Query!
State/province [82]
0
0
Gauteng
Query!
Country [83]
0
0
South Africa
Query!
State/province [83]
0
0
Western Cape
Query!
Country [84]
0
0
Switzerland
Query!
State/province [84]
0
0
Bern
Query!
Country [85]
0
0
Switzerland
Query!
State/province [85]
0
0
Lausanne
Query!
Country [86]
0
0
Switzerland
Query!
State/province [86]
0
0
Zurich
Query!
Country [87]
0
0
Turkey
Query!
State/province [87]
0
0
Diyarbakir
Query!
Country [88]
0
0
Turkey
Query!
State/province [88]
0
0
Istanbul
Query!
Country [89]
0
0
Turkey
Query!
State/province [89]
0
0
Seyhan
Query!
Country [90]
0
0
United Kingdom
Query!
State/province [90]
0
0
Cornwall
Query!
Country [91]
0
0
United Kingdom
Query!
State/province [91]
0
0
Midlothian
Query!
Country [92]
0
0
United Kingdom
Query!
State/province [92]
0
0
Leicester
Query!
Country [93]
0
0
United Kingdom
Query!
State/province [93]
0
0
London
Query!
Country [94]
0
0
United Kingdom
Query!
State/province [94]
0
0
Manchester
Query!
Country [95]
0
0
United Kingdom
Query!
State/province [95]
0
0
Southampton
Query!
Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Query!
Name
Bristol-Myers Squibb
Query!
Address
Query!
Country
Query!
Other collaborator category [1]
0
0
Commercial sector/Industry
Query!
Name [1]
0
0
Ono Pharmaceutical Co. Ltd
Query!
Address [1]
0
0
Query!
Country [1]
0
0
Query!
Ethics approval
Ethics application status
Query!
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.
Query!
Trial website
https://clinicaltrials.gov/ct2/show/NCT02899299
Query!
Trial related presentations / publications
Query!
Public notes
Query!
Contacts
Principal investigator
Name
0
0
Bristol-Myers Squibb
Query!
Address
0
0
Bristol-Myers Squibb
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for public queries
Name
0
0
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT02899299
Download to PDF