Please note that the ANZCTR website will be unavailable from 6pm until 6.30pm (AEST) on Monday 22nd July for website maintenance. Please be sure to log out of the system in order to avoid any loss of data. Thank you and apologies for any inconvenience caused.

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
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT02899299




Registration number
NCT02899299
Ethics application status
Date submitted
31/08/2016
Date registered
14/09/2016
Date last updated
3/07/2019

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
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
Secondary ID [1] 0 0
2016-001859-43
Secondary ID [2] 0 0
CA209-743
Universal Trial Number (UTN)
Trial acronym
CheckMate743
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Mesothelioma 0 0
Condition category
Condition code
Cancer 0 0 0 0
Lung - Mesothelioma

Intervention/exposure
Study type
Interventional
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


Intervention code [1] 0 0
Other interventions
Intervention code [2] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Overall Survival (OS) - Final OS analysis
Timepoint [1] 0 0
4.5 years
Secondary outcome [1] 0 0
Objective Response Rate (ORR)
Timepoint [1] 0 0
4.5 years
Secondary outcome [2] 0 0
Disease Control Rate (DCR)
Timepoint [2] 0 0
4.5 years
Secondary outcome [3] 0 0
Composite correlation of PD-L1 expression level and efficacy - Efficacy determined by the ORR, PFS, and OS
Timepoint [3] 0 0
4.5 years
Secondary outcome [4] 0 0
Progression Free Survival (PFS)
Timepoint [4] 0 0
4.5 years

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
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC,WA
Recruitment hospital [1] 0 0
Concord Repatriation General Hospital - Sydney
Recruitment hospital [2] 0 0
Sunshine Coast University Hospital - Birtinya
Recruitment hospital [3] 0 0
Monash Medical Centre Clayton - Clayton
Recruitment hospital [4] 0 0
Cabrini Hospital - Malvern
Recruitment hospital [5] 0 0
Sir Charles Gairdner Hospital - Nedlands
Recruitment postcode(s) [1] 0 0
2139 - Sydney
Recruitment postcode(s) [2] 0 0
4575 - Birtinya
Recruitment postcode(s) [3] 0 0
3168 - Clayton
Recruitment postcode(s) [4] 0 0
3144 - Malvern
Recruitment postcode(s) [5] 0 0
6009 - Nedlands
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Connecticut
Country [3] 0 0
United States of America
State/province [3] 0 0
Florida
Country [4] 0 0
United States of America
State/province [4] 0 0
Illinois
Country [5] 0 0
United States of America
State/province [5] 0 0
Maryland
Country [6] 0 0
United States of America
State/province [6] 0 0
Michigan
Country [7] 0 0
United States of America
State/province [7] 0 0
Minnesota
Country [8] 0 0
United States of America
State/province [8] 0 0
New York
Country [9] 0 0
United States of America
State/province [9] 0 0
Ohio
Country [10] 0 0
United States of America
State/province [10] 0 0
Pennsylvania
Country [11] 0 0
United States of America
State/province [11] 0 0
Texas
Country [12] 0 0
United States of America
State/province [12] 0 0
West Virginia
Country [13] 0 0
Belgium
State/province [13] 0 0
Brussels
Country [14] 0 0
Belgium
State/province [14] 0 0
Edegem
Country [15] 0 0
Belgium
State/province [15] 0 0
Liege
Country [16] 0 0
Belgium
State/province [16] 0 0
Sint-Niklaas
Country [17] 0 0
Brazil
State/province [17] 0 0
SAO Paulo
Country [18] 0 0
Brazil
State/province [18] 0 0
Sao Paulo
Country [19] 0 0
Chile
State/province [19] 0 0
Santiago DE Chile
Country [20] 0 0
China
State/province [20] 0 0
Beijing
Country [21] 0 0
China
State/province [21] 0 0
Heilongjiang
Country [22] 0 0
China
State/province [22] 0 0
Jilin
Country [23] 0 0
China
State/province [23] 0 0
Liaoning
Country [24] 0 0
China
State/province [24] 0 0
Zhejiang
Country [25] 0 0
China
State/province [25] 0 0
Kunming
Country [26] 0 0
China
State/province [26] 0 0
Shanghai
Country [27] 0 0
Colombia
State/province [27] 0 0
Bogota
Country [28] 0 0
France
State/province [28] 0 0
Caen
Country [29] 0 0
France
State/province [29] 0 0
Creteil
Country [30] 0 0
France
State/province [30] 0 0
La Tronche
Country [31] 0 0
France
State/province [31] 0 0
Lille Cedex
Country [32] 0 0
France
State/province [32] 0 0
Marseille Cedex 20
Country [33] 0 0
France
State/province [33] 0 0
Paris
Country [34] 0 0
France
State/province [34] 0 0
Saint Herblain
Country [35] 0 0
France
State/province [35] 0 0
Strasbourg Cedex
Country [36] 0 0
France
State/province [36] 0 0
Toulon Cedex
Country [37] 0 0
France
State/province [37] 0 0
Toulouse Cedex 9
Country [38] 0 0
Germany
State/province [38] 0 0
Coswig
Country [39] 0 0
Germany
State/province [39] 0 0
Essen
Country [40] 0 0
Germany
State/province [40] 0 0
Gottingen
Country [41] 0 0
Germany
State/province [41] 0 0
Grosshansdorf
Country [42] 0 0
Germany
State/province [42] 0 0
Hamburg
Country [43] 0 0
Germany
State/province [43] 0 0
Heidelberg
Country [44] 0 0
Germany
State/province [44] 0 0
Homburg an d. Saar
Country [45] 0 0
Germany
State/province [45] 0 0
Immenhausen
Country [46] 0 0
Germany
State/province [46] 0 0
Koeln
Country [47] 0 0
Germany
State/province [47] 0 0
Moers
Country [48] 0 0
Greece
State/province [48] 0 0
Athens
Country [49] 0 0
Greece
State/province [49] 0 0
Thessaloniki
Country [50] 0 0
Italy
State/province [50] 0 0
Aviano
Country [51] 0 0
Italy
State/province [51] 0 0
Bari
Country [52] 0 0
Italy
State/province [52] 0 0
Catania
Country [53] 0 0
Italy
State/province [53] 0 0
Genova
Country [54] 0 0
Italy
State/province [54] 0 0
Napoli
Country [55] 0 0
Italy
State/province [55] 0 0
Ravenna
Country [56] 0 0
Italy
State/province [56] 0 0
Rozzano
Country [57] 0 0
Italy
State/province [57] 0 0
Siena
Country [58] 0 0
Japan
State/province [58] 0 0
Aichi
Country [59] 0 0
Japan
State/province [59] 0 0
Chiba
Country [60] 0 0
Japan
State/province [60] 0 0
Hiroshima
Country [61] 0 0
Japan
State/province [61] 0 0
Hokkaido
Country [62] 0 0
Japan
State/province [62] 0 0
Hyogo
Country [63] 0 0
Japan
State/province [63] 0 0
Kanagawa
Country [64] 0 0
Japan
State/province [64] 0 0
Miyagi
Country [65] 0 0
Japan
State/province [65] 0 0
Niigata
Country [66] 0 0
Japan
State/province [66] 0 0
Okayama
Country [67] 0 0
Japan
State/province [67] 0 0
Saitama
Country [68] 0 0
Japan
State/province [68] 0 0
Tokyo
Country [69] 0 0
Japan
State/province [69] 0 0
Yamaguchi
Country [70] 0 0
Japan
State/province [70] 0 0
Osakasayama-city
Country [71] 0 0
Mexico
State/province [71] 0 0
Distrito Federal
Country [72] 0 0
Mexico
State/province [72] 0 0
Jalisco
Country [73] 0 0
Mexico
State/province [73] 0 0
Chihuahua
Country [74] 0 0
Netherlands
State/province [74] 0 0
Amsterdam
Country [75] 0 0
Netherlands
State/province [75] 0 0
Rotterdam
Country [76] 0 0
Poland
State/province [76] 0 0
Bytom
Country [77] 0 0
Poland
State/province [77] 0 0
Krakow
Country [78] 0 0
Poland
State/province [78] 0 0
Warszawa
Country [79] 0 0
Romania
State/province [79] 0 0
Bucharest
Country [80] 0 0
Romania
State/province [80] 0 0
Bucuresti
Country [81] 0 0
Romania
State/province [81] 0 0
Craiova
Country [82] 0 0
Romania
State/province [82] 0 0
Romania
Country [83] 0 0
Russian Federation
State/province [83] 0 0
Moscow
Country [84] 0 0
Russian Federation
State/province [84] 0 0
St.petersburg
Country [85] 0 0
South Africa
State/province [85] 0 0
Gauteng
Country [86] 0 0
South Africa
State/province [86] 0 0
Western CAPE
Country [87] 0 0
Switzerland
State/province [87] 0 0
Bern
Country [88] 0 0
Switzerland
State/province [88] 0 0
Lausanne
Country [89] 0 0
Switzerland
State/province [89] 0 0
Zurich
Country [90] 0 0
Turkey
State/province [90] 0 0
Diyarbak?r
Country [91] 0 0
Turkey
State/province [91] 0 0
Istanbul
Country [92] 0 0
Turkey
State/province [92] 0 0
Seyhan
Country [93] 0 0
United Kingdom
State/province [93] 0 0
Cornwall
Country [94] 0 0
United Kingdom
State/province [94] 0 0
Midlothian
Country [95] 0 0
United Kingdom
State/province [95] 0 0
Leicester
Country [96] 0 0
United Kingdom
State/province [96] 0 0
London
Country [97] 0 0
United Kingdom
State/province [97] 0 0
Manchester
Country [98] 0 0
United Kingdom
State/province [98] 0 0
Southampton

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Bristol-Myers Squibb
Address
Country
Other collaborator category [1] 0 0
Commercial sector/Industry
Name [1] 0 0
Ono Pharmaceutical Co. Ltd
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/show/NCT02899299
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Bristol-Myers Squibb
Address 0 0
Bristol-Myers Squibb
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications