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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02576509




Registration number
NCT02576509
Ethics application status
Date submitted
13/10/2015
Date registered
15/10/2015
Date last updated
19/03/2024

Titles & IDs
Public title
An Investigational Immuno-therapy Study of Nivolumab Compared to Sorafenib as a First Treatment in Patients With Advanced Hepatocellular Carcinoma
Scientific title
A Randomized, Multi-center Phase III Study of Nivolumab Versus Sorafenib as First-Line Treatment in Patients With Advanced Hepatocellular Carcinoma (CheckMate 459: CHECKpoint Pathway and nivoluMAb Clinical Trial Evaluation 459)
Secondary ID [1] 0 0
CA209-459
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hepatocellular Carcinoma 0 0
Condition category
Condition code
Cancer 0 0 0 0
Non melanoma skin cancer
Cancer 0 0 0 0
Kidney
Cancer 0 0 0 0
Liver

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Nivolumab
Treatment: Drugs - Sorafenib

Experimental: Nivolumab - Nivolumab specified dose on specified days

Active comparator: Sorafenib - Sorafenib specified dose on specified days


Treatment: Drugs: Nivolumab
Specified Dose on Specified Days

Treatment: Drugs: Sorafenib
Specified Dose on Specified Days
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Overall Survival (OS)
Timepoint [1] 0 0
time from the date of randomization to the date of death due to any cause, assessed up to June 2019 (approximately 41 months)
Secondary outcome [1] 0 0
Objective Response Rate (ORR) Per BICR RECIST 1.1
Timepoint [1] 0 0
the date of randomization and the date of first objectively documented progression or the date of subsequent anti-cancer therapy, whichever occurs first, assessed up to May 2019 (approximately 40 months)
Secondary outcome [2] 0 0
Progression-Free Survival (PFS)
Timepoint [2] 0 0
time from the date of randomization to the date of the first objectively documented tumor progression or death, assessed up to May 2019 (approximately 40 months)
Secondary outcome [3] 0 0
Efficacy Based on PD-L1 Expression - OS and PFS
Timepoint [3] 0 0
the date of randomization and the date of first objectively documented progression or the date of subsequent anti-cancer therapy, whichever occurs first, assessed up to May 2019 (approximately 40 months)
Secondary outcome [4] 0 0
Efficacy Based on PD-L1 Expression - ORR
Timepoint [4] 0 0
the date of randomization and the date of first objectively documented progression or the date of subsequent anti-cancer therapy, whichever occurs first, assessed up to May 2019 (approximately 40 months)

Eligibility
Key inclusion criteria
* Histologically confirmed advanced hepatocellular carcinoma, not eligible for surgical and/or locoregional therapies; or progressive disease after surgical and /or locoregional therapies
* Locoregional therapy for hepatocellular carcinoma (HCC) must be completed at least 4 weeks prior to the baseline scan
* Child-Pugh Class A
* Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Known fibrolamellar HCC, sarcomatoid HCC, or mixed cholangiocarcinoma and HCC
* Prior liver transplant
* Active, known, or suspected autoimmune disease

Other protocol-defined inclusion/exclusion criteria 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
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
7/12/2015
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
7/02/2024
Sample size
Target
Accrual to date
Final
743
Recruitment in Australia
Recruitment state(s)
NSW,SA,VIC,WA
Recruitment hospital [1] 0 0
Local Institution - 0005 - Camperdown
Recruitment hospital [2] 0 0
Local Institution - 0007 - Adelaide
Recruitment hospital [3] 0 0
Local Institution - 0001 - Clayton
Recruitment hospital [4] 0 0
Local Institution - 0002 - Heidelberg
Recruitment hospital [5] 0 0
Local Institution - 0003 - Prahran
Recruitment hospital [6] 0 0
Local Institution - 0008 - Nedlands
Recruitment postcode(s) [1] 0 0
2050 - Camperdown
Recruitment postcode(s) [2] 0 0
5000 - Adelaide
Recruitment postcode(s) [3] 0 0
3168 - Clayton
Recruitment postcode(s) [4] 0 0
3084 - Heidelberg
Recruitment postcode(s) [5] 0 0
3181 - Prahran
Recruitment postcode(s) [6] 0 0
6009 - Nedlands
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Illinois
Country [4] 0 0
United States of America
State/province [4] 0 0
Louisiana
Country [5] 0 0
United States of America
State/province [5] 0 0
New York
Country [6] 0 0
United States of America
State/province [6] 0 0
North Carolina
Country [7] 0 0
United States of America
State/province [7] 0 0
Pennsylvania
Country [8] 0 0
United States of America
State/province [8] 0 0
Texas
Country [9] 0 0
United States of America
State/province [9] 0 0
Washington
Country [10] 0 0
United States of America
State/province [10] 0 0
Wisconsin
Country [11] 0 0
Austria
State/province [11] 0 0
Graz
Country [12] 0 0
Austria
State/province [12] 0 0
Wien
Country [13] 0 0
Belgium
State/province [13] 0 0
Bruxelles
Country [14] 0 0
Belgium
State/province [14] 0 0
Leuven
Country [15] 0 0
Belgium
State/province [15] 0 0
Liege
Country [16] 0 0
Canada
State/province [16] 0 0
Alberta
Country [17] 0 0
Canada
State/province [17] 0 0
British Columbia
Country [18] 0 0
Canada
State/province [18] 0 0
Quebec
Country [19] 0 0
China
State/province [19] 0 0
Anhui
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China
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Beijing
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China
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Fujian
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China
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Guangdong
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China
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Guangxi
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China
State/province [24] 0 0
Heilongjiang
Country [25] 0 0
China
State/province [25] 0 0
Hunan
Country [26] 0 0
China
State/province [26] 0 0
Jiangsu
Country [27] 0 0
China
State/province [27] 0 0
Jilin
Country [28] 0 0
China
State/province [28] 0 0
Liaoning
Country [29] 0 0
China
State/province [29] 0 0
Shan3xi
Country [30] 0 0
China
State/province [30] 0 0
Shanghai
Country [31] 0 0
China
State/province [31] 0 0
Tianjin
Country [32] 0 0
China
State/province [32] 0 0
Zhejiang
Country [33] 0 0
Czechia
State/province [33] 0 0
Brno
Country [34] 0 0
Czechia
State/province [34] 0 0
Hradec Kralove
Country [35] 0 0
Czechia
State/province [35] 0 0
Olomouc
Country [36] 0 0
France
State/province [36] 0 0
La Tronche
Country [37] 0 0
France
State/province [37] 0 0
Lille Cedex
Country [38] 0 0
France
State/province [38] 0 0
Lyon
Country [39] 0 0
France
State/province [39] 0 0
Montpellier Cedex
Country [40] 0 0
France
State/province [40] 0 0
Paris Cedex 13
Country [41] 0 0
France
State/province [41] 0 0
Pessac
Country [42] 0 0
France
State/province [42] 0 0
Rennes Cedex
Country [43] 0 0
France
State/province [43] 0 0
Toulouse Cedex 9
Country [44] 0 0
Germany
State/province [44] 0 0
Berlin
Country [45] 0 0
Germany
State/province [45] 0 0
Essen
Country [46] 0 0
Germany
State/province [46] 0 0
Frankfurt
Country [47] 0 0
Germany
State/province [47] 0 0
Hamburg
Country [48] 0 0
Germany
State/province [48] 0 0
Leipzig
Country [49] 0 0
Germany
State/province [49] 0 0
Mainz
Country [50] 0 0
Germany
State/province [50] 0 0
Munich
Country [51] 0 0
Germany
State/province [51] 0 0
Regensburg
Country [52] 0 0
Germany
State/province [52] 0 0
Tuebingen
Country [53] 0 0
Hong Kong
State/province [53] 0 0
Hong Kong
Country [54] 0 0
Israel
State/province [54] 0 0
Haifa
Country [55] 0 0
Israel
State/province [55] 0 0
Jerusalem
Country [56] 0 0
Israel
State/province [56] 0 0
Petah-tikva
Country [57] 0 0
Israel
State/province [57] 0 0
Tel Aviv
Country [58] 0 0
Italy
State/province [58] 0 0
Benevento
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Italy
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Bergamo
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Italy
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Milan
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Italy
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Orbassano
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Italy
State/province [62] 0 0
Siena
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Japan
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Chiba
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Japan
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Ehime
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Japan
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Fukuoka
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Japan
State/province [66] 0 0
Gifu
Country [67] 0 0
Japan
State/province [67] 0 0
Hokkaido
Country [68] 0 0
Japan
State/province [68] 0 0
Ishikawa
Country [69] 0 0
Japan
State/province [69] 0 0
Kanagawa
Country [70] 0 0
Japan
State/province [70] 0 0
Kyoto
Country [71] 0 0
Japan
State/province [71] 0 0
Osaka
Country [72] 0 0
Japan
State/province [72] 0 0
Saga
Country [73] 0 0
Japan
State/province [73] 0 0
Tokyo
Country [74] 0 0
Japan
State/province [74] 0 0
Hiroshima
Country [75] 0 0
Korea, Republic of
State/province [75] 0 0
Seocho-gu
Country [76] 0 0
Korea, Republic of
State/province [76] 0 0
Daegu
Country [77] 0 0
Korea, Republic of
State/province [77] 0 0
Goyang-si
Country [78] 0 0
Korea, Republic of
State/province [78] 0 0
Jeollanam-do
Country [79] 0 0
Korea, Republic of
State/province [79] 0 0
Seoul-si
Country [80] 0 0
Korea, Republic of
State/province [80] 0 0
Seoul
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Poland
State/province [81] 0 0
Gdansk
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Poland
State/province [82] 0 0
Warszawa
Country [83] 0 0
Poland
State/province [83] 0 0
Wroclaw
Country [84] 0 0
Russian Federation
State/province [84] 0 0
Moscow
Country [85] 0 0
Singapore
State/province [85] 0 0
Singapore
Country [86] 0 0
Spain
State/province [86] 0 0
Alicante
Country [87] 0 0
Spain
State/province [87] 0 0
Majadahonda - Madrid
Country [88] 0 0
Spain
State/province [88] 0 0
Pamplona
Country [89] 0 0
Spain
State/province [89] 0 0
Santiago Compostela
Country [90] 0 0
Sweden
State/province [90] 0 0
Goteborg
Country [91] 0 0
Sweden
State/province [91] 0 0
Stockholm
Country [92] 0 0
Switzerland
State/province [92] 0 0
Basel
Country [93] 0 0
Switzerland
State/province [93] 0 0
Bern
Country [94] 0 0
Taiwan
State/province [94] 0 0
Kaohsiung County
Country [95] 0 0
Taiwan
State/province [95] 0 0
Taichung
Country [96] 0 0
Taiwan
State/province [96] 0 0
Tainan
Country [97] 0 0
Taiwan
State/province [97] 0 0
Taipei
Country [98] 0 0
Taiwan
State/province [98] 0 0
Taoyuan County
Country [99] 0 0
United Kingdom
State/province [99] 0 0
Greater London
Country [100] 0 0
United Kingdom
State/province [100] 0 0
Lanarkshire
Country [101] 0 0
United Kingdom
State/province [101] 0 0
Liverpool

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
Trial website
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

No information has been provided regarding IPD availability


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results are available at https://clinicaltrials.gov/study/NCT02576509