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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04340193




Registration number
NCT04340193
Ethics application status
Date submitted
7/04/2020
Date registered
9/04/2020
Date last updated
26/11/2024

Titles & IDs
Public title
A Study of Nivolumab and Ipilimumab and Nivolumab Alone in Combination With Trans-arterial ChemoEmbolization (TACE) in Participants With Intermediate Stage Liver Cancer
Scientific title
A Randomized, Multi-center, Double-blinded, Placebo-controlled Phase 3 Study of Nivolumab and Ipilimumab, Nivolumab Monotherapy, or Placebo in Combination With Trans-arterial ChemoEmbolization (TACE) in Patients With Intermediate-stage Hepatocellular Carcinoma (HCC)
Secondary ID [1] 0 0
CA209-74W
Universal Trial Number (UTN)
Trial acronym
CheckMate 74W
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cancer, Hepatocellular 0 0
Condition category
Condition code
Cancer 0 0 0 0
Liver
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional(has expanded access)
Description of intervention(s) / exposure
Treatment: Drugs - nivolumab
Treatment: Drugs - ipilimumab
Treatment: Surgery - TACE

Experimental: Nivolumab + Ipilimumab + TACE - TACE (Trans-arterial ChemoEmbolization)

Experimental: Nivolumab + TACE -

Active comparator: TACE -


Treatment: Drugs: nivolumab
Specified dose on specified days

Treatment: Drugs: ipilimumab
Specified dose on specified days

Treatment: Surgery: TACE
TACE (Trans-arterial ChemoEmbolization)
Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Treatment: Surgery
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of Participants With Adverse Events
Timepoint [1] 0 0
From first dose and 30 days after last dose of study therapy (up to approximately 25 months)
Primary outcome [2] 0 0
Number of Participants With Serious Adverse Events (SAEs)
Timepoint [2] 0 0
From first dose and 30 days after last dose of study therapy (up to approximately 25 months)
Primary outcome [3] 0 0
Number of Participants Who Died
Timepoint [3] 0 0
From first dose and 100 days after last dose of study therapy (up to approximately 27 months)
Primary outcome [4] 0 0
Number of Participants With Adverse Events Leading to Study Drug Discontinuation
Timepoint [4] 0 0
From first dose and 30 days after last dose of study therapy (up to approximately 25 months)
Primary outcome [5] 0 0
Number of Participants With Worst Grade (Grade 3/4) Laboratory Results
Timepoint [5] 0 0
From first dose and 30 days after last dose of study therapy (up to approximately 25 months)
Primary outcome [6] 0 0
Number of Participants With Laboratory Abnormalities in Specific Thyroid Tests
Timepoint [6] 0 0
From first dose and 30 days after last dose of study therapy (up to approximately 25 months)
Primary outcome [7] 0 0
Number of Participants With Clinical Laboratory Abnormalities in Specific Liver Tests
Timepoint [7] 0 0
From first dose and 30 days after last dose of study therapy (up to approximately 25 months)

Eligibility
Key inclusion criteria
* Participant has intermediate-stage hepatocellular carcinoma (HCC) whose tumor characteristics exceed the Beyond Milan and Up-to-7 (BMU7) criteria and is eligible for trans-arterial ChemoEmbolization (TACE)
* Participant has no extrahepatic spreading (EHS), no regional lymph node involvement, no main, left main, or right main portal vein thrombosis, and no macrovascular invasion (MVI)
* 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 or participants who are on the waiting list for liver transplantation
* 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
14/09/2020
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
12/12/2023
Sample size
Target
Accrual to date
Final
26
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC,WA
Recruitment hospital [1] 0 0
Local Institution - Wollongong
Recruitment hospital [2] 0 0
Local Institution - 0037 - Birtinya
Recruitment hospital [3] 0 0
Local Institution - 0010 - Adelaide
Recruitment hospital [4] 0 0
Local Institution - 0001 - Melbourne
Recruitment hospital [5] 0 0
Local Institution - 0139 - Murdoch
Recruitment postcode(s) [1] 0 0
2500 - Wollongong
Recruitment postcode(s) [2] 0 0
4575 - Birtinya
Recruitment postcode(s) [3] 0 0
5000 - Adelaide
Recruitment postcode(s) [4] 0 0
3065 - Melbourne
Recruitment postcode(s) [5] 0 0
6150 - Murdoch
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
District of Columbia
Country [3] 0 0
United States of America
State/province [3] 0 0
Kentucky
Country [4] 0 0
United States of America
State/province [4] 0 0
Texas
Country [5] 0 0
Austria
State/province [5] 0 0
Graz
Country [6] 0 0
Austria
State/province [6] 0 0
St. Polten
Country [7] 0 0
Austria
State/province [7] 0 0
Vienna
Country [8] 0 0
Austria
State/province [8] 0 0
West Springfield
Country [9] 0 0
Austria
State/province [9] 0 0
Wiener Neustadt
Country [10] 0 0
Belgium
State/province [10] 0 0
Brussels
Country [11] 0 0
Belgium
State/province [11] 0 0
Federal District
Country [12] 0 0
Belgium
State/province [12] 0 0
Gent
Country [13] 0 0
Belgium
State/province [13] 0 0
Plainfield
Country [14] 0 0
Canada
State/province [14] 0 0
Quebec
Country [15] 0 0
China
State/province [15] 0 0
Beijing
Country [16] 0 0
China
State/province [16] 0 0
Guangdong
Country [17] 0 0
China
State/province [17] 0 0
Hebei
Country [18] 0 0
China
State/province [18] 0 0
Jiangsu
Country [19] 0 0
China
State/province [19] 0 0
Jiangxi
Country [20] 0 0
China
State/province [20] 0 0
Liaoning
Country [21] 0 0
China
State/province [21] 0 0
Shan3xi
Country [22] 0 0
China
State/province [22] 0 0
Shanghai
Country [23] 0 0
China
State/province [23] 0 0
Sichuan
Country [24] 0 0
China
State/province [24] 0 0
Zhejiang
Country [25] 0 0
Czechia
State/province [25] 0 0
Olomouc
Country [26] 0 0
Czechia
State/province [26] 0 0
Praha 5
Country [27] 0 0
France
State/province [27] 0 0
Mount
Country [28] 0 0
France
State/province [28] 0 0
Caen
Country [29] 0 0
France
State/province [29] 0 0
Clichy
Country [30] 0 0
France
State/province [30] 0 0
Dijon
Country [31] 0 0
France
State/province [31] 0 0
Englewood
Country [32] 0 0
France
State/province [32] 0 0
La Tronche
Country [33] 0 0
France
State/province [33] 0 0
Marseil
Country [34] 0 0
France
State/province [34] 0 0
Nantes
Country [35] 0 0
France
State/province [35] 0 0
Nice
Country [36] 0 0
France
State/province [36] 0 0
Paris
Country [37] 0 0
France
State/province [37] 0 0
Reims
Country [38] 0 0
France
State/province [38] 0 0
Villejuif cedex
Country [39] 0 0
Germany
State/province [39] 0 0
Goettingen
Country [40] 0 0
Germany
State/province [40] 0 0
Hannover
Country [41] 0 0
Germany
State/province [41] 0 0
Heidelberg
Country [42] 0 0
Germany
State/province [42] 0 0
Leipzig
Country [43] 0 0
Hong Kong
State/province [43] 0 0
Hong Kong
Country [44] 0 0
Hong Kong
State/province [44] 0 0
HongKong
Country [45] 0 0
Italy
State/province [45] 0 0
TO
Country [46] 0 0
Italy
State/province [46] 0 0
Messina
Country [47] 0 0
Italy
State/province [47] 0 0
Milano
Country [48] 0 0
Italy
State/province [48] 0 0
Monserrato
Country [49] 0 0
Italy
State/province [49] 0 0
Parma
Country [50] 0 0
Italy
State/province [50] 0 0
Roma
Country [51] 0 0
Italy
State/province [51] 0 0
Siena
Country [52] 0 0
Italy
State/province [52] 0 0
Vicenza
Country [53] 0 0
Japan
State/province [53] 0 0
Chiba
Country [54] 0 0
Japan
State/province [54] 0 0
Ehime
Country [55] 0 0
Japan
State/province [55] 0 0
Hokkaido
Country [56] 0 0
Japan
State/province [56] 0 0
Ishikawa
Country [57] 0 0
Japan
State/province [57] 0 0
Kanagawa
Country [58] 0 0
Japan
State/province [58] 0 0
Kyoto
Country [59] 0 0
Japan
State/province [59] 0 0
Osaka
Country [60] 0 0
Japan
State/province [60] 0 0
Shizuoka
Country [61] 0 0
Japan
State/province [61] 0 0
Tokyo
Country [62] 0 0
Japan
State/province [62] 0 0
Hiroshima
Country [63] 0 0
Japan
State/province [63] 0 0
Saitama
Country [64] 0 0
Korea, Republic of
State/province [64] 0 0
Busan
Country [65] 0 0
Korea, Republic of
State/province [65] 0 0
Daegu
Country [66] 0 0
Korea, Republic of
State/province [66] 0 0
Gyeongsangnam-do
Country [67] 0 0
Korea, Republic of
State/province [67] 0 0
Hwasun-Gun
Country [68] 0 0
Korea, Republic of
State/province [68] 0 0
Seoul
Country [69] 0 0
Poland
State/province [69] 0 0
Warszawa
Country [70] 0 0
Puerto Rico
State/province [70] 0 0
San Juan
Country [71] 0 0
Russian Federation
State/province [71] 0 0
Barnaul
Country [72] 0 0
Russian Federation
State/province [72] 0 0
Saint Petersburg
Country [73] 0 0
Russian Federation
State/province [73] 0 0
Saint-Petersburg
Country [74] 0 0
Singapore
State/province [74] 0 0
Singapore
Country [75] 0 0
Spain
State/province [75] 0 0
Alicante
Country [76] 0 0
Spain
State/province [76] 0 0
Cordoba
Country [77] 0 0
Spain
State/province [77] 0 0
Madrid
Country [78] 0 0
Spain
State/province [78] 0 0
Pamplona
Country [79] 0 0
Spain
State/province [79] 0 0
Sabadell
Country [80] 0 0
Spain
State/province [80] 0 0
Santiago de Compostela
Country [81] 0 0
Taiwan
State/province [81] 0 0
Kaohsiung
Country [82] 0 0
Taiwan
State/province [82] 0 0
Puzi City
Country [83] 0 0
Taiwan
State/province [83] 0 0
Taichung City
Country [84] 0 0
Taiwan
State/province [84] 0 0
Taichung
Country [85] 0 0
Taiwan
State/province [85] 0 0
Tainan City
Country [86] 0 0
Taiwan
State/province [86] 0 0
Taipei
Country [87] 0 0
Taiwan
State/province [87] 0 0
Tapei

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Bristol-Myers Squibb
Address
Country

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/NCT04340193