Trial Review

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

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/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
The purpose of this study is to evaluate the safety and tolerability of nivolumab with and without ipilimumab in combination with Trans-arterial ChemoEmbolization (TACE) to TACE alone in participants with intermediate liver cancer.
Trial website
https://clinicaltrials.gov/study/NCT04340193
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

For IPD and results data, please see https://clinicaltrials.gov/study/NCT04340193