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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT04340193




Registration number
NCT04340193
Ethics application status
Date submitted
7/04/2020
Date registered
9/04/2020
Date last updated
11/01/2024

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 treated participants with adverse events (AEs)
Timepoint [1] 0 0
Up to 2 years and 4 months
Primary outcome [2] 0 0
Number of deaths in all treated patients
Timepoint [2] 0 0
Up to 2 years and 4 months
Primary outcome [3] 0 0
Number of treated participants with laboratory abnormalities
Timepoint [3] 0 0
Up to 2 years and 4 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
Terminated
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
15/09/2020
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
4560 - 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
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Austria
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Niederosterreich
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Austria
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Graz
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Austria
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St. Polten
Country [8] 0 0
Austria
State/province [8] 0 0
Vienna
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Austria
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West Springfield
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Belgium
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Brussels
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Belgium
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Federal District
Country [12] 0 0
Belgium
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Gent
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Belgium
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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
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China
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Jiangsu
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China
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Jiangxi
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China
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Liaoning
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China
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Shan3xi
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China
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Shanghai
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China
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Sichuan
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China
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Zhejiang
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Czechia
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Olomouc
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Czechia
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Praha 5
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France
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Mount
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France
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Caen
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France
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Clichy
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France
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Dijon
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France
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Englewood
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France
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La Tronche
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France
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Marseil
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France
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Nantes
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France
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Nice
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France
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Paris
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France
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Reims
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France
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Villejuif cedex
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Germany
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Goettingen
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Germany
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Hannover
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Germany
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Heidelberg
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Germany
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Leipzig
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Hong Kong
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Hong Kong
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Hong Kong
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HongKong
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Italy
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TO
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Italy
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Messina
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Italy
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Milano
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Italy
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Monserrato
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Italy
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Parma
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Italy
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Roma
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Italy
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Siena
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Italy
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Vicenza
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Japan
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Ehime
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Japan
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Hokkaido
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Japan
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Ishikawa
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Japan
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Kanagawa
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Japan
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Kyoto
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Japan
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Osaka
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Japan
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Shizuoka
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Japan
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Tokyo
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Japan
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Chiba
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Japan
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Hiroshima
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Japan
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Saitama
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Korea, Republic of
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Busan
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Korea, Republic of
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Daegu
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Korea, Republic of
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Gyeongsangnam-do
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Korea, Republic of
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Hwasun-Gun
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Korea, Republic of
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Seoul
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Poland
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Warszawa
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Puerto Rico
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San Juan
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Russian Federation
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Barnaul
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Russian Federation
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Saint Petersburg
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Russian Federation
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Saint-Petersburg
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Singapore
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Singapore
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Spain
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Alicante
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Spain
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Cordoba
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Spain
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Madrid
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Spain
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Pamplona
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Spain
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Sabadell
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Spain
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Santiago de Compostela
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Taiwan
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Kaohsiung
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Taiwan
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Puzi City
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Taiwan
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Taichung City
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Taiwan
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Taichung
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Taiwan
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Tainan City
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Taiwan
State/province [86] 0 0
Taipei
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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/ct2/show/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/ct2/show/NCT04340193