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Trial details imported from ClinicalTrials.gov

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




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

Titles & IDs
Public title
A Study of Nivolumab and Ipilimumab in Combination With Transarterial 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:
Liver Cancer 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
Description of intervention(s) / exposure
Other interventions - nivolumab
Other interventions - ipilimumab

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

Experimental: Nivolumab + Ipilimumab Placebo + TACE - TACE (Trans-arterial Chemoembolization)

Placebo Comparator: Nivolumab Placebo + Ipilimumab Placebo + TACE - TACE (Trans-arterial Chemoembolization)


Other interventions: nivolumab
specified dose on specified days

Other interventions: ipilimumab
specified dose on specified days

Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Time to TACE progression (TTTP) will be assed by the blinded independent central review (BICR): Arm A versus Arm C
Timepoint [1] 0 0
up to 2 years
Primary outcome [2] 0 0
Overall Survival (OS): Arm A versus Arm C
Timepoint [2] 0 0
up to 2.5 years
Secondary outcome [1] 0 0
Time to TACE progression (TTTP) will be assed by the blinded independent central review (BICR): Arm B versus Arm C
Timepoint [1] 0 0
up to 2 years
Secondary outcome [2] 0 0
Overall Survival (OS): Arm B versus Arm C
Timepoint [2] 0 0
up to 2.5 years
Secondary outcome [3] 0 0
Event-Free Survival (EFS)
Timepoint [3] 0 0
up to 2 years
Secondary outcome [4] 0 0
Progression-free survival (PFS)
Timepoint [4] 0 0
up to 2 years

Eligibility
Key inclusion criteria
For more information regarding Bristol-Myers Squibb Clinical Trial participation, please
visit www.BMSStudyConnect.com



- Participant has intermediate-stage HCC (hepatocellular carcinoma) whose tumor
characteristics exceed the BMU7 criteria and is eligible for TACE

- Participant has histologic confirmation of HCC

- Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1

- Men and Women must agree to follow methods of contraception

- Participants are eligible to enroll if they have non-viral related HCC, or if they
have HBV-HCC, or HCV-HCC
Minimum age
18 Years
Maximum age
No limit
Gender
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

- Participants with a condition requiring systemic treatment with either corticosteroids
or other immunosuppressive medications

- Any previous TACE or TAE (trans-arterial embolization without instillation of
chemotherapy agent) procedure for HCC

- Known or suspected allergy to nivolumab, ipilimumab, or study drug components given in
association with this trial

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
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
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,SA,VIC,WA
Recruitment hospital [1] 0 0
Local Institution - Sydney
Recruitment hospital [2] 0 0
Local Institution - Birtinya
Recruitment hospital [3] 0 0
Local Institution - Adelaide
Recruitment hospital [4] 0 0
Local Institution - Fitzroy
Recruitment hospital [5] 0 0
Local Institution - Murdoch
Recruitment postcode(s) [1] 0 0
2145 - Sydney
Recruitment postcode(s) [2] 0 0
4560 - Birtinya
Recruitment postcode(s) [3] 0 0
5000 - Adelaide
Recruitment postcode(s) [4] 0 0
3065 - Fitzroy
Recruitment postcode(s) [5] 0 0
6150 - Murdoch
Recruitment outside Australia
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United States of America
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California
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District of Columbia
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Graz
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Linz
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St. Polten
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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 compare effectiveness and safety 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/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
Recruiting sites have contact information. Please contact the sites directly. If there is no contact information,
Address 0 0
Country 0 0
Phone 0 0
please email:
Fax 0 0
Email 0 0
Clinical.Trials@bms.com
Contact person for scientific queries

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