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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04039607




Registration number
NCT04039607
Ethics application status
Date submitted
30/07/2019
Date registered
31/07/2019
Date last updated
2/05/2024

Titles & IDs
Public title
A Study of Nivolumab in Combination With Ipilimumab in Participants With Advanced Hepatocellular Carcinoma
Scientific title
A Randomized, Multi-center, Phase 3 Study of Nivolumab in Combination With Ipilimumab Compared to Sorafenib or Lenvatinib as First-Line Treatment in Participants With Advanced Hepatocellular Carcinoma
Secondary ID [1] 0 0
CA209-9DW
Universal Trial Number (UTN)
Trial acronym
CheckMate 9DW
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(has expanded access)
Description of intervention(s) / exposure
Treatment: Drugs - Nivolumab
Treatment: Drugs - Ipilimumab
Treatment: Drugs - Sorafenib
Treatment: Drugs - lenvatinib

Experimental: Nivolumab + Ipilimumab -

Active comparator: Sorafenib/lenvatinib -


Treatment: Drugs: Nivolumab
Participants will receive nivolumab as intravenous (IV) infusion.

Treatment: Drugs: Ipilimumab
Participants will receive ipilimumab as IV infusion.

Treatment: Drugs: Sorafenib
Participants will receive sorafenib as oral tablets.

Treatment: Drugs: lenvatinib
Participants will receive lenvatinib as oral capsules.
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
Up to 4 years
Secondary outcome [1] 0 0
Objective Response Rate (ORR)
Timepoint [1] 0 0
Up to 4 years
Secondary outcome [2] 0 0
Duration of Response (DOR)
Timepoint [2] 0 0
Up to 4 years
Secondary outcome [3] 0 0
Time to Symptom Deterioration (TTSD)
Timepoint [3] 0 0
Up to 4 years

Eligibility
Key inclusion criteria
* Participants must have a diagnosis of HCC based on histological confirmation
* Participants must have an advanced HCC
* Participants must have at least one Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 measurable previously untreated lesion
* Child-Pugh score 5 or 6
* 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
* Episodes of hepatic encephalopathy (greater than or equal to [>=] Grade 2) within 12 months prior to randomization
* Active brain metastases or leptomeningeal metastases

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
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
30/09/2019
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
30/09/2026
Actual
Sample size
Target
Accrual to date
Final
732
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC
Recruitment hospital [1] 0 0
Local Institution - 0003 - Kogarah
Recruitment hospital [2] 0 0
Local Institution - 0038 - Liverpool
Recruitment hospital [3] 0 0
Local Institution - 0002 - Westmead
Recruitment hospital [4] 0 0
Local Institution - 0004 - Birtinya
Recruitment hospital [5] 0 0
Local Institution - 0013 - Herston
Recruitment hospital [6] 0 0
Local Institution - 0009 - Adelaide
Recruitment hospital [7] 0 0
Local Institution - 0019 - Clayton
Recruitment hospital [8] 0 0
Local Institution - 0026 - Fitzroy
Recruitment hospital [9] 0 0
Local Institution - 0001 - Melbourne
Recruitment hospital [10] 0 0
Local Institution - 0020 - St Albans
Recruitment postcode(s) [1] 0 0
2217 - Kogarah
Recruitment postcode(s) [2] 0 0
1871 - Liverpool
Recruitment postcode(s) [3] 0 0
2145 - Westmead
Recruitment postcode(s) [4] 0 0
4560 - Birtinya
Recruitment postcode(s) [5] 0 0
4029 - Herston
Recruitment postcode(s) [6] 0 0
5000 - Adelaide
Recruitment postcode(s) [7] 0 0
3168 - Clayton
Recruitment postcode(s) [8] 0 0
3065 - Fitzroy
Recruitment postcode(s) [9] 0 0
3004 - Melbourne
Recruitment postcode(s) [10] 0 0
3021 - St Albans
Recruitment outside Australia
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United States of America
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Arizona
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Santa Fe
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Tucuman
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Austria
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Niederosterreich
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Graz
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Klagenfurt
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London

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

Ethics approval
Ethics application status

Summary
Brief summary
The main purpose of this study is to compare the overall survival (OS) of nivolumab plus ipilimumab versus standard of care (SOC) (sorafenib or lenvatinib) in all randomized participants with advanced hepatocellular carcinoma (HCC) who have not received prior systemic therapy.
Trial website
https://clinicaltrials.gov/study/NCT04039607
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/NCT04039607