Trial Review

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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
Country [1] 0 0
United States of America
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Arizona
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United States of America
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California
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United States of America
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District of Columbia
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United States of America
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Kentucky
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United States of America
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Maryland
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United States of America
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Michigan
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United States of America
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New Jersey
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Ohio
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Pennsylvania
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Texas
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Utah
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Argentina
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Buenos Aires
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Argentina
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Santa Fe
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Argentina
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Tucuman
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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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Klagenfurt
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Austria
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Viena
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Belgium
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Brussels
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Belgium
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Federal District
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Belgium
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Gent
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Belgium
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Haine-Saint-Paul
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Belgium
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Leuven
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Belgium
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Liege
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Bahia
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Brazil
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DF
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Brazil
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Espirito Santo
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Brazil
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Rio Grande Do Sul
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Brazil
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RIO Grande DO SUL
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Brazil
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SAO Paulo
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Brazil
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Sao Paulo
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Brazil
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Parana
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Brazil
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Rio de Janeiro
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Canada
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Alberta
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Chile
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Araucania
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Chile
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Coquimbo
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Chile
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Metropolitana
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Chile
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RM
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Chile
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Valparaiso
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China
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Anhui
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China
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Beijing
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China
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Fujian
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China
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Guangdong
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China
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Heilongjiang
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China
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Hunan
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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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Jilin
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Liaoning
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Shan3xi
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Zhejiang
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Prague
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Czechia
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Brno
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Amiens
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Clichy
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Lyon
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Marseille
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Montpellier
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Nice
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Pessac
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Poitiers
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France
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Toulouse Cedex 9
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France
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Vandoeuvre les Nancy
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France
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Villejuif
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Germany
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Hessen
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Germany
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Bonn
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Germany
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Essen
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Germany
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Freiburg
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Germany
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Hamburg
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Germany
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Hannover
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Germany
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Koeln
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Germany
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Leipzig
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Germany
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Mainz
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Germany
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Mannheim
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Germany
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Munchen
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Germany
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North Rhine-Westphalia
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Hong Kong
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Hong Kong
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Italy
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Forli-Cesena
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Italy
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Milano
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Italy
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Candiolo
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Novara
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Italy
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Padova
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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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Rome
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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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Chiba
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Ehime
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Ishikawa
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Kanagawa
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Kyoto
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Nara
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Osaka
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Saga
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Saitama
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Shizuoka
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Tokyo
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Fukuoka
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Hiroshima
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Sapporo
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Korea, Republic of
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Gyeonggi-do
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Seoul
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Busan
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Poland
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Craiova
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Romania
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Timisoara
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Russian Federation
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Arkhangelsk
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Russian Federation
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Barnaul
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Russian Federation
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Russian Federation
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Moscow
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Russian Federation
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Russian Federation
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Sochi
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Singapore
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Barcelona
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Pamplona
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Santander
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Zaragoza
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Switzerland
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Bern
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Taiwan
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Kaohsiung
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Taiwan
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Taichung
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Taiwan
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Tainan
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Taiwan
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Taipei
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Taiwan
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Taoyuan
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United Kingdom
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Greater London
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United Kingdom
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Surrey
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United Kingdom
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Edinburgh
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United Kingdom
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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
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?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT04039607