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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/NCT02576509
Registration number
NCT02576509
Ethics application status
Date submitted
13/10/2015
Date registered
15/10/2015
Date last updated
19/03/2024
Titles & IDs
Public title
An Investigational Immuno-therapy Study of Nivolumab Compared to Sorafenib as a First Treatment in Patients With Advanced Hepatocellular Carcinoma
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Scientific title
A Randomized, Multi-center Phase III Study of Nivolumab Versus Sorafenib as First-Line Treatment in Patients With Advanced Hepatocellular Carcinoma (CheckMate 459: CHECKpoint Pathway and nivoluMAb Clinical Trial Evaluation 459)
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Secondary ID [1]
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CA209-459
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Hepatocellular Carcinoma
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0
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Condition category
Condition code
Cancer
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0
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Non melanoma skin cancer
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Cancer
0
0
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0
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Kidney
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Cancer
0
0
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0
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Liver
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Nivolumab
Treatment: Drugs - Sorafenib
Experimental: Nivolumab - Nivolumab specified dose on specified days
Active Comparator: Sorafenib - Sorafenib specified dose on specified days
Treatment: Drugs: Nivolumab
Specified Dose on Specified Days
Treatment: Drugs: Sorafenib
Specified Dose on Specified Days
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Overall Survival (OS)
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Assessment method [1]
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OS is defined as the time from the date of randomization to the date of death due to any cause in all randomized participants. Participants who are alive will be censored at the last known alive dates.
Based on Kaplan-Meier Estimates.
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Timepoint [1]
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time from the date of randomization to the date of death due to any cause, assessed up to June 2019 (approximately 41 months)
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Secondary outcome [1]
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Objective Response Rate (ORR) Per BICR RECIST 1.1
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Assessment method [1]
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ORR is defined as the proportion of participants whose best overall response (BOR) is either a complete response (CR) or partial response (PR). BOR is defined as the best response designation, as determined based on BICR-assessed tumor response according to RECIST 1.1, recorded between the date of randomization and the date of first objectively documented progression or the date of subsequent anti-cancer therapy, whichever occurs first. For participants without documented progression or subsequent anti-cancer therapy, all available response designations will contribute to the BOR determination. For a BOR of CR or PR, the initial response assessment must be confirmed by a consecutive assessment no less than 4 weeks (28 days) later.
Estimate of (Nivolumab - Sorafenib) is based on CMH method of weighting, stratified by stratification factors
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Timepoint [1]
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the date of randomization and the date of first objectively documented progression or the date of subsequent anti-cancer therapy, whichever occurs first, assessed up to May 2019 (approximately 40 months)
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Secondary outcome [2]
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Progression-Free Survival (PFS)
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Assessment method [2]
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PFS is defined as the time from the date of randomization to the date of the first objectively documented tumor progression as assessed by BICR according to RECIST 1.1 or death due to any cause in all randomized participants. Participants who die without a reported prior progression and without initiation of subsequent anti-cancer therapy will be considered to have progressed on the date of their death. Participants who did not progress or die will be censored on the date of their last tumor assessment. Participants who did not have baseline tumor assessment will be censored on the date they were randomized. Participants who did not have any on study tumor assessments and did not die will be censored on the date they were randomized. Participants who started any subsequent anti-cancer therapy without a prior reported progression will be censored at the last tumor assessment prior to subsequent anti-cancer therapy.
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Timepoint [2]
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time from the date of randomization to the date of the first objectively documented tumor progression or death, assessed up to May 2019 (approximately 40 months)
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Secondary outcome [3]
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Efficacy Based on PD-L1 Expression - OS and PFS
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Assessment method [3]
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PD-L1 expression is defined as the percent of tumor cell membrane staining in a minimum of 100 evaluable tumor cells per Dako PD-L1 IHC assay unless otherwise specified. This is referred as quantifiable PD-L1 expression. If the PD-L1 staining could not be quantified, it is further classifies as:
Indeterminate: Tumor cell membrane staining hampered for reasons attributed to the biology of the tumor biopsy specimen and not because of improper sample preparation or handling.
Not evaluable: Tumor biopsy specimen was not optimally collected or prepared (e.g. PD-L1 expression is neither quantifiable nor indeterminate).
PD-L1 status is a dichotomized variable using an X% cut-off for quantifiable PD-L1 expression:
PD-L1 > X %: = X % PD-L1 expression
PD-L1 < X %: < X % PD-L1 expression where X% denotes the PD-L1 expression cut-off of 1%. Additional cut off values may also be explored.
Confidence interval based on the Clopper and Pearson method.
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Timepoint [3]
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the date of randomization and the date of first objectively documented progression or the date of subsequent anti-cancer therapy, whichever occurs first, assessed up to May 2019 (approximately 40 months)
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Secondary outcome [4]
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Efficacy Based on PD-L1 Expression - ORR
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Assessment method [4]
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PD-L1 expression is defined as the percent of tumor cell membrane staining in a minimum of 100 evaluable tumor cells per Dako PD-L1 IHC assay unless otherwise specified. This is referred as quantifiable PD-L1 expression. If the PD-L1 staining could not be quantified, it is further classifies as:
Indeterminate: Tumor cell membrane staining hampered for reasons attributed to the biology of the tumor biopsy specimen and not because of improper sample preparation or handling.
Not evaluable: Tumor biopsy specimen was not optimally collected or prepared (e.g. PD-L1 expression is neither quantifiable nor indeterminate).
PD-L1 status is a dichotomized variable using an X% cut-off for quantifiable PD-L1 expression:
PD-L1 > X %: = X % PD-L1 expression
PD-L1 < X %: < X % PD-L1 expression where X% denotes the PD-L1 expression cut-off of 1%. Additional cut off values may also be explored.
Confidence interval based on the Clopper and Pearson method.
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Timepoint [4]
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the date of randomization and the date of first objectively documented progression or the date of subsequent anti-cancer therapy, whichever occurs first, assessed up to May 2019 (approximately 40 months)
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Eligibility
Key inclusion criteria
- Histologically confirmed advanced hepatocellular carcinoma, not eligible for surgical
and/or locoregional therapies; or progressive disease after surgical and /or
locoregional therapies
- Locoregional therapy for hepatocellular carcinoma (HCC) must be completed at least 4
weeks prior to the baseline scan
- Child-Pugh Class A
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
- Known fibrolamellar HCC, sarcomatoid HCC, or mixed cholangiocarcinoma and HCC
- Prior liver transplant
- Active, known, or suspected autoimmune disease
Other protocol-defined inclusion/exclusion criteria apply
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Phase
Phase 3
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
7/12/2015
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Date of last participant enrolment
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Actual
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Date of last data collection
Anticipated
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Actual
7/02/2024
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Sample size
Target
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Accrual to date
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Final
743
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Recruitment in Australia
Recruitment state(s)
NSW,SA,VIC,WA
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Local Institution - 0005 - Camperdown
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Local Institution - 0008 - Nedlands
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2050 - Camperdown
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5000 - Adelaide
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3168 - Clayton
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3084 - Heidelberg
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3181 - Prahran
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6009 - Nedlands
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Liverpool
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Bristol-Myers Squibb
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Address
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Other collaborator category [1]
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Commercial sector/Industry
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Ono Pharmaceutical Co. Ltd
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Ethics approval
Ethics application status
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Summary
Brief summary
The purpose of this study is to determine if nivolumab or sorafenib is more effective in the
treatment of Advanced Hepatocellular Carcinoma.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT02576509
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
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Bristol Myers Squibb
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Bristol-Myers Squibb
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT02576509
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