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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT04567615
Registration number
NCT04567615
Ethics application status
Date submitted
24/09/2020
Date registered
28/09/2020
Date last updated
25/03/2025
Titles & IDs
Public title
A Study of Relatlimab in Combination With Nivolumab in Participants With Advanced Liver Cancer Who Have Never Been Treated With Immuno-oncology Therapy After Prior Treatment With Tyrosine Kinase Inhibitors
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Scientific title
A Phase 2, Randomized, Open-label Study of Relatlimab in Combination With Nivolumab in Participants With Advanced Hepatocellular Carcinoma Who Are Naive to IO Therapy But Progressed on Tyrosine Kinase Inhibitors (RELATIVITY-073)
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Secondary ID [1]
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2018-003151-38
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Secondary ID [2]
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CA224-073
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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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Hepatoma
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Liver Cancer, Adult
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Liver Cell Carcinoma
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Liver Cell Carcinoma, Adult
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Condition category
Condition code
Cancer
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Non melanoma skin cancer
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Cancer
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Kidney
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Cancer
0
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Liver
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Oral and Gastrointestinal
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Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Other - Nivolumab
Treatment: Other - Relatlimab
Experimental: Arm A : Nivolumab -
Experimental: Arm B : Nivolumab + Relatlimab Dose 1 -
Experimental: Arm C : Nivolumab + Relatlimab Dose 2 -
Treatment: Other: Nivolumab
Specified dose on specified days
Treatment: Other: Relatlimab
Specified dose on specified days
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Intervention code [1]
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Treatment: Other
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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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Objective Response Rate(ORR) Assessed by BICR
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Assessment method [1]
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Objective Response Rate (ORR) (as per Recists v1.1) is defined as the percentage of participants whose best overall response (BOR) is either confirmed complete response (CR) or confirmed partial response (PR) based on BICR assessments among all participants in the respective analysis set. BOR is defined as the best response, as determined by the BICR, recorded between the date of randomization and the date of first objectively documented progression or death due to any cause or the date of subsequent therapy, whichever occurs first. For participants without documented progression or subsequent therapy, all available response designations will contribute to the BOR determination. Confirmation of response is required at least 4 weeks after the initial response.
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Timepoint [1]
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From randomization to primary completion date (Approximately 29.5 Months)
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Secondary outcome [1]
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Disease Control Rate Assessed by BICR
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Assessment method [1]
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Disease Control Rate (DCR) (as per Recists v1.1) is defined as the number of randomized participants who achieve a BOR of confirmed CR, confirmed PR, or stable disease (SD), based on BICR assessments divided by the number of all randomized participants.
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Timepoint [1]
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From randomization to primary completion date (Approximately 29.5 Months)
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Secondary outcome [2]
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Duration of Response Assessed by BICR
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Assessment method [2]
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Duration of Response (DOR) (as per Recists v1.1) is defined as the time between the date of first documented response (CR or PR) that is subsequently confirmed, to the date of the first objectively documented tumor progression as determined by the BICR, or death due to any cause, whichever occurs first. Participants who die without a reported prior progression will be considered to have an event on the date of their death. Participants who neither progress nor die will be censored on the date of their last evaluable tumor assessment. DOR will be evaluated for responders (confirmed CR or PR) only.
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Timepoint [2]
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From randomization to primary completion date (Approximately 29.5 Months)
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Secondary outcome [3]
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Progression Free Survival(PFS) Assessed by BICR
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Assessment method [3]
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PFS (as per Recists v1.1) is defined as the time between the date of randomization and the date of first documented tumor progression or death due to any cause, whichever occurs first. Participants who die without a reported progression will be considered to have progressed on the date of their death.
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Timepoint [3]
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From randomization to primary completion date (Approximately 29.5 Months)
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Secondary outcome [4]
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Objective Response Rate Assessed by Investigator
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Assessment method [4]
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Objective Response Rate (ORR) (as per Recists v1.1) is defined as the percentage of participants whose best overall response (BOR) is either confirmed complete response (CR) or confirmed partial response (PR) based on investigator assessments among all participants in the respective analysis set. BOR is defined as the best response, as determined by the investigator, recorded between the date of randomization and the date of first objectively documented progression or death due to any cause or the date of subsequent therapy, whichever occurs first. For participants without documented progression or subsequent therapy, all available response designations will contribute to the BOR determination. Confirmation of response is required at least 4 weeks after the initial response.
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Timepoint [4]
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From randomization to primary completion date (Approximately 29.5 Months)
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Secondary outcome [5]
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Disease Control Rate Assessed by Investigator
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Assessment method [5]
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Disease Control Rate (DCR) (as per Recists v1.1) is defined as the number of randomized participants who achieve a BOR of confirmed CR, confirmed PR, or stable disease (SD), based on BICR assessments divided by the number of all randomized participants.
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Timepoint [5]
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From randomization to primary completion date (Approximately 29.5 Months)
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Secondary outcome [6]
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Duration of Response Assessed by Investigator
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Assessment method [6]
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Duration of Response (DOR) (as per Recists v1.1) is defined as the time between the date of first documented response (CR or PR) that is subsequently confirmed, to the date of the first objectively documented tumor progression as determined by the investigator, or death due to any cause, whichever occurs first. Participants who die without a reported prior progression will be considered to have an event on the date of their death. Participants who neither progress nor die will be censored on the date of their last evaluable tumor assessment. DOR will be evaluated for responders (confirmed CR or PR) only.
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Timepoint [6]
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From randomization to primary completion date (Approximately 29.5 Months)
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Secondary outcome [7]
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Progression Free Survival(PFS) Assessed by Investigator
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Assessment method [7]
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PFS (as per Recists v1.1) is defined as the time between the date of randomization and the date of first documented tumor progression or death due to any cause, whichever occurs first. Participants who die without a reported progression will be considered to have progressed on the date of their death.
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Timepoint [7]
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From randomization to primary completion date (Approximately 29.5 Months)
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Secondary outcome [8]
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Overall Survival (OS)
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Assessment method [8]
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Overall survival (OS) is defined as the time from randomization to the date of death from any cause. Overall survival will be censored at the date of randomization for participants who were randomized but had no follow-up.
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Timepoint [8]
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From randomization to primary completion date (Approximately 29.5 Months)
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Secondary outcome [9]
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Number of Participants With Adverse Events
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Assessment method [9]
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Number of participants with an Adverse Event. An Adverse Event is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment.
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Timepoint [9]
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From randomization to primary completion date (Approximately 29.5 Months). Includes events reported between first dose and 30 days after last dose of study therapy.
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Secondary outcome [10]
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Number of Participants With Serious Adverse Events
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Assessment method [10]
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Number of participants with Serious Adverse Events A serious adverse event is defined as any untoward medical occurrence that, at any dose: results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is an important medical event.
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Timepoint [10]
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From randomization to primary completion date (Approximately 29.5 Months). Includes events reported between first dose and 30 days after last dose of study therapy.
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Secondary outcome [11]
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Number of Participants With Adverse Events Leading to Discontinuation
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Assessment method [11]
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Number of participants with Adverse Events Leading to Discontinuation
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Timepoint [11]
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From randomization to primary completion date (Approximately 29.5 Months). Includes events reported between first dose and 30 days after last dose of study therapy.
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Secondary outcome [12]
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Death Summary
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Assessment method [12]
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Number of participants who died.
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Timepoint [12]
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From randomization to primary completion date (Approximately 29.5 Months)
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Secondary outcome [13]
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Number of Participants With Clinical Laboratory Abnormalities in Specific Liver Tests
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Assessment method [13]
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Number of participants with clinical laboratory abnormalities in specific liver tests
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Timepoint [13]
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From randomization to primary completion date (Approximately 29.5 Months). Includes events reported between first dose and 30 days after last dose of study therapy.
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Secondary outcome [14]
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Number of Participants With Clinical Laboratory Abnormalities in Thyroid Tests
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Assessment method [14]
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Number of participants with clinical laboratory abnormalities in thyroid tests
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Timepoint [14]
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From randomization to primary completion date (Approximately 29.5 Months). Includes events reported between first dose and 30 days after last dose of study therapy.
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Eligibility
Key inclusion criteria
Key
* Must have a diagnosis of hepatocellular carcinoma (HCC) based on histological confirmation
* Must have advanced/metastatic HCC
* Have to be immunotherapy treatment-naive in the advanced/metastatic setting
* Must have at least one Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 measurable untreated lesion
* Child-Pugh score of 5 or 6
* Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 for ECOG performance status scale
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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, combined hepatocellular cholangiocarcinoma
* Prior organ allograft or allogeneic bone marrow transplantation
* No uncontrolled or significant cardiovascular disease
* No active known autoimmune disease
* Have received one or two lines of tyrosine kinase inhibitor therapies
* Evidence of radiographic progression on or after the last line of tyrosine kinase inhibitor therapy
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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Other design features
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Phase
Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Active, not recruiting
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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
5/02/2021
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
3/10/2025
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Actual
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Sample size
Target
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Accrual to date
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Final
266
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Recruitment in Australia
Recruitment state(s)
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Recruitment outside Australia
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Argentina
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Buenos Aires
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Argentina
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Distrito Federal
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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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Brazil
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Minas Gerais
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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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Chile
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Araucanía
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Chile
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Metropolitana
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Chile
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Región Metropolitana De Santiago
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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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Shaanxi
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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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Zhejiang
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Czechia
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Brno
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Czechia
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Hradec Kralove
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Prague
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Meurthe-et-Moselle
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France
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Clichy
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France
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France
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Lyon
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France
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Pessac
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Ehime
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Kanagawa
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Osaka
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Ishikawa
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Japan
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Kyoto
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Seoul-teukbyeolsi
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Malopolskie
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Bytom
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Edirne
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Turkey
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Kadiköy/Istanbul
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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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Ethics approval
Ethics application status
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Summary
Brief summary
The purpose of this study is to evaluate the effectiveness and safety of relatlimab in combination with nivolumab in participants with advanced liver cancer who have never been treated with immuno-oncology therapy, after prior treatment with tyrosine kinase inhibitor therapy.
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Trial website
https://clinicaltrials.gov/study/NCT04567615
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Bristol-Myers Squibb
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Address
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Bristol-Myers Squibb
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Contact person for scientific queries
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Type
Other Details
Attachment
Study protocol
Study Protocol and Statistical Analysis Plan
https://cdn.clinicaltrials.gov/large-docs/15/NCT04567615/Prot_SAP_000.pdf
Statistical analysis plan
Study Protocol and Statistical Analysis Plan
https://cdn.clinicaltrials.gov/large-docs/15/NCT04567615/Prot_SAP_000.pdf
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results are available at
https://clinicaltrials.gov/study/NCT04567615
Download to PDF