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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/NCT04246177
Registration number
NCT04246177
Ethics application status
Date submitted
27/01/2020
Date registered
29/01/2020
Date last updated
13/09/2023
Titles & IDs
Public title
Safety and Efficacy of Lenvatinib (E7080/MK-7902) With Pembrolizumab (MK-3475) in Combination With Transarterial Chemoembolization (TACE) in Participants With Incurable/Non-metastatic Hepatocellular Carcinoma (MK-7902-012/E7080-G000-318/LEAP-012)
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Scientific title
A Phase 3 Multicenter, Randomized, Double-blinded, Active-controlled, Clinical Study to Evaluate the Safety and Efficacy of Lenvatinib (E7080/MK-7902) With Pembrolizumab (MK-3475) in Combination With Transarterial Chemoembolization (TACE) Versus TACE in Participants With Incurable/Non-metastatic Hepatocellular Carcinoma (LEAP-012)
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Secondary ID [1]
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MK-7902-012
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Secondary ID [2]
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7902-012
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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:
Carcinoma, Hepatocellular
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Condition category
Condition code
Cancer
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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
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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 - Lenvatinib
Other interventions - Pembrolizumab
Treatment: Drugs - Oral Placebo
Treatment: Drugs - IV Placebo
Treatment: Surgery - TACE
Experimental: Lenvatinib plus Pembrolizumab plus TACE - Participants will receive a combination of lenvatinib, pembrolizumab, and TACE. Lenvatinib will be administered at a dose of 12 mg (for participants with screening body weight =60 kg) or 8 mg (for participants with screening body weight <60 kg) orally once a day during each 21-day cycle until progressive disease or unacceptable toxicity (up to 2 years [~35 cycles] or longer with Sponsor approval). Pembrolizumab will be administered via IV infusion at a dose of 400 mg once every 6 weeks (Q6W) for up to 2 years (~17 doses). Participants will undergo TACE as a background procedure of chemotherapeutic and embolic agent(s).
Active Comparator: Oral Placebo plus IV Placebo plus TACE - Participants will receive a combination of lenvatinib-matching oral placebo, pembrolizumab-matching IV placebo, and TACE. Lenvatinib-matching oral placebo will be administered once a day during each 21-day cycle for up to 2 years (~35 cycles) or longer with Sponsor approval and pembrolizumab-matching IV placebo will be administered once every 6 weeks (Q6W) for up to 2 years (~17 doses). Participants will undergo TACE as a background procedure of chemotherapeutic and embolic agent(s).
Treatment: Drugs: Lenvatinib
Administered at a dose of 12 mg (for participants with screening body weight =60 kg) or 8 mg (for participants with screening body weight <60 kg) via oral capsules once a day during each 21-day cycle.
Other interventions: Pembrolizumab
Administered via IV infusion at a dose of 400 mg once every 6 weeks (Q6W).
Treatment: Drugs: Oral Placebo
Lenvatinib-matching placebo administered via oral capsules once a day during each 21-day cycle.
Treatment: Drugs: IV Placebo
Pembrolizumab-matching placebo administered via IV infusion once every 6 weeks (Q6W).
Treatment: Surgery: TACE
Conducted as a background procedure of chemotherapeutic and embolic agent(s).
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Intervention code [1]
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Treatment: Drugs
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Intervention code [2]
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Other interventions
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Intervention code [3]
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Treatment: Surgery
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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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Progression-free Survival (PFS) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)
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Assessment method [1]
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PFS is defined as the time from randomization to the first documented progressive disease or death due to any cause, whichever occurs first. Responses are according to RECIST 1.1 as assessed by blinded independent central review (BICR).
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Timepoint [1]
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Up to ~43 months
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Primary outcome [2]
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Overall Survival (OS)
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Assessment method [2]
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OS is defined as the time from randomization to death due to any cause.
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Timepoint [2]
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Up to ~95 months
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Secondary outcome [1]
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PFS per Modified Response Evaluation Criteria in Solid Tumors (mRECIST)
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Assessment method [1]
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PFS is defined as the time from randomization to the first documented progressive disease or death due to any cause, whichever occurs first. Responses are according to mRECIST as assessed by BICR.
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Timepoint [1]
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Up to ~43 months
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Secondary outcome [2]
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Objective Response Rate (ORR) per mRECIST
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Assessment method [2]
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ORR is defined as the percentage of participants who have a confirmed complete response (CR: disappearance of any intratumoral arterial enhancement in all target lesions) or partial response (PR: at least a 30% decrease in the sum of diameters of viable [enhancement in the arterial phase] target lesions, taking as reference the baseline sum of the diameters of target lesions). Responses are according to mRECIST as assessed by BICR.
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Timepoint [2]
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Up to ~95 months
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Secondary outcome [3]
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Disease Control Rate (DCR) per mRECIST
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Assessment method [3]
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DCR is defined as the percentage of participants who have a best overall response of CR (disappearance of any intratumoral arterial enhancement in all target lesions), PR (at least a 30% decrease in the sum of diameters of viable [enhancement in the arterial phase] target lesions, taking as reference the baseline sum of the diameters of target lesions), or stable disease (SD). Responses are according to mRECIST as assessed by BICR.
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Timepoint [3]
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0
Up to ~95 months
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Secondary outcome [4]
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Duration of Response (DOR) per mRECIST
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Assessment method [4]
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DOR is determined by disease assessment and is defined as the time from the first documented evidence of a response of CR (disappearance of any intratumoral arterial enhancement in all target lesions) or PR (at least a 30% decrease in the sum of diameters of viable [enhancement in the arterial phase] target lesions, taking as reference the baseline sum of the diameters of target lesions) until the first documented disease progression or death due to any cause, whichever occurs first. Responses are according to mRECIST as assessed by BICR.
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Timepoint [4]
0
0
Up to ~95 months
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Secondary outcome [5]
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Time to Progression (TTP) per mRECIST
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Assessment method [5]
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TTP is defined as the time from randomization to the first documented disease progression. Responses are according to mRECIST as assessed by BICR.
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Timepoint [5]
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Up to ~95 months
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Secondary outcome [6]
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Percentage of Participants Who Experience At Least One Adverse Event (AE)
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Assessment method [6]
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An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The percentage of participants who experience at least one AE will be reported.
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Timepoint [6]
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Up to ~95 months
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Secondary outcome [7]
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Percentage of Participants Who Experience At Least One Serious Adverse Event (SAE)
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Assessment method [7]
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An SAE is an AE that results in death, is life threatening, requires or prolongs a hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly or birth defect, is a cancer, is associated with an overdose, or is another important medical event. The percentage of participants who experience at least one SAE will be reported.
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Timepoint [7]
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Up to ~95 months
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Secondary outcome [8]
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Percentage of Participants Who Experience At Least One Hepatic Event of Clinical Interest (ECI)
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Assessment method [8]
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Percentage of participants with Hepatic ECIs not due to disease progression or TACE as assessed by the investigator will be reported.
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Timepoint [8]
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Up to ~95 months
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Secondary outcome [9]
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Percentage of Participants Who Discontinue Study Drug Due to an AE
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Assessment method [9]
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An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The percentage of participants who discontinue study drug due to an AE will be reported.
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Timepoint [9]
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Up to ~95 months
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Secondary outcome [10]
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ORR per RESCIST 1.1
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Assessment method [10]
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ORR is defined as the percentage of participants who have a confirmed complete response (CR: disappearance of all target lesions) or partial response (PR: at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters). Responses are according to RECIST 1.1 as assessed by BICR.
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Timepoint [10]
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Up to ~95 months
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Secondary outcome [11]
0
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DCR per RECIST 1.1
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Assessment method [11]
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DCR is defined as the percentage of participants who have a best overall response of CR (disappearance of all target lesions), PR (at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters), or SD. Responses are according to RECIST 1.1 as assessed by BICR.
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Timepoint [11]
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Up to ~95 months
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Secondary outcome [12]
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DOR per RECIST 1.1
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Assessment method [12]
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DOR is determined by disease assessment and is defined as the time from the first documented evidence of a response of CR (disappearance of all target lesions) or PR (at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters) until the first documented disease progression or death due to any cause, whichever occurs first. Responses are according to RECIST 1.1 as assessed by BICR.
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Timepoint [12]
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Up to ~95 months
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Secondary outcome [13]
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TTP per RECIST 1.1
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Assessment method [13]
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TTP is defined as the time from randomization to the first documented disease progression. Responses are according to RECIST 1.1 as assessed by BICR.
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Timepoint [13]
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Up to ~95 months
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Eligibility
Key inclusion criteria
- Has a diagnosis of HCC confirmed by radiology, histology, or cytology
- Has HCC localized to the liver and not amenable to curative treatment
- Participants with Hepatitis C virus (HCV) are eligible if treatment was completed at
least 1 month prior to starting study intervention
- Participants with Hepatitis B virus (HBV) are eligible
- Has adequately controlled blood pressure with or without antihypertensive medications
- Has adequate organ function
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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
- Is currently a candidate for liver transplantation
- Has had gastric bleeding within the last 6 months
- Has ascites that is not controlled with medication
- Has significant cardiovascular impairment within 12 months of the first dose of study
intervention such as congestive heart failure
- Has a serious nonhealing wound, ulcer, or bone fracture
- Has received locoregional therapy to existing liver lesions
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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
Blinded (masking used)
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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
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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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
22/05/2020
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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
31/12/2029
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Actual
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Sample size
Target
450
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC,WA
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Recruitment hospital [1]
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St George Hospital ( Site 0005) - Kogarah
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Recruitment hospital [2]
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Westmead Hospital-Gastroenterology & Hepatology ( Site 0009) - Westmead
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Recruitment hospital [3]
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Princess Alexandra Hospital ( Site 0006) - Brisbane
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Recruitment hospital [4]
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Austin Health ( Site 0008) - Heidelberg
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Recruitment hospital [5]
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Alfred Health ( Site 0004) - Melbourne
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Recruitment hospital [6]
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Royal Perth Hospital ( Site 0002) - Perth
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Recruitment postcode(s) [1]
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2217 - Kogarah
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Recruitment postcode(s) [2]
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2145 - Westmead
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Recruitment postcode(s) [3]
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4102 - Brisbane
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Recruitment postcode(s) [4]
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3084 - Heidelberg
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Recruitment postcode(s) [5]
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3004 - Melbourne
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Recruitment postcode(s) [6]
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6000 - Perth
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Recruitment outside Australia
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United States of America
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Arizona
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California
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Connecticut
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Florida
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Idaho
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Iowa
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Kansas
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Kentucky
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Louisiana
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Michigan
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Missouri
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Anhui
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Shatin
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Hungary
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Somogy
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Zala
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Afula
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Israel
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Haifa
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Israel
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Israel
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Campania
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Piemonte
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Sicilia
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Brescia
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Napoli
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Italy
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Ravenna
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Italy
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Roma
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Japan
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State/province [86]
0
0
Chiba
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Country [87]
0
0
Japan
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State/province [87]
0
0
Ehime
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Country [88]
0
0
Japan
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State/province [88]
0
0
Fukuoka
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Country [89]
0
0
Japan
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State/province [89]
0
0
Hokkaido
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Country [90]
0
0
Japan
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State/province [90]
0
0
Ishikawa
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Country [91]
0
0
Japan
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State/province [91]
0
0
Kagawa
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Country [92]
0
0
Japan
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State/province [92]
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0
Kanagawa
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Country [93]
0
0
Japan
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State/province [93]
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0
Nara
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Country [94]
0
0
Japan
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State/province [94]
0
0
Osaka
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Country [95]
0
0
Japan
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State/province [95]
0
0
Saitama
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Country [96]
0
0
Japan
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State/province [96]
0
0
Shizuoka
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Country [97]
0
0
Japan
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State/province [97]
0
0
Tochigi
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Country [98]
0
0
Japan
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State/province [98]
0
0
Hiroshima
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Country [99]
0
0
Japan
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State/province [99]
0
0
Kumamoto
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Country [100]
0
0
Japan
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State/province [100]
0
0
Kyoto
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Country [101]
0
0
Japan
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State/province [101]
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0
Saga
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Country [102]
0
0
Japan
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State/province [102]
0
0
Tokyo
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Country [103]
0
0
Korea, Republic of
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State/province [103]
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0
Jeonranamdo
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Country [104]
0
0
Korea, Republic of
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State/province [104]
0
0
Kyonggi-do
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Country [105]
0
0
Korea, Republic of
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State/province [105]
0
0
Pusan-Kwangyokshi
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Country [106]
0
0
Korea, Republic of
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State/province [106]
0
0
Taegu-Kwangyokshi
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Country [107]
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0
Korea, Republic of
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State/province [107]
0
0
Seoul
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Country [108]
0
0
Netherlands
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State/province [108]
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0
Limburg
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Country [109]
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0
Netherlands
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State/province [109]
0
0
Noord-Holland
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Country [110]
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0
Netherlands
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State/province [110]
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0
Zuid-Holland
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Country [111]
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0
Netherlands
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State/province [111]
0
0
Utrecht
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Country [112]
0
0
New Zealand
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State/province [112]
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0
Auckland
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Country [113]
0
0
Norway
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State/province [113]
0
0
Oslo
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Country [114]
0
0
Portugal
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State/province [114]
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0
Coimbra
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Country [115]
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0
Portugal
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State/province [115]
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0
Lisboa
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Country [116]
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0
Portugal
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State/province [116]
0
0
Porto
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Country [117]
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0
Puerto Rico
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State/province [117]
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Ponce
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Country [118]
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0
Puerto Rico
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State/province [118]
0
0
San Juan
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Country [119]
0
0
Spain
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State/province [119]
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0
Madrid
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Country [120]
0
0
Spain
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State/province [120]
0
0
Valenciana, Comunitat
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Country [121]
0
0
Spain
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State/province [121]
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0
Sevilla
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Country [122]
0
0
Taiwan
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State/province [122]
0
0
Kaohsiung
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Country [123]
0
0
Taiwan
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State/province [123]
0
0
Taichung
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Country [124]
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0
Taiwan
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State/province [124]
0
0
Tainan
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Country [125]
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0
Taiwan
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State/province [125]
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Taipei
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Country [126]
0
0
Taiwan
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State/province [126]
0
0
Taoyuan
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Country [127]
0
0
Thailand
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State/province [127]
0
0
Krung Thep Maha Nakhon
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Country [128]
0
0
Turkey
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State/province [128]
0
0
Ankara
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Country [129]
0
0
Turkey
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State/province [129]
0
0
Edirne
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Country [130]
0
0
Turkey
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State/province [130]
0
0
Istanbul
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Country [131]
0
0
Turkey
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State/province [131]
0
0
Izmir
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Country [132]
0
0
Turkey
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State/province [132]
0
0
Konya
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Country [133]
0
0
Turkey
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State/province [133]
0
0
Malatya
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Country [134]
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0
Ukraine
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State/province [134]
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0
Kharkivska Oblast
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Country [135]
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Ukraine
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State/province [135]
0
0
Kyivska Oblast
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Country [136]
0
0
United Kingdom
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State/province [136]
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0
London, City Of
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Merck Sharp & Dohme LLC
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Address
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Country
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Other collaborator category [1]
0
0
Commercial sector/Industry
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Name [1]
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0
Eisai Inc.
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Address [1]
0
0
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Country [1]
0
0
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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 efficacy and safety of lenvatinib and
pembrolizumab in combination with TACE versus TACE plus oral and intravenous (IV) placebos in
participants with incurable, non-metastatic hepatocellular carcinoma (HCC). The primary
hypotheses are that pembrolizumab plus lenvatinib in combination with TACE is superior to
placebo plus TACE with respect to progression-free survival (PFS) and overall survival (OS).
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Trial website
https://clinicaltrials.gov/ct2/show/NCT04246177
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
0
0
Medical Director
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Address
0
0
Merck Sharp & Dohme LLC
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Country
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0
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Phone
0
0
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Fax
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0
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Email
0
0
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Contact person for public queries
Name
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Address
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0
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Phone
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT04246177
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