Hepatocellular CarcinomaPhase 1NCT03006926
A Trial of Lenvatinib Plus Pembrolizumab in Participants With Hepatocellular Carcinoma
A Phase 1 study testing lenvatinib and pembrolizumab (200 mg) in people with Hepatocellular Carcinoma, run by Eisai Co., Ltd. at 26 sites in 7 countries.
Trial summary
This is an open-label Phase 1b study designed to evaluate the tolerability and safety of lenvatinib in combination with pembrolizumab in participants with hepatocellular carcinoma (HCC). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatocellular Carcinoma
- What is being tested?
- lenvatinib and pembrolizumab (200 mg)
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 104 participants
- Where
- 26 sitesin 7 countries
- Study dates
- 13 Feb 2017to 22 Nov 2022
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Confirmed diagnosis of hepatocellular carcinoma (HCC)
- HCC for which no other appropriate therapy is available. Note: Expansion Part: No prior systemic therapy for advanced/unresectable HCC
- Stage B (not applicable for transarterial chemoembolization [TACE]), or stage C based on Barcelona Clinic Liver Cancer (BCLC) staging system
- At least 1 measurable target lesion according to modified Response Evaluation Criteria in Solid Tumors (mRECIST)
- Child-Pugh score A
- Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0 to 1
Show all 14Show fewer
- Total triiodothyronine (T3) or free T3 and free thyroxine (T4) are within normal limits. (control by thyroid replacement therapy is acceptable.) Participants with T3, free T3 or free T4 abnormalities at screening who are asymptomatic can be eligible
- Adequately controlled blood pressure
- Adequate renal function
- Adequate bone marrow function
- Adequate blood coagulation function
- Adequate liver function
- Males or females age ≥ 18 years at the time of informed consent
- Voluntary agreement to provide written informed consent and the willingness and ability to comply with all aspects of the protocol
Who cannot join
- Prior treatment with lenvatinib or any anti-PD-1, anti-PD-L1, or anti-PD-L2 agent
- Active malignancy (except for HCC or definitively treated melanoma in-situ, basal or squamous cell carcinoma of the skin, or carcinoma in-situ of the cervix) within the past 36 months
- Any medical or other condition which, in the opinion of the investigator, would preclude participation in a clinical trial
- Active infection (any infection requiring systemic treatment). Hepatitis B or C [HBV/HCV] is allowed
- Participants with CNS metastases are not eligible, unless they have completed local therapy (eg, whole brain radiation therapy [WBRT], surgery or radiosurgery) and have discontinued the use of corticosteroids for this indication for at least 4 weeks before starting treatment in this study. Any signs (eg, radiologic) or symptoms of brain metastases must be stable for at least 4 weeks before starting study treatment
Trial locations and contacts
26 sites in 7 countries.
26 sites in 7 countries
United States6 sites
Mercy Medical Center
Baltimore, Maryland, 21202
Massachusetts General Hospital
Boston, Massachusetts, 02114
BRCR Global Texas
Edinburg, Texas, 78539
Icahn School of Medicine Mount Sinai
New York, New York, 10029
California Pacific Medical Center (CPMC)
San Francisco, California, 94115
Ronald Reagan UCLA Medical Center
Santa Monica, California, 90095
Spain5 sites
Hospital Infanta Cristina de Badajoz
Badajoz, Province of Badajoz, 06080
Hospital General Universitario Gregorio Marañón
Madrid, Madrid, 28007
Hospital Universitario 12 de Octubre
Madrid, Madrid, 28041
Hospital Universitario de Salamanca
Salamanca, Province of Salamanca, 37007
Hospital Universitario Marqués de Valdecilla
Santander, Cantabria, 39008
France4 sites
Hôpital Timone
Marseille, Provence-Alpes-Côte d'Azur Region, 13005
Hôpital Haut-Levêque Centre médico-chirurgical Magellan
Pessac, Bordeaux, 33604
Centre Eugène Marquis de Rennes
Rennes, Brittany Region, 35042
CHU Toulouse
Toulouse, Occitanie, 31059
Japan4 sites
Eisai Trial Site 1
Chuo-ku, Tokyo
Eisai Trial Site 2
Kashiwa, Chiba
Eisai Trial Site 4
Kawasaki, Kanagawa
Eisai Trial Site 3
Sayama, Osaka
Russia4 sites
Altay Regional Oncology Dispensary
Barnaul
S.I. Russian Oncological Research Center n.a. N. N. Blokhin RAMS
Moscow, Moscow Oblast
St. Petersburg City Clinical Oncology Dispansery
Saint Petersburg, Leningradskaya Oblast'
Republican Clinical Oncology Dispensary
Ufa, Bashkortostan Republic
Italy2 sites
Azienda Ospedaliera Universitaria Policlinico Sant'Orsola Malpighi
Bologna, Province Of Bologna, 15-40138
IRCCS Istituto Clinico Humanitas
Milan, Lombardy, 20089
United Kingdom1 site
Royal Free Hospital
London, Greater London, NW3 2QG
About this study
Official title: An Open-Label Phase 1b Trial of Lenvatinib Plus Pembrolizumab in Subjects With Hepatocellular Carcinoma
This is an open-label Phase 1b study designed to evaluate the tolerability and safety of lenvatinib in combination with pembrolizumab in participants with hepatocellular carcinoma (HCC). The study will evaluate objective response rate and duration of response by modified Response Evaluation Criteria In Solid Tumors (mRECIST) for HCC and Response Evaluation Criteria In Solid Tumors (RECIST 1.1) based on independent imaging review (IIR).
- Conditions
- Hepatocellular Carcinoma
- Being tested
- lenvatinib, pembrolizumab (200 mg)
- Keywords
- hepatocellular carcinoma, E7080, lenvatinib, pembrolizumab, Japan
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lenvatinibDrug
4 mg capsules
pembrolizumab (200 mg)Drug
30-minute intravenous infusion
| Study group | Role | What they receive |
|---|---|---|
| lenvatinib 8 or 12 mg plus pembrolizumab 200 mg | Experimental | Participants will receive oral lenvatinib at a starting dose of 8 or 12 milligrams (mg) once a day (QD) in combination with intravenous pembrolizumab 200 mg every 3 weeks (Q3W) on a 21-day treatment cycle. The starting dose of lenvatinib will be based on Baseline body weight. Participants weighing greater than or equal to 60 kilograms (kg) will receive 12 mg QD; participants weighing less than 60 kg will receive 8 mg QD. Receives: Drug: lenvatinib; Drug: pembrolizumab (200 mg) |
What is being measured
The primary outcome is the main question the study is designed to answer.
DLT Part: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
A TEAE was defined as an adverse event (AE) that emerged during the time from the first dose of study drug to 120 days (if participant initiated new anticancer therapy) following last dose of study drug, was absent at pretreatment (Baseline) or reemerged during treatment, was at pretreatment (Baseline) but stopped before treatment or worsened in severity during treatment relative to the pretreatment state, when AE was continuous. An SAE was any untoward medical occurrence that at any dose: resulted in death, was life-threatening (that is, participant was at immediate risk of death from AE as it occurred; this did not include an event that, had it occurred in a more severe form or was allowed to continue, might have caused death), required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect (in the child of a participant who was exposed to the study drug).
Measured: From first dose until 120 days after the last dose (up to 50.2 months)
Expansion Part: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
A TEAE was defined as an AE that emerged during the time from the first dose of study drug to 120 days (if participant initiated new anticancer therapy) following last dose of study drug, was absent at pretreatment (Baseline) or reemerged during treatment, was at pretreatment (Baseline) but stopped before treatment or worsened in severity during treatment relative to the pretreatment state, when AE was continuous. An SAE was any untoward medical occurrence that at any dose: resulted in death, was life-threatening (that is, participant was at immediate risk of death from AE as it occurred; this did not include an event that, had it occurred in a more severe form or was allowed to continue, might have caused death), required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect (in the child of a participant who was exposed to the study drug).
Measured: From first dose until 120 days after the last dose (up to 50.2 months)
DLT Part: Number of Participants With Dose Limiting Toxicities (DLTs)
DLT was graded according to Common Terminology Criteria for Adverse Events version 4.03 (CTCAE v4.03). DLT was defined as any of the following: (1) any of the hematological or nonhematological toxicities considered to be at least possibly related to lenvatinib and/or pembrolizumab occurring during Cycle 1; (2) failure to administer >=75 percent (%) of the planned dosage of lenvatinib as a result of treatment-related toxicity during Cycle 1; (3) participants who discontinued treatment due to treatment-related toxicity in Cycle 1; (4) greater than (>) 2 week delay in starting pembrolizumab in Cycle 2 because of a treatment-related toxicity, even if the toxicity did not meet DLT criteria.
Measured: From first dose of study drug up to Cycle 1 Day 21 (Cycle length= 21 days)
DLT+Expansion Part: Objective Response Rate (ORR) Based on mRECIST and RECIST Version (v) 1.1 Assessed by Independent Imaging Review (IIR)
ORR was defined as the percentage of participants who had best overall response (BOR) of complete response (CR) or partial response (PR) based on modified Response Evaluation Criteria in Solid Tumors (mRECIST) and Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 assessed by IIR analysis. Responses (PR or CR) were confirmed no less than 4 weeks after the initial response. CR defined as disappearance of all target lesions and non-target lesions (a short diameter is <10 millimeter [mm] if it exists in a lymph node). PR defined as at least 30% decrease in the sum of the long diameter (LD) (hereafter referred to as sum of LD) of all target lesions, as compared with Baseline summed LD.
Measured: From the first dose of study drug to the first date of documentation of PD or death, whichever occurred first (up to 46.2 months)
DLT+Expansion Part: Duration of Response (DOR) Based on mRECIST Assessed by IIR
DOR was defined as the time from the first documentation of CR or PR to the date of first documentation of PD or death (whichever occurred first) in participants with confirmed CR or PR based on mRECIST assessed by IIR analysis. CR defined as disappearance of all target lesions and non-target lesions (a short diameter is <10 mm if it exists in a lymph node). PR defined as at least 30% decrease in the sum of the LD (hereafter referred to as sum of LD) of all target and non-target lesions, as compared with Baseline summed LD. PD was defined as at least a 20% increase in the sum of LD of target and non-target lesions as compared with the smallest sum of LD, and the increase of LD was at least 5 mm (including new lesions).
Measured: From date of first documented confirmed CR or PR until date of first documentation of PD or death, whichever occurred first (up to 46.2 months)
DLT+Expansion Part: Duration of Response (DOR) Based on RECIST v1.1 Assessed by IIR
DOR was defined as the time from the first documentation of CR or PR to the date of first documentation of PD or death (whichever occurred first) in participants with confirmed CR or PR based on RECIST v1.1 assessed by IIR analysis. CR defined as disappearance of all target lesions and non-target lesions (a short diameter is <10 mm if it exists in a lymph node). PR defined as at least 30% decrease in the sum of the LD (hereafter referred to as sum of LD) of all target and non-target lesions, as compared with Baseline summed LD. PD was defined as at least a 20% increase in the sum of LD of target and non-target lesions as compared with the smallest sum of LD, and the increase of LD was at least 5 mm (including new lesions).
Measured: From date of first documented confirmed CR or PR until date of first documentation of PD or death, whichever occurred first (up to 46.2 months)
Secondary outcomes (28)
DLT+Expansion Part: Objective Response Rate (ORR) Based on mRECIST Assessed by Investigator Review
ORR was defined as the percentage of participants who had BOR of CR or PR based on mRECIST assessed by investigator review. Responses (PR or CR) were confirmed no less than 4 weeks after the initial response. CR defined as disappearance of all target lesions and non-target lesions (a short diameter is <10 mm if it exists in a lymph node). PR defined as at least 30% decrease in the sum of the LD (hereafter referred to as sum of LD) of all target and non-target lesions, as compared with Baseline summed LD.
Measured: From the first dose of study drug to the first date of documentation of PD or death, whichever occurred first (up to 46.2 months)
DLT+Expansion Part: Duration of Response (DOR) Based on mRECIST Assessed by Investigator Review
DOR was defined as the time from the first documentation of CR or PR to the date of first documentation of PD or death (whichever occurred first) based on mRECIST assessed by investigator review. CR defined as disappearance of all target and non-target lesions (a short diameter is <10 mm if it exists in a lymph node). PR defined as at least 30% decrease in the sum of the LD (hereafter referred to as sum of LD) of all target and non-target lesions, as compared with Baseline summed LD. PD was defined as at least a 20% increase in the sum of LD of target and non-target lesions as compared with the smallest sum of LD, and the increase of LD was at least 5 mm (including new lesions).
Measured: From date of first documented confirmed CR or PR until date of first documentation of PD or death, whichever occurred first (up to 46.2 months)
DLT+Expansion Part: Progression-free Survival (PFS) Based on mRECIST and RECIST v1.1 Assessed by IIR and Based on mRECIST Assessed by Investigator Review
PFS was defined as the time from the first study dose date to the date of first documentation of PD or death (whichever occurred first) based on mRECIST and RECIST v1.1 assessed by IIR, and mRECIST assessed by investigator review. PD was defined as at least a 20% increase in the sum of LD of target and non-target lesions as compared with the smallest sum of LD, and the increase of LD was at least 5 mm (including new lesions).
Measured: From the first study dose date to the date of first documentation of PD or death, whichever occurred first (up to 46.2 months)
DLT+Expansion Part: Time-to-Progression (TTP) Based on mRECIST and RECIST v1.1 Assessed by IIR and Based on mRECIST Assessed by Investigator Review
TTP was defined as the time from the first study dose date to the date of first documentation of PD, based on mRECIST and RECIST v1.1 assessed by IIR and mRECIST assessed by an investigator review. PD was defined as at least a 20% increase in the sum of LD of target and non-target lesions as compared with the smallest sum of LD, and the increase of LD was at least 5 mm (including new lesions).
Measured: From date of first dose of study drug until PD (up to 46.2 months)
DLT+Expansion Part: Time-to-Response (TTR) Based on mRECIST Assessed by IIR
TTR was defined as the time from the date of first study dose to the date of first documentation of CR or PR, in participants with confirmed CR or PR. It was evaluated according to mRECIST assessed by IIR. CR defined as disappearance of all target and non-target lesions (a short diameter is <10 mm if it exists in a lymph node). PR defined as at least 30% decrease in the sum of the LD (hereafter referred to as sum of LD) of all target and non-target lesions, as compared with Baseline summed LD.
Measured: From date of first dose of study drug until CR or PR (up to 46.2 months)
DLT+Expansion Part: Time-to-Response (TTR) Based on RECIST v1.1 Assessed by IIR
TTR was defined as the time from the date of first study dose to the date of first documentation of CR or PR, in participants with confirmed CR or PR. It was evaluated according to RECIST v1.1 assessed by IIR. CR defined as disappearance of all target and non-target lesions (a short diameter is <10 mm if it exists in a lymph node). PR defined as at least 30% decrease in the sum of the LD (hereafter referred to as sum of LD) of all target and non-target lesions, as compared with Baseline summed LD.
Measured: From date of first dose of study drug until CR or PR (up to 46.2 months)
DLT+Expansion Part: Time-to-Response (TTR) Based on mRECIST Assessed by Investigator Review
TTR was defined as the time from the date of first study dose to the date of first documentation of CR or PR, in participants with confirmed CR or PR. It was evaluated according to mRECIST assessed by investigator review. CR defined as disappearance of all target and non-target lesions (a short diameter is <10 mm if it exists in a lymph node). PR defined as at least 30% decrease in the sum of the LD (hereafter referred to as sum of LD) of all target and non-target lesions, as compared with Baseline summed LD.
Measured: From date of first dose of study drug until CR or PR (up to 46.2 months)
DLT+Expansion Part: Overall Survival (OS)
OS was measured from the date of first dose of study drug until date of death from any cause. Participants who were lost to follow-up or who were alive at the date of data cutoff were censored at the date the participants were last known alive, whichever came earlier.
Measured: From the date of first dose of study drug until date of death from any cause (up to 48.1 months)
DLT+Expansion Part, Cmax: Maximum Observed Plasma Concentration for Lenvatinib
Cmax was defined as the maximum plasma concentration for lenvatinib. Cmax was derived by non-compartmental analysis using lenvatinib plasma concentrations quantified by liquid chromatography with tandem mass spectrometry (LC-MS/MS). As per pharmacokinetic (PK) planned analysis for lenvatinib and as per sponsor's practice, the lenvatinib PK data was collected, analyzed and summarized according to Japanese and non-Japanese population in this study.
Measured: Cycle 1 Day 1: 0-24 hours post-dose (Cycle length=21 days)
DLT+Expansion Part, Tmax: Time to Reach the Cmax for Lenvatinib
Tmax was defined as the time to reach maximum observed plasma concentration (Cmax) for lenvatinib. Tmax was derived by non-compartmental analysis using lenvatinib plasma concentrations quantified by LC-MS/MS. As per PK planned analysis for lenvatinib and as per sponsor's practice, the lenvatinib PK data was collected, analyzed and summarized according to Japanese and non-Japanese population in this study.
Measured: Cycle 1 Day 1: 0-24 hours post-dose (Cycle length=21 days)
DLT+Expansion Part, AUC(0-t): Area Under the Plasma Concentration-time Curve From Zero Time to the Last Measurable Point for Lenvatinib
AUC(0-t) was defined as the area under the plasma concentration-time curve from 0 time to last measurable point for lenvatinib. AUC(0-t) was derived by non-compartmental analysis using lenvatinib plasma concentrations quantified by LC-MS/MS. As per PK planned analysis for lenvatinib and as per sponsor's practice, the lenvatinib PK data was collected, analyzed and summarized according to Japanese and non-Japanese population in this study.
Measured: Cycle 1 Day 1: 0-24 hours post-dose (Cycle length=21 days)
DLT+Expansion Part, AUC(0-ti): Area Under The Plasma Concentration-time Curve From Zero (Pre-Dose) to a Given Sampling Time (ti) for Lenvatinib
AUC(0-ti) was defined as the area under the plasma concentration-time curve from 0 to a given sampling time for lenvatinib. AUC(0-ti) was derived by non-compartmental analysis using lenvatinib plasma concentrations quantified by LC-MS/MS. As per PK planned analysis for lenvatinib and as per sponsor's practice, the lenvatinib PK data was collected, analyzed and summarized according to Japanese and non-Japanese population in this study.
Measured: Cycle 1 Days 1 and 15: 0-8 hours post-dose (Cycle length=21 days)
DLT+Expansion Part, AUC(0-Inf): Area Under the Plasma Concentration-time Curve From Zero to Infinity for Lenvatinib
AUC(0-Inf) was defined as the area under the plasma concentration-time curve from 0 to infinity for lenvatinib. AUC(0-Inf) was derived by non-compartmental analysis using lenvatinib plasma concentrations quantified by LC-MS/MS. As per PK planned analysis for lenvatinib and as per sponsor's practice, the lenvatinib PK data was collected, analyzed and summarized according to Japanese and non-Japanese population in this study.
Measured: Cycle 1 Days 1 and 15: 0-24 hours post-dose (Cycle length=21 days)
DLT+Expansion Part, t1/2: Terminal Elimination Phase Half-Life for Lenvatinib
t1/2 was defined as the terminal elimination phase half-life for lenvatinib. t1/2 was derived by non-compartmental analysis using lenvatinib plasma concentrations quantified by LC-MS/MS. As per PK planned analysis for lenvatinib and as per sponsor's practice, the lenvatinib PK data was collected, analyzed and summarized according to Japanese and non-Japanese population in this study.
Measured: Cycle 1 Days 1 and 15: 0-24 hours post-dose (Cycle length=21 days)
DLT+Expansion Part, CL/F: Apparent Total Clearance for Lenvatinib
Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. CL/F was calculated as (Dose/AUC(0-inf))/F. Where AUC(0-inf) is the area under the plasma concentration-time curve from zero to infinity and F is the bioavailability of the drug. As per PK planned analysis for lenvatinib and as per sponsor's practice, the lenvatinib PK data was collected, analyzed and summarized according to Japanese and non-Japanese population in this study.
Measured: Cycle 1 Day 15: 0-24 hours post-dose (Cycle length=21 days)
DLT+Expansion Part, Vz/F: Apparent Terminal Volume of Distribution for Lenvatinib
Volume of distribution was defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Vz/F was calculated as (CL/F)/Lambda Z. Where, CL/F is the apparent total clearance and lambda Z is the apparent terminal elimination rate constant. As per PK planned analysis for lenvatinib and as per sponsor's practice, the lenvatinib PK data was collected, analyzed and summarized according to Japanese and non-Japanese population in this study.
Measured: Cycle 1 Day 1: 0-24 hours post-dose (Cycle length=21 days)
DLT+Expansion Part, Css,Max: Maximum Observed Plasma Concentration at Steady State for Lenvatinib
Css,max was defined as the maximum plasma concentration at steady state for lenvatinib. Css,max was derived by non-compartmental analysis using lenvatinib plasma concentrations quantified by LC-MS/MS. As per PK planned analysis for lenvatinib and as per sponsor's practice, the lenvatinib PK data was collected, analyzed and summarized according to Japanese and non-Japanese population in this study.
Measured: Cycle 1 Day 15: 0-24 hours post-dose (Cycle length=21 days)
DLT+Expansion Part, Css,Min: Minimum Observed Plasma Concentration at Steady State for Lenvatinib
Css,min is the minimum plasma concentration at steady state for lenvatinib. Css,min was derived by non-compartmental analysis using lenvatinib plasma concentrations quantified by LC-MS/MS. As per PK planned analysis for lenvatinib and as per sponsor's practice, the lenvatinib PK data was collected, analyzed and summarized according to Japanese and non-Japanese population in this study.
Measured: Cycle 1 Day 15: 0-24 hours post-dose (Cycle length=21 days)
DLT+Expansion Part, Tss,Max: Time to Maximum Observed Concentration at Steady State For Lenvatinib
Tss,Max was defined as the time to reach maximum observed plasma concentration of lenvatinib at steady state. Tss,Max was derived by non-compartmental analysis using lenvatinib plasma concentrations quantified by LC-MS/MS. As per PK planned analysis for lenvatinib and as per sponsor's practice, the lenvatinib PK data was collected, analyzed and summarized according to Japanese and non-Japanese population in this study.
Measured: Cycle 1 Day 15: 0-24 hours post-dose (Cycle length=21 days)
DLT+Expansion Part, AUC(0-tau): Area Under the Plasma Concentration-time Curve Over the Dosing Interval for Lenvatinib
AUC(0-tau) was defined as the area under the plasma concentration-time curve over dosing interval for lenvatinib. AUC(0-tau) was derived by non-compartmental analysis using lenvatinib plasma concentrations quantified by LC-MS/MS. As per PK planned analysis for lenvatinib and as per sponsor's practice, the lenvatinib PK data was collected, analyzed and summarized according to Japanese and non-Japanese population in this study.
Measured: Cycle 1 Day 15: 0-24 hours post-dose (Cycle length=21 days)
DLT+Expansion Part, Clss/F: Apparent Total Clearance Following Oral Administration at Steady State for Lenvatinib
Clearance of a drug at steady state is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. CLss/F was calculated as (Dose/AUC(0-tau))/F. Where, AUC(0-tau) is the area under the plasma concentration-time curve over the dosing interval and F is the bioavailability of the drug. As per PK planned analysis for lenvatinib and as per sponsor's practice, the lenvatinib PK data was collected, analyzed and summarized according to Japanese and non-Japanese population in this study.
Measured: Cycle 1 Day 15: 0-24 hours post-dose (Cycle length=21 days)
DLT+Expansion Part, Css,Av: Average Steady State Plasma Concentration for Lenvatinib
Css,Av was defined as the average plasma concentration at steady state for lenvatinib. Css,Av was derived by non-compartmental analysis using lenvatinib plasma concentrations quantified by LC-MS/MS. Css,Av was calculated as AUC(0-tau)/tau. Where, AUC(0-tau) is the area under the plasma concentration-time curve over the dosing interval and tau is the length of dosing interval. As per PK planned analysis for lenvatinib and as per sponsor's practice, the lenvatinib PK data was collected, analyzed and summarized according to Japanese and non-Japanese population in this study.
Measured: Cycle 1 Day 15: 0-24 hours post-dose (Cycle length=21 days)
DLT+Expansion Part, Vz,ss/F: Apparent Terminal Volume of Distribution at Steady State for Lenvatinib
Volume of distribution at steady state was defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Vz,ss/F was calculated as (CLss/F)/Lambda Z. Where, CLss/F is the apparent total clearance following oral administration at steady state and lambda Z is the apparent terminal elimination rate constant. As per PK planned analysis for lenvatinib and as per sponsor's practice, the lenvatinib PK data was collected, analyzed and summarized according to Japanese and non-Japanese population in this study.
Measured: Cycle 1 Day 15: 0-24 hours post-dose (Cycle length=21 days)
DLT+Expansion Part, Rac (Cmax): Accumulation Ratio of Cmax for Lenvatinib
Rac(Cmax) was calculated as Css,max at Cycle 1 Day 15/Cmax at Cycle 1 Day 1. As per PK planned analysis for lenvatinib and as per sponsor's practice, the lenvatinib PK data was collected, analyzed and summarized according to Japanese and non-Japanese population in this study.
Measured: Cycle 1 Days 1 and 15: 0-24 hours post-dose (Cycle length=21 days)
DLT+Expansion Part, Rac (AUC0-8 Hour): Accumulation Ratio of AUC(0-8 Hour) for Lenvatinib
Rac(AUC0-8 hour) was calculated as AUC(0-8 hour) at Cycle 1 Day 15/AUC(0-8 hour) at Cycle 1 Day 1. As per PK planned analysis for lenvatinib and as per sponsor's practice, the lenvatinib PK data was collected, analyzed and summarized according to Japanese and non-Japanese population in this study.
Measured: Cycle 1 Days 1 and 15: 0-8 hours post-dose (Cycle length=21 days)
DLT+Expansion Part, %PTF: Percent (%) Peak-trough Fluctuation for Lenvatinib
The PTF within complete dosing interval at steady state, calculated as PTF (%) = ([Css,max - Css,min]/Css,Av)* 100. Where, Css,max is the maximum observed plasma concentration at steady state and Css,min is the minimum observed plasma concentration at steady state and Css,Av average steady state plasma concentration. As per PK planned analysis for lenvatinib and as per sponsor's practice, the lenvatinib PK data was collected, analyzed and summarized according to Japanese and non-Japanese population in this study.
Measured: Cycle 1 Day 15: 0-24 hours post-dose (Cycle length=21 days)
DLT+Expansion Part, Ctrough: Trough (Pre-dose) Serum Concentration for Pembrolizumab
Ctrough was defined as trough (pre-dose) serum concentration for pembrolizumab at steady state.
Measured: Cycles 1, 2, 4, 6, 8, 12, 16, 20, 24, 28, 32, 36: Pre-dose (each Cycle length=21 days)
DLT+Expansion Part: Number of Participants Positive for Serum Anti-drug Antibodies (ADA) Status
ADA positive was defined as participants with at least one pre-treatment or post-dose sample positive in the confirmatory assay for antibodies against pembrolizumab. ADA was assessed using a validated electrochemiluminescence (ECL) immunoassay.
Measured: Cycles 1 and 6 Day 1: Pre-dose (each cycle length=21 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2016 (estimated)
- Study start13 Feb 2017
- Primary completion31 Oct 2019
- Study completion22 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hepatocellular CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 104 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eisai Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Merck Sharp & Dohme LLC
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03006926
- Sponsor's protocol ID
- E7080-J081-116
- Other IDs
- KEYNOTE 524, 2018-000522-55, 2018
- Status last verified
- Nov 2023
- First submitted
- 27 Dec 2016
- Last updated
- 13 Dec 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Finn RS, Ikeda M, Zhu AX, Sung MW, Baron AD, Kudo M, Okusaka T, Kobayashi M, Kumada H, Kaneko S, Pracht M, Mamontov K, Meyer T, Kubota T, Dutcus CE, Saito K, Siegel AB, Dubrovsky L, Mody K, Llovet JM. Phase Ib Study of Lenvatinib Plus Pembrolizumab in Patients With Unresectable Hepatocellular Carcinoma. J Clin Oncol. 2020 Sep 10;38(26):2960-2970. doi: 10.1200/JCO.20.00808. Epub 2020 Jul 27.
PubMed 32716739
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label Phase 1b Trial of Lenvatinib Plus Pembrolizumab in Subjects With Hepatocellular Carcinoma
- ClinicalTrials.gov ID
- NCT03006926
- Acronym / sponsor ID
- E7080-J081-116
- Conditions
- Hepatocellular Carcinoma
- Keywords
- hepatocellular carcinoma, E7080, lenvatinib, pembrolizumab, Japan
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 104 participants (actual)
- Lead sponsor
- Eisai Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Merck Sharp & Dohme LLC
- Study start
- 13 Feb 2017 (actual)
- Primary completion
- 31 Oct 2019 (actual)
- Study completion
- 22 Nov 2022 (actual)
- First posted
- 30 Dec 2016 (estimated)
- Results
- Posted 31 Dec 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is an open-label Phase 1b study designed to evaluate the tolerability and safety of lenvatinib in combination with pembrolizumab in participants with hepatocellular carcinoma (HCC). The study will evaluate objective response rate and duration of response by modified Response Evaluation Criteria In Solid Tumors (mRECIST) for HCC and Response Evaluation Criteria In Solid Tumors (RECIST 1.1) based on independent imaging review (IIR).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| lenvatinib 8 or 12 mg plus pembrolizumab 200 mg | Experimental | Drug: lenvatinib, Drug: pembrolizumab (200 mg)Participants will receive oral lenvatinib at a starting dose of 8 or 12 milligrams (mg) once a day (QD) in combination with intravenous pembrolizumab 200 mg every 3 weeks (Q3W) on a 21-day treatment cycle. The starting dose of lenvatinib will be based on Baseline body weight. Participants weighing greater than or equal to 60 kilograms (kg) will receive 12 mg QD; participants weighing less than 60 kg will receive 8 mg QD. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Confirmed diagnosis of hepatocellular carcinoma (HCC)
- HCC for which no other appropriate therapy is available. Note: Expansion Part: No prior systemic therapy for advanced/unresectable HCC
- Stage B (not applicable for transarterial chemoembolization [TACE]), or stage C based on Barcelona Clinic Liver Cancer (BCLC) staging system
- At least 1 measurable target lesion according to modified Response Evaluation Criteria in Solid Tumors (mRECIST)
- Child-Pugh score A
Key exclusion criteria (5 listed)
- Prior treatment with lenvatinib or any anti-PD-1, anti-PD-L1, or anti-PD-L2 agent
- Active malignancy (except for HCC or definitively treated melanoma in-situ, basal or squamous cell carcinoma of the skin, or carcinoma in-situ of the cervix) within the past 36 months
- Any medical or other condition which, in the opinion of the investigator, would preclude participation in a clinical trial
- Active infection (any infection requiring systemic treatment). Hepatitis B or C [HBV/HCV] is allowed
- Participants with CNS metastases are not eligible, unless they have completed local therapy (eg, whole brain radiation therapy [WBRT], surgery or radiosurgery) and have discontinued the use of corticosteroids for this indication for at least 4 weeks before starting treatment in this study. Any signs (eg, radiologic) or symptoms of brain metastases must be stable for at least 4 weeks before starting study treatment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| lenvatinib4 mg capsules | Drug | lenvatinib 8 or 12 mg plus pembrolizumab 200 mg |
| pembrolizumab (200 mg)30-minute intravenous infusion | Drug | lenvatinib 8 or 12 mg plus pembrolizumab 200 mg |
Primary outcome
DLT Part: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Time frame: From first dose until 120 days after the last dose (up to 50.2 months)
A TEAE was defined as an adverse event (AE) that emerged during the time from the first dose of study drug to 120 days (if participant initiated new anticancer therapy) following last dose of study drug, was absent at pretreatment (Baseline) or reemerged during treatment, was at pretreatment (Baseline) but stopped before treatment or worsened in severity during treatment relative to the pretreatment state, when AE was continuous. An SAE was any untoward medical occurrence that at any dose: resulted in death, was life-threatening (that is, participant was at immediate risk of death from AE as it occurred; this did not include an event that, had it occurred in a more severe form or was allowed to continue, might have caused death), required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect (in the child of a participant who was exposed to the study drug).
Expansion Part: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Time frame: From first dose until 120 days after the last dose (up to 50.2 months)
A TEAE was defined as an AE that emerged during the time from the first dose of study drug to 120 days (if participant initiated new anticancer therapy) following last dose of study drug, was absent at pretreatment (Baseline) or reemerged during treatment, was at pretreatment (Baseline) but stopped before treatment or worsened in severity during treatment relative to the pretreatment state, when AE was continuous. An SAE was any untoward medical occurrence that at any dose: resulted in death, was life-threatening (that is, participant was at immediate risk of death from AE as it occurred; this did not include an event that, had it occurred in a more severe form or was allowed to continue, might have caused death), required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect (in the child of a participant who was exposed to the study drug).
DLT Part: Number of Participants With Dose Limiting Toxicities (DLTs)
Time frame: From first dose of study drug up to Cycle 1 Day 21 (Cycle length= 21 days)
DLT was graded according to Common Terminology Criteria for Adverse Events version 4.03 (CTCAE v4.03). DLT was defined as any of the following: (1) any of the hematological or nonhematological toxicities considered to be at least possibly related to lenvatinib and/or pembrolizumab occurring during Cycle 1; (2) failure to administer >=75 percent (%) of the planned dosage of lenvatinib as a result of treatment-related toxicity during Cycle 1; (3) participants who discontinued treatment due to treatment-related toxicity in Cycle 1; (4) greater than (>) 2 week delay in starting pembrolizumab in Cycle 2 because of a treatment-related toxicity, even if the toxicity did not meet DLT criteria.
DLT+Expansion Part: Objective Response Rate (ORR) Based on mRECIST and RECIST Version (v) 1.1 Assessed by Independent Imaging Review (IIR)
Time frame: From the first dose of study drug to the first date of documentation of PD or death, whichever occurred first (up to 46.2 months)
ORR was defined as the percentage of participants who had best overall response (BOR) of complete response (CR) or partial response (PR) based on modified Response Evaluation Criteria in Solid Tumors (mRECIST) and Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 assessed by IIR analysis. Responses (PR or CR) were confirmed no less than 4 weeks after the initial response. CR defined as disappearance of all target lesions and non-target lesions (a short diameter is <10 millimeter [mm] if it exists in a lymph node). PR defined as at least 30% decrease in the sum of the long diameter (LD) (hereafter referred to as sum of LD) of all target lesions, as compared with Baseline summed LD.
DLT+Expansion Part: Duration of Response (DOR) Based on mRECIST Assessed by IIR
Time frame: From date of first documented confirmed CR or PR until date of first documentation of PD or death, whichever occurred first (up to 46.2 months)
DOR was defined as the time from the first documentation of CR or PR to the date of first documentation of PD or death (whichever occurred first) in participants with confirmed CR or PR based on mRECIST assessed by IIR analysis. CR defined as disappearance of all target lesions and non-target lesions (a short diameter is <10 mm if it exists in a lymph node). PR defined as at least 30% decrease in the sum of the LD (hereafter referred to as sum of LD) of all target and non-target lesions, as compared with Baseline summed LD. PD was defined as at least a 20% increase in the sum of LD of target and non-target lesions as compared with the smallest sum of LD, and the increase of LD was at least 5 mm (including new lesions).
DLT+Expansion Part: Duration of Response (DOR) Based on RECIST v1.1 Assessed by IIR
Time frame: From date of first documented confirmed CR or PR until date of first documentation of PD or death, whichever occurred first (up to 46.2 months)
DOR was defined as the time from the first documentation of CR or PR to the date of first documentation of PD or death (whichever occurred first) in participants with confirmed CR or PR based on RECIST v1.1 assessed by IIR analysis. CR defined as disappearance of all target lesions and non-target lesions (a short diameter is <10 mm if it exists in a lymph node). PR defined as at least 30% decrease in the sum of the LD (hereafter referred to as sum of LD) of all target and non-target lesions, as compared with Baseline summed LD. PD was defined as at least a 20% increase in the sum of LD of target and non-target lesions as compared with the smallest sum of LD, and the increase of LD was at least 5 mm (including new lesions).
28 secondary outcomes
DLT+Expansion Part: Objective Response Rate (ORR) Based on mRECIST Assessed by Investigator Review
Time frame: From the first dose of study drug to the first date of documentation of PD or death, whichever occurred first (up to 46.2 months)
DLT+Expansion Part: Duration of Response (DOR) Based on mRECIST Assessed by Investigator Review
Time frame: From date of first documented confirmed CR or PR until date of first documentation of PD or death, whichever occurred first (up to 46.2 months)
DLT+Expansion Part: Progression-free Survival (PFS) Based on mRECIST and RECIST v1.1 Assessed by IIR and Based on mRECIST Assessed by Investigator Review
Time frame: From the first study dose date to the date of first documentation of PD or death, whichever occurred first (up to 46.2 months)
DLT+Expansion Part: Time-to-Progression (TTP) Based on mRECIST and RECIST v1.1 Assessed by IIR and Based on mRECIST Assessed by Investigator Review
Time frame: From date of first dose of study drug until PD (up to 46.2 months)
DLT+Expansion Part: Time-to-Response (TTR) Based on mRECIST Assessed by IIR
Time frame: From date of first dose of study drug until CR or PR (up to 46.2 months)
DLT+Expansion Part: Time-to-Response (TTR) Based on RECIST v1.1 Assessed by IIR
Time frame: From date of first dose of study drug until CR or PR (up to 46.2 months)
DLT+Expansion Part: Time-to-Response (TTR) Based on mRECIST Assessed by Investigator Review
Time frame: From date of first dose of study drug until CR or PR (up to 46.2 months)
DLT+Expansion Part: Overall Survival (OS)
Time frame: From the date of first dose of study drug until date of death from any cause (up to 48.1 months)
DLT+Expansion Part, Cmax: Maximum Observed Plasma Concentration for Lenvatinib
Time frame: Cycle 1 Day 1: 0-24 hours post-dose (Cycle length=21 days)
DLT+Expansion Part, Tmax: Time to Reach the Cmax for Lenvatinib
Time frame: Cycle 1 Day 1: 0-24 hours post-dose (Cycle length=21 days)
DLT+Expansion Part, AUC(0-t): Area Under the Plasma Concentration-time Curve From Zero Time to the Last Measurable Point for Lenvatinib
Time frame: Cycle 1 Day 1: 0-24 hours post-dose (Cycle length=21 days)
DLT+Expansion Part, AUC(0-ti): Area Under The Plasma Concentration-time Curve From Zero (Pre-Dose) to a Given Sampling Time (ti) for Lenvatinib
Time frame: Cycle 1 Days 1 and 15: 0-8 hours post-dose (Cycle length=21 days)
DLT+Expansion Part, AUC(0-Inf): Area Under the Plasma Concentration-time Curve From Zero to Infinity for Lenvatinib
Time frame: Cycle 1 Days 1 and 15: 0-24 hours post-dose (Cycle length=21 days)
DLT+Expansion Part, t1/2: Terminal Elimination Phase Half-Life for Lenvatinib
Time frame: Cycle 1 Days 1 and 15: 0-24 hours post-dose (Cycle length=21 days)
DLT+Expansion Part, CL/F: Apparent Total Clearance for Lenvatinib
Time frame: Cycle 1 Day 15: 0-24 hours post-dose (Cycle length=21 days)
DLT+Expansion Part, Vz/F: Apparent Terminal Volume of Distribution for Lenvatinib
Time frame: Cycle 1 Day 1: 0-24 hours post-dose (Cycle length=21 days)
DLT+Expansion Part, Css,Max: Maximum Observed Plasma Concentration at Steady State for Lenvatinib
Time frame: Cycle 1 Day 15: 0-24 hours post-dose (Cycle length=21 days)
DLT+Expansion Part, Css,Min: Minimum Observed Plasma Concentration at Steady State for Lenvatinib
Time frame: Cycle 1 Day 15: 0-24 hours post-dose (Cycle length=21 days)
DLT+Expansion Part, Tss,Max: Time to Maximum Observed Concentration at Steady State For Lenvatinib
Time frame: Cycle 1 Day 15: 0-24 hours post-dose (Cycle length=21 days)
DLT+Expansion Part, AUC(0-tau): Area Under the Plasma Concentration-time Curve Over the Dosing Interval for Lenvatinib
Time frame: Cycle 1 Day 15: 0-24 hours post-dose (Cycle length=21 days)
DLT+Expansion Part, Clss/F: Apparent Total Clearance Following Oral Administration at Steady State for Lenvatinib
Time frame: Cycle 1 Day 15: 0-24 hours post-dose (Cycle length=21 days)
DLT+Expansion Part, Css,Av: Average Steady State Plasma Concentration for Lenvatinib
Time frame: Cycle 1 Day 15: 0-24 hours post-dose (Cycle length=21 days)
DLT+Expansion Part, Vz,ss/F: Apparent Terminal Volume of Distribution at Steady State for Lenvatinib
Time frame: Cycle 1 Day 15: 0-24 hours post-dose (Cycle length=21 days)
DLT+Expansion Part, Rac (Cmax): Accumulation Ratio of Cmax for Lenvatinib
Time frame: Cycle 1 Days 1 and 15: 0-24 hours post-dose (Cycle length=21 days)
DLT+Expansion Part, Rac (AUC0-8 Hour): Accumulation Ratio of AUC(0-8 Hour) for Lenvatinib
Time frame: Cycle 1 Days 1 and 15: 0-8 hours post-dose (Cycle length=21 days)
DLT+Expansion Part, %PTF: Percent (%) Peak-trough Fluctuation for Lenvatinib
Time frame: Cycle 1 Day 15: 0-24 hours post-dose (Cycle length=21 days)
DLT+Expansion Part, Ctrough: Trough (Pre-dose) Serum Concentration for Pembrolizumab
Time frame: Cycles 1, 2, 4, 6, 8, 12, 16, 20, 24, 28, 32, 36: Pre-dose (each Cycle length=21 days)
DLT+Expansion Part: Number of Participants Positive for Serum Anti-drug Antibodies (ADA) Status
Time frame: Cycles 1 and 6 Day 1: Pre-dose (each cycle length=21 days)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 32716739Finn RS, Ikeda M, Zhu AX, Sung MW, Baron AD, Kudo M, Okusaka T, Kobayashi M, Kumada H, Kaneko S, Pracht M, Mamontov K, Meyer T, Kubota T, Dutcus CE, Saito K, Siegel AB, Dubrovsky L, Mody K, Llovet JM. Phase Ib Study of Lenvatinib Plus Pembrolizumab in Patients With Unresectable Hepatocellular Carcinoma. J Clin Oncol. 2020 Sep 10;38(26):2960-2970. doi: 10.1200/JCO.20.00808. Epub 2020 Jul 27.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
26 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing lenvatinib and pembrolizumab (200 mg) in people with Hepatocellular Carcinoma, run by Eisai Co., Ltd. at 26 sites in 7 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 26 sites in United States, Spain, France, Japan, Russia and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 31 Dec 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
DLT Part: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) (time frame: From first dose until 120 days after the last dose (up to 50.2 months)). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03006926, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Dec 2023.