A Study of Lenvatinib in Combination With Pembrolizumab in Korean Patients
A Post Marketing Surveillance Study of Lenvatinib in Combination With Pembrolizumab in Korean Patients
1 other identifier
observational
135
1 country
19
Brief Summary
The purpose of this study is to collect and evaluate the following information in relation to the safety and the efficacy of Lenvatinib in lenvatinib/pembrolizumab combination therapy in the post marketing setting: (1) Serious adverse events and serious adverse drug reactions (2) Unexpected adverse events and adverse drug reactions not reflected in the approved product package insert of lenvatinib in lenvatinib/pembrolizumab combination therapy (3) Known adverse drug reactions (4) Non-serious adverse drug reactions (5) Other safety and efficacy related information.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Jun 2021
Typical duration for all trials
19 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 25, 2021
CompletedFirst Submitted
Initial submission to the registry
May 10, 2022
CompletedFirst Posted
Study publicly available on registry
May 16, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 7, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
November 7, 2023
CompletedMarch 25, 2024
July 1, 2023
2.4 years
May 10, 2022
March 22, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (6)
Number of Participants With Serious Adverse Events (SAEs)
A SAE is defined as any untoward medical occurrence: resulting in death; life threatening requiring hospitalization or prolongation of hospitalization; resulting in persistent or significant disability or incapacity; resulting in birth defect or congenital anomaly or medically important due to other reasons than above mentioned criteria.
From the first dose of the study drug up to 48 weeks
Number of Participants With Serious Adverse Drug Reactions (ADRs)
An ADR is defined as harmful and unintended responses to the normal administration/use of drugs, in which a causal relationship with the drug in question cannot be ruled out. Adverse events (AEs) with unknown causality to the drug among those voluntarily reported will be also considered ADRs.
From the first dose of the study drug up to 48 weeks
Number of Participants With Unexpected AEs
An AE is defined as any untoward and unintended signs (.example, anomalies in laboratory test results) or symptoms/diseases occurring during administration/use of drugs, etc., which do not necessarily have a causal relationship with the drug in question.
From the first dose of the study drug up to 48 weeks
Number of Participants With Unexpected ADRs
An ADR is defined as harmful and unintended responses to the normal administration/use of drugs, in which a causal relationship with the drug in question cannot be ruled out. AEs with unknown causality to the drug among those voluntarily reported will be also considered ADRs.
From the first dose of the study drug up to 48 weeks
Number of Participants With Known ADRs
An ADR is defined as harmful and unintended responses to the normal administration/use of drugs, in which a causal relationship with the drug in question cannot be ruled out. AEs with unknown causality to the drug among those voluntarily reported will be also considered ADRs.
From the first dose of the study drug up to 48 weeks
Number of Participants With Non-serious ADRs
An ADR is defined as harmful and unintended responses to the normal administration/use of drugs, in which a causal relationship with the drug in question cannot be ruled out. AEs with unknown causality to the drug among those voluntarily reported will be also considered ADRs.
From the first dose of the study drug up to 48 weeks
Secondary Outcomes (1)
Percentage of Participants With a Best Overall Response (BOR) of Complete Response (CR), Partial Response (PR) and Stable Disease (SD) [Objective Response Rate (ORR)]
From the first dose of the study drug up to 48 weeks
Study Arms (1)
All Participants
Participants who are prescribed with lenvatinib/pembrolizumab combination per approved prescribing information of lenvatinib and pembrolizumab in the post marketing setting will be enrolled and observed for up to 48 weeks or until clinical benefit or unacceptable toxicity occurs or discontinuation of therapy due to any reason, whichever occurs first.
Interventions
Eligibility Criteria
Korean participants who are prescribed with lenvatinib in combination with pembrolizumab per the approved prescribing information will be enrolled in the study.
You may qualify if:
- Greater than (\>) 18 years
- Considered by the treating physician for lenvatinib/pembolizumab combination therapy for the approved indications in Korea, prior to study
- Provided written consent for use of personal medical information for the study purpose
- Meets the approved indication and none of the contraindications for lenvatinib/pembrolizumab combination therapy in Korea, as confirmed by the treating physician
You may not qualify if:
- \. Currently receiving lenvatinib and pembrolizumab as part of a clinical trial
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Eisai Korea Inc.lead
Study Sites (19)
Eisai Site #04
Bundang, South Korea
Eisai Site #02
Busan, South Korea
Eisai Site #10
Busan, South Korea
Eisai Site #17
Busan, South Korea
Eisai Site #06
Daegu, South Korea
Eisai Site #03
Ilsan, South Korea
Eisai Site #05
Jeonju, South Korea
Eisai Site #08
Seoul, South Korea
Eisai Site #09
Seoul, South Korea
Eisai Site #11
Seoul, South Korea
Eisai Site #12
Seoul, South Korea
Eisai Site #13
Seoul, South Korea
Eisai Site #14
Seoul, South Korea
Eisai Site #15
Seoul, South Korea
Eisai Site #16
Seoul, South Korea
Eisai Site #19
Seoul, South Korea
Eisai Site #21
Seoul, South Korea
Eisai Site #22
Seoul, South Korea
Eisai Site #23
Seoul, South Korea
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 10, 2022
First Posted
May 16, 2022
Study Start
June 25, 2021
Primary Completion
November 7, 2023
Study Completion
November 7, 2023
Last Updated
March 25, 2024
Record last verified: 2023-07
Data Sharing
- IPD Sharing
- Will share
Eisai's data sharing commitment and further information on how to request data can be found on our website http://eisaiclinicaltrials.com/.