A Study of Lenvatinib in Combination With Pembrolizumab in Korean Patients

March 22, 2024 updated by: Eisai Korea Inc.

A Post Marketing Surveillance Study of Lenvatinib in Combination With Pembrolizumab in Korean Patients

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

135

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Korea, Republic of
      • Bundang, Korea, Republic of
        • Eisai Site #04
      • Busan, Korea, Republic of
        • Eisai Site #02
      • Busan, Korea, Republic of
        • Eisai Site #10
      • Busan, Korea, Republic of
        • Eisai Site #17
      • Daegu, Korea, Republic of
        • Eisai Site #06
      • Ilsan, Korea, Republic of
        • Eisai Site #03
      • Jeonju, Korea, Republic of
        • Eisai Site #05
      • Seoul, Korea, Republic of
        • Eisai Site #13
      • Seoul, Korea, Republic of
        • Eisai Site #08
      • Seoul, Korea, Republic of
        • Eisai Site #09
      • Seoul, Korea, Republic of
        • Eisai Site #11
      • Seoul, Korea, Republic of
        • Eisai Site #12
      • Seoul, Korea, Republic of
        • Eisai Site #14
      • Seoul, Korea, Republic of
        • Eisai Site #15
      • Seoul, Korea, Republic of
        • Eisai Site #16
      • Seoul, Korea, Republic of
        • Eisai Site #19
      • Seoul, Korea, Republic of
        • Eisai Site #21
      • Seoul, Korea, Republic of
        • Eisai Site #22
      • Seoul, Korea, Republic of
        • Eisai Site #23

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Korean participants who are prescribed with lenvatinib in combination with pembrolizumab per the approved prescribing information will be enrolled in the study.

Description

Inclusion Criteria:

  1. Greater than (>) 18 years
  2. Considered by the treating physician for lenvatinib/pembolizumab combination therapy for the approved indications in Korea, prior to study
  3. Provided written consent for use of personal medical information for the study purpose
  4. Meets the approved indication and none of the contraindications for lenvatinib/pembrolizumab combination therapy in Korea, as confirmed by the treating physician

Exclusion Criteria:

1. Currently receiving lenvatinib and pembrolizumab as part of a clinical trial

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
Other: Non-interventional
No intervention will be administered.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants With Serious Adverse Events (SAEs)
Time Frame: From the first dose of the study drug up to 48 weeks
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)
Time Frame: From the first dose of the study drug up to 48 weeks
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
Time Frame: From the first dose of the study drug up to 48 weeks
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
Time Frame: From the first dose of the study drug up to 48 weeks
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
Time Frame: From the first dose of the study drug up to 48 weeks
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
Time Frame: From the first dose of the study drug up to 48 weeks
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants With a Best Overall Response (BOR) of Complete Response (CR), Partial Response (PR) and Stable Disease (SD) [Objective Response Rate (ORR)]
Time Frame: From the first dose of the study drug up to 48 weeks
ORR is defined as the percentage of participants with BOR of CR, PR and SD as determined by investigator.
From the first dose of the study drug up to 48 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Eisai Korea Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 25, 2021

Primary Completion (Actual)

November 7, 2023

Study Completion (Actual)

November 7, 2023

Study Registration Dates

First Submitted

May 10, 2022

First Submitted That Met QC Criteria

May 10, 2022

First Posted (Actual)

May 16, 2022

Study Record Updates

Last Update Posted (Actual)

March 25, 2024

Last Update Submitted That Met QC Criteria

March 22, 2024

Last Verified

July 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • E7080-M065-513

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Eisai's data sharing commitment and further information on how to request data can be found on our website http://eisaiclinicaltrials.com/.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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