A Study of Lenvatinib in Combination With Pembrolizumab in Korean Patients

NCT ID: NCT05375136

Last Updated: 2024-03-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

135 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-06-25

Study Completion Date

2023-11-07

Brief Summary

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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.

Detailed Description

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Conditions

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Endometrial Neoplasms Endometrium Carcinoma Renal Cell Carcinoma

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

Non-interventional

Intervention Type OTHER

No intervention will be administered.

Interventions

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Non-interventional

No intervention will be administered.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Eisai Korea Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Eisai Site #04

Bundang, , South Korea

Site Status

Eisai Site #02

Busan, , South Korea

Site Status

Eisai Site #10

Busan, , South Korea

Site Status

Eisai Site #17

Busan, , South Korea

Site Status

Eisai Site #06

Daegu, , South Korea

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Eisai Site #03

Ilsan, , South Korea

Site Status

Eisai Site #05

Jeonju, , South Korea

Site Status

Eisai Site #08

Seoul, , South Korea

Site Status

Eisai Site #09

Seoul, , South Korea

Site Status

Eisai Site #11

Seoul, , South Korea

Site Status

Eisai Site #12

Seoul, , South Korea

Site Status

Eisai Site #13

Seoul, , South Korea

Site Status

Eisai Site #14

Seoul, , South Korea

Site Status

Eisai Site #15

Seoul, , South Korea

Site Status

Eisai Site #16

Seoul, , South Korea

Site Status

Eisai Site #19

Seoul, , South Korea

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Eisai Site #21

Seoul, , South Korea

Site Status

Eisai Site #22

Seoul, , South Korea

Site Status

Eisai Site #23

Seoul, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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E7080-M065-513

Identifier Type: -

Identifier Source: org_study_id

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