A Study of Lenvatinib in Combination With Pembrolizumab in Korean Patients

Study Overview
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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.

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

Conditions
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Endometrial Neoplasms, Endometrium, Carcinoma, Renal Cell Carcinoma

Intervention / Treatment
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* Other: Non-interventional


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 1. Currently receiving lenvatinib and pembrolizumab as part of a clinical trial

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| All Participants<br>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<br>* No intervention will be administered.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 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)] | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Lenvatinib, Pembrolizumab