A Study of Lenvatinib in Combination With Pembrolizumab in Korean Patients

NCT05375136CompletedOBSERVATIONAL

Summary

Key Facts

Lead Sponsor

Eisai Korea Inc.

Enrollment

135

Start Date

2021-06-25

Completion Date

2023-11-07

Study Type

OBSERVATIONAL

Official Title

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

Interventions

Non-interventional

Conditions

Endometrial NeoplasmsEndometriumCarcinomaRenal Cell Carcinoma

Eligibility

Age Range

18 Years+

Sex

ALL

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

Outcome Measures

Primary Outcomes

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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: From the first dose of the study drug up to 48 weeks

Secondary Outcomes

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.

Time frame: From the first dose of the study drug up to 48 weeks

Locations

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