A Study of Lenvatinib in Combination With Pembrolizumab in Korean Patients

Renal Cell Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05375136
• Other study ID #: E7080-M065-513
• Status: Completed
• Start date: June 25, 2021
• Est. completion date: November 7, 2023

Study information

• Verified date: July 2023
• Source: Eisai Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 135
• Est. completion date: November 7, 2023
• Est. primary completion date: November 7, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Renal Cell
• Endometrial Neoplasms
• Endometrium
• Renal Cell Carcinoma

Intervention

Other:
• Non-interventional
No intervention will be administered.

Locations

Country	Name	City	State
Korea, Republic of	Eisai Site #04	Bundang
Korea, Republic of	Eisai Site #02	Busan
Korea, Republic of	Eisai Site #10	Busan
Korea, Republic of	Eisai Site #17	Busan
Korea, Republic of	Eisai Site #06	Daegu
Korea, Republic of	Eisai Site #03	Ilsan
Korea, Republic of	Eisai Site #05	Jeonju
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 #13	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	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Eisai Korea Inc.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	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