Clinical trial NCT05375136: A Study of Lenvatinib in Combination With Pembrolizumab in Korean Patients
Official title: A Post Marketing Surveillance Study of Lenvatinib in Combination With Pembrolizumab in Korean Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Endometrial Neoplasms
Endometrium
Carcinoma
Renal Cell Carcinoma
Keywords: Lenvatinib
Pembrolizumab
Lead sponsor: Eisai Inc.
Sponsor class: INDUSTRY
First posted: 2022-05-16
Enrollment: 135
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Number of Participants With Serious Adverse Events (SAEs)
timeFrame: From the first dose of the study drug up to 48 weeks
measure: Number of Participants With Serious Adverse Drug Reactions (ADRs)
timeFrame: From the first dose of the study drug up to 48 weeks
measure: Number of Participants With Unexpected AEs
timeFrame: From the first dose of the study drug up to 48 weeks
measure: Number of Participants With Unexpected ADRs
timeFrame: From the first dose of the study drug up to 48 weeks
measure: Number of Participants With Known ADRs
timeFrame: From the first dose of the study drug up to 48 weeks
measure: Number of Participants With Non-serious ADRs
timeFrame: From the first dose of the study drug up to 48 weeks
Secondary outcomes:
measure: Percentage of Participants With a Best Overall Response (BOR) of Complete Response (CR), Partial Response (PR) and Stable Disease (SD) [Objective Response Rate (ORR)]
timeFrame: From the first dose of the study drug up to 48 weeks
Other outcomes:
Locations:
city: Bundang
country: Korea, Republic of
facility: Eisai Site #04
city: Busan
country: Korea, Republic of
facility: Eisai Site #02
city: Busan
country: Korea, Republic of
facility: Eisai Site #10
city: Busan
country: Korea, Republic of
facility: Eisai Site #17
city: Daegu
country: Korea, Republic of
facility: Eisai Site #06
city: Ilsan
country: Korea, Republic of
facility: Eisai Site #03
city: Jeonju
country: Korea, Republic of
facility: Eisai Site #05
city: Seoul
country: Korea, Republic of
facility: Eisai Site #08
city: Seoul
country: Korea, Republic of
facility: Eisai Site #09
city: Seoul
country: Korea, Republic of
facility: Eisai Site #11
city: Seoul
country: Korea, Republic of
facility: Eisai Site #12
city: Seoul
country: Korea, Republic of
facility: Eisai Site #13
city: Seoul
country: Korea, Republic of
facility: Eisai Site #14
city: Seoul
country: Korea, Republic of
facility: Eisai Site #15
city: Seoul
country: Korea, Republic of
facility: Eisai Site #16
city: Seoul
country: Korea, Republic of
facility: Eisai Site #19
city: Seoul
country: Korea, Republic of
facility: Eisai Site #21
city: Seoul
country: Korea, Republic of
facility: Eisai Site #22
city: Seoul
country: Korea, Republic of
facility: Eisai Site #23
Study officials:
References: