A Study of Lenvatinib in Combination With Pembrolizumab in Korean Patients

Eisai

Status: Completed

Conditions: Endometrium; Carcinoma; Renal Cell Carcinoma; Endometrial Neoplasms

Treatments: Other: Non-interventional

Study type: Observational

Funder types: Industry

Identifiers

NCT05375136

E7080-M065-513

Details and patient eligibility

About

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.

Enrollment: 135 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

135 participants in 1 patient group

All Participants

Description:

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.

Treatment:

Other: Non-interventional