A Post Marketing Surveillance Study of Lenvatinib in Combination With Pembrolizumab in Korean Patients
| Registry | NCT05375136 |
|---|---|
| Status | Completed |
| Study type | Observational |
| Enrollment | 135 (Actual) |
| Sponsor | Eisai Korea Inc. (Industry) |
| Conditions | Endometrial Neoplasms, Endometrium, Carcinoma, Renal Cell Carcinoma |
| Interventions | Non-interventional (Other) |
| Dates | start 2021-06-25, primary completion 2023-11-07, completion 2023-11-07, first posted 2022-05-16, last updated 2024-03-25 |
| Locations | 19 sites in South Korea |
Related Papers Related Patents Related Grants Related Experts
All trials for Endometrial Neoplasms All trials for Endometrium All trials of Non-interventional
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| All Participants | Other: Non-interventional | 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. |
Sex: All, ages: 18 Years to any
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
| Facility | City | Country | Status |
|---|---|---|---|
| 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 |