Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| All Participants | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Non-interventional | Other | No intervention will be administered. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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 |
| 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 |
| 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 |
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
1. Currently receiving lenvatinib and pembrolizumab as part of a clinical trial
Not provided
Not provided
Not provided
Korean participants who are prescribed with lenvatinib in combination with pembrolizumab per the approved prescribing information will be enrolled in the study.
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Eisai Site #04 | Bundang | South Korea | ||||
| Eisai Site #02 |
Eisai's data sharing commitment and further information on how to request data can be found on our website http://eisaiclinicaltrials.com/.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 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. | From the first dose of the study drug up to 48 weeks |
| 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 |
| ID | Term |
|---|---|
| D016889 | Endometrial Neoplasms |
| D002277 | Carcinoma |
| D002292 | Carcinoma, Renal Cell |
| ID | Term |
|---|---|
| D014594 | Uterine Neoplasms |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D000230 | Adenocarcinoma |
| D007680 | Kidney Neoplasms |
| D014571 | Urologic Neoplasms |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052801 | Male Urogenital Diseases |
Not provided
Not provided