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Completed

NCT Number: NCT05375136

A Study of Lenvatinib in Combination With Pembrolizumab in Korean Patients

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.

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Key information

Conditions

Endometrial Neoplasms Adenocarcinoma Carcinoma Carcinoma, Renal Cell Endometrium Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Kidney Diseases Kidney Neoplasms Male Urogenital Diseases Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Renal Cell Carcinoma Urogenital Diseases Urogenital Neoplasms Urologic Diseases Urologic Neoplasms Uterine Diseases Uterine Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Eisai Site #04, Bundang, South Korea

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Greater than (>) 18 years
  • Considered by the treating physician for lenvatinib/pembolizumab combination therapy for the approved indications in Korea, prior to study
  • Provided written consent for use of personal medical information for the study purpose
  • Meets the approved indication and none of the contraindications for lenvatinib/pembrolizumab combination therapy in Korea, as confirmed by the treating physician

Exclusion criteria

  • Currently receiving lenvatinib and pembrolizumab as part of a clinical trial

Treatment and study plan

Non-Interventional

Other

No intervention will be administered.

Primary outcomes

  1. Number of Participants With Serious Adverse Events (SAEs)

    Time frame: From the first dose of the study drug up to 48 weeks

    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.

  2. Number of Participants With Serious Adverse Drug Reactions (ADRs)

    Time frame: From the first dose of the study drug up to 48 weeks

    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.

  3. Number of Participants With Unexpected AEs

    Time frame: From the first dose of the study drug up to 48 weeks

    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.

  4. Number of Participants With Unexpected ADRs

    Time frame: From the first dose of the study drug up to 48 weeks

    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.

  5. Number of Participants With Known ADRs

    Time frame: From the first dose of the study drug up to 48 weeks

    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.

  6. Number of Participants With Non-serious ADRs

    Time frame: From the first dose of the study drug up to 48 weeks

    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.

Secondary outcomes

  1. Percentage of Participants With a Best Overall Response (BOR) of Complete Response (CR), Partial Response (PR) and Stable Disease (SD) [Objective Response Rate (ORR)]

    Time frame: From the first dose of the study drug up to 48 weeks

    ORR is defined as the percentage of participants with BOR of CR, PR and SD as determined by investigator.

Sponsors and collaborators

Lead sponsor

Eisai Korea Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
May 16, 2022
Registry last updated
Mar 25, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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