Endometrial NeoplasmsNCT05375136
A Study of Lenvatinib in Combination With Pembrolizumab in Korean Patients
An observational study of Endometrial Neoplasms and Endometrium, run by Eisai Korea Inc. at 19 sites in South Korea.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Endometrial Neoplasms, Endometrium, Carcinoma
- What is being tested?
- Non-interventional
- How many people
- 135 participants
- Where
- 19 sitesSouth Korea
- Study dates
- 25 Jun 2021to 7 Nov 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Korean participants who are prescribed with lenvatinib in combination with pembrolizumab per the approved prescribing information will be enrolled in the study.
Who may be able to join
- 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
Who cannot join
- 1. Currently receiving lenvatinib and pembrolizumab as part of a clinical trial
Trial locations and contacts
19 sites in 1 country.
19 sites in 1 country
South Korea19 sites
Eisai Site #04
Bundang
Eisai Site #02
Busan
Eisai Site #10
Busan
Eisai Site #17
Busan
Eisai Site #06
Daegu
Eisai Site #03
Ilsan
Eisai Site #05
Jeonju
Eisai Site #08
Seoul
Eisai Site #09
Seoul
Eisai Site #11
Seoul
Eisai Site #12
Seoul
Eisai Site #13
Seoul
Eisai Site #14
Seoul
Eisai Site #15
Seoul
Eisai Site #16
Seoul
Eisai Site #19
Seoul
Eisai Site #21
Seoul
Eisai Site #22
Seoul
Eisai Site #23
Seoul
About this study
Official title: A Post Marketing Surveillance 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.
- Conditions
- Endometrial Neoplasms, Endometrium, Carcinoma, Renal Cell Carcinoma
- Being tested
- Non-interventional
- Keywords
- Lenvatinib, Pembrolizumab
- Medical subject headings
- Endometrial Neoplasms, Carcinoma, Carcinoma, Renal Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-interventionalOther
No intervention will be administered.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Non-interventional |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: From the first dose of the study drug up to 48 weeks
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)]
ORR is defined as the percentage of participants with BOR of CR, PR and SD as determined by investigator.
Measured: From the first dose of the study drug up to 48 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2022
- Study start25 Jun 2021
- Primary completion7 Nov 2023
- Study completion7 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Endometrial NeoplasmsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 135 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eisai Korea Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05375136
- Sponsor's protocol ID
- E7080-M065-513
- Status last verified
- Jul 2023
- First submitted
- 10 May 2022
- Last updated
- 25 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Eisai's data sharing commitment and further information on how to request data can be found on our website http://eisaiclinicaltrials.com/.
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Post Marketing Surveillance Study of Lenvatinib in Combination With Pembrolizumab in Korean Patients
- ClinicalTrials.gov ID
- NCT05375136
- Acronym / sponsor ID
- E7080-M065-513
- Conditions
- Endometrial Neoplasms, Endometrium, Carcinoma, Renal Cell Carcinoma
- Keywords
- Lenvatinib, Pembrolizumab
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 135 participants (actual)
- Lead sponsor
- Eisai Korea Inc.Industry (pharma, biotech, devices)
- Study start
- 25 Jun 2021 (actual)
- Primary completion
- 7 Nov 2023 (actual)
- Study completion
- 7 Nov 2023 (actual)
- First posted
- 16 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All Participants | – | Other: Non-interventionalParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Korean participants who are prescribed with lenvatinib in combination with pembrolizumab per the approved prescribing information will be enrolled in the study.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- 1. Currently receiving lenvatinib and pembrolizumab as part of a clinical trial
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Non-interventionalNo intervention will be administered. | Other | All Participants |
Primary outcome
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.
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.
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.
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.
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.
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.
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2024.
- Individual participant dataSharing planned: Yes. Eisai's data sharing commitment and further information on how to request data can be found on our website http://eisaiclinicaltrials.com/.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
19 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Endometrial Neoplasms and Endometrium, run by Eisai Korea Inc. at 19 sites in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Serious Adverse Events (SAEs) (time frame: From the first dose of the study drug up to 48 weeks). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2024.