Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05375136
Other study ID # E7080-M065-513
Secondary ID
Status Completed
Phase
First received
Last updated
Start date June 25, 2021
Est. completion date November 7, 2023

Study information

Verified date July 2023
Source Eisai Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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 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.


Recruitment information / eligibility

Status Completed
Enrollment 135
Est. completion date November 7, 2023
Est. primary completion date November 7, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Intervention

Other:
Non-interventional
No intervention will be administered.

Locations

Country Name City State
Korea, Republic of Eisai Site #04 Bundang
Korea, Republic of Eisai Site #02 Busan
Korea, Republic of Eisai Site #10 Busan
Korea, Republic of Eisai Site #17 Busan
Korea, Republic of Eisai Site #06 Daegu
Korea, Republic of Eisai Site #03 Ilsan
Korea, Republic of Eisai Site #05 Jeonju
Korea, Republic of Eisai Site #08 Seoul
Korea, Republic of Eisai Site #09 Seoul
Korea, Republic of Eisai Site #11 Seoul
Korea, Republic of Eisai Site #12 Seoul
Korea, Republic of Eisai Site #13 Seoul
Korea, Republic of Eisai Site #14 Seoul
Korea, Republic of Eisai Site #15 Seoul
Korea, Republic of Eisai Site #16 Seoul
Korea, Republic of Eisai Site #19 Seoul
Korea, Republic of Eisai Site #21 Seoul
Korea, Republic of Eisai Site #22 Seoul
Korea, Republic of Eisai Site #23 Seoul

Sponsors (1)

Lead Sponsor Collaborator
Eisai Korea Inc.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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. From the first dose of the study drug up to 48 weeks
Primary 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
Secondary 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
See also
  Status Clinical Trial Phase
Active, not recruiting NCT04987203 - Study to Compare Tivozanib in Combination With Nivolumab to Tivozanib Monotherapy in Subjects With Renal Cell Carcinoma Phase 3
Recruiting NCT06391879 - Establishment of a Multidimensional Prediction Model for the Natural Course of VHL Disease-related Renal Cell Carcinoma
Completed NCT02526017 - Study of Cabiralizumab in Combination With Nivolumab in Patients With Selected Advanced Cancers Phase 1
Recruiting NCT05059444 - ORACLE: Observation of ResiduAl Cancer With Liquid Biopsy Evaluation
Terminated NCT03655613 - APL-501 or Nivolumab in Combination With APL-101 in Locally Advanced or Metastatic HCC and RCC Phase 1/Phase 2
Active, not recruiting NCT03170960 - Study of Cabozantinib in Combination With Atezolizumab to Subjects With Locally Advanced or Metastatic Solid Tumors Phase 1/Phase 2
Withdrawn NCT05418387 - A Social Support Intervention to Improve Treatment Among Hispanic Kidney and Liver Cancer Patients in Arizona N/A
Recruiting NCT04623502 - An Investigation of Kidney and Urothelial Tumor Metabolism in Patients Undergoing Surgical Resection and/or Biopsy N/A
Completed NCT02853344 - Study of Pembrolizumab (MK-3475) Monotherapy in Locally Advanced/Metastatic Renal Cell Carcinoma (MK-3475-427/KEYNOTE-427) Phase 2
Terminated NCT04088500 - A Study of Combination Nivolumab and Ipilimumab Retreatment in Patients With Advanced Renal Cell Carcinoma Phase 2
Completed NCT05070637 - Circulating Tumor Cell Reducing No-touch Nephrectomy N/A
Active, not recruiting NCT03634540 - A Trial of Belzutifan (PT2977, MK-6482) in Combination With Cabozantinib in Patients With Clear Cell Renal Cell Carcinoma (ccRCC) (MK-6482-003) Phase 2
Not yet recruiting NCT06049030 - A Study of HS-10516 in Patients With Advanced Clear Cell Renal Cell Carcinoma Phase 1
Completed NCT03652077 - A Safety and Tolerability Study of INCAGN02390 in Select Advanced Malignancies Phase 1
Completed NCT01358721 - Phase I Biomarker Study (BMS-936558) Phase 1
Active, not recruiting NCT04503148 - Anesthesia and Cancer Study: Renal Cell Carcinoma N/A
Completed NCT02386826 - INC280 Combined With Bevacizumab in Patients With Glioblastoma Multiforme Phase 1
Not yet recruiting NCT05808608 - A Study of AK104 Plus Axitinib in Advanced/Metastatic Special Pathological Subtypes of Renal Cell Carcinoma Phase 1/Phase 2
Withdrawn NCT03323710 - Study of Propranolol Plus Sunitinib in First-line Treatment of Metastatic Renal Cell Carcinoma Phase 2
Not yet recruiting NCT02787915 - DC1s-CTL Cellular Therapy for Renal Cell Carcinoma Phase 1/Phase 2