Lenvatinib and Pembrolizumab Simultaneous Combination Study (Lenva+Pembro)
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ClinicalTrials.gov Identifier: NCT03609359 |
Recruitment Status :
Completed
First Posted : August 1, 2018
Last Update Posted : April 26, 2021
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Tracking Information | |||||
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First Submitted Date ICMJE | July 23, 2018 | ||||
First Posted Date ICMJE | August 1, 2018 | ||||
Last Update Posted Date | April 26, 2021 | ||||
Actual Study Start Date ICMJE | October 15, 2018 | ||||
Actual Primary Completion Date | March 25, 2019 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
Objective response rate (ORR) according to Response Evaluation Criteria in Solid Tumours (RECIST) version. 1.1, and immune-related (ir) RECIST [ Time Frame: 1 year 9months ] Objective response rate (ORR) according to Response Evaluation Criteria in Solid Tumours (RECIST) version. 1.1, and immune-related (ir) RECIST
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Original Primary Outcome Measures ICMJE | Same as current | ||||
Change History | |||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | ||||
Current Other Pre-specified Outcome Measures |
Tests of various biomarkers [ Time Frame: 1 year 9months ] Tests of various biomarkers
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Original Other Pre-specified Outcome Measures | Same as current | ||||
Descriptive Information | |||||
Brief Title ICMJE | Lenvatinib and Pembrolizumab Simultaneous Combination Study | ||||
Official Title ICMJE | An Open Label Phase 2 Study to Evaluate the Safety and Efficacy of Lenvatinib With Pembrolizumab in Patients With Advanced Gastric Cancer | ||||
Brief Summary | The efficacy and safety of the use of pembrolizumab in combination with lenvatinib. | ||||
Detailed Description | In this study, if combination therapy with lenvatinib and pembrolizumab in patients with gastric cancer is judged to be effective, a prospective treatment regimen can be expected for a larger number of participating subjects. The anticipated disadvantages include any adverse events associated with lenvatinib and pembrolizumab. To minimize the risk and disadvantages of adverse events, the data center together with the Data and Safety Monitoring Committee will monitor any adverse events in the present trial to determine whether or not they are within the expected range. These bodies will also conduct a thorough examination in the event that serious or unexpected adverse events occur, and adopt an appropriate system to take any necessary actions. |
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Study Type ICMJE | Interventional | ||||
Study Phase ICMJE | Phase 2 | ||||
Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE | Advanced Gastric Cancer | ||||
Intervention ICMJE |
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Study Arms ICMJE | Experimental: Lenvatinib + Pembrolizumab
Lenvatinib and Pembrolizumab will be administrated simultaneously for advanced gastric cancer patients.
Interventions:
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Publications * | Kawazoe A, Fukuoka S, Nakamura Y, Kuboki Y, Wakabayashi M, Nomura S, Mikamoto Y, Shima H, Fujishiro N, Higuchi T, Sato A, Kuwata T, Shitara K. Lenvatinib plus pembrolizumab in patients with advanced gastric cancer in the first-line or second-line setting (EPOC1706): an open-label, single-arm, phase 2 trial. Lancet Oncol. 2020 Aug;21(8):1057-1065. doi: 10.1016/S1470-2045(20)30271-0. Epub 2020 Jun 23. | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Completed | ||||
Actual Enrollment ICMJE |
29 | ||||
Original Estimated Enrollment ICMJE | Same as current | ||||
Actual Study Completion Date ICMJE | April 1, 2021 | ||||
Actual Primary Completion Date | March 25, 2019 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 20 Years and older (Adult, Older Adult) | ||||
Accepts Healthy Volunteers ICMJE | No | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Listed Location Countries ICMJE | Japan | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number ICMJE | NCT03609359 | ||||
Other Study ID Numbers ICMJE | EPOC 1706 study | ||||
Has Data Monitoring Committee | No | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE | Not Provided | ||||
Current Responsible Party | Kohei Shitara, National Cancer Center Hospital East | ||||
Original Responsible Party | Same as current | ||||
Current Study Sponsor ICMJE | National Cancer Center Hospital East | ||||
Original Study Sponsor ICMJE | Same as current | ||||
Collaborators ICMJE |
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Investigators ICMJE |
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PRS Account | National Cancer Center Hospital East | ||||
Verification Date | April 2021 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |