Lenvatinib and Pembrolizumab Simultaneous Combination Study (Lenva+Pembro)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03609359|
Recruitment Status : Recruiting
First Posted : August 1, 2018
Last Update Posted : October 17, 2018
|Condition or disease||Intervention/treatment||Phase|
|Advanced Gastric Cancer||Drug: Lenvatinib Drug: Pembrolizumab||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||29 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||An Open Label Phase 2 Study to Evaluate the Safety and Efficacy of Lenvatinib With Pembrolizumab in Patients With Advanced Gastric Cancer|
|Actual Study Start Date :||October 15, 2018|
|Estimated Primary Completion Date :||June 30, 2020|
|Estimated Study Completion Date :||December 31, 2021|
Experimental: Lenvatinib + Pembrolizumab
Lenvatinib and Pembrolizumab will be administrated simultaneously for advanced gastric cancer patients.
Lenvatinib will be administered with water orally once a day (with or without food) in 21-day cycles at approximately the same time each day. On Day 1 of each cycle, in case concomitantly administered, it will be administered approximately within 1 hour after completion of pembrolizumab administration.
Other Name: E7080
Pembrolizumab will be administered as a dose of 200 mg as a 30-minute IV infusion, Q3W (25 minutes to 40 minutes are acceptable).
Other Name: MK3475
- 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
- The incidences and types of adverse events [ Time Frame: 1 year 9months ]The incidences and types of adverse events that occur during treatment will be evaluated according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
- Objective response rate according to immune-related (ir) RECIST [ Time Frame: 1 year 9months ]Objective response rate according to immune-related (ir) RECIST
- Progression-free survival (PFS) [ Time Frame: 1 year 9months ]Progression-free survival (PFS)
- Overall survival (OS) [ Time Frame: 1 year 9months ]Overall survival (OS)
- Disease control rate (DCR) [ Time Frame: 1 year 9months ]Disease control rate (DCR)
- Tests of various biomarkers [ Time Frame: 1 year 9months ]Tests of various biomarkers
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03609359
|Contact: Shota Fukuoka, Dr||+81-4-7133-1111 ext 91283||LenvaPembro_core@east.ncc.go.jp|
|Contact: Akihito Kawazoe, Dr||+81-4-7133-1111 ext 91588||LenvaPembro_core@east.ncc.go.jp|
|Kashiwa, Tokyo, Japan, 2778577|
|Contact: Shota Fukuoka, Dr +81-4-7133-1111 ext 91283 firstname.lastname@example.org|
|Contact: Akihito Kawazoe, Dr +81-4-7133-1111 ext 91588 email@example.com|
|Principal Investigator:||Kohei Shitara, Dr||National Cancer Center Hospital East|