Trials / Completed
CompletedNCT03609359
Lenvatinib and Pembrolizumab Simultaneous Combination Study
An Open Label Phase 2 Study to Evaluate the Safety and Efficacy of Lenvatinib With Pembrolizumab in Patients With Advanced Gastric Cancer
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 29 (actual)
- Sponsor
- National Cancer Center Hospital East · Academic / Other
- Sex
- All
- Age
- 20 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Lenvatinib | 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. |
| DRUG | Pembrolizumab | Pembrolizumab will be administered as a dose of 200 mg as a 30-minute IV infusion, every 3 weeks (25 minutes to 40 minutes are acceptable). |
Timeline
- Start date
- 2018-10-03
- Primary completion
- 2021-04-30
- Completion
- 2021-04-30
- First posted
- 2018-08-01
- Last updated
- 2025-04-16
- Results posted
- 2025-04-16
Locations
1 site across 1 country: Japan
Source: ClinicalTrials.gov record NCT03609359. Inclusion in this directory is not an endorsement.