Trials / Completed
CompletedNCT03006926
A Trial of Lenvatinib Plus Pembrolizumab in Participants With Hepatocellular Carcinoma
An Open-Label Phase 1b Trial of Lenvatinib Plus Pembrolizumab in Subjects With Hepatocellular Carcinoma
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 104 (actual)
- Sponsor
- Eisai Co., Ltd. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This is an open-label Phase 1b study designed to evaluate the tolerability and safety of lenvatinib in combination with pembrolizumab in participants with hepatocellular carcinoma (HCC). The study will evaluate objective response rate and duration of response by modified Response Evaluation Criteria In Solid Tumors (mRECIST) for HCC and Response Evaluation Criteria In Solid Tumors (RECIST 1.1) based on independent imaging review (IIR).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | lenvatinib | 4 mg capsules |
| DRUG | pembrolizumab (200 mg) | 30-minute intravenous infusion |
Timeline
- Start date
- 2017-02-13
- Primary completion
- 2019-10-31
- Completion
- 2022-11-22
- First posted
- 2016-12-30
- Last updated
- 2023-12-13
- Results posted
- 2020-12-31
Locations
26 sites across 7 countries: United States, France, Italy, Japan, Russia, Spain, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03006926. Inclusion in this directory is not an endorsement.