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NCT03713593 · ClinicalTrials.gov registry record · Phase 3
Safety and Efficacy of Lenvatinib (E7080/MK-7902) in Combination With Pembrolizumab (MK-3475) Versus Lenvatinib as First-line Therapy in Participants With Advanced Hepatocellular Carcinoma (MK-7902-002/E7080-G000-311/LEAP-002)
A Phase 3 study, sponsored by Merck Sharp & Dohme.
- Completed
- Registry status
- Phase 3
- Development phase
- 794
- Enrollment target
NCT03713593 is a Phase 3 study that has completed, run by Merck Sharp & Dohme. The registered enrollment target is 794 participants.
The verdict
NCT03713593, a Phase 3 study, has completed, sponsored by Merck Sharp & Dohme.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 794 participants
- Enrollment target
Study Summary
The purpose of this study is to evaluate the safety and efficacy of lenvatinib (E7080/MK-7902) in combination with pembrolizumab (MK-3745) versus lenvatinib in combination with placebo as first-line therapy for the treatment of advanced hepatocellular carcinoma in adult participants. The primary hypotheses of this study are that lenvatinib plus pembrolizumab is superior to lenvatinib plus placebo with respect to progression-free survival (PFS) and overall survival (OS).
Interventions
- BIOLOGICAL pembrolizumab
- DRUG saline placebo
- DRUG lenvatinib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 794 participants |
| Start Date | 2018-12-31 |
| Est. Completion | 2024-09-24 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03713593
The ClinicalTrials.gov registry entry for NCT03713593 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 794 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Merck Sharp & Dohme, which has 558 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which pembrolizumab is the first listed.
NCT03713593 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03713593 about?
NCT03713593 is a clinical study titled "Safety and Efficacy of Lenvatinib (E7080/MK-7902) in Combination With Pembrolizumab (MK-3475) Versus Lenvatinib as First-line Therapy in Participants With Advanced Hepatocellular Carcinoma (MK-7902-002/E7080-G000-311/LEAP-002)". The purpose of this study is to evaluate the safety and efficacy of lenvatinib (E7080/MK-7902) in combination with pembrolizumab (MK-3745) versus lenvatinib in combination with placebo as first-line therapy for the treatment of advanced hepatocellular carcinoma in adult participants. The primary hy...
What is the current status of trial NCT03713593?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 794 participants. The study started on 2018-12-31. Estimated completion is 2024-09-24.
What interventions are being tested in trial NCT03713593?
The interventions under investigation include: pembrolizumab (BIOLOGICAL), saline placebo (DRUG), lenvatinib (DRUG).
Who is sponsoring clinical trial NCT03713593?
This trial is sponsored by Merck Sharp & Dohme, which has 558 total clinical trials registered on ClinicalTrials.gov.
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