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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: Completed Phase 3 study, sponsored by Merck Sharp & Dohme.
NCT03713593 is a Phase 3 study that has completed, run by Merck Sharp & Dohme. The registered enrollment target is 794 participants, roughly in line with the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
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).
Primary Outcome
PFS was defined as the time from the date of the first documentation of disease progression, as determined by blinded independent central review (BICR) per RECIST 1.1 or death due to any cause (whichever occurred first). Disease progression was defined as at least 20 percent (%) increase (including an absolute increase of at least 5 millimeter \[mm\]) in the sum of diameter of target lesions, taking as reference the smallest sum and/or unequivocal progression of existing non-target lesions and/o
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 |
What the finished NCT03713593 record still lists
NCT03713593 is an interventional study that assigns participants to a tested intervention. The registered 794 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target.
The record links to 0 conditions, and to 3 interventions - of which pembrolizumab is the first listed.
NCT03713593 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03713593's enrollment target sits among peer trials
794 429th of 2000 higher than 1,572 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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