CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 842 enrolled
Drug / intervention
Lenvatinib +3 moredrug
Likely dose
Lenvatinib 4 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03884101
NCT03884101Phase 3Completed
CompareCT.gov

A Phase 3 Randomized, Open-Label, Study of Pembrolizumab (MK-3475) Plus Lenvatinib (E7080/MK-7902) Versus Chemotherapy for First-line Treatment of Advanced or Recurrent Endometrial Carcinoma (LEAP-001)

Merck Sharp & Dohme LLC·interventional·Posted Mar 21, 2019·Updated Feb 2, 2026

In Brief

A Phase 3 clinical trial evaluating Lenvatinib, Pembrolizumab, and 2 other interventions for Endometrial Neoplasms. Completed, enrolled 842 participants across 195 sites in 22 countries.

Detailed Summary

The purpose of this study is to compare the efficacy of pembrolizumab + lenvatinib to chemotherapy in female participants with Stage III, IV, or recurrent endometrial carcinoma. It is hypothesized that the combination of pembrolizumab + lenvatinib will be superior to chemotherapy for progression-free survival (PFS) per Response Evaluation Criteria In Solid Tumors version 1.1 (RECIST 1.1) by blinded independent central review (BICR). It is also hypothesized that the combination of pembrolizumab + lenvatinib will be superior to chemotherapy for overall survival (OS). As of Amendment 7 eligible participants on study completion will be able to transition to an extension study, if available, in which they can continue to receive pembrolizumab monotherapy, lenvatinib monotherapy, or a combination of both pembrolizumab and lenvatinib as received in the parent study.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsEndometrial Neoplasms
CountriesArgentina, Australia, Austria, Belgium, Brazil, Canada, China, Germany, Ireland, Israel, Italy, Japan, Mexico, Poland, Russia, South Korea, Spain, Taiwan, Turkey (Türkiye), Ukraine, United Kingdom, United States
CollaboratorsEisai Inc.

Timeline

Phase 3CompletedFinished
2020202120222023202420252026
First PostedMar 21, 2019
Enrollment StartApr 11, 2019
Primary CompletionOct 2, 2023
Study CompletionFeb 5, 2025
TodayJul 2, 2026
Enrollment to primary: 4.5 yearsPosted 7.3 years ago

Interventions

Lenvatinibdrug

Lenvatinib 4 mg or 10 mg capsules at a total daily dose of 20 mg taken by mouth once per day.

Pembrolizumabbiological

Pembrolizumab 200 mg intravenous (IV) infusion given on Day 1 of each cycle.

Paclitaxeldrug

Paclitaxel 175 mg/m\^2 IV infusion given on Day 1 of each cycle.

Carboplatindrug

Carboplatin 10 mg/mL IV infusion at a total dose of are-under-the-curve (AUC) 6 (per Calvert's formula) given on Day 1 of each cycle.