CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 827 enrolled
Drug / intervention
Pembrolizumab +3 moredrug
Likely dose
Pembrolizumab 200 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/NCT03517449
NCT03517449Phase 3Completed
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A Multicenter, Open-label, Randomized, Phase 3 Trial to Compare the Efficacy and Safety of Lenvatinib in Combination With Pembrolizumab Versus Treatment of Physician's Choice in Participants With Advanced Endometrial Cancer

Eisai Inc.·interventional·Posted May 7, 2018·Updated Mar 19, 2026

In Brief

A Phase 3 clinical trial evaluating Pembrolizumab, Lenvatinib, and 2 other interventions for Endometrial Neoplasms. Completed, enrolled 827 participants across 169 sites in 21 countries.

Detailed Summary

This is a study of pembrolizumab (MK-3475, KEYTRUDA®) in combination with lenvatinib (E7080) versus treatment of physician's choice (doxorubicin or paclitaxel) for the treatment of advanced endometrial cancer. Participants will be randomly assigned to receive either pembrolizumab and lenvatinib or treatment of physician's choice. The primary study hypothesis is that pembrolizumab in combination with lenvatinib prolongs progression free survival (PFS) and overall survival (OS) when compared to treatment of physician's choice.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsEndometrial Neoplasms
CountriesArgentina, Australia, Brazil, Canada, Colombia, France, Germany, Ireland, Israel, Italy, Japan, Mexico, New Zealand, Poland, Russia, South Korea, Spain, Taiwan, Turkey (Türkiye), United Kingdom, United States
CollaboratorsMerck Sharp & Dohme LLC

Timeline

Phase 3CompletedFinished
20192020202120222023202420252026
First PostedMay 7, 2018
Enrollment StartJun 11, 2018
Primary CompletionMar 1, 2022
Study CompletionFeb 26, 2025
TodayJul 2, 2026
Enrollment to primary: 3.7 yearsPosted 8.2 years ago

Interventions

Pembrolizumabdrug

200 mg administered by IV infusion on Day 1 of each 21-day cycle.

Lenvatinibdrug

20 mg administered orally (PO) QD during each 21-day cycle.

Paclitaxeldrug

80 mg/m\^2 administered by IV on a 28-day cycle: 3 weeks receiving paclitaxel once a week and 1 week not receiving paclitaxel.

Doxorubicindrug

60 mg/m\^2 administered by IV on Day 1 of each 21-day cycle.