NCT03517449

Lenvatinib in Combination With Pembrolizumab Versus Treatment of Physician's Choice in Participants With Advanced Endometrial Cancer (MK-3475-775/E7080-G000-309 Per Merck Standard Convention [KEYNOTE-775])

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 827 (actual)
• Sponsor: Eisai Inc. · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Endometrial Neoplasms

Interventions

Type	Name	Description
DRUG	Pembrolizumab	200 mg administered by IV infusion on Day 1 of each 21-day cycle.
DRUG	Lenvatinib	20 mg administered orally (PO) QD during each 21-day cycle.
DRUG	Paclitaxel	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.
DRUG	Doxorubicin	60 mg/m\^2 administered by IV on Day 1 of each 21-day cycle.

Timeline

• Start date: 2018-06-11
• Primary completion: 2022-03-01
• Completion: 2025-02-26
• First posted: 2018-05-07
• Last updated: 2026-03-19
• Results posted: 2021-11-17

Locations

169 sites across 21 countries: United States, Argentina, Australia, Brazil, Canada, Colombia, France, Germany, Ireland, Israel, Italy, Japan, Mexico, New Zealand, Poland, Russia, South Korea, Spain, Taiwan, Turkey (Türkiye), United Kingdom

Regulatory

• FDA-regulated drug study