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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])

NCT03517449 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 827

Last updated 2026-03-19

Study results available
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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

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.

Sponsors & Collaborators

Principal Investigators

  • Medical Director · Eisai Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-06-11
Primary Completion
2022-03-01
Completion
2025-02-26
FDA Drug
Yes

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

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03517449 on ClinicalTrials.gov