Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

NCT03517449 · ClinicalTrials.gov registry record · Phase 3

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 Phase 3 study, sponsored by Eisai.

Completed
Registry status
Phase 3
Development phase
827
Enrollment target

NCT03517449: Completed Phase 3 study, sponsored by Eisai.

NCT03517449 is a Phase 3 study that has completed, run by Eisai. The registered enrollment target is 827 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.

View on ClinicalTrials.gov ↗

View your shortlist →

The verdict

NCT03517449, a Phase 3 study, has completed, sponsored by Eisai.

COMPLETED
Registry status
Phase 3
Development phase
827 participants
Enrollment target

Study 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.

Primary Outcome

PFS was defined as the time from the date of randomization to the date of the first documentation of disease progression, as determined by Blinded Independent Central Review (BICR) per Response Evaluation Criteria In Solid Tumors (RECIST) version 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

Interventions

  • DRUG Pembrolizumab
  • DRUG Doxorubicin
  • DRUG Paclitaxel
  • DRUG Lenvatinib

Trial Details

FieldValue
Enrollment Target 827 participants
Start Date 2018-06-11
Est. Completion 2025-02-26
Phase Phase 3
Eisai

287 total trials

What the finished NCT03517449 record still lists

NCT03517449 is an interventional study that assigns participants to a tested intervention. The registered 827 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 4 interventions - of which Pembrolizumab is the first listed.

NCT03517449 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT03517449 about?

NCT03517449 is a clinical study titled "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])". 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 t...

What is the current status of trial NCT03517449?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 827 participants. The study started on 2018-06-11. Estimated completion is 2025-02-26.

What interventions are being tested in trial NCT03517449?

The interventions under investigation include: Pembrolizumab (DRUG), Doxorubicin (DRUG), Paclitaxel (DRUG), Lenvatinib (DRUG).

Who is sponsoring clinical trial NCT03517449?

This trial is sponsored by Eisai, which has 287 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT03517449's enrollment target sits among peer trials

827 400th of 2000 higher than 1,601 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

Nationwide trials with similar profiles

Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.

Similar enrollment target

  • NCT03547973 · 827 participants · Phase 2

    Study of Sacituzumab Govitecan in Participants With Urothelial Cancer That Cannot Be Removed or Has Spread

  • NCT05124808 · 828 participants · NA

    Intensive Glycemic Targets in Overweight and Obese Women With Gestational Diabetes

  • NCT05630482 · 825 participants · NA

    Randomized Trial of Healthy Family Foundations

  • NCT06097728 · 825 participants · Phase 3

    MEDI5752 in Combination With Carboplatin Plus Pemetrexed in Unresectable Pleural Mesothelioma

Similar registry start date

  • NCT05962346 · started 2026-12 · NA

    Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia

  • NCT07125183 · started 2026-12 · Phase 2

    Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma

  • NCT07292298 · started 2026-11 · Phase 2

    Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates

  • NCT04263285 · started 2026-10 · NA

    Treatment of Depression Post-SCI

Source: ClinicalTrials.gov NCT03517449, the US trial registry maintained by the National Library of Medicine. NCT03517449 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.