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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.
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
| Field | Value |
|---|---|
| Enrollment Target | 827 participants |
| Start Date | 2018-06-11 |
| Est. Completion | 2025-02-26 |
| Phase | Phase 3 |
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.
Learn More About Clinical Trials
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
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