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NCT03884101 · ClinicalTrials.gov registry record · Phase 3
Pembrolizumab (MK-3475) Plus Lenvatinib (E7080/MK-7902) Versus Chemotherapy for Endometrial Carcinoma (ENGOT-en9 / MK-7902-001)
A Phase 3 study, sponsored by Merck Sharp & Dohme.
- Completed
- Registry status
- Phase 3
- Development phase
- 842
- Enrollment target
NCT03884101: Completed Phase 3 study, sponsored by Merck Sharp & Dohme.
NCT03884101 is a Phase 3 study that has completed, run by Merck Sharp & Dohme. The registered enrollment target is 842 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
NCT03884101, a Phase 3 study, has completed, sponsored by Merck Sharp & Dohme.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 842 participants
- Enrollment target
Study Summary
The purpose of this study is to compare the efficacy of pembrolizumab + lenvatinib to chemotherapy in female participants with Stage III, IV, or recurrent endometrial carcinoma. It is hypothesized that the combination of pembrolizumab + lenvatinib will be superior to chemotherapy for progression-free survival (PFS) per Response Evaluation Criteria In Solid Tumors version 1.1 (RECIST 1.1) by blinded independent central review (BICR). It is also hypothesized that the combination of pembrolizumab + lenvatinib will be superior to chemotherapy for overall survival (OS). As of Amendment 7 eligible participants on study completion will be able to transition to an extension study, if available, in which they can continue to receive pembrolizumab monotherapy, lenvatinib monotherapy, or a combination of both pembrolizumab and lenvatinib as received in the parent study.
Primary Outcome
PFS was defined as the time from randomization to the first documented progressive disease (PD) per RECIST 1.1 based on BICR, or death due to any cause, whichever occurred first. Per RECIST 1.1, PD was defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum had to demonstrate an absolute increase of ≥5 mm. The appearance of one or more new lesions was also considered PD. The PFS of pMMR participants was presented.
Interventions
- BIOLOGICAL Pembrolizumab
- DRUG Carboplatin
- DRUG Paclitaxel
- DRUG Lenvatinib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 842 participants |
| Start Date | 2019-04-11 |
| Est. Completion | 2025-02-05 |
| Phase | Phase 3 |
What the finished NCT03884101 record still lists
NCT03884101 is an interventional study that assigns participants to a tested intervention. The registered 842 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.
NCT03884101 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03884101 about?
NCT03884101 is a clinical study titled "Pembrolizumab (MK-3475) Plus Lenvatinib (E7080/MK-7902) Versus Chemotherapy for Endometrial Carcinoma (ENGOT-en9 / MK-7902-001)". The purpose of this study is to compare the efficacy of pembrolizumab + lenvatinib to chemotherapy in female participants with Stage III, IV, or recurrent endometrial carcinoma. It is hypothesized that the combination of pembrolizumab + lenvatinib will be superior to chemotherapy for progression-fre...
What is the current status of trial NCT03884101?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 842 participants. The study started on 2019-04-11. Estimated completion is 2025-02-05.
What interventions are being tested in trial NCT03884101?
The interventions under investigation include: Pembrolizumab (BIOLOGICAL), Carboplatin (DRUG), Paclitaxel (DRUG), Lenvatinib (DRUG).
Who is sponsoring clinical trial NCT03884101?
This trial is sponsored by Merck Sharp & Dohme, which has 558 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03884101's enrollment target sits among peer trials
842 392nd of 2000 higher than 1,609 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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