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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 is a Phase 3 study that has completed, run by Merck Sharp & Dohme. The registered enrollment target is 842 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03884101
The ClinicalTrials.gov registry entry for NCT03884101 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 842 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Merck Sharp & Dohme, which has 558 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 4 interventions - of which Pembrolizumab is the first listed.
NCT03884101 reports 0 study locations.
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.
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