Trials / Completed
CompletedNCT03884101
Pembrolizumab (MK-3475) Plus Lenvatinib (E7080/MK-7902) Versus Chemotherapy for Endometrial Carcinoma (ENGOT-en9 / MK-7902-001)
A Phase 3 Randomized, Open-Label, Study of Pembrolizumab (MK-3475) Plus Lenvatinib (E7080/MK-7902) Versus Chemotherapy for First-line Treatment of Advanced or Recurrent Endometrial Carcinoma (LEAP-001)
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 842 (actual)
- Sponsor
- Merck Sharp & Dohme LLC · Industry
- Sex
- Female
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Lenvatinib | Lenvatinib 4 mg or 10 mg capsules at a total daily dose of 20 mg taken by mouth once per day. |
| BIOLOGICAL | Pembrolizumab | Pembrolizumab 200 mg intravenous (IV) infusion given on Day 1 of each cycle. |
| DRUG | Paclitaxel | Paclitaxel 175 mg/m\^2 IV infusion given on Day 1 of each cycle. |
| DRUG | Carboplatin | Carboplatin 10 mg/mL IV infusion at a total dose of are-under-the-curve (AUC) 6 (per Calvert's formula) given on Day 1 of each cycle. |
Timeline
- Start date
- 2019-04-11
- Primary completion
- 2023-10-02
- Completion
- 2025-02-05
- First posted
- 2019-03-21
- Last updated
- 2026-02-02
- Results posted
- 2024-10-16
Locations
195 sites across 22 countries: United States, Argentina, Australia, Austria, Belgium, Brazil, Canada, China, Germany, Ireland, Israel, Italy, Japan, Mexico, Poland, Russia, South Korea, Spain, Taiwan, Turkey (Türkiye), Ukraine, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03884101. Inclusion in this directory is not an endorsement.