Pembrolizumab (MK-3475) Plus Lenvatinib (E7080/MK-7902) Versus Chemotherapy for Endometrial Carcinoma (ENGOT-en9 / MK-7902-001)
Public ClinicalTrials.gov record NCT03884101. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
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)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT03884101
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 842 participants
Conditions and interventions
Conditions
Interventions
- Lenvatinib Drug
- Pembrolizumab Biological
- Paclitaxel Drug
- Carboplatin Drug
Drug · Biological
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- Female
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Apr 10, 2019
- Primary completion
- Oct 1, 2023
- Completion
- Feb 4, 2025
- Last update posted
- Feb 1, 2026
2019 – 2025
United States locations
- U.S. sites
- 29
- U.S. states
- 18
- U.S. cities
- 27
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of South Alabama, Mitchell Cancer Institute ( Site 0245) | Mobile | Alabama | 36604 | — |
| Arizona Oncology Associates PC- HOPE ( Site 8005) | Tucson | Arizona | 85711 | — |
| UCLA Hematology and Oncology Clinic (Westwood) ( Site 0233) | Los Angeles | California | 90095 | — |
| University of Colorado Cancer Center ( Site 0204) | Aurora | Colorado | 80045 | — |
| Smilow Cancer Hospital at Yale New Haven ( Site 0202) | New Haven | Connecticut | 06511 | — |
| University of Miami Health System ( Site 0249) | Miami | Florida | 33136 | — |
| Georgia Cancer Center at Augusta University ( Site 0222) | Augusta | Georgia | 30912 | — |
| Women's Cancer Care ( Site 0208) | Covington | Louisiana | 70433 | — |
| Maine Medical Partners ( Site 0217) | Scarborough | Maine | 04074 | — |
| Minnesota Oncology Hematology, PA ( Site 8003) | Minneapolis | Minnesota | 55404 | — |
| Memorial Sloan-Kettering Cancer Center At Basking Ridge ( Site 0268) | Basking Ridge | New Jersey | 07920 | — |
| John Theurer Cancer Center at Hackensack University Med Ctr ( Site 0226) | Hackensack | New Jersey | 07601 | — |
| Memorial Sloan Kettering Cancer Center- Monmouth ( Site 0273) | Middletown | New Jersey | 07748 | — |
| MSKCC-Bergen ( Site 0276) | Montvale | New Jersey | 07645 | — |
| Holy Name Medical Center ( Site 0235) | Teaneck | New Jersey | 07666 | — |
| Memorial Sloan-Kettering Cancer Center at Commack ( Site 0267) | Commack | New York | 11725 | — |
| Memorial Sloan Kettering Cancer Center - West Harrison ( Site 0274) | Harrison | New York | 10604 | — |
| The Blavatnik Family- Chelsea Medical Center at Mount Sinai ( Site 0206) | New York | New York | 10011 | — |
| Memorial Sloan Kettering Cancer Center ( Site 0246) | New York | New York | 10022 | — |
| University of Rochester ( Site 0238) | Rochester | New York | 14642 | — |
| Memorial Sloan Kettering Cancer Center - Nassau ( Site 0275) | Uniondale | New York | 11553 | — |
| University of North Carolina- Chapel Hill ( Site 0254) | Chapel Hill | North Carolina | 27599 | — |
| Roger Maris Cancer Center ( Site 0277) | Fargo | North Dakota | 58102 | — |
| Willamette Valley Cancer Institute and Research Center ( Site 8004) | Eugene | Oregon | 97401 | — |
| Sanford Cancer Center Oncology Clinic ( Site 0205) | Sioux Falls | South Dakota | 57104 | — |
| Parkland Health & Hospital System ( Site 0272) | Dallas | Texas | 75235 | — |
| University of Texas Southwestern Medical Center ( Site 0264) | Dallas | Texas | 75390-9015 | — |
| Texas Oncology-The Woodlands ( Site 8000) | The Woodlands | Texas | 77380 | — |
| Legacy Salmon Creek Medical Center ( Site 0253) | Vancouver | Washington | 98686 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 166 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03884101, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Feb 1, 2026 · Synced Sep 25, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT03884101 live on ClinicalTrials.gov.