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Pembrolizumab (MK-3475) Plus Lenvatinib (E7080/MK-7902) Versus Chemotherapy for Endometrial Carcinoma (ENGOT-en9 / MK-7902-001) - China Extension Study | Clinical Trials | Clareo Health

COMPLETEDPHASE3

Pembrolizumab (MK-3475) Plus Lenvatinib (E7080/MK-7902) Versus Chemotherapy for Endometrial Carcinoma (ENGOT-en9 / MK-7902-001) - China Extension Study

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)

NCT04865289•Merck Sharp & Dohme LLC

View on ClinicalTrials.gov

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.

Detailed Description

This China extension study will include participants previously enrolled in China in the global study for MK-7902-001 (NCT03884101) plus those enrolled during the China extension enrollment period.

Eligibility

Age

18 - No limit years

Sex

FEMALE

Healthy Volunteers

Inclusion Criteria

•Has Stage III, Stage IV, or recurrent, histologically-confirmed endometrial carcinoma with disease that is either measurable or nonmeasurable but radiographically apparent, per RECIST 1.1 as assessed by BICR (note: may have received prior chemotherapy only if administered concurrently with radiation; may have received prior radiation without concurrent chemotherapy; may have received prior hormonal therapy for treatment of endometrial carcinoma, provided that it was discontinued ≥1 week prior to randomization; and may have received 1 prior line of systemic platinum-based adjuvant and/or neoadjuvant chemotherapy)
•Has provided archival tumor tissue sample or newly obtained core or excisional biopsy of a tumor lesion that was not previously irradiated, for determination of mismatch repair (MMR) status
•Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1, as assessed within 7 days prior to the first dose of study intervention
•Is not pregnant or breastfeeding, and is either not a woman of childbearing potential (WOCBP) or is a WOCBP who agrees to use contraception during the study and for ≥120 days after pembrolizumab, ≥30 days after lenvatinib, or ≥180 days after (chemotherapy) \[if a WOCBP, a pregnancy test will be required within 24 hours of first dose of study drug\]
•Has adequately controlled blood pressure within 7 days prior to randomization
•Has adequate organ function based on assessment within 7 days prior to the first dose of study intervention

Exclusion Criteria

•Has carcinosarcoma (malignant mixed Műllerian tumor), endometrial leiomyosarcoma or other high grade sarcomas, or endometrial stromal sarcomas
•Has a central nervous system (CNS) metastasis, unless local therapy (e.g., whole brain radiation therapy, surgery, or radiosurgery) has been completed and have discontinued use of corticosteroids for this indication for ≥4 weeks prior to starting study medication (major surgery within 3 weeks of the first dose of study drug will be exclusionary)
•Has a known additional malignancy (other than endometrial carcinoma) that is progressing or has required active treatment in the last 3 years
•Has gastrointestinal malabsorption or any other condition that might affect the absorption of lenvatinib
•Has a pre-existing Grade ≥3 gastrointestinal or nongastrointestinal fistula
•Has radiographic evidence of major blood vessel invasion/infiltration
•Has active hemoptysis (bright red blood of ≥0.5 teaspoon) within 3 weeks prior to the first dose of study intervention, or tumor bleeding within 2 weeks prior to randomization
•Has clinically significant cardiovascular disease within 12 months from first dose of study intervention including New York Heart Association Class III or IV congestive heart failure, unstable angina, myocardial infarction, cerebral vascular accident, or cardiac arrhythmia associated with hemodynamic instability
•Has any infection requiring systemic treatment
•Has not recovered adequately from any toxicity and/or complications from major surgery prior to randomization
+15 more criteria

Locations (22)

Anhui Cancer Hospital-Gynecological Oncology ( Site 2509)

Hefei, Anhui, China

Beijing Obstetrics and Gynecology Hospital Capital Medical University ( Site 2505)

Beijing, Beijing Municipality, China

Peking Union Medical College Hospital ( Site 2501)

Beijing, Beijing Municipality, China

Beijing Cancer Hospital ( Site 2504)

Beijing, Beijing Municipality, China

Chongqing Cancer Hospital ( Site 2513)

Chongqing, Chongqing Municipality, China

The First Affiliated hospital of Xiamen University-Obstetrics and gynecology department ( Site 2522)

Xiamen, Fujian, China

The First Affiliated Hospital.Sun Yat-sen University ( Site 2507)

Guangzhou, Guangdong, China

Guang Xi Tumour Hospital, Department of Chemotherapy ( Site 2517)

Nanning, Guangxi, China

Harbin Medical University Cancer Hospital ( Site 2520)

Harbin, Heilongjiang, China

Hubei Cancer Hospital ( Site 2510)

Wuhan, Hubei, China

Key Dates

Start Date

October 22, 2019

Primary Completion Date

October 2, 2023

Completion Date

January 14, 2025

Last Updated

December 2, 2025

Enrollment

130

ACTUAL participants

Conditions

Endometrial Neoplasms

Interventions

Lenvatinib

DRUG

Pembrolizumab

BIOLOGICAL

Paclitaxel

DRUG

Carboplatin

DRUG

A Study of LY4175408 in Participants With Advanced Cancer

NCT07046923

Carcinoma, Non-Small-Cell LungSmall Cell Lung Carcinoma+3 more

View study

RECRUITING

Registry Platform Ovarian and Endometrial Cancer

NCT05129969

Ovarian CancerEndometrial Cancer+5 more

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 2, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Pembrolizumab (MK-3475) Plus Lenvatinib (E7080/MK-7902) Versus Chemotherapy for Endometrial Carcinoma (ENGOT-en9 / MK-7902-001) - China Extension Study

Inclusion Criteria

Exclusion Criteria

A Study of LY4175408 in Participants With Advanced Cancer

Registry Platform Ovarian and Endometrial Cancer

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