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

NCT ID: NCT04865289

Last Updated: 2025-12-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 130 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-10-22
• Study Completion Date: 2025-01-14

Brief 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.

Conditions

Endometrial Neoplasms

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Lenvatinib + Pembrolizumab

Participants receive lenvatinib daily and pembrolizumab once at the start of each 3-week treatment cycle.

Group Type: EXPERIMENTAL

Lenvatinib

Intervention Type: DRUG

Lenvatinib 4 mg or 10 mg capsules at a total daily dose of 20 mg taken by mouth once per day.

Pembrolizumab

Intervention Type: BIOLOGICAL

Pembrolizumab 200 mg IV infusion given on Day 1 of each cycle.

Paclitaxel + Carboplatin

Participants receive paclitaxel and carboplatin once at the start of each 3-week treatment cycle.

Group Type: ACTIVE_COMPARATOR

Paclitaxel

Intervention Type: DRUG

Paclitaxel 175 mg/m\^2 IV infusion given on Day 1 of each cycle.

Carboplatin

Intervention Type: DRUG

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.

Interventions

Lenvatinib

Lenvatinib 4 mg or 10 mg capsules at a total daily dose of 20 mg taken by mouth once per day.

Intervention Type: DRUG

Pembrolizumab

Pembrolizumab 200 mg IV infusion given on Day 1 of each cycle.

Intervention Type: BIOLOGICAL

Paclitaxel

Paclitaxel 175 mg/m\^2 IV infusion given on Day 1 of each cycle.

Intervention Type: 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.

Intervention Type: DRUG

Other Intervention Names

E7080, MK-7902, LENVIMA®; MK-3475, KEYTRUDA®; TAXOL®, ONXAL®; PARAPLATIN®

Eligibility Criteria

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
• Has a known history of human immunodeficiency virus (HIV) infection (HIV test is required at screening)
• Has a known history of hepatitis B (defined as hepatitis B surface antigen [HBsAg] reactive) or known active hepatitis C virus (hepatitis B and C testing is required at screening)
• Has a history of (noninfectious) pneumonitis that required treatment with steroids, or has current pneumonitis
• Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the participant's participation for the full duration of the study, or is not in the best interest of the participant to participate, in the opinion of the treating investigator
• Has a known psychiatric or substance abuse disorder that would interfere with cooperation with the requirements of the study
• Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to randomization
• Has an active autoimmune disease (with the exception of psoriasis) that has required systemic treatment in the past 2 years (i.e., with use of disease modifying agents, corticosteroids or immunosuppressive drugs)
• Has received prior systemic chemotherapy in any setting for the treatment of endometrial carcinoma (note: prior chemotherapy administered concurrently with radiation is permitted)
• Has received prior radiotherapy within 4 weeks prior to randomization (participants must have recovered from all radiation-related toxicities, not require corticosteroids, and not have had radiation pneumonitis - a 2-week washout is permitted for palliative radiation to non-CNS disease and vaginal brachytherapy)
• Has received prior hormonal therapy for the treatment of endometrial carcinoma within 1 week of randomization
• Has received prior therapy with any treatment targeting vascular endothelial growth factor (VEGF)-directed angiogenesis, an anti-programmed cell death (PD)-1, anti-PD ligand (L)1, or anti-PD L2 agent, or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (e.g., CTLA-4, OX 40, CD137)
• Has received a live or live attenuated vaccine within 30 days prior to the first dose of study intervention
• Has known intolerance to study intervention (or any of the excipients)
• Has had an allogenic tissue/solid organ transplant
• Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to randomization

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Eisai Inc.

INDUSTRY

Sponsor Role: collaborator

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Director

Role: STUDY_DIRECTOR

Merck Sharp & Dohme LLC

Locations

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

Xiangya Hospital Central-South University ( Site 2512)

Changsha, Hunan, China

Hunan Cancer Hospital ( Site 2523)

Changsha, Hunan, China

Nanjing Maternity and Child Health Care Hospital ( Site 2508)

Nanjing, Jiangsu, China

Jiangxi Maternal and Child Health Hospital ( Site 2519)

Nanchang, Jiangxi, China

The First Hospital Of Jilin University ( Site 2518)

Changchun, Jilin, China

The first affiliated Hospital of Xi an Jiaotong University ( Site 2502)

Xi'an, Shaanxi, China

Fudan University Shanghai Cancer Center ( Site 2500)

Shanghai, Shanghai Municipality, China

Obstetrics and Gynecology Hosp. Fudan University ( Site 2503)

Shanghai, Shanghai Municipality, China

Shanghai First Maternity and Infant Hospital ( Site 2524)

Shanghai, Shanghai Municipality, China

The First Affiliated Hospital of Xinjiang Medical University ( Site 2515)

Ürümqi, Xinjiang, China

Women s Hospital School of Medicine Zhejiang University ( Site 2511)

Hangzhou, Zhejiang, China

Zhejiang Cancer Hospital ( Site 2506)

Hangzhou, Zhejiang, China

Countries

China

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Related Links

https://www.merckclinicaltrials.com/

Merck Clinical Trials Information

Other Identifiers

MK-7902-001

Identifier Type: OTHER

Identifier Source: secondary_id

ENGOT-en9

Identifier Type: OTHER

Identifier Source: secondary_id

194710

Identifier Type: REGISTRY

Identifier Source: secondary_id

2023-505614-17

Identifier Type: OTHER

Identifier Source: secondary_id

7902-001 China Extension

Identifier Type: -

Identifier Source: org_study_id