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Endometrial NeoplasmsPhase 3LEAP-001NCT04865289

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

A Phase 3 study testing Lenvatinib, Pembrolizumab and Paclitaxel in people with Endometrial Neoplasms, run by Merck Sharp & Dohme LLC at 22 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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)… Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Endometrial Neoplasms
What is being tested?
Lenvatinib, Pembrolizumab and Paclitaxel
Could I receive a placebo?
No, everyone receives an active treatment
How many people
130 participants
Where
22 sitesChina
Study dates
22 Oct 2019to 14 Jan 2025
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 25Show fewer
  • 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

Trial locations and contacts

22 sites in 1 country.

22 sites in 1 country

China22 sites

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

    Beijing, Beijing Municipality, 100032

  • Peking Union Medical College Hospital ( Site 2501)

    Beijing, Beijing Municipality, 100032

  • Beijing Cancer Hospital ( Site 2504)

    Beijing, Beijing Municipality, 100142

  • The First Hospital Of Jilin University ( Site 2518)

    Changchun, Jilin, 130012

  • Xiangya Hospital Central-South University ( Site 2512)

    Changsha, Hunan, 410008

  • Hunan Cancer Hospital ( Site 2523)

    Changsha, Hunan, 410013

  • Chongqing Cancer Hospital ( Site 2513)

    Chongqing, Chongqing Municipality, 400030

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

    Guangzhou, Guangdong, 510080

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

    Hangzhou, Zhejiang, 310006

  • Zhejiang Cancer Hospital ( Site 2506)

    Hangzhou, Zhejiang, 310022

  • Harbin Medical University Cancer Hospital ( Site 2520)

    Harbin, Heilongjiang, 150081

  • Anhui Cancer Hospital-Gynecological Oncology ( Site 2509)

    Hefei, Anhui, 230031

  • Jiangxi Maternal and Child Health Hospital ( Site 2519)

    Nanchang, Jiangxi, 530021

  • Nanjing Maternity and Child Health Care Hospital ( Site 2508)

    Nanjing, Jiangsu, 210011

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

    Nanning, Guangxi, 530021

  • Fudan University Shanghai Cancer Center ( Site 2500)

    Shanghai, Shanghai Municipality, 200032

  • Obstetrics and Gynecology Hosp. Fudan University ( Site 2503)

    Shanghai, Shanghai Municipality, 200090

  • Shanghai First Maternity and Infant Hospital ( Site 2524)

    Shanghai, Shanghai Municipality, 201204

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

    Ürümqi, Xinjiang, 830054

  • Hubei Cancer Hospital ( Site 2510)

    Wuhan, Hubei, 430079

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

    Xi'an, Shaanxi, 710061

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

    Xiamen, Fujian, 361003

Other trials in China

About this study

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)

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.

Read the 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.

Medical subject headings
Endometrial Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • LenvatinibDrug

    Also called E7080, MK-7902, LENVIMA®

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

  • PembrolizumabBiological

    Also called MK-3475, KEYTRUDA®

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

  • PaclitaxelDrug

    Also called TAXOL®, ONXAL®

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

  • CarboplatinDrug

    Also called PARAPLATIN®

    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.

Study groups in NCT04865289
Study groupRoleWhat they receive
Lenvatinib + PembrolizumabExperimentalParticipants receive lenvatinib daily and pembrolizumab once at the start of each 3-week treatment cycle.
Receives: Drug: Lenvatinib; Biological: Pembrolizumab
Paclitaxel + CarboplatinActive comparatorParticipants receive paclitaxel and carboplatin once at the start of each 3-week treatment cycle.
Receives: Drug: Paclitaxel; Drug: Carboplatin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Progression-free Survival (PFS) Based on Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Review (BICR) in Mismatch Repair Proficient (pMMR) Participants

    PFS was defined as the time from randomization to the first documented progressive disease (PD) per RECIST 1.1 based on BICR, or death due to any cause, whichever occurred first. Per RECIST 1.1, PD was defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum had to demonstrate an absolute increase of ≥5 mm. The appearance of one or more new lesions was also considered PD. The PFS of pMMR participants was presented.

    Measured: Up to approximately 45 months

  2. PFS Based on RECIST 1.1 as Assessed by BICR in All Randomized Participants

    PFS was defined as the time from randomization to the first documented PD per RECIST 1.1 based on BICR, or death due to any cause, whichever occurred first. Per RECIST 1.1, PD was defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum had to demonstrate an absolute increase of ≥5 mm. The appearance of one or more new lesions was also considered PD. The PFS of all randomized participants was presented.

    Measured: Up to approximately 45 months

  3. Overall Survival (OS) in pMMR Participants

    OS was measured from the time of randomization up to death due to any cause. Participants without documented death at the time of the final analysis were to be censored at the date of the last follow-up. The OS for pMMR participants is presented.

    Measured: Up to approximately 45 months

  4. OS in All Randomized Participants

    OS was measured from the time of randomization up to death due to any cause. Participants without documented death at the time of the final analysis were to be censored at the date of the last follow-up. The OS for all randomized participants is presented.

    Measured: Up to approximately 45 months

Secondary outcomes (8)

  1. Objective Response Rate (ORR) Based on RECIST 1.1 as Assessed by BICR in pMMR Participants

    ORR was defined as the percentage of participants who had a Complete Response (CR: Disappearance of all target lesions) or a Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions) as assessed using RECIST 1.1. The percentage of pMMR participants who experienced a CR or PR is presented.

    Measured: Up to approximately 45 months

  2. ORR Based on RECIST 1.1 as Assessed by BICR in All Randomized Participants

    ORR was defined as the percentage of participants who had a CR: Disappearance of all target lesions or a PR: At least a 30% decrease in the sum of diameters of target lesions as assessed using RECIST 1.1. The percentage of all randomized participants who experienced a CR or PR is presented.

    Measured: Up to approximately 45 months

  3. Mean Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core-30 (QLQ-C30) Global Health Status/Quality of Life (Items 29 and 30) Score in pMMR Participants

    The EORTC QLQ-C30 was developed to assess the quality of life of patients with cancer. Participant responses to the questions "How would you rate your overall health during the past week?" and "How would you rate your overall quality of life during the past week?" were scored on a 7-point scale (1=Very Poor to 7=Excellent). The combined score of Global Health Status (EORTC QLQ-C30 Item 29) and Quality of Life (EORTC QLQ-C30 Item 30) was computed by averaging the raw scores of the 2 items and then applying a linear transformation to standardize the average score, so that the combined scores ranged from 0-100. A higher score indicates a better outcome. The change from baseline in GHS/QoL combined score was reported for each arm.

    Measured: Baseline and up to approximately 18 weeks

  4. Mean Change From Baseline in EORTC QLQ-C30 Global Health Status/Quality of Life (Items 29 and 30) Score in All Randomized Participants

    The EORTC QLQ-C30 was developed to assess the quality of life of patients with cancer. Participant responses to the questions "How would you rate your overall health during the past week?" and "How would you rate your overall quality of life during the past week?" were scored on a 7-point scale (1=Very Poor to 7=Excellent). The combined score of Global Health Status (EORTC QLQ-C30 Item 29) and Quality of Life (EORTC QLQ-C30 Item 30) was computed by averaging the raw scores of the 2 items and then applying a linear transformation to standardize the average score, so that the combined scores ranged from 0-100. A higher score indicates a better outcome. The change from baseline in GHS/QoL combined score was reported for each arm.

    Measured: Baseline and up to approximately 18 weeks

  5. Number of Participants Experiencing an Adverse Event (AE)

    An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.

    Measured: From first dose date to 120 days after last dose date (up to approximately 58 months)

  6. Number of Participants Experiencing a Serious Adverse Event (SAE)

    An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An SAE is an AE that results in death, is life-threatening, requires or prolongs hospitalization, results in persistent or significant disability, is a congenital birth defect, or is another important medical event.

    Measured: From first dose date to 120 days after last dose date (up to approximately 58 months)

  7. Number of Participants Experiencing an Immune-related AE (irAE)

    An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Immune-related AEs (irAEs) were AEs that were considered immune-mediated or potentially immune-mediated and are well-documented for pembrolizumab. These irAEs may occur shortly after the first dose or several months after the last dose of pembrolizumab treatment and may affect more than one body system simultaneously. The number of participants with irAEs was reported for each arm.

    Measured: From first dose date to 120 days after last dose date (up to approximately 58 months)

  8. Number of Participants Discontinuing From Study Treatment Due to an AE(s)

    An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants who discontinued study treatment due to an AE was reported for each arm.

    Measured: From first dose date to last dose date (up to approximately 54 months)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Apr 2021
  2. Study start22 Oct 2019
  3. Primary completion2 Oct 2023
  4. Study completion14 Jan 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
130 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04865289
Sponsor's protocol ID
7902-001 China Extension
Other IDs
MK-7902-001, ENGOT-en9, 194710, 2023-505614-17, 2023
Acronym
LEAP-001
Status last verified
Nov 2025
First submitted
26 Apr 2021
Last updated
2 Dec 2025
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Lenvatinib, Pembrolizumab and Paclitaxel in people with Endometrial Neoplasms, run by Merck Sharp & Dohme LLC at 22 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 22 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 18 Oct 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression-free Survival (PFS) Based on Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Review (BICR) in Mismatch Repair Proficient (pMMR) Participants (time frame: Up to approximately 45 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04865289.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Dec 2025.

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