Pembrolizumab (MK-3475) Plus Lenvatinib (E7080/MK-7902) Versus Chemotherapy for Endometrial Carcinoma (ENGOT-en9 / MK-7902-001) - China Extension Study
CompletedPhase 3Results postedLast updated 2 December 2025
What this trial tests
Phase 3 trial testing Lenvatinib in Endometrial Neoplasms in 130 participants. Completed in 14 January 2025.
18 and older, female only, with Endometrial Neoplasms. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
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) ParticipantsPrimary· Up to approximately 45 months
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.
Group
Value
95% CI
Lenvatinib + Pembrolizumab
10.3
6.4 – 12.7
Paclitaxel + Carboplatin
10.2
8.3 – 10.6
PFS Based on RECIST 1.1 as Assessed by BICR in All Randomized ParticipantsPrimary· Up to approximately 45 months
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.
Group
Value
95% CI
Lenvatinib + Pembrolizumab
11.7
8.3 – 19.4
Paclitaxel + Carboplatin
10.3
8.3 – 12.5
Overall Survival (OS) in pMMR ParticipantsPrimary· Up to approximately 45 months
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.
Group
Value
95% CI
Lenvatinib + Pembrolizumab
37.1
19.5 – NA
Paclitaxel + Carboplatin
NA
21.7 – NA
OS in All Randomized ParticipantsPrimary· Up to approximately 45 months
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.
Group
Value
95% CI
Lenvatinib + Pembrolizumab
NA
29.8 – NA
Paclitaxel + Carboplatin
NA
25.1 – NA
Objective Response Rate (ORR) Based on RECIST 1.1 as Assessed by BICR in pMMR ParticipantsSecondary· Up to approximately 45 months
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.
Group
Value
95% CI
Lenvatinib + Pembrolizumab
50.9
37.1 – 64.6
Paclitaxel + Carboplatin
61.4
45.5 – 75.6
ORR Based on RECIST 1.1 as Assessed by BICR in All Randomized ParticipantsSecondary· Up to approximately 45 months
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.
Group
Value
95% CI
Lenvatinib + Pembrolizumab
56.9
44.7 – 68.6
Paclitaxel + Carboplatin
66.1
52.2 – 78.2
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 ParticipantsSecondary· Baseline and up to approximately 18 weeks
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 ran
Group
Value
95% CI
Lenvatinib + Pembrolizumab
-7.00
-12.49 – -1.51
Paclitaxel + Carboplatin
-4.87
-11.52 – 1.79
Mean Change From Baseline in EORTC QLQ-C30 Global Health Status/Quality of Life (Items 29 and 30) Score in All Randomized ParticipantsSecondary· Baseline and up to approximately 18 weeks
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 ran
Group
Value
95% CI
Lenvatinib + Pembrolizumab
-6.69
-11.42 – -1.96
Paclitaxel + Carboplatin
-5.96
-11.65 – -0.26
Number of Participants Experiencing an Adverse Event (AE)Secondary· From first dose date to 120 days after last dose date (up to approximately 58 months)
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.
Group
Value
95% CI
Lenvatinib + Pembrolizumab
72
Paclitaxel + Carboplatin
56
Number of Participants Experiencing a Serious Adverse Event (SAE)Secondary· From first dose date to 120 days after last dose date (up to approximately 58 months)
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.
Group
Value
95% CI
Lenvatinib + Pembrolizumab
40
Paclitaxel + Carboplatin
17
Number of Participants Experiencing an Immune-related AE (irAE)Secondary· From first dose date to 120 days after last dose date (up to approximately 58 months)
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.
Group
Value
95% CI
Lenvatinib + Pembrolizumab
49
Paclitaxel + Carboplatin
10
Number of Participants Discontinuing From Study Treatment Due to an AE(s)Secondary· From first dose date to last dose date (up to approximately 54 months)
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.
Group
Value
95% CI
Lenvatinib + Pembrolizumab
32
Paclitaxel + Carboplatin
8
Adverse events — posted to ClinicalTrials.gov
Time frame: From randomization to the date of death or last participant data collection (up to approximately 61 months)..
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
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.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
NCT07383441 — Adding Biotherapy or Placebo to Standard Treatment for Advanced Kidney Cancer
· Phase 3
· not yet recruiting
NCT07537946 — Local Consolidation After Sintilimab Plus Lenvatinib for Metastatic Liver Cancer
· Phase 3
· not yet recruiting
NCT07475026 — A Study of Neoadjuvant Tislelizumab Plus Lenvatinib in Resectable HCC at High Risk of Recurrence
· Phase 3
· not yet recruiting
NCT07518706 — Neoadjuvant Tislelizumab-Lenvatinib vs Surgery Alone in Stage Ia HCC With Narrow Margin
· Phase 2
· not yet recruiting
NCT07493668 — Fostrox Plus Lenvatinib vs Lenvatinib in Advanced Hepatocellular Carcinoma After First-line Immunotherapy
· Phase 2
· not yet recruiting
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NCT06023862 — A Three-arm Randomized Phase II Study of Dostarlimab Alone or With Bevacizumab Versus Nonplatinum Chemotherapy in Recurr
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Other Merck Sharp & Dohme LLC trials
Trials by the same sponsor.
NCT07224477 — A Clinical Study of V540A in Healthy Female Participants (V540A-005)
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NCT07302347 — A Study of Pembrolizumab in Japanese Pediatric Participants With Solid Tumors or Lymphomas and Japanese Adult Participan
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NCT07528508 — A Clinical Trial in Healthy Participants to Study the Effect of a Single Dose of MK-8527 on Levels of Methadone (MK-8527
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NCT07513376 — A Clinical Trial of Adjuvant Intismeran (V940) With or Without Pembrolizumab Coformulated With Berahyaluronidase Alfa (M
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Merck Sharp & Dohme LLC
Last refreshed: 2 December 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04865289.