Trial · NCT04865289
Pembrolizumab (MK-3475) Plus Lenvatinib (E7080/MK-7902) Versus Chemotherapy for Endometrial Carcinoma (ENGOT-en9 / MK-7902-001) - China Extension Study
NCT04865289, Phase 3, Completed, Merck Sharp & Dohme LLC; results first posted 2024-10-18
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Pembrolizumab (MK-3475) Plus Lenvatinib (E7080/MK-7902) Versus Chemotherapy for Endometrial Carcinoma (ENGOT-en9 / MK-7902-001) - China Extension Study. Trials, record NCT04865289. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04865289
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Pembrolizumab (MK-3475) Plus Lenvatinib (E7080/MK-7902) Versus Chemotherapy for Endometrial Carcinoma (ENGOT-en9 / MK-7902-001) - China Extension Study
- NCT number
- NCT04865289
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 130 participants, actual
- Lead sponsor
- Merck Sharp & Dohme LLC
- Conditions
- Endometrial Neoplasms
- Interventions
- Lenvatinib, Pembrolizumab, Paclitaxel, Carboplatin
- First posted
- 2021-04-29
- Last updated
- 2025-12-02
- Results first posted
- 2024-10-18
Source ClinicalTrials.gov
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 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 | 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. |
| Primary | PFS Based on RECIST 1.1 as Assessed by BICR in All Randomized Participants | 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. |
| Primary | Overall Survival (OS) in pMMR Participants | 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. |
| Primary | OS in All Randomized Participants | 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. |
| Secondary | Objective Response Rate (ORR) Based on RECIST 1.1 as Assessed by BICR in pMMR Participants | 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. |
| Secondary | ORR Based on RECIST 1.1 as Assessed by BICR in All Randomized Participants | 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. |
| Secondary | 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 | 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 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. |
| Secondary | Mean Change From Baseline in EORTC QLQ-C30 Global Health Status/Quality of Life (Items 29 and 30) Score in All Randomized Participants | 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 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. |
| Secondary | Number of Participants Experiencing an Adverse Event (AE) | 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. |
| Secondary | Number of Participants Experiencing a Serious Adverse Event (SAE) | 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. |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 registered outcomesOutcomes12
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | 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 | Up to approximately 45 months | All pMMR Chinese participants who were randomized to the global study (NCT03884101) and to the extension portion were analyzed according to the treatment arm to which they were randomized. | Months | MEDIAN |
| PRIMARY | PFS Based on RECIST 1.1 as Assessed by BICR in All Randomized Participants | Up to approximately 45 months | All Chinese participants who were randomized to the global study (NCT03884101) and to the extension portion were analyzed according to the treatment arm to which they were randomized. | Months | MEDIAN |
| PRIMARY | Overall Survival (OS) in pMMR Participants | Up to approximately 45 months | All pMMR Chinese participants who were randomized to the global study (NCT03884101) and to the extension portion were analyzed according to the treatment arm to which they were randomized. | Months | MEDIAN |
| PRIMARY | OS in All Randomized Participants | Up to approximately 45 months | All Chinese participants who were randomized to the global study (NCT03884101) and to the extension portion were analyzed according to the treatment arm to which they were randomized. | Months | MEDIAN |
| SECONDARY | Objective Response Rate (ORR) Based on RECIST 1.1 as Assessed by BICR in pMMR Participants | Up to approximately 45 months | Per the statistical analysis plan, all pMMR Chinese participants who were randomized to the global study (NCT03884101) and to the extension portion with measurable disease at the baseline scan were analyzed according to the treatment arm to which they were randomized. | Percentage of Participants | NUMBER |
| SECONDARY | ORR Based on RECIST 1.1 as Assessed by BICR in All Randomized Participants | Up to approximately 45 months | Per the statistical analysis plan, all Chinese participants who were randomized to the global study (NCT03884101) and to the extension portion with measurable disease at the baseline scan were analyzed according to the treatment arm to which they were randomized. | Percentage of Participants | NUMBER |
| SECONDARY | 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 | Baseline and up to approximately 18 weeks | All pMMR Chinese participants who were randomized to the global study (NCT03884101) and to the extension portion who had at least one assessment available for EORTC QLQ-C30 and received at least one dose of the study intervention were analyzed. | Scores on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Mean Change From Baseline in EORTC QLQ-C30 Global Health Status/Quality of Life (Items 29 and 30) Score in All Randomized Participants | Baseline and up to approximately 18 weeks | All Chinese participants who were randomized to the global study (NCT03884101) and to the extension portion who had at least one assessment available for EORTC QLQ-C30 and received at least one dose of the study intervention were analyzed. | Scores on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Number of Participants Experiencing an Adverse Event (AE) | From first dose date to 120 days after last dose date (up to approximately 58 months) | All Chinese participants who were randomized to the global study (NCT03884101) and to the extension portion and received at least one dose of the study intervention were analyzed | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants Experiencing a Serious Adverse Event (SAE) | From first dose date to 120 days after last dose date (up to approximately 58 months) | All Chinese participants who were randomized to the global study (NCT03884101) and to the extension portion and received at least one dose of the study intervention were analyzed | Participants | COUNT_OF_PARTICIPANTS |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 outcomesResults by group24
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
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 | Lenvatinib + Pembrolizumab | 10.3 | 95% Confidence Interval 6.4 to 12.7 | Months | |
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 | Paclitaxel + Carboplatin | 10.2 | 95% Confidence Interval 8.3 to 10.6 | Months | |
| PFS Based on RECIST 1.1 as Assessed by BICR in All Randomized Participants | Lenvatinib + Pembrolizumab | 11.7 | 95% Confidence Interval 8.3 to 19.4 | Months | |
| PFS Based on RECIST 1.1 as Assessed by BICR in All Randomized Participants | Paclitaxel + Carboplatin | 10.3 | 95% Confidence Interval 8.3 to 12.5 | Months | |
| Overall Survival (OS) in pMMR Participants | Lenvatinib + Pembrolizumab | 37.1 | 95% Confidence Interval 19.5 to NA | Months | |
| Overall Survival (OS) in pMMR Participants | Paclitaxel + Carboplatin | NA | 95% Confidence Interval 21.7 to NA | Months | |
| OS in All Randomized Participants | Lenvatinib + Pembrolizumab | NA | 95% Confidence Interval 29.8 to NA | Months | |
| OS in All Randomized Participants | Paclitaxel + Carboplatin | NA | 95% Confidence Interval 25.1 to NA | Months | |
| Objective Response Rate (ORR) Based on RECIST 1.1 as Assessed by BICR in pMMR Participants | Lenvatinib + Pembrolizumab | 50.9 | 95% Confidence Interval 37.1 to 64.6 | Percentage of Participants | |
| Objective Response Rate (ORR) Based on RECIST 1.1 as Assessed by BICR in pMMR Participants | Paclitaxel + Carboplatin | 61.4 | 95% Confidence Interval 45.5 to 75.6 | Percentage of Participants |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 results by groupParticipant flow8
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Lenvatinib + Pembrolizumab | 74 | |
| Overall Study | STARTED | Paclitaxel + Carboplatin | 56 | |
| Overall Study | Treated | Lenvatinib + Pembrolizumab | 73 | |
| Overall Study | Treated | Paclitaxel + Carboplatin | 56 | |
| Overall Study | COMPLETED | Lenvatinib + Pembrolizumab | 0 | |
| Overall Study | COMPLETED | Paclitaxel + Carboplatin | 0 | |
| Overall Study | NOT COMPLETED | Lenvatinib + Pembrolizumab | 74 | |
| Overall Study | NOT COMPLETED | Paclitaxel + Carboplatin | 56 |
Source ClinicalTrials.gov
Adverse events324
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anaemia | Blood and lymphatic system disorders | Lenvatinib + Pembrolizumab | 21 | 73 | 34 |
| other | Anaemia | Blood and lymphatic system disorders | Paclitaxel + Carboplatin | 43 | 56 | 107 |
| other | Leukopenia | Blood and lymphatic system disorders | Lenvatinib + Pembrolizumab | 2 | 73 | 7 |
| other | Leukopenia | Blood and lymphatic system disorders | Paclitaxel + Carboplatin | 9 | 56 | 49 |
| other | Neutropenia | Blood and lymphatic system disorders | Lenvatinib + Pembrolizumab | 0 | 73 | 0 |
| other | Neutropenia | Blood and lymphatic system disorders | Paclitaxel + Carboplatin | 9 | 56 | 26 |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Lenvatinib + Pembrolizumab | 5 | 73 | 8 |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Paclitaxel + Carboplatin | 8 | 56 | 12 |
| other | Palpitations | Cardiac disorders | Lenvatinib + Pembrolizumab | 4 | 73 | 4 |
| other | Palpitations | Cardiac disorders | Paclitaxel + Carboplatin | 1 | 56 | 1 |
1 to 10 of 324Source ClinicalTrials.gov
See all 324 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Lenvatinib + Pembrolizumab | 34 | 74 |
| Total, all-cause mortality | Paclitaxel + Carboplatin | 25 | 56 |
| Total, other adverse events | Lenvatinib + Pembrolizumab | 72 | 73 |
| Total, other adverse events | Paclitaxel + Carboplatin | 55 | 56 |
| Total, serious adverse events | Lenvatinib + Pembrolizumab | 40 | 73 |
| Total, serious adverse events | Paclitaxel + Carboplatin | 17 | 56 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons6
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Lenvatinib + Pembrolizumab vs Paclitaxel + Carboplatin: Number of Participants Experiencing an Immune-related AE (irAE) | Trial comparisons |
| Lenvatinib + Pembrolizumab vs Paclitaxel + Carboplatin: Number of Participants Discontinuing From Study Treatment Due to an AE(s) | Trial comparisons |
| Lenvatinib + Pembrolizumab vs Paclitaxel + Carboplatin: Number of Participants Experiencing a Serious Adverse Event (SAE) | Trial comparisons |
| Lenvatinib + Pembrolizumab vs Paclitaxel + Carboplatin: deaths from any cause | Trial comparisons |
| Lenvatinib + Pembrolizumab vs Paclitaxel + Carboplatin: Number of Participants Experiencing an Adverse Event (AE) | Trial comparisons |
| Lenvatinib + Pembrolizumab vs Paclitaxel + Carboplatin: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT04865289
GET https://conductscience.org/api/trials/v1/NCT04865289/results?page=2