Trial · NCT03884101
Pembrolizumab (MK-3475) Plus Lenvatinib (E7080/MK-7902) Versus Chemotherapy for Endometrial Carcinoma (ENGOT-en9 / MK-7902-001)
NCT03884101, Phase 3, Completed, Merck Sharp & Dohme LLC; results first posted 2024-10-16
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). Trials, record NCT03884101. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03884101
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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)
- NCT number
- NCT03884101
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 842 participants, actual
- Lead sponsor
- Merck Sharp & Dohme LLC
- Conditions
- Endometrial Neoplasms
- Interventions
- Lenvatinib, Pembrolizumab, Paclitaxel, Carboplatin
- First posted
- 2019-03-21
- Last updated
- 2026-02-02
- Other registries' IDs
- eudract:2018-003009-24
- Results first posted
- 2024-10-16
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 44 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 44 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 51 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 51 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 51 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 51 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 the Global Health Status/Quality of Life Score of the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core-30 (QLQ-C30) 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. It contains 30 questions (items), 24 of which aggregate into nine multi-item scales representing various aspects, or dimensions, of quality of life (QoL): one global scale, five functional scales (physical, role, cognitive, emotional, and social), 3 symptom scales (fatigue, nausea, pain), and six additional single-symptom items assessing additional symptoms commonly reported by cancer patients (dyspnoea, loss of appetite, insomnia, constipation and diarrhoea) and perceived financial impact of the disease. Individual items are scored on a 4-point scale (1=not at all, 2=a little, 3=quite a bit, 4=very much). Raw scores for each scale are standardized into a range of 0 to 100 by linear transformation; a higher score on the global and functional scales represents a higher ("better") level of functioning, and a higher score on the symptom scale represents a higher ("worse") level of symptoms. |
| Secondary | Mean Change From Baseline in the Global Health Status/Quality of Life Score of the EORTC QLQ-C30 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. It contains 30 questions (items), 24 of which aggregate into nine multi-item scales representing various aspects, or dimensions, of QoL: one global scale, five functional scales (physical, role, cognitive, emotional, and social), 3 symptom scales (fatigue, nausea, pain), and six additional single-symptom items assessing additional symptoms commonly reported by cancer patients (dyspnoea, loss of appetite, insomnia, constipation and diarrhoea) and perceived financial impact of the disease. Individual items are scored on a 4-point scale (1=not at all, 2=a little, 3=quite a bit, 4=very much). Raw scores for each scale are standardized into a range of 0 to 100 by linear transformation; a higher score on the global and functional scales represents a higher ("better") level of functioning, and a higher score on the symptom scale represents a higher ("worse") level of symptoms. |
| Secondary | Number of Participants Who Experienced an Adverse Event (AE) | Up to approximately 68 months | An AE was 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 AE could have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated). Per protocol, the number of participants who experienced one or more AEs was reported for the first course lenvatinib + pembrolizumab and paclitaxel + carboplatin arms. |
| Secondary | Number of Participants Who Experienced a Serious Adverse Event (SAE) | Up to approximately 68 months | An SAE was an AE that resulted in death, was life-threatening, required or prolonged hospitalization, resulted in persistent or significant disability, was a congenital birth defect, or was another important medical event. Per protocol, the number of participants who experienced one or more SAEs was reported for the first course lenvatinib + pembrolizumab and paclitaxel + carboplatin arms. |
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 44 months | All randomized pMMR participants 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 44 months | All randomized participants were analyzed according to the treatment arm to which they were randomized. | Months | MEDIAN |
| PRIMARY | Overall Survival (OS) in pMMR Participants | Up to approximately 51 months | All randomized pMMR participants were analyzed according to the treatment arm to which they were randomized. | Months | MEDIAN |
| PRIMARY | OS in All Randomized Participants | Up to approximately 51 months | All randomized participants 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 51 months | Per protocol, all randomized pMMR participants 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 51 months | Per protocol, all randomized participants 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 the Global Health Status/Quality of Life Score of the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core-30 (QLQ-C30) in pMMR Participants | Baseline and up to approximately 18 weeks | All randomized pMMR participants 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 the Global Health Status/Quality of Life Score of the EORTC QLQ-C30 in All Randomized Participants | Baseline and up to approximately 18 weeks | All randomized participants 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 Who Experienced an Adverse Event (AE) | Up to approximately 68 months | All randomized participants who received at least one dose of study intervention were analyzed. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants Who Experienced a Serious Adverse Event (SAE) | Up to approximately 68 months | All randomized participants who received at least one dose of 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 | 9.6 | 95% Confidence Interval 8.2 to 11.9 | 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 8.4 to 10.4 | Months | |
| PFS Based on RECIST 1.1 as Assessed by BICR in All Randomized Participants | Lenvatinib + Pembrolizumab | 12.5 | 95% Confidence Interval 10.3 to 15.1 | Months | |
| PFS Based on RECIST 1.1 as Assessed by BICR in All Randomized Participants | Paclitaxel + Carboplatin | 10.2 | 95% Confidence Interval 8.4 to 10.4 | Months | |
| Overall Survival (OS) in pMMR Participants | Lenvatinib + Pembrolizumab | 30.9 | 95% Confidence Interval 25.4 to 37.7 | Months | |
| Overall Survival (OS) in pMMR Participants | Paclitaxel + Carboplatin | 29.4 | 95% Confidence Interval 26.2 to 35.4 | Months | |
| OS in All Randomized Participants | Lenvatinib + Pembrolizumab | 37.7 | 95% Confidence Interval 32.2 to 43.6 | Months | |
| OS in All Randomized Participants | Paclitaxel + Carboplatin | 32.1 | 95% Confidence Interval 27.2 to 35.7 | Months | |
| Objective Response Rate (ORR) Based on RECIST 1.1 as Assessed by BICR in pMMR Participants | Lenvatinib + Pembrolizumab | 50.9 | 95% Confidence Interval 45.3 to 56.6 | Percentage of Participants | |
| Objective Response Rate (ORR) Based on RECIST 1.1 as Assessed by BICR in pMMR Participants | Paclitaxel + Carboplatin | 55.2 | 95% Confidence Interval 49.5 to 60.8 | Percentage of Participants |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 results by groupParticipant flow10
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Lenvatinib + Pembrolizumab | 420 | |
| Overall Study | STARTED | Paclitaxel + Carboplatin | 422 | |
| Overall Study | Treated | Lenvatinib + Pembrolizumab | 420 | |
| Overall Study | Treated | Paclitaxel + Carboplatin | 411 | |
| Overall Study | Received a Second Course of Pembrolizumab | Lenvatinib + Pembrolizumab | 17 | |
| Overall Study | Received a Second Course of Pembrolizumab | Paclitaxel + Carboplatin | 0 | |
| Overall Study | COMPLETED | Lenvatinib + Pembrolizumab | 0 | |
| Overall Study | COMPLETED | Paclitaxel + Carboplatin | 0 | |
| Overall Study | NOT COMPLETED | Lenvatinib + Pembrolizumab | 420 | |
| Overall Study | NOT COMPLETED | Paclitaxel + Carboplatin | 422 |
Source ClinicalTrials.gov
Adverse events1,176
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 | First Course: Lenvatinib + Pembrolizumab | 95 | 420 | 130 |
| other | Anaemia | Blood and lymphatic system disorders | Paclitaxel + Carboplatin | 209 | 411 | 300 |
| other | Anaemia | Blood and lymphatic system disorders | Second Course: Lenvatinib + Pembrolizumab | 4 | 17 | 4 |
| other | Leukocytosis | Blood and lymphatic system disorders | First Course: Lenvatinib + Pembrolizumab | 6 | 420 | 8 |
| other | Leukocytosis | Blood and lymphatic system disorders | Paclitaxel + Carboplatin | 0 | 411 | 0 |
| other | Leukocytosis | Blood and lymphatic system disorders | Second Course: Lenvatinib + Pembrolizumab | 1 | 17 | 1 |
| other | Leukopenia | Blood and lymphatic system disorders | First Course: Lenvatinib + Pembrolizumab | 14 | 420 | 45 |
| other | Leukopenia | Blood and lymphatic system disorders | Paclitaxel + Carboplatin | 53 | 411 | 149 |
| other | Leukopenia | Blood and lymphatic system disorders | Second Course: Lenvatinib + Pembrolizumab | 1 | 17 | 3 |
| other | Lymphopenia | Blood and lymphatic system disorders | First Course: Lenvatinib + Pembrolizumab | 8 | 420 | 14 |
1 to 10 of 1,176Source ClinicalTrials.gov
See all 1,176 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | First Course: Lenvatinib + Pembrolizumab | 233 | 420 |
| Total, all-cause mortality | Paclitaxel + Carboplatin | 253 | 422 |
| Total, all-cause mortality | Second Course: Lenvatinib + Pembrolizumab | 3 | 17 |
| Total, other adverse events | First Course: Lenvatinib + Pembrolizumab | 416 | 420 |
| Total, other adverse events | Paclitaxel + Carboplatin | 397 | 411 |
| Total, other adverse events | Second Course: Lenvatinib + Pembrolizumab | 15 | 17 |
| Total, serious adverse events | First Course: Lenvatinib + Pembrolizumab | 230 | 420 |
| Total, serious adverse events | Paclitaxel + Carboplatin | 84 | 411 |
| Total, serious adverse events | Second Course: Lenvatinib + Pembrolizumab | 3 | 17 |
Source ClinicalTrials.gov
Papers4
The papers the trial lists on ClinicalTrials.gov.
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 comparisons4
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 Who Experienced a Serious Adverse Event (SAE) | Trial comparisons |
| Lenvatinib + Pembrolizumab vs Paclitaxel + Carboplatin: Number of Participants Who Discontinued Study Intervention Due to an AE | Trial comparisons |
| Lenvatinib + Pembrolizumab vs Paclitaxel + Carboplatin: Number of Participants Who Experienced an Adverse Event (AE) | Trial comparisons |
| Lenvatinib + Pembrolizumab vs Paclitaxel + Carboplatin: Number of Participants Who Experienced an Immune-Related Adverse Event (irAE) | 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/NCT03884101
GET https://conductscience.org/api/trials/v1/NCT03884101/results?page=2