Trial · NCT03517449
Lenvatinib in Combination With Pembrolizumab Versus Treatment of Physician's Choice in Participants With Advanced Endometrial Cancer (MK-3475-775/E7080-G000-309 Per Merck Standard Convention [KEYNOTE-775])
NCT03517449, Phase 3, Completed, Eisai Inc.; results first posted 2021-11-17
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Lenvatinib in Combination With Pembrolizumab Versus Treatment of Physician's Choice in Participants With Advanced Endometrial Cancer (MK-3475-775/E7080-G000-309 Per Merck Standard Convention [KEYNOTE-775]). Trials, record NCT03517449. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03517449
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
Lenvatinib in Combination With Pembrolizumab Versus Treatment of Physician's Choice in Participants With Advanced Endometrial Cancer (MK-3475-775/E7080-G000-309 Per Merck Standard Convention [KEYNOTE-775])
- NCT number
- NCT03517449
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 827 participants, actual
- Lead sponsor
- Eisai Inc.
- Conditions
- Endometrial Neoplasms
- Interventions
- Pembrolizumab, Lenvatinib, Paclitaxel, Doxorubicin
- First posted
- 2018-05-07
- Last updated
- 2026-03-19
- Other registries' IDs
- eudract:2017-004387-35
- Results first posted
- 2021-11-17
Source ClinicalTrials.gov
Registered outcomes17
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Progression Free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) Based on Blinded Independent Central Review (BICR) in Mismatch Repair Proficient (pMMR) Participants | Up to approximately 27 months | PFS was defined as the time from the date of randomization to the date of the first documentation of disease progression, as determined by Blinded Independent Central Review (BICR) per Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1 or death due to any cause (whichever occurred first). Disease progression was defined as at least 20 percent (%) increase (including an absolute increase of at least 5 millimeter \[mm\]) in the sum of diameter of target lesions, taking as reference the smallest sum and/or unequivocal progression of existing non-target lesions and/or appearance of 1 or more new lesions. PFS was estimated and analyzed using Kaplan-Meier method. |
| Primary | PFS Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) Based on BICR in All-comer Participants | Up to approximately 27 months | PFS was defined as the time from the date of randomization to the date of the first documentation of disease progression, as determined by Blinded Independent Central Review (BICR) per Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1 or death due to any cause (whichever occurred first). Disease progression was defined as at least 20 percent (%) increase (including an absolute increase of at least 5 millimeter \[mm\]) in the sum of diameter of target lesions, taking as reference the smallest sum and/or unequivocal progression of existing non-target lesions and/or appearance of 1 or more new lesions. PFS was estimated and analyzed using Kaplan-Meier method. |
| Primary | Overall Survival (OS) in pMMR Participants | Up to approximately 43 months | OS was defined as the time from the date of randomization to the date of death due to any cause. Participants who were lost to follow-up and those who were alive at the date of data cut-off were censored at the date the participant was last known alive, or date of data cut-off, whichever occurred first. |
| Primary | OS in All-comer Participants | Up to approximately 43 months | OS was defined as the time from the date of randomization to the date of death due to any cause. Participants who were lost to follow-up and those who were alive at the date of data cut-off were censored at the date the participant was last known alive, or date of data cut-off, whichever occurred first. |
| Secondary | Objective Response Rate (ORR) in pMMR Participants | Up to approximately 80 months | ORR was defined as the percentage of participants who had best overall response of either complete response (CR) or partial response (PR) as determined by BICR per RECIST 1.1. CR was defined as the disappearance of all target and non-target lesions (non-lymph nodes). All pathological lymph nodes (whether target or non-target) must have a reduction in their short axis to less than (\<) 10mm. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters. |
| Secondary | ORR in All-comer Participants | Up to approximately 80 months | ORR was defined as the percentage of participants who had best overall response of either complete response (CR) or partial response (PR) as determined by BICR per RECIST 1.1. CR was defined as the disappearance of all target and non-target lesions (non-lymph nodes). All pathological lymph nodes (whether target or non-target) must have a reduction in their short axis to less than (\<) 10mm. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters. |
| Secondary | Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) in pMMR Participants | Baseline, Week 12 | EORTC QLQ-C30 was a questionnaire which included 30 questions that rates the overall quality of life in cancer participants. The first 28 questions use a 4-point scale (1=not at all to 4=very much) for evaluating function (physical, role, social, cognitive, emotional), symptoms (diarrhea, fatigue, dyspnea, appetite loss, insomnia, nausea/vomiting, constipation, and pain) and financial difficulties. The last 2 questions use a 7-point scale (1=very poor to 7=excellent) to evaluate overall health and quality of life. Scores are transformed to a range of 0 to 100 using a standard EORTC algorithm. A high score for a functional scale represents a high/healthy level of functioning, a high score for the global health status/quality of life (QoL) represents a high QoL, but a high score for a symptom scale/item represents a high level of symptomatology/problem. |
| Secondary | Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) in All-comer Participants | Baseline, Week 12 | EORTC QLQ-C30 was a questionnaire which included 30 questions that rates the overall quality of life in cancer participants. The first 28 questions use a 4-point scale (1=not at all to 4=very much) for evaluating function (physical, role, social, cognitive, emotional), symptoms (diarrhea, fatigue, dyspnea, appetite loss, insomnia, nausea/vomiting, constipation, and pain) and financial difficulties. The last 2 questions use a 7-point scale (1=very poor to 7=excellent) to evaluate overall health and quality of life. Scores are transformed to a range of 0 to 100 using a standard EORTC algorithm. A high score for a functional scale represents a high/healthy level of functioning, a high score for the global health status/quality of life (QoL) represents a high QoL, but a high score for a symptom scale/item represents a high level of symptomatology/problem. |
| Secondary | Number of Partricipants With Treatment-emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and Immune-Related Adverse Events (irAEs) | Up to approximately 77 months | TEAEs were AEs that occurred (or worsened, if present at baseline) after the first dose of study drug through 28 days after the last dose. An AE was any untoward medical occurrence in a participant temporally associated with use of study treatment, whether or not related to the treatment. An SAE was any untoward medical occurrence at any dose that resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity or substantial disruption of the ability to conduct normal life functions, or was a congenital anomaly/birth defect. An irAE was any unfavorable and unintended immune-related sign, symptom, or disease (new or worsening) temporally associated with study therapy, regardless of whether a causal relationship with the therapy could be determined. |
| Secondary | Number of Participants Who Discontinued Study Treatment Due to a TEAE in pMMR Participants | Up to approximately 77 months | TEAEs was defined as those AEs that occurred (or worsened, if present at Baseline) after the first dose of study drug through 30 days after the last dose of study drug. An AE was defined as any untoward medical occurrence in a participants or clinical study participant temporally associated with the use of study treatment, whether or not considered related to the study treatment. |
1 to 10 of 17Source ClinicalTrials.gov
See all 17 registered outcomesOutcomes17
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) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) Based on Blinded Independent Central Review (BICR) in Mismatch Repair Proficient (pMMR) Participants | Up to approximately 27 months | Analysis population consisted of ITT (intent to treat) population which included all randomized participants. Data is reported for pMMR participants. | Months | MEDIAN |
| PRIMARY | PFS Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) Based on BICR in All-comer Participants | Up to approximately 27 months | Analysis population consisted of ITT population which included all randomized participants. | Months | MEDIAN |
| PRIMARY | Overall Survival (OS) in pMMR Participants | Up to approximately 43 months | Analysis population consisted of ITT population which included all randomized participants. Data is reported for pMMR participants. | Months | MEDIAN |
| PRIMARY | OS in All-comer Participants | Up to approximately 43 months | Analysis population consisted of ITT population which included all randomized participants. | Months | NUMBER |
| SECONDARY | Objective Response Rate (ORR) in pMMR Participants | Up to approximately 80 months | Analysis population consisted of ITT population which included all randomized participants. Data is reported for pMMR participants. | Percentage of participants | NUMBER |
| SECONDARY | ORR in All-comer Participants | Up to approximately 80 months | Analysis population consisted of ITT population which included all randomized participants. | Percentage of Participants | NUMBER |
| SECONDARY | Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) in pMMR Participants | Baseline, Week 12 | Analysis population consisted of ITT population which included all randomized participants. Data is reported for pMMR participants. Here overall number of participants analyzed signifies participants who were evaluable for this outcome measure. | Score on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) in All-comer Participants | Baseline, Week 12 | Analysis population consisted of ITT population which included all randomized participants. Here overall number of participants analyzed signifies participants who were evaluable for this outcome measure. | Score on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Number of Partricipants With Treatment-emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and Immune-Related Adverse Events (irAEs) | Up to approximately 77 months | The analysis population included all randomized participants who received at least 1 dose of study treatment. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants Who Discontinued Study Treatment Due to a TEAE in pMMR Participants | Up to approximately 77 months | Safety analysis population included all randomized participants who received at least 1 dose of study treatment. Data is reported for pMMR participants. Here overall number of participants analyzed signifies participants who were evaluable for this outcome measure. | Participants | COUNT_OF_PARTICIPANTS |
1 to 10 of 17Source ClinicalTrials.gov
See all 17 outcomesResults by group42
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) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) Based on Blinded Independent Central Review (BICR) in Mismatch Repair Proficient (pMMR) Participants | Lenvatinib 20 mg + Pembrolizumab 200 mg | 6.6 | 95% Confidence Interval 5.6 | Months | |
Progression Free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) Based on Blinded Independent Central Review (BICR) in Mismatch Repair Proficient (pMMR) Participants | Treatment of Physician's Choice (TPC): Doxorubicin or Paclitaxel | 3.8 | 95% Confidence Interval 3.6 | Months | |
| PFS Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) Based on BICR in All-comer Participants | Lenvatinib 20 mg + Pembrolizumab 200 mg | 7.2 | 95% Confidence Interval 5.7 | Months | |
| PFS Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) Based on BICR in All-comer Participants | Treatment of Physician's Choice(TPC):Doxorubicin or Paclitaxel | 3.8 | 95% Confidence Interval 3.6 | Months | |
| Overall Survival (OS) in pMMR Participants | Lenvatinib 20 mg + Pembrolizumab 200 mg | 18.0 | 95% Confidence Interval 14.9 to 20.5 | Months | |
| Overall Survival (OS) in pMMR Participants | Treatment of Physician's Choice(TPC):Doxorubicin or Paclitaxel | 12.2 | 95% Confidence Interval 11.0 to 14.1 | Months | |
| OS in All-comer Participants | Lenvatinib 20 mg + Pembrolizumab 200 mg | 18.7 | 95% Confidence Interval 15.6 | Months | |
| OS in All-comer Participants | Treatment of Physician's Choice(TPC):Doxorubicin or Paclitaxel | 11.9 | 95% Confidence Interval 10.7 | Months | |
| Objective Response Rate (ORR) in pMMR Participants | Lenvatinib 20 mg + Pembrolizumab 200 mg | 30.3 | 95% Confidence Interval 25.5 | Percentage of participants | |
| Objective Response Rate (ORR) in pMMR Participants | Treatment of Physician's Choice(TPC):Doxorubicin or Paclitaxel | 15.1 | 95% Confidence Interval 11.5 | Percentage of participants |
1 to 10 of 42Source ClinicalTrials.gov
See all 42 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Lenvatinib 20 mg + Pembrolizumab 200 mg | 411 | |
| Overall Study | STARTED | Treatment of Physician's Choice (TPC): Doxorubicin or Paclitaxel | 416 | |
| Overall Study | COMPLETED | Lenvatinib 20 mg + Pembrolizumab 200 mg | 411 | |
| Overall Study | COMPLETED | Treatment of Physician's Choice (TPC): Doxorubicin or Paclitaxel | 416 | |
| Overall Study | NOT COMPLETED | Lenvatinib 20 mg + Pembrolizumab 200 mg | 0 | |
| Overall Study | NOT COMPLETED | Treatment of Physician's Choice (TPC): Doxorubicin or Paclitaxel | 0 |
Source ClinicalTrials.gov
Adverse events1,576
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 | 115 | 406 | 171 |
| other | Anaemia | Blood and lymphatic system disorders | First Course: TPC Doxorubicin or Paclitaxel | 181 | 388 | 240 |
| other | Anaemia | Blood and lymphatic system disorders | Second Course: Lenvatinib + Pembrolizumab | 1 | 21 | 1 |
| other | Anaemia | Blood and lymphatic system disorders | TPC Crossover | 1 | 6 | 3 |
| other | Leukopenia | Blood and lymphatic system disorders | First Course: Lenvatinib + Pembrolizumab | 28 | 406 | 72 |
| other | Leukopenia | Blood and lymphatic system disorders | First Course: TPC Doxorubicin or Paclitaxel | 50 | 388 | 89 |
| other | Leukopenia | Blood and lymphatic system disorders | Second Course: Lenvatinib + Pembrolizumab | 1 | 21 | 3 |
| other | Leukopenia | Blood and lymphatic system disorders | TPC Crossover | 0 | 6 | 0 |
| other | Lymphopenia | Blood and lymphatic system disorders | First Course: Lenvatinib + Pembrolizumab | 26 | 406 | 61 |
| other | Lymphopenia | Blood and lymphatic system disorders | First Course: TPC Doxorubicin or Paclitaxel | 30 | 388 | 45 |
1 to 10 of 1,576Source ClinicalTrials.gov
See all 1,576 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | First Course: Lenvatinib + Pembrolizumab | 317 | 406 |
| Total, all-cause mortality | First Course: TPC Doxorubicin or Paclitaxel | 362 | 388 |
| Total, all-cause mortality | Second Course: Lenvatinib + Pembrolizumab | 8 | 21 |
| Total, all-cause mortality | TPC Crossover | 1 | 6 |
| Total, other adverse events | First Course: Lenvatinib + Pembrolizumab | 404 | 406 |
| Total, other adverse events | First Course: TPC Doxorubicin or Paclitaxel | 379 | 388 |
| Total, other adverse events | Second Course: Lenvatinib + Pembrolizumab | 20 | 21 |
| Total, other adverse events | TPC Crossover | 6 | 6 |
| Total, serious adverse events | First Course: Lenvatinib + Pembrolizumab | 237 | 406 |
| Total, serious adverse events | First Course: TPC Doxorubicin or Paclitaxel | 121 | 388 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers6
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 comparisons3
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
Lenvatinib 20 mg + Pembrolizumab 200 mg vs Treatment of Physician's Choice(TPC):Doxorubicin or Paclitaxel: Number of Participants Who Discontinued Study Treatment Due to a TEAE in All-comer Participants | Trial comparisons |
Lenvatinib 20 mg + Pembrolizumab 200 mg vs Treatment of Physician's Choice(TPC):Doxorubicin or Paclitaxel: Number of Partricipants With Treatment-emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and Immune-Related Adverse Events (irAEs) | Trial comparisons |
| Lenvatinib 20 mg + Pembrolizumab 200 mg vs Treatment of Physician's Choice(TPC):Doxorubicin or Paclitaxel: Number of Participants Who Discontinued Study Treatment Due to a TEAE in pMMR Participants | 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.
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