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| ID | Type | Description | Link |
|---|---|---|---|
| MK-7902-001 | Other Identifier | MSD | |
| ENGOT-en9 | Other Identifier | European Network for Gynaecological Oncological Trial groups | |
| 194710 | Registry Identifier | JAPIC-CTI | |
| 2023-505614-17 | Other Identifier | EU CT |
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| Name | Class |
|---|---|
| Eisai Inc. | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lenvatinib + Pembrolizumab | Experimental | Participants receive lenvatinib daily and pembrolizumab once at the start of each 3-week treatment cycle. |
|
| Paclitaxel + Carboplatin | Active Comparator | Participants receive paclitaxel and carboplatin once at the start of each 3-week treatment cycle. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lenvatinib | Drug | Lenvatinib 4 mg or 10 mg capsules at a total daily dose of 20 mg taken by mouth once per day. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Up to approximately 45 months |
| 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. | Up to approximately 45 months |
| 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. | Up to approximately 45 months |
| 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. | Up to approximately 45 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Merck Sharp & Dohme LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Anhui Cancer Hospital-Gynecological Oncology ( Site 2509) | Hefei | Anhui | 230031 | China | ||
| Beijing Obstetrics and Gynecology Hospital Capital Medical University ( Site 2505) |
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| Label | URL |
|---|---|
| Merck Clinical Trials Information | View source |
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130 participants were enrolled in China. 66 participants were randomized in the global portion for MK-7902-001 (NCT03884101) and 64 in the China extension portion.
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| ID | Title | Description |
|---|---|---|
| FG000 | Lenvatinib + Pembrolizumab | Participants received lenvatinib daily and pembrolizumab once at the start of each 3-week treatment cycle. |
| FG001 | Paclitaxel + Carboplatin | Participants received paclitaxel and carboplatin once at the start of each 3-week treatment cycle. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Feb 13, 2024 | Oct 31, 2025 |
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| Pembrolizumab | Biological | Pembrolizumab 200 mg IV infusion given on Day 1 of each cycle. |
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| Paclitaxel | Drug | Paclitaxel 175 mg/m^2 IV infusion given on Day 1 of each cycle. |
|
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| Carboplatin | Drug | 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. |
|
|
| Up to approximately 45 months |
| 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. | Up to approximately 45 months |
| 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. | Baseline and up to approximately 18 weeks |
| 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. | Baseline and up to approximately 18 weeks |
| 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. | From first dose date to 120 days after last dose date (up to approximately 58 months) |
| 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. | From first dose date to 120 days after last dose date (up to approximately 58 months) |
| 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. | From first dose date to 120 days after last dose date (up to approximately 58 months) |
| 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. | From first dose date to last dose date (up to approximately 54 months) |
| Beijing |
| Beijing Municipality |
| 100032 |
| China |
| Peking Union Medical College Hospital ( Site 2501) | Beijing | Beijing Municipality | 100032 | China |
| Beijing Cancer Hospital ( Site 2504) | Beijing | Beijing Municipality | 100142 | China |
| Chongqing Cancer Hospital ( Site 2513) | Chongqing | Chongqing Municipality | 400030 | China |
| The First Affiliated hospital of Xiamen University-Obstetrics and gynecology department ( Site 2522) | Xiamen | Fujian | 361003 | China |
| The First Affiliated Hospital.Sun Yat-sen University ( Site 2507) | Guangzhou | Guangdong | 510080 | China |
| Guang Xi Tumour Hospital, Department of Chemotherapy ( Site 2517) | Nanning | Guangxi | 530021 | China |
| Harbin Medical University Cancer Hospital ( Site 2520) | Harbin | Heilongjiang | 150081 | China |
| Hubei Cancer Hospital ( Site 2510) | Wuhan | Hubei | 430079 | China |
| Xiangya Hospital Central-South University ( Site 2512) | Changsha | Hunan | 410008 | China |
| Hunan Cancer Hospital ( Site 2523) | Changsha | Hunan | 410013 | China |
| Nanjing Maternity and Child Health Care Hospital ( Site 2508) | Nanjing | Jiangsu | 210011 | China |
| Jiangxi Maternal and Child Health Hospital ( Site 2519) | Nanchang | Jiangxi | 530021 | China |
| The First Hospital Of Jilin University ( Site 2518) | Changchun | Jilin | 130012 | China |
| The first affiliated Hospital of Xi an Jiaotong University ( Site 2502) | Xi'an | Shaanxi | 710061 | China |
| Fudan University Shanghai Cancer Center ( Site 2500) | Shanghai | Shanghai Municipality | 200032 | China |
| Obstetrics and Gynecology Hosp. Fudan University ( Site 2503) | Shanghai | Shanghai Municipality | 200090 | China |
| Shanghai First Maternity and Infant Hospital ( Site 2524) | Shanghai | Shanghai Municipality | 201204 | China |
| The First Affiliated Hospital of Xinjiang Medical University ( Site 2515) | Ürümqi | Xinjiang | 830054 | China |
| Women s Hospital School of Medicine Zhejiang University ( Site 2511) | Hangzhou | Zhejiang | 310006 | China |
| Zhejiang Cancer Hospital ( Site 2506) | Hangzhou | Zhejiang | 310022 | China |
| Treated |
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| COMPLETED |
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| NOT COMPLETED |
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All Chinese participants who were randomized to the global study (NCT03884101) and to the extension portion.
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| ID | Title | Description |
|---|---|---|
| BG000 | Lenvatinib + Pembrolizumab | Participants received lenvatinib daily and pembrolizumab once at the start of each 3-week treatment cycle. |
| BG001 | Paclitaxel + Carboplatin | Participants received paclitaxel and carboplatin once at the start of each 3-week treatment cycle. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Eastern Cooperative Oncology Group (ECOG) Performance Status | Participants were stratified by an ECOG Performance Status of 0 (Fully active, able to carry on all pre-disease performance without restriction) or 1 (Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature). | Count of Participants | Participants |
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| Prior Chemotherapy and/or Chemoradiation | Participants were stratified by whether or not they had received prior chemotherapy and/or chemoradiation treatment; yes or no. | Count of Participants | Participants |
| |||||||||||||||
| Mismatch Repair (MMR) Status | Participants were stratified by their MMR status; Mismatch Repair Proficient (pMMR) or Mismatch Repair Deficient (dMMR). | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | 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. | 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. | Posted | Median | 95% Confidence Interval | Months | Up to approximately 45 months |
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| Primary | 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. | 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. | Posted | Median | 95% Confidence Interval | Months | Up to approximately 45 months |
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| Primary | 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. | 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. | Posted | Median | 95% Confidence Interval | Months | Up to approximately 45 months |
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| Primary | 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. | 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. | Posted | Median | 95% Confidence Interval | Months | Up to approximately 45 months |
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| Secondary | 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. | 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. | Posted | Number | 95% Confidence Interval | Percentage of Participants | Up to approximately 45 months |
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| Secondary | 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. | 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. | Posted | Number | 95% Confidence Interval | Percentage of Participants | Up to approximately 45 months |
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| 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 | 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. | 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. | Posted | Least Squares Mean | 95% Confidence Interval | Scores on a scale | Baseline and up to approximately 18 weeks |
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| Secondary | 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. | 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. | Posted | Least Squares Mean | 95% Confidence Interval | Scores on a scale | Baseline and up to approximately 18 weeks |
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| Secondary | 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. | 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 | Posted | Count of Participants | Participants | From first dose date to 120 days after last dose date (up to approximately 58 months) |
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| Secondary | 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. | 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 | Posted | Count of Participants | Participants | From first dose date to 120 days after last dose date (up to approximately 58 months) |
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| Secondary | 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. | 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. | Posted | Count of Participants | Participants | From first dose date to 120 days after last dose date (up to approximately 58 months) |
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| Secondary | 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. | 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 | Posted | Count of Participants | Participants | From first dose date to last dose date (up to approximately 54 months) |
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From randomization to the date of death or last participant data collection (up to approximately 61 months).
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" & "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Lenvatinib + Pembrolizumab | Participants received lenvatinib daily and pembrolizumab once at the start of each 3-week treatment cycle. | 34 | 74 | 40 | 73 | 72 | 73 |
| EG001 | Paclitaxel + Carboplatin | Participants received paclitaxel and carboplatin once at the start of each 3-week treatment cycle. | 25 | 56 | 17 | 56 | 55 | 56 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Granulocytopenia | Blood and lymphatic system disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Myelosuppression | Blood and lymphatic system disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Acute myocardial infarction | Cardiac disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Arrhythmia | Cardiac disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Arteriosclerosis coronary artery | Cardiac disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Myocardial injury | Cardiac disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Myocarditis | Cardiac disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Hypophysitis | Endocrine disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Ascites | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Functional gastrointestinal disorder | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Haemorrhoids | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Pancreatitis | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Pancreatitis acute | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Small intestinal perforation | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
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| Death | General disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Hyperthermia malignant | General disorders | MedDRA 27.1 | Systematic Assessment |
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| Malaise | General disorders | MedDRA 27.1 | Systematic Assessment |
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| Pain | General disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Peripheral swelling | General disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Cholecystitis | Hepatobiliary disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Drug-induced liver injury | Hepatobiliary disorders | MedDRA 27.1 | Systematic Assessment |
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| Hepatic function abnormal | Hepatobiliary disorders | MedDRA 27.1 | Systematic Assessment |
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| Immune-mediated hepatitis | Hepatobiliary disorders | MedDRA 27.1 | Systematic Assessment |
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| Liver injury | Hepatobiliary disorders | MedDRA 27.1 | Systematic Assessment |
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| Anaphylactic shock | Immune system disorders | MedDRA 27.1 | Systematic Assessment |
| |
| COVID-19 pneumonia | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Infected cyst | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Infection | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
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| Septic shock | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Spinal fracture | Injury, poisoning and procedural complications | MedDRA 27.1 | Systematic Assessment |
| |
| Sternal fracture | Injury, poisoning and procedural complications | MedDRA 27.1 | Systematic Assessment |
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| Thoracic vertebral fracture | Injury, poisoning and procedural complications | MedDRA 27.1 | Systematic Assessment |
| |
| Wound haemorrhage | Injury, poisoning and procedural complications | MedDRA 27.1 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA 27.1 | Systematic Assessment |
| |
| Electrocardiogram QT prolonged | Investigations | MedDRA 27.1 | Systematic Assessment |
| |
| Neutrophil count decreased | Investigations | MedDRA 27.1 | Systematic Assessment |
| |
| Platelet count decreased | Investigations | MedDRA 27.1 | Systematic Assessment |
| |
| Protein urine present | Investigations | MedDRA 27.1 | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA 27.1 | Systematic Assessment |
| |
| White blood cell count decreased | Investigations | MedDRA 27.1 | Systematic Assessment |
| |
| Cachexia | Metabolism and nutrition disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Diabetes mellitus | Metabolism and nutrition disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Ketoacidosis | Metabolism and nutrition disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Immune-mediated myositis | Musculoskeletal and connective tissue disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Sjogren's syndrome | Musculoskeletal and connective tissue disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Cerebral infarction | Nervous system disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Epilepsy | Nervous system disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Neuralgia | Nervous system disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Subarachnoid haemorrhage | Nervous system disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Hydronephrosis | Renal and urinary disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Pyelocaliectasis | Renal and urinary disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Renal impairment | Renal and urinary disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Immune-mediated lung disease | Respiratory, thoracic and mediastinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Upper-airway cough syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Dermatitis | Skin and subcutaneous tissue disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Haemorrhage subcutaneous | Skin and subcutaneous tissue disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Aortic dissection | Vascular disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 27.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Palpitations | Cardiac disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Hyperthyroidism | Endocrine disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Hypothyroidism | Endocrine disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Abdominal distension | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Flatulence | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Haematochezia | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Mouth ulceration | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Chest discomfort | General disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Malaise | General disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Pain | General disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Peripheral swelling | General disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Hepatic function abnormal | Hepatobiliary disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Anaphylactic reaction | Immune system disorders | MedDRA 27.1 | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Gingivitis | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Periodontitis | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA 27.1 | Systematic Assessment |
| |
| Amylase increased | Investigations | MedDRA 27.1 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA 27.1 | Systematic Assessment |
| |
| Bilirubin conjugated increased | Investigations | MedDRA 27.1 | Systematic Assessment |
| |
| Blood alkaline phosphatase increased | Investigations | MedDRA 27.1 | Systematic Assessment |
| |
| Blood bilirubin increased | Investigations | MedDRA 27.1 | Systematic Assessment |
| |
| Blood cholesterol increased | Investigations | MedDRA 27.1 | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA 27.1 | Systematic Assessment |
| |
| Blood glucose increased | Investigations | MedDRA 27.1 | Systematic Assessment |
| |
| Blood lactate dehydrogenase increased | Investigations | MedDRA 27.1 | Systematic Assessment |
| |
| Blood pressure increased | Investigations | MedDRA 27.1 | Systematic Assessment |
| |
| Blood thyroid stimulating hormone increased | Investigations | MedDRA 27.1 | Systematic Assessment |
| |
| Gamma-glutamyltransferase increased | Investigations | MedDRA 27.1 | Systematic Assessment |
| |
| Hepatic enzyme increased | Investigations | MedDRA 27.1 | Systematic Assessment |
| |
| Lipase increased | Investigations | MedDRA 27.1 | Systematic Assessment |
| |
| Lymphocyte count decreased | Investigations | MedDRA 27.1 | Systematic Assessment |
| |
| Neutrophil count decreased | Investigations | MedDRA 27.1 | Systematic Assessment |
| |
| Platelet count decreased | Investigations | MedDRA 27.1 | Systematic Assessment |
| |
| Tri-iodothyronine decreased | Investigations | MedDRA 27.1 | Systematic Assessment |
| |
| Urinary occult blood positive | Investigations | MedDRA 27.1 | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA 27.1 | Systematic Assessment |
| |
| White blood cell count decreased | Investigations | MedDRA 27.1 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Hypercholesterolaemia | Metabolism and nutrition disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Hyperlipidaemia | Metabolism and nutrition disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Hypertriglyceridaemia | Metabolism and nutrition disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Hyperuricaemia | Metabolism and nutrition disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Hypochloraemia | Metabolism and nutrition disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Anaesthesia | Nervous system disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Hypoaesthesia | Nervous system disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Neuropathy peripheral | Nervous system disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Proteinuria | Renal and urinary disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Dysphonia | Respiratory, thoracic and mediastinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Palmar-plantar erythrodysaesthesia syndrome | Skin and subcutaneous tissue disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 27.1 | Systematic Assessment |
|
The Sponsor will generally support publication of multicenter studies only in their entirety and not as individual site data. In this case, a coordinating investigator will be designated by mutual agreement. If publication activity is not directed by the Sponsor, the investigator agrees to submit all manuscripts or abstracts to the Sponsor before submission. This allows the Sponsor to protect proprietary information and to provide comments.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Vice President, Global Clinical Development | Merck Sharp & Dohme LLC | 1-800-672-6372 | ClinicalTrialsDisclosure@msd.com |
| Prot_001.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jan 18, 2022 | Nov 18, 2025 | SAP_002.pdf |
| ID | Term |
|---|---|
| D016889 | Endometrial Neoplasms |
| ID | Term |
|---|---|
| D014594 | Uterine Neoplasms |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C531958 | lenvatinib |
| C582435 | pembrolizumab |
| D017239 | Paclitaxel |
| D016190 | Carboplatin |
| ID | Term |
|---|---|
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D056831 | Coordination Complexes |
Not provided
Not provided
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| ECOG = 1 |
|
| No |
|
| pMMR |
|
|
|
|
|
|
|
|
|
|
|
|
|
Participants received paclitaxel and carboplatin once at the start of each 3-week treatment cycle. |
|
|
|
|
|
|
|
|
|
| Units | Counts |
|---|
| Participants |
|
|
|