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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
130
Lenvatinib 4 mg or 10 mg capsules at a total daily dose of 20 mg taken by mouth once per day.
Pembrolizumab 200 mg IV infusion given on Day 1 of each cycle.
Paclitaxel 175 mg/m\^2 IV infusion given on Day 1 of each cycle.
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.
Anhui Cancer Hospital-Gynecological Oncology ( Site 2509)
Hefei, Anhui, China
Beijing Obstetrics and Gynecology Hospital Capital Medical University ( Site 2505)
Beijing, Beijing Municipality, China
Peking Union Medical College Hospital ( Site 2501)
Beijing, Beijing Municipality, China
Beijing Cancer Hospital ( Site 2504)
Beijing, Beijing Municipality, China
Chongqing Cancer Hospital ( Site 2513)
Chongqing, Chongqing Municipality, China
The First Affiliated hospital of Xiamen University-Obstetrics and gynecology department ( Site 2522)
Xiamen, Fujian, China
The First Affiliated Hospital.Sun Yat-sen University ( Site 2507)
Guangzhou, Guangdong, China
Guang Xi Tumour Hospital, Department of Chemotherapy ( Site 2517)
Nanning, Guangxi, China
Harbin Medical University Cancer Hospital ( Site 2520)
Harbin, Heilongjiang, China
Hubei Cancer Hospital ( Site 2510)
Wuhan, Hubei, China
...and 12 more locations
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Up to approximately 45 months
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: From first dose date to last dose date (up to approximately 54 months)