Spots Global Cancer Trial Database for Pembrolizumab (MK-3475) Plus Lenvatinib (E7080/MK-7902) Versus Chemotherapy for Endometrial Carcinoma (ENGOT-en9 / MK-7902-001) - China Extension Study
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Trial Identification
Brief Title: Pembrolizumab (MK-3475) Plus Lenvatinib (E7080/MK-7902) Versus Chemotherapy for Endometrial Carcinoma (ENGOT-en9 / MK-7902-001) - China Extension Study
Official Title: A Phase 3 Randomized, Open-Label, Study of Pembrolizumab (MK-3475) Plus Lenvatinib (E7080/MK-7902) Versus Chemotherapy for First-line Treatment of Advanced or Recurrent Endometrial Carcinoma (LEAP-001)
Study ID: NCT04865289
Conditions
Study Description
Brief Summary: 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.
Detailed Description: 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.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
Locations
Anhui Cancer Hospital-Gynecological Oncology ( Site 2509), Hefei, Anhui, China
Beijing Obstetrics and Gynecology Hospital Capital Medical University ( Site 2505), Beijing, Beijing, China
Peking Union Medical College Hospital ( Site 2501), Beijing, Beijing, China
Beijing Cancer Hospital ( Site 2504), Beijing, Beijing, China
Chongqing Cancer Hospital ( Site 2513), Chongqing, Chongqing, 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
Xiangya Hospital Central-South University ( Site 2512), Changsha, Hunan, China
Hunan Cancer Hospital ( Site 2523), Changsha, Hunan, China
Nanjing Maternity and Child Health Care Hospital ( Site 2508), Nanjing, Jiangsu, China
Jiangxi Maternal and Child Health Hospital ( Site 2519), Nanchang, Jiangxi, China
The First Hospital Of Jilin University ( Site 2518), Changchun, Jilin, China
The first affiliated Hospital of Xi an Jiaotong University ( Site 2502), XI An, Shaanxi, China
Fudan University Shanghai Cancer Center ( Site 2500), Shanghai, Shanghai, China
Obstetrics and Gynecology Hosp. Fudan University ( Site 2503), Shanghai, Shanghai, China
Shanghai First Maternity and Infant Hospital ( Site 2524), Shanghai, Shanghai, China
The First Affiliated Hospital of Xinjiang Medical University ( Site 2515), Urumqi, Xinjiang, China
Women s Hospital School of Medicine Zhejiang University ( Site 2511), Hangzhou, Zhejiang, China
Zhejiang Cancer Hospital ( Site 2506), Hangzhou, Zhejiang, China
Contact Details
Name: Medical Director
Affiliation: Merck Sharp & Dohme LLC
Role: STUDY_DIRECTOR
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