Spots Global Cancer Trial Database for First-line Esophageal Carcinoma Study With Chemo vs. Chemo Plus Pembrolizumab (MK-3475-590/KEYNOTE-590)-China Extension Study
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Trial Identification
Brief Title: First-line Esophageal Carcinoma Study With Chemo vs. Chemo Plus Pembrolizumab (MK-3475-590/KEYNOTE-590)-China Extension Study
Official Title: A Randomized, Double-Blind, Placebo-Controlled Phase III Clinical Trial of Pembrolizumab (MK-3475) in Combination With Cisplatin and 5-Fluorouracil Versus Placebo in Combination With Cisplatin and 5-Fluorouracil as First-Line Treatment in Subjects With Advanced/Metastatic Esophageal Carcinoma (KEYNOTE-590)
Study ID: NCT03881111
Conditions
Study Description
Brief Summary: The purpose of this Chinese extension study is to evaluate efficacy and safety of pembrolizumab plus cisplatin and 5-fluorouracil (5-FU) chemotherapy versus placebo plus cisplatin and 5-FU chemotherapy as first-line treatment in a Chinese cohort of participants with locally advanced or metastatic esophageal carcinoma. The primary efficacy hypotheses are that both progression-free survival (PFS), according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 and determined by blinded independent central review, and overall survival (OS) are superior with pembrolizumab plus chemotherapy compared with placebo plus chemotherapy in all Chinese participants as well as Chinese participants whose tumors are programmed cell death-ligand 1 (PD-L1)-positive.
Detailed Description: The Chinese extension to MK-3475-590 (NCT03189719) will enroll a total of approximately 90 participants.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Anhui Provincial Hospital ( Site 0106), Hefei, Anhui, China
The First Affiliated Hospital of Anhui Medical University ( Site 0112), Hefei, Anhui, China
Peking Union Medical College Hospital ( Site 0123), Beijing, Beijing, China
The First Affiliated Hospital of Xiamen University ( Site 0119), Xiamen, Fujian, China
Guangdong General Hospital ( Site 0103), Guangzhou, Guangdong, China
The Affiliated Tumour Hospital of Harbin Medical University ( Site 0102), Harbin, Heilongjiang, China
Hunan Cancer Hospital ( Site 0105), Changsha, Hunan, China
PLA Cancer Centre of Nanjing Bayi Hospital ( Site 0110), Nanjing, Jiangsu, China
Jiangsu Cancer Hospital ( Site 0117), Nanjing, Jiangsu, China
Zhongda Hospital Southeast University ( Site 0125), Nanjing, Jiangsu, China
Jilin Cancer Hospital ( Site 0101), Changchun, Jilin, China
The First Affiliated Hospital of Xi an Jiaotong University ( Site 0120), Xi'an, Shannxi, China
Zhejiang Cancer Hospital ( Site 0116), Hangzhou, Zhejiang, China
Beijing Cancer Hospital ( Site 0100), Beijing, , China
Fujian Provincial Cancer Hospital ( Site 0104), Fuzhou, , China
Shanghai Chest Hospital ( Site 0111), Shanghai, , China
Fudan University Shanghai Cancer Center ( Site 0108), Shanghai, , China
Renji Hospital Shanghai Jiaotong University School of Medicine ( Site 0114), Shanghai, , China
Tongji Medical College Huazhong University of Science and Technology ( Site 0109), Wuhan, , China
Henan Cancer Hospital ( Site 0107), Zhengzhou, , China
Contact Details
Name: Medical Director
Affiliation: Merck Sharp & Dohme LLC
Role: STUDY_DIRECTOR
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