Spots Global Cancer Trial Database for Efficacy and Safety Study of Pembrolizumab (MK-3475) Versus Paclitaxel in Asian Participants With Advanced Gastric or Gastroesophageal Junction Adenocarcinoma Who Progressed After First-line Therapy With Platinum and Fluoropyrimidine (MK-3475-063/KEYNOTE-063)
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Trial Identification
Brief Title: Efficacy and Safety Study of Pembrolizumab (MK-3475) Versus Paclitaxel in Asian Participants With Advanced Gastric or Gastroesophageal Junction Adenocarcinoma Who Progressed After First-line Therapy With Platinum and Fluoropyrimidine (MK-3475-063/KEYNOTE-063)
Official Title: A Phase III, Randomized, Open-label Clinical Trial of Pembrolizumab (MK-3475) Versus Paclitaxel in Asian Subjects With Advanced Gastric or Gastroesophageal Junction Adenocarcinoma Who Progressed After First-Line Therapy With Platinum and Fluoropyrimidine
Study ID: NCT03019588
Study Description
Brief Summary: The study will compare the efficacy and safety of treatment with pembrolizumab (MK-3475) versus paclitaxel in Asian, programmed death-ligand 1 (PD-L1) positive participants with advanced gastric or gastroesophageal junction (GEJ) adenocarcinoma who have progressed after failure of any combination chemotherapy containing a platinum and a fluoropyrimidine agent. The primary study hypotheses are that pembrolizumab prolongs Overall Survival (OS) compared to paclitaxel and that pembrolizumab prolongs Progression-free Survival (PFS) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) assessed by blinded central radiologists' review compared to paclitaxel.
Detailed Description: Once the participant has achieved the study objective or the study has ended, the participant will be discontinued from the study and may be enrolled in an extension study to continue protocol-defined assessments and treatment. Enrollment in the extension study will be conditional on participant consent. Treatment with pembrolizumab or paclitaxel will continue until documented disease progression, unacceptable adverse event(s), intercurrent illness that prevents further administration of treatment, investigator's decision to discontinue the participant, participant withdraws consent, pregnancy of the participant, participant receives 35 administrations (approximately 2 years) of pembrolizumab, or administrative reasons requiring cessation of treatment.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Beijing Cancer Hospital ( Site 0022), Beijing, Beijing, China
Fuzhou General Hospital of Nanjing Military Command ( Site 0023), Fuzhou, Fujian, China
The First People's Hospital of Changzhou ( Site 0024), Changzhou, Jiangsu, China
Nanjing 81 PLA Hospital, Dept. of Oncology ( Site 0001), Nanjing, Jiangsu, China
Jilin Province Cancer Hospital, Department of Chemotherapy ( Site 0002), Changchun, Jilin, China
Tangdu Hospital ( Site 0030), XI An, Shanxi, China
2nd Affil Hosp of Zhejiang University College of Medicine ( Site 0014), Hangzhou, Zhejiang, China
301 Hospital ( Site 0008), Beijing, , China
307 Hospital of PLA, Dept. of Oncology ( Site 0006), Beijing, , China
Peking Union Medical College Hospital ( Site 0011), Beijing, , China
Xiangya Hospital Central -South University ( Site 0021), Changsha, , China
Sir Sun Sun Shaw Hosp, Zhejiang Univ,Oncology dept. ( Site 0016), Hangzhou, , China
The First Affiliated Hospital of Zhejiang University ( Site 0004), Hangzhou, , China
Harbin Medical University Cancer Hospital ( Site 0020), Harbin, , China
Anhui Provincial Hospital ( Site 0017), Hefei, , China
The First Affiliated Hospital of Anhui Medical University ( Site 0012), Hefei, , China
The Second Hospital of Anhui Medical University ( Site 0013), Hefei, , China
Jiangsu Cancer Hospital ( Site 0003), Nanjing, , China
Renji Hospital Shanghai Jiaotong University School of Medicine ( Site 0028), Shanghai, , China
Ruijin Hospital, Shanghai Jiaotong University ( Site 0018), Shanghai, , China
Shanghai East Hospital ( Site 0033), Shanghai, , China
Shanghai Tenth People's Hospital ( Site 0026), Shanghai, , China
Zhongshan Hospital affiliated to Fudan University ( Site 0005), Shanghai, , China
Shanghai First People's Hospital ( Site 0027), Songjiang, , China
Tongji Medical College Huazhong Uinversity Of Science and Technology ( Site 0025), Wuhan, , China
CHA Bundang Medical Center CHA University ( Site 0203), Seongnam si, Gyeonggi Do, Korea, Republic of
National Cancer Center ( Site 0202), Goyang-si, Gyeonggi-do, Korea, Republic of
The Catholic University of Korea, St. Vincent's Hospital ( Site 0201), Suwon, Gyeonggi-do, Korea, Republic of
Asan Medical Center ( Site 0204), Seoul, , Korea, Republic of
Kangbuk Samsung Hospital ( Site 0205), Seoul, , Korea, Republic of
Severance Hospital Yonsei University Health System ( Site 0206), Seoul, , Korea, Republic of
University Malaya Medical Centre (UMMC) ( Site 0126), Kuala Lumpur, Wilayah Persekutuan, Malaysia
Chang Gung Medical Foundation - Kaohsiung ( Site 0227), Kaohsiung, , Taiwan
China Medical University Hospital. ( Site 0226), Taichung, , Taiwan
Koo Foundation Sun Yat-Sen Cancer Center ( Site 0228), Taipei, , Taiwan
MacKay Memorial Hospital ( Site 0229), Taipei, , Taiwan
Contact Details
Name: Medical Director
Affiliation: Merck Sharp & Dohme LLC
Role: STUDY_DIRECTOR
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