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Brief Title: A Study of Penpulimab (AK105) in the First-line Treatment of Recurrent or Metastatic Nasopharyngeal Carcinoma
Official Title: A Randomized, Double-blind, Multi-center Phase III Study of Penpulimab (AK105) Combined With Chemotherapy Versus Placebo Combined With Chemotherapy in the First-line Treatment of Recurrent or Metastatic Nasopharyngeal Carcinoma
Study ID: NCT04974398
Brief Summary: This study is a randomized, double-blind, multi-center phase III clinical study to compare the efficacy and safety of penpulimab combined with chemotherapy and placebo combined with chemotherapy in the first-line treatment of recurrent or metastatic nasopharyngeal carcinoma.
Detailed Description:
Minimum Age: 12 Years
Eligible Ages: CHILD, ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
City of Hope, Duarte, California, United States
Winship Cancer Institute/Emory University, Atlanta, Georgia, United States
University of Michigan, Ann Arbor, Michigan, United States
Icahn School of Medicine at Mount Sinai, New York, New York, United States
Memorial Sloan Kettering Cancer Center, New York, New York, United States
Chris O'Brien Lifehouse, Camperdown, New South Wales, Australia
St Vincent's Public Hospital Sydney, Darlinghurst, New South Wales, Australia
Genesis Care North Shore, St Leonards, New South Wales, Australia
Sir Charles Gardner, Heidelberg, Victoria, Australia
Austin Health, Nedlands, Western Australia, Australia
Hospital de Câncer de Barretos - Fundação Pio XII, Barretos, Reg1, Brazil
Grupo Oncoclínicas, Botafogo, Reg1, Brazil
Hospital Bruno Born, Lajeado, Reg1, Brazil
Hospital Nossa Senhora da Conceicao, Porto Alegre, Reg1, Brazil
Centro de Estudos e Pesquisa de Hematologia, Santo André, Reg1, Brazil
Instituto do Câncer do Estado de São Paulo (ICESP), São Paulo, Reg1, Brazil
Centro de Câncer A. C. Camargo, São Paulo, Reg1, Brazil
Alberta Health Services (Tom Baker Cancer Centre), Calgary, Alberta, Canada
Toronto Sunnybrook Hospital, Toronto, Ontario, Canada
The First Affiliated Hospital of Anhui Medical University, Hefei, Anhui, China
Fujian Cancer Hospital, Fuzhou, Fujian, China
The First Affiliated Hospital of Xiamen University, Xiamen, Fujian, China
Dongguan People's Hospital, Dongguan, Guangdong, China
The First Affiliated Hospital of Sun Yat-sen University, Guangzhou, Guangdong, China
Affiliated Cancer Hospital and Institute of Guangzhou Medical University, Guangzhou, Guangdong, China
Sun Yat-sen Memorial Hospital, Sun Yat-sen University, Guangzhou, Guangdong, China
The First Affiliated Hospital of Guangzhou Medical University, Guangzhou, Guangdong, China
Zhujiang Hospital of Southern Medical University, Guangzhou, Guangdong, China
Nanfang Hospital, Southern Medical University, Guangzhou, Guangdong, China
The Sixth Affiliated Hospital of Sun Yat-sen University, Guangzhou, Guangdong, China
The First Affiliated Hospital of Guangdong Pharmaceutical University, Guangzhou, Guangdong, China
Guangzhou Panyu Central Hospital, Guangzhou, Guangdong, China
Jiangmen Central Hospital, Jiangmen, Guangdong, China
Cancer Hospital of Shantou University Medical College, Shantou, Guangdong, China
Shenzhen People's Hospital, Shenzhen, Guangdong, China
Affiliated Hospital of Guangdong Medical University, Zhanjiang, Guangdong, China
The Fifth Affiliated Hospital of Sun Yat-sen University, Zhuhai, Guangdong, China
Affiliated Hospital of Guilin Medical University, Guilin, Guangxi, China
The People's Hospital of Guangxi Zhuang Autonomous Region, Nanning, Guangxi, China
Guangxi Medical University Cancer Hospital, Nanning, Guangxi, China
The First Affiliated Hospital of Guangxi Medical University, Nanning, Guangxi, China
Guizhou Cancer Hospital, Guiyang, Guizhou, China
The First Affiliated Hospital of Hainan Medical University, Haikou, Hainan, China
Hainan General Hospital, Haikou, Hainan, China
Hubei Cancer Hospital, Wuhan, Hubei, China
The Second Xiangya Hospital of Central South University, Changsha, Hunan, China
Hunan Cancer Hospital, Changsha, Hunan, China
The First Affiliated Hospital of University of South China, Hengyang, Hunan, China
The Second Affiliated Hospital of Nanchang University, Nanchang, Jiangxi, China
Jiangxi Cancer Hospital, Nanchang, Jiangxi, China
Fudan University Shanghai Cancer Center, Shanghai, Shanghai, China
Sichuan Cancer Hospital, Chengdu, Sichuan, China
The Affiliated Hospital of Southwest Medical University, Luzhou, Sichuan, China
Yunnan Cancer Hospital, Kunming, Yunnan, China
Zhejiang Cancer Hospital, Hangzhou, Zhejiang, China
Taizhou Hospital of Zhejiang Province, Taizhou, Zhejiang, China
Name: Chaosu Hu, MD
Affiliation: Fudan University
Role: PRINCIPAL_INVESTIGATOR
Name: Xiaozhong Chen, MD
Affiliation: Cancer Hospital of The University of Chinese Academy of Sciences
Role: PRINCIPAL_INVESTIGATOR
Name: David G. Pfister, MD
Affiliation: Memorial Sloan Kettering Cancer Center
Role: PRINCIPAL_INVESTIGATOR