Tislelizumab Combined With Chemotherapy Versus Chemotherapy Alone in Recurrent or Metastatic Nasopharyngeal Cancer (NPC)

PHASE3CompletedINTERVENTIONAL
Enrollment

263

Participants

Timeline

Start Date

March 27, 2019

Primary Completion Date

March 26, 2021

Study Completion Date

December 8, 2023

Conditions
Recurrent or Metastatic Nasopharyngeal Cancer
Interventions
DRUG

Tislelizumab

200 mg intravenously (IV) once every 3 weeks (Q3W)

DRUG

Placebo

Placebo to match tislelizumab (administered intravenously Q3W)

DRUG

Gemcitabine

1 gram per square meter of body surface area (g/m\^2) on Day 1 and day 8 of each cycle, administered as an IV infusion within 30 minutes, for 4 to 6 cycles

DRUG

Cisplatin

80 milligrams per square meter of body surface area (mg/m\^2) on Day 1 of each cycle, administered as an IV infusion for over 4 hours if possible or with proper infusion time based on local clinical guidelines or clinical practice and according to the treating physician's clinical judgment, for 4 to 6 cycles.

Trial Locations (37)

704

National Cheng Kung University Hospital, Tainan City

10400

Ramathibodi Hospital Mahidol University Hematology, Bangkok

40002

Srinagarind Hospital (Khon Kaen University), Muang

40705

Veterans General Hospital Taichung, Taichung

50006

Changhua Christian Hospital, Changhua

50200

Maharaj Nakorn Chiang Mai Hospital (Chiang Mai University), Muang

90110

Songklanagarind Hospital (Prince of Songkhla University), Hat Yai

100142

Beijing Cancer Hospital, Beijing

150000

Harbin Medical University Cancer Hospital, Harbin

200032

Affiliated Zhongshan Hospital of Fudan University, Shanghai

200120

Shanghai East Hospital, Shanghai

201203

Affiliated Hospital of Nantong University, Nantong

230000

Anhui Provincial Hospital, Hefei

310022

Zhejiang Cancer Hospital, Hangzhou

330006

The First Affiliated Hospital of Nanchang University Branch Donghu, Nanchang

350014

Fujian Cancer Hospital, Fuzhou

361003

The First Affiliated Hospital of Xiamen University, Xiamen

400030

Chongqing Cancer Hospital, Chongqing

404000

Chongqing Three Gorges Central Hospital, Chongqing

410004

Changsha Central Hospital, Changsha

410013

Hunan Cancer Hospital, Changsha

430022

Union Hospital of Tongji Medical College, Huazhong University of Science and Technology, Wuhan

430079

Hubei Cancer Hospital, Wuhan

510000

Sun Yat Sen Memorial Hospital, Sun Yat Sen University (North), Guangzhou

510030

Cancer Center of Guangzhou Medical University, Guangzhou

510060

Sun Yat Sen University Cancer Center, Guangzhou

510080

Guangdong Provincial Peoples Hospital, Guangzhou

510405

The First Affiliated Hospital of Guangzhou University of Traditional Chinese Medicine, Guangzhou

515031

Cancer Hospital of Shantou University Medical College, Shantou

519000

The Fifth Affiliated Hospital Sun Yat Sen University, Zhuhai

524000

Affiliated Hospital of Guangdong Medical University, Zhanjiang

528403

The Peoples Hospital of Zhongshan City, Zhongshan

530021

The Peoples Hospital of Guangxi Zhuang Autonomous Region, Nanning

The Tumor Hospital Affiliated to Guangxi Medical University, Nanning

570206

Hainan General Hospital, Haikou

610041

Sichuan Cancer Hospital and Institute, Chengdu

West China Hospital, Sichuan University, Chengdu

Sponsors

Lead Sponsor

All Listed Sponsors
lead

BeiGene

INDUSTRY