Back to resultsTislelizumab Combined With Chemotherapy Versus Chemotherapy Alone in Recurrent or Metastatic Nasopharyngeal Cancer
Primary Purpose
Recurrent or Metastatic Nasopharyngeal Cancer
Status
Active
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Tislelizumab
Placebo
Gemcitabin
Cisplatin
Sponsored by
About this trial
This is an interventional treatment trial for Recurrent or Metastatic Nasopharyngeal Cancer
Eligibility Criteria
Key Inclusion Criteria:
- Able to provide written informed consent and can understand and agree to comply with the requirements of the study and the schedule of assessments
- Aged between 18 to 75 years on the day of signing the informed consent form (or the legal age of consent in the jurisdiction in which the study is taking place)
- Histologically or cytologically confirmed, recurrent or metastatic NPC
- Participants must be able to provide fresh or archival tumor tissues (FFPE blocks or approximately 10 [≥ 6] freshly cut unstained FFPE slides) with an associated pathological report. The archival tumor tissues must be collected within 2 years before screening. In the absence of sufficient archival tumor tissues, a fresh biopsy of a tumor lesion at baseline is mandatory
- ECOG performance status ≤ 1
- Must have ≥ 1 measurable lesions as defined per RECIST v1.1
- Must be treatment-naive for recurrent or metastatic nasopharyngeal cancer (NPC)
Key Exclusion Criteria:
- Participants with locally recurrence suitable for curative surgery or radiotherapy
Received any approved systemic anticancer therapy, including hormonal therapy, within 28 days prior to initiation of study treatment. The following exception is allowed:
-Palliative radiotherapy for bone metastases or soft tissue lesions should be completed > 7 days prior to baseline imaging.
- Has received any immunotherapy (including but not limited to interferons, interleukin 2, tumor necrosis factor interleukin, and thymoxin) or any investigational therapies within 14 days or 5 half-lives (whichever is longer) of randomization
- Received prior therapies targeting PD-1 or PD-L1
- Active leptomeningeal disease or uncontrolled, untreated brain metastasis
- Active autoimmune diseases or history of autoimmune diseases that may relapse
- Any active malignancy ≤ 2 years before randomization except for the specific cancer under investigation in this study and any locally recurring cancer that has been treated curatively (eg, resected basal or squamous cell skin cancer, superficial bladder cancer, carcinoma in situ of the cervix or breast)
NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
Sites / Locations
- Anhui Provincial Cancer Hospital
- Beijing Cancer Hospital
- Cancer Hospital Chinese Academy of Medical Science
- Chongqing Three Gorges Central Hospital
- Chongqing University Cancer Hospital
- Fujian Provincial Cancer Hospital
- First Affiliated Hospital of Xiamen University
- The first Affiliated Hospital of guangzhou University of traditional chinese medicine - Oncology
- Cancer Center of Guangzhou Medical University
- Guangdong Provincial People's Hospital
- Sun Yat-sen Memorial Hospital , Sun Yat-sen University
- Cancer Hospital of Shantou University Medical College - Oncology
- Affiliated Hospital of Guangdong Medical University
- People's Hospital of Zhongshan City
- The Fifth Affiliated Hospital Sun Yat-Sen University
- Guangxi Medical University Affiliated Tumor Hospital& Oncology Medical College
- The People's Hospital of Guangxi Zhuang Autonomous Region
- Hainan General Hospital - Oncology
- Harbin Medical University Cancer Hospital - Oncology
- Hubei Cancer Hospital - Oncology
- Union Hospital of Tongji Medical College, Huazhong University of Science and Technology
- Hunan Cancer Hospital
- Changsha Central Hospital
- Affiliated hospital of Nantong university
- The First affiliated hospital of Nanchang University
- Affiliated Zhongshan Hospital of Fudan University
- Shanghai East Hospital
- West China Hospital ,Sichuan University
- Sichuan Cancer Hospital
- Zhejiang Cancer Hospital
- Changhua Christian Hospital
- Taichung Veterans General Hospital
- National Cheng Kung University Hospital
- National Taiwan University Hospital
- Taipei Veterans General Hospital
- Vajira Hospital [SSU]
- Ramathibodi Hospital - Mahidol University - Hematology [SSU]
- Prince of Songkla University [SSU]
- Maharaj Nakorn Chiang Mai Hospital [SSU]
- Khon Kaen University, Srinagarind Hospital [SSU]
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Tislelizumab combined with Gemcitabine Plus Cisplatin
Placebo combined with Gemcitabine Plus Cisplatin
Arm Description
Tislelizumab will be administered once every 3 weeks (Q3W) Gemcitabine on Day 1, Day 8 of each 3 week cycle, for 4 to 6 cycles Cisplatin on Day 1 of each 3 week cycle, for 4 to 6 cycles
Placebo will be administered once every 3 weeks (Q3W) Gemcitabine on Day 1, Day 8 of 3 week each cycle, for 4 to 6 cycles Cisplatin on Day 1 of 3 week each cycle, for 4 to 6 cycles
Outcomes
Primary Outcome Measures
Progression-free Survival
Progression-free survival as assessed by the Independent Review Committee: the time from randomization to the first objectively documented disease progression, or death from any cause, whichever occurs first, as assessed by the Independent Review Committee per RECIST v1.1 in an Intent-to-Treat analysis set.
Secondary Outcome Measures
Overall Survival
The time from the date of randomization to the date of death due to any cause in an Intent-to-Treat analysis set.
Duration of response
Duration of response as assessed by the Independent Review Committee: the time from the first occurrence of a documented objective response to the time of relapse, or death from any cause, whichever comes first, as assessed by the Independent Review Committee per RECIST v1.1 in all randomized participants with documented objective responses.
Overall response rate
Overall response rate as assessed by the Independent Review Committee: the proportion of participants who had complete response or partial response as assessed by the Independent Review Committee per RECIST v1.1 in all randomized participants with measurable disease at baseline.
Progression-free survival as assessed by the investigator
The time from randomization to the first objectively documented disease progression, or death from any cause, whichever occurs first, as assessed by the investigator per RECIST v1.1 in an Intent-to-Treat analysis set.
Progression-free survival after next line of treatment as assessed by the investigator
The time from randomization to second/subsequent disease progression after initiation of new anticancer therapy, or death from any cause, whichever occurs first.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03924986
Brief Title
Tislelizumab Combined With Chemotherapy Versus Chemotherapy Alone in Recurrent or Metastatic Nasopharyngeal Cancer
Official Title
Phase 3, Double-Blind, Randomized Study to Compare the Efficacy and Safety of Tislelizumab Combined With Chemotherapy Versus Chemotherapy as First-Line Treatment for Recurrent or Metastatic Nasopharyngeal Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
April 18, 2019 (Actual)
Primary Completion Date
March 26, 2021 (Actual)
Study Completion Date
June 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
BeiGene
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This is a Phase 3, Multicenter, Double-Blind, Randomized, Placebo-controlled Study to Compare the Efficacy and Safety of Tislelizumab (BGB-A317) Combined With Gemcitabine Plus Cisplatin Versus Placebo Combined With Gemcitabine Plus Cisplatin as First Line Treatment for Recurrent or Metastatic Nasopharyngeal Cancer.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Recurrent or Metastatic Nasopharyngeal Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
256 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Tislelizumab combined with Gemcitabine Plus Cisplatin
Arm Type
Experimental
Arm Description
Tislelizumab will be administered once every 3 weeks (Q3W)
Gemcitabine on Day 1, Day 8 of each 3 week cycle, for 4 to 6 cycles
Cisplatin on Day 1 of each 3 week cycle, for 4 to 6 cycles
Arm Title
Placebo combined with Gemcitabine Plus Cisplatin
Arm Type
Placebo Comparator
Arm Description
Placebo will be administered once every 3 weeks (Q3W)
Gemcitabine on Day 1, Day 8 of 3 week each cycle, for 4 to 6 cycles
Cisplatin on Day 1 of 3 week each cycle, for 4 to 6 cycles
Intervention Type
Drug
Intervention Name(s)
Tislelizumab
Other Intervention Name(s)
BGB-A317
Intervention Description
200 mg administered intravenously (IV)
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo to match Tislelizumab
Intervention Type
Drug
Intervention Name(s)
Gemcitabin
Intervention Description
1 g/m2, administered as an IV infusion within 30 minutes
Intervention Type
Drug
Intervention Name(s)
Cisplatin
Intervention Description
80 mg/m2, administered as an IV infusion over 4 hours
Primary Outcome Measure Information:
Title
Progression-free Survival
Description
Progression-free survival as assessed by the Independent Review Committee: the time from randomization to the first objectively documented disease progression, or death from any cause, whichever occurs first, as assessed by the Independent Review Committee per RECIST v1.1 in an Intent-to-Treat analysis set.
Time Frame
up to 2 years.
Secondary Outcome Measure Information:
Title
Overall Survival
Description
The time from the date of randomization to the date of death due to any cause in an Intent-to-Treat analysis set.
Time Frame
up to 2 years.
Title
Duration of response
Description
Duration of response as assessed by the Independent Review Committee: the time from the first occurrence of a documented objective response to the time of relapse, or death from any cause, whichever comes first, as assessed by the Independent Review Committee per RECIST v1.1 in all randomized participants with documented objective responses.
Time Frame
up to 2 years.
Title
Overall response rate
Description
Overall response rate as assessed by the Independent Review Committee: the proportion of participants who had complete response or partial response as assessed by the Independent Review Committee per RECIST v1.1 in all randomized participants with measurable disease at baseline.
Time Frame
up to 2 years.
Title
Progression-free survival as assessed by the investigator
Description
The time from randomization to the first objectively documented disease progression, or death from any cause, whichever occurs first, as assessed by the investigator per RECIST v1.1 in an Intent-to-Treat analysis set.
Time Frame
up to 2 years.
Title
Progression-free survival after next line of treatment as assessed by the investigator
Description
The time from randomization to second/subsequent disease progression after initiation of new anticancer therapy, or death from any cause, whichever occurs first.
Time Frame
up to 2 years.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Key Inclusion Criteria:
Able to provide written informed consent and can understand and agree to comply with the requirements of the study and the schedule of assessments
Aged between 18 to 75 years on the day of signing the informed consent form (or the legal age of consent in the jurisdiction in which the study is taking place)
Histologically or cytologically confirmed, recurrent or metastatic NPC
Participants must be able to provide fresh or archival tumor tissues (FFPE blocks or approximately 10 [≥ 6] freshly cut unstained FFPE slides) with an associated pathological report. The archival tumor tissues must be collected within 2 years before screening. In the absence of sufficient archival tumor tissues, a fresh biopsy of a tumor lesion at baseline is mandatory
ECOG performance status ≤ 1
Must have ≥ 1 measurable lesions as defined per RECIST v1.1
Must be treatment-naive for recurrent or metastatic nasopharyngeal cancer (NPC)
Key Exclusion Criteria:
Participants with locally recurrence suitable for curative surgery or radiotherapy
Received any approved systemic anticancer therapy, including hormonal therapy, within 28 days prior to initiation of study treatment. The following exception is allowed:
-Palliative radiotherapy for bone metastases or soft tissue lesions should be completed > 7 days prior to baseline imaging.
Has received any immunotherapy (including but not limited to interferons, interleukin 2, tumor necrosis factor interleukin, and thymoxin) or any investigational therapies within 14 days or 5 half-lives (whichever is longer) of randomization
Received prior therapies targeting PD-1 or PD-L1
Active leptomeningeal disease or uncontrolled, untreated brain metastasis
Active autoimmune diseases or history of autoimmune diseases that may relapse
Any active malignancy ≤ 2 years before randomization except for the specific cancer under investigation in this study and any locally recurring cancer that has been treated curatively (eg, resected basal or squamous cell skin cancer, superficial bladder cancer, carcinoma in situ of the cervix or breast)
NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Li Zhang, MD
Organizational Affiliation
Sun Yat-sen University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Anhui Provincial Cancer Hospital
City
Hefei
State/Province
Anhui
ZIP/Postal Code
230088
Country
China
Facility Name
Beijing Cancer Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100142
Country
China
Facility Name
Cancer Hospital Chinese Academy of Medical Science
City
Beijing
State/Province
Beijing
Country
China
Facility Name
Chongqing Three Gorges Central Hospital
City
Chongqing
State/Province
Chongqing
ZIP/Postal Code
404199
Country
China
Facility Name
Chongqing University Cancer Hospital
City
Haikou
State/Province
Chongqing
ZIP/Postal Code
570311
Country
China
Facility Name
Fujian Provincial Cancer Hospital
City
Fuzhou
State/Province
Fujian
ZIP/Postal Code
350014
Country
China
Facility Name
First Affiliated Hospital of Xiamen University
City
Xiamen
State/Province
Fujian
ZIP/Postal Code
361003
Country
China
Facility Name
The first Affiliated Hospital of guangzhou University of traditional chinese medicine - Oncology
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510000
Country
China
Facility Name
Cancer Center of Guangzhou Medical University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510059
Country
China
Facility Name
Guangdong Provincial People's Hospital
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510080
Country
China
Facility Name
Sun Yat-sen Memorial Hospital , Sun Yat-sen University
City
Guangzhou
State/Province
Guangdong
Country
China
Facility Name
Cancer Hospital of Shantou University Medical College - Oncology
City
Shantou
State/Province
Guangdong
ZIP/Postal Code
515031
Country
China
Facility Name
Affiliated Hospital of Guangdong Medical University
City
Zhanjiang
State/Province
Guangdong
ZIP/Postal Code
524000
Country
China
Facility Name
People's Hospital of Zhongshan City
City
Zhongshan
State/Province
Guangdong
ZIP/Postal Code
528400
Country
China
Facility Name
The Fifth Affiliated Hospital Sun Yat-Sen University
City
Zhuhai
State/Province
Guangdong
ZIP/Postal Code
519000
Country
China
Facility Name
Guangxi Medical University Affiliated Tumor Hospital& Oncology Medical College
City
Nanning
State/Province
Guangxi
ZIP/Postal Code
530021
Country
China
Facility Name
The People's Hospital of Guangxi Zhuang Autonomous Region
City
Nanning
State/Province
Guangxi
ZIP/Postal Code
530021
Country
China
Facility Name
Hainan General Hospital - Oncology
City
Haikou
State/Province
Hainan
Country
China
Facility Name
Harbin Medical University Cancer Hospital - Oncology
City
Haerbin
State/Province
Heilongjiang
ZIP/Postal Code
150081
Country
China
Facility Name
Hubei Cancer Hospital - Oncology
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
400037
Country
China
Facility Name
Union Hospital of Tongji Medical College, Huazhong University of Science and Technology
City
Wuhan
State/Province
Hubei
Country
China
Facility Name
Hunan Cancer Hospital
City
Changsha
State/Province
Hunan
ZIP/Postal Code
410006
Country
China
Facility Name
Changsha Central Hospital
City
Changsha
State/Province
Hunan
ZIP/Postal Code
410018
Country
China
Facility Name
Affiliated hospital of Nantong university
City
Nantong
State/Province
Jiangsu
ZIP/Postal Code
226001
Country
China
Facility Name
The First affiliated hospital of Nanchang University
City
Nanchang
State/Province
Jiangxi
ZIP/Postal Code
330006
Country
China
Facility Name
Affiliated Zhongshan Hospital of Fudan University
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200032
Country
China
Facility Name
Shanghai East Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200120
Country
China
Facility Name
West China Hospital ,Sichuan University
City
Chengdu
State/Province
Sichuan
ZIP/Postal Code
610041
Country
China
Facility Name
Sichuan Cancer Hospital
City
Chengdu
State/Province
Sichuan
ZIP/Postal Code
610042
Country
China
Facility Name
Zhejiang Cancer Hospital
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310022
Country
China
Facility Name
Changhua Christian Hospital
City
Changhua
State/Province
NAP
ZIP/Postal Code
500-06
Country
Taiwan
Facility Name
Taichung Veterans General Hospital
City
Taichung
Country
Taiwan
Facility Name
National Cheng Kung University Hospital
City
Tainan
ZIP/Postal Code
704
Country
Taiwan
Facility Name
National Taiwan University Hospital
City
Taipei
ZIP/Postal Code
100
Country
Taiwan
Facility Name
Taipei Veterans General Hospital
City
Taipei
ZIP/Postal Code
112
Country
Taiwan
Facility Name
Vajira Hospital [SSU]
City
Dusit
State/Province
Bangkok
ZIP/Postal Code
10300
Country
Thailand
Facility Name
Ramathibodi Hospital - Mahidol University - Hematology [SSU]
City
Ratchathewi
State/Province
Bangkok
ZIP/Postal Code
10400
Country
Thailand
Facility Name
Prince of Songkla University [SSU]
City
Song Phi Nong
State/Province
Hat Yai
ZIP/Postal Code
90110
Country
Thailand
Facility Name
Maharaj Nakorn Chiang Mai Hospital [SSU]
City
Chiang Mai
State/Province
Muang
ZIP/Postal Code
50200
Country
Thailand
Facility Name
Khon Kaen University, Srinagarind Hospital [SSU]
City
Khon Kaen
State/Province
Muang
ZIP/Postal Code
40002
Country
Thailand
12. IPD Sharing Statement
Plan to Share IPD
Yes
Learn more about this trial
Tislelizumab Combined With Chemotherapy Versus Chemotherapy Alone in Recurrent or Metastatic Nasopharyngeal Cancer
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