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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT03924986
Other study ID # BGB-A317-309
Secondary ID CTR20182534
Status Active, not recruiting
Phase Phase 3
First received
Last updated
Start date April 18, 2019
Est. completion date June 2025

Study information

Verified date May 2024
Source BeiGene
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 256
Est. completion date June 2025
Est. primary completion date March 26, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility Key Inclusion Criteria: 1. Able to provide written informed consent and can understand and agree to comply with the requirements of the study and the schedule of assessments 2. 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) 3. Histologically or cytologically confirmed, recurrent or metastatic NPC 4. 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 5. ECOG performance status = 1 6. Must have = 1 measurable lesions as defined per RECIST v1.1 7. Must be treatment-naive for recurrent or metastatic nasopharyngeal cancer (NPC) Key Exclusion Criteria: 1. Participants with locally recurrence suitable for curative surgery or radiotherapy 2. 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. 3. 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 4. Received prior therapies targeting PD-1 or PD-L1 5. Active leptomeningeal disease or uncontrolled, untreated brain metastasis 6. Active autoimmune diseases or history of autoimmune diseases that may relapse 7. 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.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Tislelizumab
200 mg administered intravenously (IV)
Placebo
Placebo to match Tislelizumab
Gemcitabin
1 g/m2, administered as an IV infusion within 30 minutes
Cisplatin
80 mg/m2, administered as an IV infusion over 4 hours

Locations

Country Name City State
China Beijing Cancer Hospital Beijing Beijing
China Cancer Hospital Chinese Academy of Medical Science Beijing Beijing
China Changsha Central Hospital Changsha Hunan
China Hunan Cancer Hospital Changsha Hunan
China Sichuan Cancer Hospital Chengdu Sichuan
China West China Hospital ,Sichuan University Chengdu Sichuan
China Chongqing Three Gorges Central Hospital Chongqing Chongqing
China Fujian Provincial Cancer Hospital Fuzhou Fujian
China Cancer Center of Guangzhou Medical University Guangzhou Guangdong
China Guangdong Provincial People's Hospital Guangzhou Guangdong
China Sun Yat-sen Memorial Hospital , Sun Yat-sen University Guangzhou Guangdong
China The first Affiliated Hospital of guangzhou University of traditional chinese medicine - Oncology Guangzhou Guangdong
China Harbin Medical University Cancer Hospital - Oncology Haerbin Heilongjiang
China Chongqing University Cancer Hospital Haikou Chongqing
China Hainan General Hospital - Oncology Haikou Hainan
China Zhejiang Cancer Hospital Hangzhou Zhejiang
China Anhui Provincial Cancer Hospital Hefei Anhui
China The First affiliated hospital of Nanchang University Nanchang Jiangxi
China Guangxi Medical University Affiliated Tumor Hospital& Oncology Medical College Nanning Guangxi
China The People's Hospital of Guangxi Zhuang Autonomous Region Nanning Guangxi
China Affiliated hospital of Nantong university Nantong Jiangsu
China Affiliated Zhongshan Hospital of Fudan University Shanghai Shanghai
China Shanghai East Hospital Shanghai Shanghai
China Cancer Hospital of Shantou University Medical College - Oncology Shantou Guangdong
China Hubei Cancer Hospital - Oncology Wuhan Hubei
China Union Hospital of Tongji Medical College, Huazhong University of Science and Technology Wuhan Hubei
China First Affiliated Hospital of Xiamen University Xiamen Fujian
China Affiliated Hospital of Guangdong Medical University Zhanjiang Guangdong
China People's Hospital of Zhongshan City Zhongshan Guangdong
China The Fifth Affiliated Hospital Sun Yat-Sen University Zhuhai Guangdong
Taiwan Changhua Christian Hospital Changhua NAP
Taiwan Taichung Veterans General Hospital Taichung
Taiwan National Cheng Kung University Hospital Tainan
Taiwan National Taiwan University Hospital Taipei
Taiwan Taipei Veterans General Hospital Taipei
Thailand Maharaj Nakorn Chiang Mai Hospital [SSU] Chiang Mai Muang
Thailand Vajira Hospital [SSU] Dusit Bangkok
Thailand Khon Kaen University, Srinagarind Hospital [SSU] Khon Kaen Muang
Thailand Ramathibodi Hospital - Mahidol University - Hematology [SSU] Ratchathewi Bangkok
Thailand Prince of Songkla University [SSU] Song Phi Nong Hat Yai

Sponsors (1)

Lead Sponsor Collaborator
BeiGene

Countries where clinical trial is conducted

China,  Taiwan,  Thailand, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. up to 2 years.
Secondary 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. up to 2 years.
Secondary 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. up to 2 years.
Secondary 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. up to 2 years.
Secondary 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. up to 2 years.
Secondary 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. up to 2 years.