Clinical Trials List
2020-01-21 - 2024-04-08
Phase III
Recruiting3
ICD-10C11.0
Malignant neoplasm of superior wall of nasopharynx
ICD-10Z51.12
Encounter for antineoplastic immunotherapy
ICD-9147.0
Malignant neoplasm of superior wall of nasopharynx
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
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Trial Applicant
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Sponsor
BeiGene
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Trial scale
Multi-Regional Multi-Center
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Update
2026/02/01
Investigators and Locations
The Actual Total Number of Participants Enrolled
0 Recruiting
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- Shang-Yin Wu Division of Hematology & Oncology
- Kwang-Yu Chang Division of Hematology & Oncology
The Actual Total Number of Participants Enrolled
0 Recruiting
Condition/Disease
Objectives
Test Drug
Active Ingredient
Dosage Form
Dosage
Endpoints
1.Progression-free Survival.
Secondary Outcome Measures:
1.Overall Survival.
2.Duration of response .
3.Overall response rate.
4.Progression-free survival as assessed by the investigator.
5.Progression-free survival after next line of treatment as assessed by the investigator.
Inclution Criteria
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).
Exclusion Criteria
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).
The Estimated Number of Participants
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Taiwan
9 participants
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Global
263 participants
