Clinical trial · Interventional
Tislelizumab Combined With Chemotherapy Versus Chemotherapy Alone in Recurrent or Metastatic Nasopharyngeal Cancer (NPC)
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This study was designed 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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Recurrent or Metastatic Nasopharyngeal Cancer | Nasopharyngeal Neoplasm | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cisplatin | Drug | Cisplatin | ALIAS |
| Gemcitabine | Drug | Gemcitabine | ALIAS |
| Placebo | Drug | — | UNRESOLVED |
| Tislelizumab | Drug | Tislelizumab | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Arm A: Tislelizumab + Gemcitabine + Cisplatin
- description
- Participants received tislelizumab 200 mg intravenously (IV) once every 3 weeks (Q3W), gemcitabine 1 g/m\^2 IV on days 1 and 8 of each 21-day cycle and cisplatin 80 mg/m\^2 IV on day 1 of each cycle for 4 to 6 treatment cycles. Participants may have received treatment for longer at the Investigator's discretion until disease progression. Participants with confirmed disease progression may have continued to receive tislelizumab monotherapy.
- interventionNames
- Drug: Tislelizumab
- Drug: Gemcitabine
- Drug: Cisplatin
- type
- PLACEBO_COMPARATOR
- label
- Arm B: Placebo + Gemcitabine + Cisplatin
- description
- Participants received placebo IV once every 3 weeks, gemcitabine 1 g/m\^2 IV on days 1 and 8 of each 21-day cycle and cisplatin 80 mg/m\^2 IV on day 1 of each cycle for 4 to 6 treatment cycles. Participants may have received treatment for longer at the Investigator's discretion until disease progression. Participants with confirmed disease progression may have crossed over to receive tislelizumab 200 mg IV Q3W monotherapy.
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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 (formalin-fixed paraffin-embedded \[FFPE\] 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. Eastern Cooperative Oncology Group (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 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 programmed cell death protein-1 (PD-1) or programmed cell death protein ligand-1 (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.
References
Publications (4)
- BACKGROUNDZhang L, Liu T, Wang H, Shi S, Yang Y. A Phase 3 Trial in Progress Comparing Tislelizumab Plus Chemotherapy With Placebo Plus Chemotherapy in Chinese Patients With Recurrent or Metastatic Nasopharyngeal Cancer. Abstract published at: 22nd Annual Meeting of the Chinese Society of Clinical Oncology; September, 2019; Xiamen, China.
- DERIVEDYang Y, Yen CJ, Pan J, Wang H, Qu S, Chen N, Chen X, Sun Y, He X, Hu C, Lin L, Wu Y, Yuan S, Chen C, Xu X, Ma X, Leaw S, Zhang L, Fang W. First-Line Tislelizumab Plus Chemotherapy for Recurrent or Metastatic Nasopharyngeal Cancer: Three-Year Follow-Up of the Phase 3 RATIONALE-309 Randomized Clinical Trial. JAMA Oncol. 2026 Apr 1;12(4):384-393. doi: 10.1001/jamaoncol.2026.0020. PMID 41746630
- DERIVEDYang Y, Pan J, Chen N, Guo Y, Huang X, Wu Y, Leaw S, Bai F, Wang Y, Zhao N, Tang B, Barnes G. Effects of tislelizumab on health-related quality of life in patients with recurrent or metastatic nasopharyngeal cancer. Head Neck. 2024 Sep;46(9):2301-2314. doi: 10.1002/hed.27785. Epub 2024 Apr 26. PMID 38671587
- DERIVEDYang Y, Pan J, Wang H, Zhao Y, Qu S, Chen N, Chen X, Sun Y, He X, Hu C, Lin L, Yu Q, Wang S, Wang G, Lei F, Wen J, Yang K, Lin Z, Guo Y, Chen S, Huang X, Wu Y, Liang L, Chen C, Bai F, Ma X, Zhang Y, Leaw S, Zhang L, Fang W. Tislelizumab plus chemotherapy as first-line treatment for recurrent or metastatic nasopharyngeal cancer: A multicenter phase 3 trial (RATIONALE-309). Cancer Cell. 2023 Jun 12;41(6):1061-1072.e4. doi: 10.1016/j.ccell.2023.04.014. Epub 2023 May 18. PMID 37207654