Phase 3
Completed N=263
Tislelizumab Combined With Chemotherapy Versus Chemotherapy Alone in Recurrent or Metastatic Nasopharyngeal Cancer (NPC)
Source: ClinicalTrials.gov NCT03924986 ↗Enrolled (actual)
263
Serious AEs
32.4%
Results posted
Jan 2025
Primary outcomePrimary: Progression-free Survival as Assessed by the Independent Review Committee (IRC) — 9.2; 7.4 Months
◆ Published Evidence
Highly cited
218citations · ~73 / year
Tislelizumab plus chemotherapy as first-line treatment for recurrent or metastatic nasopharyngeal cancer: A multicenter phase 3 trial (RATIONALE-309).
Summary
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.
Linked Publications (3)
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Tislelizumab plus chemotherapy as first-line treatment for recurrent or metastatic nasopharyngeal cancer: A multicenter phase 3 trial (RATIONALE-309).
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First-Line Tislelizumab Plus Chemotherapy for Recurrent or Metastatic Nasopharyngeal Cancer: Three-Year Follow-Up of the Phase 3 RATIONALE-309 Randomized Clinical Trial.
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Effects of tislelizumab on health-related quality of life in patients with recurrent or metastatic nasopharyngeal cancer.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Progression-free Survival as Assessed by the Independent Review Committee (IRC) |
9.2; 7.4 | — |
| SECONDARY Overall Response Rate (ORR) as Assessed by the IRC |
69.5; 55.3 | — |
| SECONDARY Duration of Response (DOR) as Assessed by the IRC |
8.5; 6.1 | — |
| SECONDARY Overall Survival (OS) as Assessed by the IRC |
45.3; 31.8 | — |
| SECONDARY PFS as Assessed by the Investigator |
9.8; 7.6 | — |
| SECONDARY Progression-free Survival After Next Line of Treatment (PFS2) as Assessed by the Investigator |
45.3; 20.5 | — |
| SECONDARY Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) Global Health Status |
0.2; -0.1 | — |
| SECONDARY Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire-Head and Neck-351 (EORTC QLQ-H&N35) Index Score |
-0.3; -0.3 | — |
| SECONDARY Number of Participants With Adverse Events |
133; 129; 47; 46 | — |
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 (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
- Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1
- Must have ≥ 1 measurable lesions as defined per RECIST v1.1
- Must be treatment-naive for recurrent or metastatic 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 programmed cell death protein-1 (PD-1) or programmed cell death protein ligand-1 (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.
Data sourced from ClinicalTrials.gov (NCT03924986) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.