2025-520487-18-00招募中2 期
Adaptive phase II randomized non-comparative trial of nivolumab after induction treatment in triple-negative breast cancer (TNBC) patients: TONIC-trial
Het Nederlands Kanker Instituut-Antoni van Leeuwenhoek Ziekenhuis Stichting1 个研究点 分布在 1 个国家目标入组 84 人开始时间: 2025年1月24日最近更新:
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 84
- 试验地点
- 1
- 主要终点
- Progression-free survival (=PFS1, time from randomization to tumor progression or death from any cause). Progression as defined by RECIST 1.1 will be used.
研究概览
简要总结
To determine the activity of nivolumab after four different immune response induction treatments in TNBC patients with metastatic disease. We hypothesize that short-term induction treatment with radiation, doxorubicin, cyclophosphamide or cisplatin induces an anticancer immune response resulting in increased activity of nivolumab as compared to unprimed, single agent nivolumab.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •Metastatic ER and HER2 negative breast cancer
- •18 years or older
- •Metastatic lesions accessible for histological biopsy
- •Maximum of three lines of chemotherapy for metastatic disease
- •Evaluable disease according to RECIST 1.1
- •WHO performance status 0 or 1
- •Subjects with brain metastases are eligible if these have been treated and there is no magnetic resonance imaging (MRI) evidence of progression for at least 4 weeks after treatment is completed and prior to first dose of study drug administration. There must also be no requirement for immunosuppressive doses of systemic corticosteroids (> 10 mg/day prednisone equivalents) for at least 2 weeks prior to study drug administration
- •Signed written informed consent
排除标准
- •Known leptomenigeal disease localization
- •History of having recceived other anticancer therapies within 2 weeks of start of the study drug
- •History of immunodeficiency, autoimmune disease, conditions requiring immunosuppression (>10 mg daily prednisone equivalents) or chronic infections
- •Current pregnancy or breastfeeding
结局指标
主要结局
Progression-free survival (=PFS1, time from randomization to tumor progression or death from any cause). Progression as defined by RECIST 1.1 will be used.
Progression-free survival (=PFS1, time from randomization to tumor progression or death from any cause). Progression as defined by RECIST 1.1 will be used.
次要结局
- Progression-free survival (=PFS1, time from randomization to tumor progression or death from any cause). Progression as defined by modified RECIST 1.1 for immune-based therapeutics (iRECIST) will be used.
- Progression-free survival (=PFS2, time from nivolumab treatment initiation to tumor progression). Progression as defined by RECIST 1.1 and iRECIST will be used.
- Overall response rate ORR (complete response CR or partial response PR) according to RECIST 1.1 and iRECIST. ORR1 (relative to randomization) and ORR2 (relative to nivolumab initiation) will be used.
- Clinical benefit rate (CR+PR+stable disease ≥ 6 months and CR+PR+stable disease ≥ 3 months) according to RECIST 1.1 and iRECIST. CBR1 (relative to randomization) and CBR2 (relative to nivolumab initiation) will be used.
- Overall survival (OS, time from nivolumab initiation to death from any cause).
- Percentage of patients with toxicity (classified according to CTCAE v4.0) and immune-related toxicity.
研究者
Marleen kok
Scientific
Het Nederlands Kanker Instituut-Antoni van Leeuwenhoek Ziekenhuis Stichting
研究点 (1)
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