Nivolumab and CAPOX in Patients With FGFR2/PD-L1-positive Metastatic Gastric Adenocarcinoma: a Single-arm, Phase 2 Study
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 23
- 试验地点
- 1
- 主要终点
- 1-year progression-free survival (PFS)
研究概览
简要总结
The goal of this phase 2 clinical trial is to evaluate the efficacy of nivolumab in combination with CAPOX in patients with FGFR2-positive/PD-L1-positive/HER2-negative metastatic gastric cancer.
详细描述
On April 16, 2021, the Food and Drug Administration approved first-line therapy with nivolumab and fluoropyrimidine-platinum-containing chemotherapy for metastatic gastric adenocarcinoma. Patients with PD-L1 expression benefit the most from this treatment.
Fibroblast growth factor receptor 2 (FGFR2) is a predictor of poor overall survival and a potential target for targeted therapy. However, there is no data of nivolumab efficacy in patients with combined expression of PD-L1 and FGFR2.
The aim of this study is to evaluate the preliminary efficacy of nivolumab in this patient population.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Previously untreated, unresectable advanced or metastatic gastric adenocarcinoma
- •Measurable lesions according to the RECIST 1.1 criteria
- •PD-L1 Combined Positive Score (CPS) of five or more assessed by Dako PD-L1 immunohistochemistry 28-8 pharmDx assay
- •Positive FGFR2 overexpression status by immunohistochemistry defined as exhibiting any moderate (2+) to strong (3+) membranous staining in more than 1% of tumor cells
- •Possibility to assess the amplification of FGFR2
- •HER2-negative status
- •ECOG PS 0-2
- •Age >= 18 years old
- •Adequate function of organs
- •Absence of any psychological, family, social or geographical circumstances that could potentially serve as obstacles to the implementation of the study
- •Signed Informed Consent
排除标准
- •Participation in another clinical study and concomitant treatment with any research drug or any study of antitumor therapy, including radiation, within 28 days before inclusion in this study
- •Presence of metastases in the central nervous system and / or carcinoma of the meninges at the time of inclusion in the study
- •Presence or history of present signs of any condition, therapy or laboratory abnormalities that could limit the interpretation of the results of this study
- •Any malignant tumor within the previous 5 years, with the exception of adequately cured cervical cancer in situ or squamous cell skin cancer, or basal cell skin cancer with limited growth, subject to adequate control over the course of this disease
- •Pregnancy
- •Known positive status for human immunodeficiency virus (HIV) or active hapatitis B and C
- •Surgery within 7 days before the first dose of the study drug
- •Signs of bleeding or hemorrhagic diathesis
研究组 & 干预措施
Nivolumab in combination with chemotherapy
Nivolumab 360 mg with CAPOX (capecitabine and oxaliplatin) every 3 weeks
干预措施: Oxaliplatin (Drug)
Nivolumab in combination with chemotherapy
Nivolumab 360 mg with CAPOX (capecitabine and oxaliplatin) every 3 weeks
干预措施: Nivolumab (Drug)
Nivolumab in combination with chemotherapy
Nivolumab 360 mg with CAPOX (capecitabine and oxaliplatin) every 3 weeks
干预措施: Capecitabine (Drug)
结局指标
主要结局
1-year progression-free survival (PFS)
时间窗: 12 months
Proportion of patients who will be progression-free at 1 year
次要结局
- Median PFS(18 months)
- Toxicity Summary(Up to 30 days post treatment)
- Median overall survival (OS)(24 months)
- Objective response rate (ORR)(18 months)