A Phase 2, Multi-centre, Open-label Study of Avelumab (MSB0010718C) in Locally Advanced or Metastatic Penile Cancer Patients Unfit for Platinum-based Chemotherapy or Progressed On or After Platinum-based Chemotherapy
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Objective Response Rate
研究概览
简要总结
This is a phase 2 study whose purpose is see how useful investigational drug, avelumab, is in patients with locally advanced or metastatic penile cancer who are unfit for or progressed on platinum-based chemotherapy.
The usefulness of avelumab in this study population will be determined by anti-tumor activity assessed by objective response rate.
Avelumab is a monoclonal antibody that binds to a protein called programmed death-ligand 1 (PD-L1) and blocks its communication with another protein called programmed death protein 1 (PD-1). The communication of these proteins are thought to be important in the growth of tumors. Blocking these proteins from communicating may stop or shrink tumors.
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
- Male
- 接受健康志愿者
- 否
入选标准
- •Histologically confirmed squamous cell carcinoma of the penis
- •Measurable disease per Immune-related Response Evaluation Criteria in Solid Tumors (iRECIST)
- •Unresectable/metastatic disease that is unfit for platinum-based chemotherapy OR disease that has progressed on or after treatment with platinum-based chemotherapy
- •≥18 years of age
- •Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2
排除标准
- •Prior immunotherapy with IL-2, IFN-α, or an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or CTLA-4 antibody (including ipilimumab), or any other antibody or drug specifically targeting T-cell co-stimulation or immune checkpoint pathways
- •Major surgery ≤4 weeks or major radiation therapy ≤2 weeks prior to enrollment
- •Known symptomatic central nervous system (CNS) metastases requiring steroids
- •Active autoimmune disease that might deteriorate when receiving an immunostimulatory agent
- •Diagnosis of prior immunodeficiency or organ transplant requiring immunosuppressive therapy
研究组 & 干预措施
Avelumab and Best Supportive Care
Avelumab will be given intravenously (by vein) at a dose of 10 mg/kg, once every 2 weeks
Best supportive care will be provided as required.
干预措施: Best Supportive Care (Other)
Avelumab and Best Supportive Care
Avelumab will be given intravenously (by vein) at a dose of 10 mg/kg, once every 2 weeks
Best supportive care will be provided as required.
干预措施: Avelumab (Drug)
结局指标
主要结局
Objective Response Rate
时间窗: 4 weeks
To demonstrate the anti-tumor activity of avelumab by objective response rate (ORR) according to Immune-related Response Evaluation Criteria in Solid Tumors (iRECIST) in patients with locally advanced or metastatic penile carcinoma unfit for platinum-based chemotherapy or progressed on or after platinum-based chemotherapy.
次要结局
- Progression-free Survival Rate(3 years)
- Overall Survival Rate(3 years)