Open Label Randomized Phase II Trial of Nivolumab + Cabiralizumab (BMS-986227, FPA008) + Gemcitabine in Patients With Stage IV Pancreatic Cancer Achieving Disease Control in Response to First-line Chemotherapy (GemCaN Trial)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 2
- 试验地点
- 1
- 主要终点
- Number of Participants With Progression Free Survival (PFS)
研究概览
简要总结
The purpose of this study is to see if the combination of nivolumab + cabiralizumab + gemcitabine can give prolonged disease control in patients with advanced pancreatic cancer compared to gemcitabine alone.
详细描述
The purpose of this study is to see if the combination of nivolumab + cabiralizumab + gemcitabine can give prolonged disease control in patients with advanced pancreatic cancer compared to gemcitabine alone.
Cabiralizumab is an antibody (a type of protein) that binds to a molecule called CSF-1r. CSF-1r is a molecule present on different types of cells in your immune system that controls parts of your immune system. Blocking CSF-lr could potentially stop the cancer cells which it appears on from escaping the immune system, which could then act to kill the cancer cells.
Nivolumab is an anti-PD-1 antibody that boost the body's immune system. It works by attaching to and blocking a molecule on white blood cells called PD-1. PD-1 is a protein that is present on different types of cells in your immune system and controls parts of your immune system by shutting it down. Antibodies that block PD-1 can potentially prevent PD-1 from shutting down the immune system, thus allowing immune cells to recognize and destroy cancer cells.
Gemcitabine is currently used to treat advanced or metastasized (spread) pancreatic cancer. It is used in patients whose disease cannot be removed by surgery and who have already been treated with other chemotherapy
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
- •Histologically or cytologically confirmed pancreatic adenocarcinoma with metastasis
- •Must be off their prior cytotoxic regimen a minimum of two weeks but no more than four weeks from initiating trial treatment.
- •Measurable disease by RECIST 1.
- •Demonstrate adequate organ function
- •Normal Vitamin D level.
- •Able to submit an archival tumor specimen (primary or metastatic site). Patients with cytology only that do not have adequate archived tumor specimen available, will require a baseline biopsy.
排除标准
- •Is currently participating and receiving trial therapy or has participated in a trial of an investigational agent and received trial therapy or used an investigational device within 3 weeks of the first dose of trial treatment.
- •Hypersensitivity to cabiralizumab, nivolumab, or gemcitabine or any of its excipients.
- •Previous malignancies (except non-melanoma skin cancers, and in situ bladder, gastric, colorectal, endometrial, cervical/dysplasia, melanoma, or breast cancers) unless complete remission was achieved at least 2 years prior to study entry and no additional therapy is required during the study period.
- •Evidence of central nervous system (CNS) metastasis
- •Participants with active, known, or suspected autoimmune disease.
- •Current or history of clinically significant muscle disorders (e.g., myositis), recent unresolved muscle injury, or any condition known to elevate serum CK levels.
- •Uncontrolled or significant cardiovascular disease
- •Prior organ allograft or allogeneic bone marrow transplantation.
- •Any uncontrolled inflammatory GI disease including Crohn's Disease and ulcerative colitis.
- •Evidence of coagulopathy or bleeding diathesis.
- •Has received prior therapy with a CSF-1R pathway inhibitors, anti-PD-1, anti-PD-L1, anti PD-L2, anti-CTLA-4.
研究组 & 干预措施
gemcitabine +nivolumab + cabiralizumab
gemcitabine +nivolumab + cabiralizumab
干预措施: Gemcitabine (Drug)
gemcitabine +nivolumab + cabiralizumab
gemcitabine +nivolumab + cabiralizumab
干预措施: Nivolumab 10 MG/ML Intravenous Solution [OPDIVO] (Drug)
gemcitabine +nivolumab + cabiralizumab
gemcitabine +nivolumab + cabiralizumab
干预措施: Cabiralizumab (Drug)
结局指标
主要结局
Number of Participants With Progression Free Survival (PFS)
时间窗: 6 months
To estimate Progression Free Survival (PFS rates) at 6 months per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
次要结局
- Number of Participants With Overall Survival (OS)(6 months)
研究者
Hitendra Patel
Associate Professor
University of California, San Diego