Nivolumab + Cabiralizumab + Gemcitabine Versus Gemcitabine in Patients With Stage IV Pancreatic Cancer Achieving Disease Control in Response to First-line Chemotherapy (GemCaN Trial).

赞助:

合作者:

信息的提供 (责任方):

Hitendra Patel，University of California, San Diego

追踪信息

首次提交日期 ^ICMJE

September 28, 2018

首次发布日期e ^ICMJE

October 5, 2018

最后更新发布日期

October 5, 2018

预计研究开始日期 ^ICMJE

October 2018

预计主要完成日期

October 2020 (主要结果测量的最终数据收集日期)

目前主要观察指标 ^ICMJE

Progression Free Survival (PFS)[ Time Frame: 6 months ]

To estimate Progression Free Survival (PFS rates) at 6 months by RECIST1.1

原始主要观察测量 ^ICMJE

与当前相同

目前的二级观察 ^ICMJE

Incidence of Treatment-Emergent Grade 2-5 Adverse Events assessed using NCI CTCAE v5.0 toxicity criteria[ Time Frame: 6 months ]
Overall Survival (OS)[ Time Frame: 6 months ]

描述性信息

简略标题 ^ICMJE

Nivolumab + Cabiralizumab + Gemcitabine Versus Gemcitabine in Patients With Stage IV Pancreatic Cancer Achieving Disease Control in Response to First-line Chemotherapy (GemCaN Trial).

正式标题 ^ICMJE

Open Label Randomized Phase II Trial of Nivolumab + Cabiralizumab (BMS-986227, FPA008) + Gemcitabine Versus Gemcitabine in Patients With Stage IV Pancreatic Cancer Achieving Disease Control in Response to First-line Chemotherapy (GemCaN Trial).

简要概况

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

详细说明

研究类型 ^ICMJE

Interventional

研究阶段

Phase 4

研究设计 ^ICMJE

分配: Randomized
干预模型: Parallel Assignment
干预模型描述:
盲法: Interventional
盲法描述:
主要目的: Treatment

适用条件 ^ICMJE

干预项目 ^ICMJE

Drug: Gemcitabine
1000 mg/m2 IV on days 1, 8, and 15 Q4W
Drug: Nivolumab 10 MG/ML Intravenous Solution [OPDIVO]
480mg IV on Day 1 Q4W
Drug: Cabiralizumab
4mg/kg IV on day 1 and 15 Q4W

研究工具

Active Comparator: gemcitabine +nivolumab + cabiralizumab
Active Comparator: gemcitabine

招募信息

招募状态 ^ICMJE

Not yet recruiting

预计入组 ^ICMJE

原始预计入组 ^ICMJE

与当前相同

预计研究完成日期

October 2020

预计主要完成日期

October 2020 (主要结果测量的最终数据收集日期)

合格标准 ^ICMJE

Inclusion Criteria: - 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 1.1. 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. Exclusion Criteria: - 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.

性别

参与研究的性别:

All

年龄

最小年龄：18 Years ，最大年龄：N/A

接受健康的志愿者

没有

可入组国家 ^ICMJE

United States

管理信息

数据检测委员会

研究涉及美国FDA监管的产品

研究美国FDA监管的药品: Yes
研究涉及美国FDA监管的设备产品: No

IPD 共享声明

计划分享 IPD:

责任方

Hitendra Patel，University of California, San Diego

研究赞助商 ^ICMJE

Hitendra Patel

合作者 ^ICMJE

研究员 ^ICMJE

Principal Investigator: Hitendra Patel, MD University of California, San Diego
Principal Investigator: Andrew Lowy, MD University of California, San Diego

PRS 账户

University of California, San Diego

验证日期

October 2018

^ICMJE 国际医学期刊编辑委员会和世界卫生组织 ICTRP 要求的元素

请使用微信扫码报名