A Phase Ib Trial Evaluating the Safety and Feasibility of Ipilimumab (BMS-734016) Alone or in Combination With Allogeneic Pancreatic Tumor Cells Transfected With a GM-CSF Gene for the Treatment of Locally Advanced, Unresectable or Metastatic Pancreatic Adenocarcinoma
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Percent of Patients Experiencing an Unacceptable Toxicity
研究概览
简要总结
Research Hypothesis: Ipilimumab (an antibody that blocks negative signals to T cells) administered alone or in combination with a pancreatic cancer vaccine (allogeneic pancreatic tumor cells transfected with a GM-CSF gene), has an acceptable safety profile in subjects with locally advanced, unresectable or metastatic pancreatic adenocarcinoma.
Primary Objective: To determine the safety profile of ipilimumab alone or in combination with a pancreatic cancer vaccine in subjects with locally advanced, unresectable or metastatic pancreatic adenocarcinoma.
Secondary Objectives:
- To estimate overall survival (OS) which will serve as the primary efficacy signal.
- To explore an association of T cell responses and immunological responses with OS in patients receiving treatment.
- To estimate overall response rate (ORR), immune related best overall response rate (irBOR), progression free survival (PFS), and duration of response in patients receiving treatment.
- To explore an association between immune-related adverse events (IRAEs) and ORR.
- To measure tumor marker kinetics (CA 19-9) in patients receiving treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •Documented cancer of the pancreas who have failed (or are not candidates for) standard therapy
- •ECOG Performance Status of 0 to 1
- •Adequate organ function as defined by study-specified laboratory tests
- •Must use acceptable form of birth control through the study and for 28 days after final dose of study drug
- •Signed informed consent form
- •Willing and able to comply with study procedures
排除标准
- •Currently have or have history of certain study-specified heart, liver, kidney, lung, neurological, immune or other medical conditions
- •Clinical metabolic or laboratory abnormalities defined as Grade 3 or 4 of the National Cancer Institute's (NCI's) Common Terminology Criteria for Adverse Events (CTCAE), version 3.0
- •Systemically active steroids
- •Another investigational product within 28 days prior to receiving study drug
- •Major surgery or significant traumatic injury (or unhealed surgical wounds) occurring within 28 days prior to receiving study drug
- •Infection with HIV, hepatitis B or C at screening
- •Pregnant or lactating
- •Conditions, including alcohol or drug dependence, or intercurrent illness that would affect the patient's ability to comply with study visits and procedures
研究组 & 干预措施
Arm 1: Ipilimumab Alone
Ipilimumab alone
干预措施: Ipilimumab (Drug)
Arm 2: Ipilimumab + Pancreatic Cancer Vaccine
Ipilimumab + Pancreatic Cancer Vaccine
干预措施: Ipilimumab (Drug)
Arm 2: Ipilimumab + Pancreatic Cancer Vaccine
Ipilimumab + Pancreatic Cancer Vaccine
干预措施: Pancreatic Cancer Vaccine (Biological)
结局指标
主要结局
Percent of Patients Experiencing an Unacceptable Toxicity
时间窗: 4 years
Unacceptable toxicity is defined as drug related \>grade 4 AEs or grade 3 AEs including IRAEs not improving to \< grade 2 under therapy within 2 weeks. In addition, \> grade 2 eye pain or reduction of visual acuity that does not respond to topical therapy and does not improve to \< grade 1 severity within 2 weeks of starting therapy, or requires systemic therapy is an unacceptable toxicity.
次要结局
- Overall Survival (OS)(4 years)
- Overall Response Rate (ORR)(6 months)
- Immune Related Best Overall Response Rate (irBOR)(4 years)
- Progression Free Survival (PFS)(6 months)