NCT03190265已完成2 期
A Randomized Phase 2 Study of the Safety, Efficacy, and Immune Response of CRS-207, Nivolumab, and Ipilimumab With or Without GVAX Pancreas Vaccine (With Cyclophosphamide) in Patients With Previously Treated Metastatic Pancreatic Adenocarcinoma
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins1 个研究点 分布在 1 个国家目标入组 61 人开始时间: 2017年12月14日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 61
- 试验地点
- 1
- 主要终点
- Objective Response Rate (ORR) Using Response Evaluation Criteria for Solid Tumors (RECIST 1.1)
研究概览
简要总结
The purpose of this study is to study the safety and clinical activity of nivolumab and ipilimumab in combination with either sequential administration of CY/GVAX pancreas vaccine followed by CRS-207 (Arm A) or with administration of CRS-207 alone (Arm B) in patients with pancreatic cancer.
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
- •Age ≥18 years.
- •Have histologically or cytologically proven adenocarcinoma of the pancreas.
- •Have metastatic disease.
- •Have disease progression.
- •Patients with the presence of at least one measurable lesion.
- •Patient's acceptance to have a tumor biopsy of an accessible lesion at baseline and on treatment if the lesion can be biopsied with acceptable clinical risk (as judged by the investigator).
- •ECOG performance status 0 or 1
- •Life expectancy of greater than 3 months.
- •Patients must have adequate organ and marrow function defined by study-specified laboratory tests.
- •Must use acceptable form of birth control while on study.
- •Ability to understand and willingness to sign a written informed consent document.
排除标准
- •Known history or evidence of brain metastases.
- •Had surgery within the last 28 days
- •Had chemotherapy, radiation, or biological cancer therapy within the last 14 days
- •Have received a prophylactic vaccine within 14 days or received a live vaccine within 30 days of planned start of study therapy.
- •Prior treatment with anti-PD-1, anti-PD-L1, anti-PD-L2,or anti-CTLA4
- •Systemic steroids within the last 14 days
- •Use more than 2 g/day of acetaminophen.
- •Patients on immunosuppressive agents.
- •Patients receiving growth factors within the last 14 days
- •Known allergy to both penicillin and sulfa.
- •Severe hypersensitivity reaction to any monoclonal antibody.
- •Have artificial joints or implants that cannot be easily removed
- •Have any evidence of clinical or radiographic ascites.
- •Have significant and/or malignant pleural effusion
- •Have had a new pulmonary embolism, extremity deep venous thromboembolism, or portal vein thrombosis within 2 months of study treatment
- •Infection with HIV or hepatitis B or C at screening
- •Significant heart disease
- •Conditions, including alcohol or drug dependence, intercurrent illness, or lack of sufficient peripheral venous access, that would affect the patient's ability to comply with study visits and procedures
- •Are pregnant or breastfeeding.
- •Have rapidly progressing disease
研究组 & 干预措施
Arm A: CY, Nivolumab, Ipilimumab, GVAX, CRS-207
Experimental
干预措施: Ipilimumab (Drug)
Arm A: CY, Nivolumab, Ipilimumab, GVAX, CRS-207
Experimental
干预措施: Cyclophosphamide (Drug)
Arm A: CY, Nivolumab, Ipilimumab, GVAX, CRS-207
Experimental
干预措施: Nivolumab (Drug)
Arm A: CY, Nivolumab, Ipilimumab, GVAX, CRS-207
Experimental
干预措施: GVAX Pancreas Vaccine (Drug)
Arm A: CY, Nivolumab, Ipilimumab, GVAX, CRS-207
Experimental
干预措施: CRS-207 (Drug)
Arm B: Nivolumab, Ipilimumab, CRS-207
Experimental
干预措施: Nivolumab (Drug)
Arm B: Nivolumab, Ipilimumab, CRS-207
Experimental
干预措施: Ipilimumab (Drug)
Arm B: Nivolumab, Ipilimumab, CRS-207
Experimental
干预措施: CRS-207 (Drug)
结局指标
主要结局
Objective Response Rate (ORR) Using Response Evaluation Criteria for Solid Tumors (RECIST 1.1)
时间窗: 18 months
Objective Response Rate (ORR) is defined as the number of patients achieving a complete response (CR) or partial response (PR) based on RECIST 1.1 criteria. CR = disappearance of all target lesions, PR is =\>30% decrease in sum of diameters of target lesions. Participants who discontinue due to toxicity or clinical progression prior to post-baseline tumor assessments will be considered as non-responders. Participants who discontinue for other reasons prior to their first dose of study drug will not included in the analysis.
次要结局
- Number of Participants Experiencing Grade 3 or Above Study Drug-related Adverse Events (AEs)(21 months)
研究者
研究点 (1)
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