NCT03250273已完成2 期
A Phase 2 Clinical Trial of Entinostat in Combination With Nivolumab for Patients With Previously Treated Unresectable or Metastatic Cholangiocarcinoma and 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 44 人开始时间: 2017年11月6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
- 44
- 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 proposed study is an open-label, two-arm study of entinostat plus nivolumab in patients with unresectable or metastatic cholangiocarcinoma (CCA) or pancreatic ductal adenocarcinoma (PDAC).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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 cholangiocarcinoma or adenocarcinoma of the pancreas that is metastatic or unresectable.
- •Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
- •Life expectancy of greater than 12 weeks.
- •Patients must have adequate organ and marrow function defined by study-specified laboratory tests.
- •Woman of child bearing potential must have a negative pregnancy test.
- •Must have progressive measurable disease.
- •Must have an accessible non-bone tumor that can be biopsied.
- •Must use acceptable form of birth control while on study.
- •Willing to provide tissue and blood samples.
- •Ability to understand and willingness to sign a written informed consent document.
排除标准
- •Chemotherapy, radiotherapy, investigational therapy, or surgery less than 3 weeks prior to trial registration
- •Prior treatment with epigenetic therapy (such as entinostat, panobinostat, vorinostat, romidepsin, 5-azacitidine, or decitabine)
- •Prior treatment with immunotherapy agents (including, anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA4, etc.).
- •Hypersensitivity reaction to any monoclonal antibody.
- •History of any autoimmune disease: inflammatory bowel disease, (including ulcerative colitis and Crohn's Disease), rheumatoid arthritis, systemic progressive sclerosis (scleroderma), systemic lupus erythematosus (SLE) autoimmune vasculitis (e.g., Wegener's Granulomatosis), central nervous system (CNS) or motor neuropathy considered to be of autoimmune origin (e.g., Guillain-Barre Syndrome, Myasthenia Gravis, Multiple Sclerosis). Patients are permitted to enroll if they have vitiligo, type I diabetes mellitus, residual hypothyroidism due to autoimmune condition only requiring hormone replacement, psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger (precipitating event).
- •Have significant and/or malignant pleural effusion
- •Has a pulse oximetry < 92% on room air.
- •Known history or evidence of brain metastases.
- •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.
- •Infection with HIV or hepatitis B or C.
- •Patients on immunosuppressive agents.
- •Requiring concurrent administration of valproic acid.
- •Patients with diverticulitis, intra-abdominal abscess, or GI obstruction
- •Any contraindication to oral agents.
- •Another active malignancy ≤ 3 years prior to registration with the exception of non-melanotic skin cancer or carcinoma-in-situ of any type.
- •Unwilling or unable to follow the study schedule for any reason.
- •Evidence of ascites on imaging.
研究组 & 干预措施
Arm A - Cholangiocarcinoma
Experimental
干预措施: Entinostat (Drug)
Arm A - Cholangiocarcinoma
Experimental
干预措施: Nivolumab (Drug)
ARM B - Pancreatic Cancer
Experimental
干预措施: Entinostat (Drug)
ARM B - Pancreatic Cancer
Experimental
干预措施: Nivolumab (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: 27 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. Subjects who discontinue due to clinical progression prior to post-baseline tumor assessments were considered as non-responders.
次要结局
- Number of Patients Experiencing a Grade 3 or Above Treatment-related Adverse Event (AE)(29 months)
- Duration of Response (DOR)(27 months)
- Overall Survival (OS) at 12 Months(12 months)
- Overall Survival (OS) at 24 Months(24 months)
- Overall Survival (OS) at 36 Months(36 months)
- Overall Survival (OS)(38 months)
- Overall Survival (OS) at 6 Months(6 months)
- Progression Free Survival (PFS) at 6 Months(6 months)
- Progression Free Survival (PFS) at 12 Months(12 months)
- Progression Free Survival (PFS) at 24 Months(24 months)
研究者
研究点 (1)
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