NCT04177810已完成2 期
A Phase 2 Study of Plerixafor and Cemiplimab in Metastatic Pancreatic Cancer
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins1 个研究点 分布在 1 个国家目标入组 25 人开始时间: 2020年11月16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
- 25
- 试验地点
- 1
- 主要终点
- Objective Response Rate (ORR) Using Immune RECIST (iRECIST) Criteria
研究概览
简要总结
The purpose of this study is to evaluate the safety and clinical activity of plerixafor in combination with cemiplimab in patients with metastatic pancreatic cancer.
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
- •Age ≥18 years.
- •Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
- •Have histologically or cytologically-proven ductal pancreatic cancer.
- •Have metastatic disease.
- •Have documented radiographic disease progression after previous systemic chemotherapy given in a neoadjuvant, adjuvant, locally advanced or metastatic setting.
- •Patients with the presence of at least one measurable lesion.
- •Willing to have to a tumor biopsy.
- •Life expectancy of greater than 3 months.
- •Patients must have adequate organ and marrow function defined by study - specified laboratory tests.
- •Woman of childbearing potential must have a negative pregnancy test and follow contraceptive guidelines as defined per protocol.
- •Men 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 chemotherapy, radiation, or steroids within 14 days prior to study treatment.
- •Have received any investigational drugs, a live vaccine, any allergen hyposensitization therapy, growth factors or major surgery within 28 days prior to study treatment.
- •Require any antineoplastic therapy.
- •Had surgery within 28 days of dosing of investigational agent.
- •Has received any prophylactic vaccine within 14 days of first dose of study drug.
- •History of prior treatment with anti-CXCR
- •Have used any systemic steroids within 14 days of study treatment.
- •Patients receiving growth factors including, but not limited to, granulocyte-colony stimulating factor (G-CSF), Granulocyte-macrophage colony-stimulating factor (GM-CSF), erythropoietin, within 14 days of study drug administration.
- •Hypersensitivity reaction to any monoclonal antibody.
- •Evidence of clinical or radiographic ascites.
- •Have clinically significant and/or malignant pleural effusion.
- •Patient with uncontrolled intercurrent illness including, but not limited to, uncontrolled infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
- •Has an active known or suspected autoimmune disease.
- •Prior tissue or organ allograft or allogeneic bone marrow transplantation.
- •All toxicities attributed to prior anti-cancer therapy other than alopecia and fatigue must have resolved to grade 1 (National Cancer Institute Common Terminology Criteria for Adverse Events [CTCAE], version 5) or baseline before administration of study drug.
- •Infection with HIV or hepatitis B or C at screening.
- •Patient has a pulse oximetry of <92% on room air.
- •Patient is on supplemental home oxygen.
- •Has uncontrolled intercurrent acute or chronic medical illness or any use of illicit drugs or substance abuse.
- •Patient is unwilling or unable to follow the study schedule for any reason.
- •Woman who are pregnant or breastfeeding.
- •Have rapidly progressing disease, as judged by the investigator.
- •History of significant, recurrent, unexplained postural hypotension in the last 6 months.
研究组 & 干预措施
Cemiplimab and Plerixafor
Experimental
All participants will receive Cemiplimab and Plerixafor.
干预措施: Cemiplimab (Drug)
Cemiplimab and Plerixafor
Experimental
All participants will receive Cemiplimab and Plerixafor.
干预措施: Plerixafor (Drug)
结局指标
主要结局
Objective Response Rate (ORR) Using Immune RECIST (iRECIST) Criteria
时间窗: 10 months
ORR is defined as the number of patients achieving a complete response (CR) or partial response (PR) based on immune Response Evaluation Criteria in Solid Tumors (iRECIST) at any time during the study. CR = disappearance of all target lesions, PR is =\>30% decrease in sum of diameters of target lesions, progressive disease (PD) is \>20% increase in sum of diameters of target lesions, stable disease (SD) is \<30% decrease or \<20% increase in sum of diameters of target lesions.
次要结局
- Number of Participants Experiencing Grade 3 or Above Drug-related Toxicities(13 months)
- Overall Response Rate (ORR) Using RECIST 1.1 Criteria(10 months)
研究者
研究点 (1)
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