A Randomized Phase II Study of Pembrolizumab With or Without Defactinib, a Focal Adhesion Kinase Inhibitor Following Chemotherapy as a Neoadjuvant and Adjuvant Treatment for Resectable Pancreatic Ductal Adenocarcinoma (PDAC)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Lei Zheng
- 入组人数
- 28
- 试验地点
- 3
- 主要终点
- Pathologic Complete Response (pCR) Rate
研究概览
简要总结
This study will test the effectiveness (anti-tumor activity), safety, and ability to increase the body's immune system to fight pancreatic cancer by combining standard chemotherapy before and after surgery, with study drug PD-1 antibody, pembrolizumab, with and without study drug, focal adhesion kinase inhibitor (FAK), defactinib, in people with "high risk" resectable (surgically removable) pancreatic cancer. The purpose of this study is to evaluate if reprograming the tumor microenvironment by targeting FAK following chemotherapy can potentiate anti-programmed death-1 (PD-1) antibody.
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 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥18 years.
- •Has pancreatic ductal adenocarcinoma
- •Has resectable disease at the time of diagnosis
- •Has not received any systemic therapy for pancreatic ductal adenocarcinoma
- •Has stage ≤ IIb disease at time of diagnosis and enrollment
- •Elevated tumor marker, CA (carbohydrate antigen) 19-9 >200
- •ECOG performance status 0 or 1
- •Patient must have adequate organ function defined by the 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
- •Patients who have received any prior chemotherapy, radiotherapy or investigational agents for pancreatic cancer.
- •Patients who have received prior treatment with anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA-4, or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (e.g., CTLA-4, OX 40, CD137).
- •Has received prior therapy with FAK inhibitor.
- •Woman who are pregnant or breastfeeding.
- •Have received a live vaccine or live-attenuated vaccine within 30 days prior to study drug.
- •Is currently or has participated in another investigational study within 4 weeks prior to receiving study drug.
- •History or current use of immunosuppressive medications within 7 days prior to study medications.
- •Has a known additional malignancy that is progressing or has required active treatment within the past 2 years or that is expected to require active treatment within two years.
- •Has active autoimmune disease that has required systemic treatment in the past 2 years.
- •Has a history of (non-infectious) pneumonitis/interstitial lung disease or current pneumonitis.
- •Has an active infection requiring systemic therapy.
- •Infection with HIV or hepatitis B or C.
- •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.
- •Known allergy or hypersensitivity to the study drugs.
- •Received any growth factors including, but not limited to, granulocyte-colony stimulating factor (G-CSF), GM-CSF, erythropoietin, within 14 days of study drug administration.
- •Has history of any organ transplant, including corneal transplants.
研究组 & 干预措施
Arm A - Pembrolizumab and Defactinib
干预措施: Pembrolizumab (Drug)
Arm A - Pembrolizumab and Defactinib
干预措施: Defactinib (Drug)
Arm B - Pembrolizumab
干预措施: Pembrolizumab (Drug)
结局指标
主要结局
Pathologic Complete Response (pCR) Rate
时间窗: 4 years
Percent of subjects with a pathologic complete response (pCR) per the tumor regression grade scores established by the College of American Pathologist: Grade 0= complete response (no viable cancer cells), Grade 1= near complete response (single cells or rare small groups of cancer cells), Grade 2= partial response (residual tumor with evidence of regression), or Grade 3= no response (extensive residual tumor with no evidence of regression).
次要结局
- Overall Survival (OS)(4 years)
- Disease Free Survival (DFS)(4 years)
- Number of Participants Experiencing Study Drug-related Toxicities(4 years)
研究者
Lei Zheng
Executive Director of University of Texas Health Science Center at San Antonio Cancer Center
The University of Texas Health Science Center at San Antonio