A Randomized Multicenter Ib/II Study to Assess the Safety & Immunological Effect of Chemoradiation Therapy in Combination With Pembrolizumab Compared to CRT Alone Resectable/Borderline Resectable Pancreatic Cancer
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 68
- 试验地点
- 6
- 主要终点
- Number of Tumor Infiltrating Lymphocytes (TILs) per high powered field (hpf) in pancreatic tissue (resected tissue).
研究概览
简要总结
The purpose of this clinical trial is to study an experimental drug called pembrolizumab or MK-3475 for use in combination with chemotherapy and radiation therapy for patients with resectable (surgical removal) or borderline resectable pancreatic cancer. In general, pancreatic cancer that cannot be removed by surgery is sometimes treated with chemotherapy and radiation therapy, called neoadjuvant treatment, to shrink the tumor so that surgery might be possible. However, this is not always effective at shrinking the tumor enough to allow it to be removed with surgery. Recent discoveries suggest that the investigators own immune system might have a role in controlling the growth of tumors. Drugs such as pembrolizumab can stimulate the immune system against cancer. The purpose of this study is to investigate whether pembrolizumab can be used safely during neoadjuvant treatment and can improve the body's immune response against pancreatic cancer.
Pembrolizumab has been approved for treatment of patients with melanoma but has not been proven to be safe or helpful in patients with pancreatic cancer and is not approved by the U.S. Food and Drug Administration (FDA) for this purpose.
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
- •Measurable disease based on Response Evaluation Criteria in Solid Tumors (RECIST)
- •Performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) Performance Scale
- •Adequate organ function
- •In subjects requiring biliary decompression, metal stent or drainage using percutaneous transhepatic cholangiogram (PTC) are allowed
排除标准
- •Immunodeficiency or taking steroid or any other form of immunosuppressive therapy
- •Has a plastic biliary stent for decompression
- •Metastatic disease
- •Prior treatment for pancreatic cancer (other than 4-8 cycles of Folfirinox) or prior treatment with radiation for other diagnoses to the expected pancreatic cancer treatment area
- •Active autoimmune disease
- •Pregnancy or Nursing
- •Known history of Human Immunodeficiency Virus (HIV) or Hepatitis B or C
- •Prior monoclonal antibody within 4 weeks prior to study Day 1
- •Known additional malignancy that is progressing or requires active treatment
- •Evidence of interstitial lung disease or active, non-infectious pneumonitis
- •Active infection requiring systemic therapy
- •Prior therapy with an anti-Program Death (PD-1) antibody, anti-PD-L1, anti-PD-L2, or anti-Cytotoxic T-lymphocyte-associated antigen-4 (CTLA-4) antibody
研究组 & 干预措施
Neodjuvant CRT + Pembrolizumab
Standard neoadjuvant chemoradiation treatment (CRT) with pembrolizumab
干预措施: Pembrolizumab (Drug)
Neodjuvant CRT + Pembrolizumab
Standard neoadjuvant chemoradiation treatment (CRT) with pembrolizumab
干预措施: Neoadjuvant Chemoradiation (Radiation)
Neoadjuvant CRT
Standard neoadjuvant chemoradiation treatment (CRT) alone
干预措施: Neoadjuvant Chemoradiation (Radiation)
结局指标
主要结局
Number of Tumor Infiltrating Lymphocytes (TILs) per high powered field (hpf) in pancreatic tissue (resected tissue).
时间窗: 2-3 years
Safety: Incidence of Dose-Limiting Toxicities (DLTs)
时间窗: 2-3 years
次要结局
- Disease-free survival (DFS)(2-4 years)
- Overall survival (OS)(2-4 years)
- Response Rate (RR)(2-3 years)
研究者
Craig L Slingluff, Jr
Director of the UVA Human Immune Therapy Center
University of Virginia