Phase I Study of Pre-operative Combination Therapy With Mogamulizumab (Anti-CCR4) and Nivolumab (Anti-PD-1) Against Solid Cancer Patients
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- Rate of Foxp3-positive patients in tumor by immunohistochemical analysis
研究概览
简要总结
To assess the safety of preoperative combination therapy with KW-0761 (anti-CCR4) and ONO-4538 (anti-PD-1).
To assess the behavior of immune cells in peripheral blood and tumor.
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
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who enable to have standard operation
- •Patients who refuse standard preoperative chemotherapy and are diagnosed with following cancers; gastric adenocarcinoma, esophageal squamous cell carcinoma, non-small-cell lung carcinoma, renal cell carcinoma or oral squamous cell carcinoma
- •Patients with Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
- •Patients with no serious disorder of major organs (born marrow, heart, lung, liver and kidney)
- •Patients with written informed consent
- •Patients who have measurable target lesion
- •Patients who are enable to undergo biopsy for sampling tumor tissue
排除标准
- •Known or previous autoimmune disease
- •Known or suspected interstitial lung disease (ILD)
- •Patients with history of serious anaphylaxis induced by antibody preparation
- •Uncontrollable hypertension
- •Uncontrollable endocrine disease
- •Patients who have active inflammatory bowel disease or other serious GI chronic conditions associated with diarrhea
- •Uncontrollable diabetes
- •Prior therapy with sustained anticancer agents, radiotherapy or surgery for primary disease
- •Pregnant or lactating females, female and male patients who cannot agree to practice the adequate birth control after the consent during the study
- •Known or suspected infection or inflammatory disease
- •Prior therapy with hematopoietic stem cell transplantation
- •Known or suspected central nervous system (CNS) involvement
研究组 & 干预措施
Cohort 2
KW-0761 (Mogamulizumab): 0.3 mg/kg, every week, 4 times ONO-4538 (Nivolumab): 3.0 mg/kg, every two weeks, 3 times
干预措施: Nivolumab (Biological)
Cohort 1
KW-0761 (Mogamulizumab): 0.1 mg/kg, every week, 4 times ONO-4538 (Nivolumab): 3.0 mg/kg, every two weeks, 3 times
干预措施: Mogamulizumab (Biological)
Cohort 3
KW-0761 (Mogamulizumab): 1.0 mg/kg, every week, 4 times ONO-4538 (Nivolumab): 3.0 mg/kg, every two weeks, 3 times
干预措施: Nivolumab (Biological)
Cohort 3
KW-0761 (Mogamulizumab): 1.0 mg/kg, every week, 4 times ONO-4538 (Nivolumab): 3.0 mg/kg, every two weeks, 3 times
干预措施: Mogamulizumab (Biological)
Cohort 2
KW-0761 (Mogamulizumab): 0.3 mg/kg, every week, 4 times ONO-4538 (Nivolumab): 3.0 mg/kg, every two weeks, 3 times
干预措施: Mogamulizumab (Biological)
Cohort 1
KW-0761 (Mogamulizumab): 0.1 mg/kg, every week, 4 times ONO-4538 (Nivolumab): 3.0 mg/kg, every two weeks, 3 times
干预措施: Nivolumab (Biological)
结局指标
主要结局
Rate of Foxp3-positive patients in tumor by immunohistochemical analysis
时间窗: from baseline until standard operation, an average of 7 weeks
Number of patients with adverse events including intraoperative and postoperative complications
时间窗: from first administration to 60 days after the final administration or to 30 days after the standard operation
Confirm the toxicity profile, which is measured by the degree of grade and seriousness, duration, causality, classification, etc. of the adverse events.
次要结局
- Objective tumor response rate according to RECIST v1.1(from baseline to 6 weeks after the first administration)
- Rate of Treg decrease in peripheral blood mononuclear cell (PBMC)(from baseline to 60 days after the final administration or to 30 days after the standard operation)