Anti-PD-1 Antibody Alone or in Combination With Low-dose Decitabine and/or Chemotherapy in Relapsed or Refractory Malignancies: an Open-label Phase I/II Trial
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 250
- 试验地点
- 1
- 主要终点
- Number of participants with treatment-related adverse events as assessed by CTCAE v4.0.
研究概览
简要总结
The purpose of this study is to assess the feasibility, safety, and efficacy of anti-PD-1 antibody alone or in combination with low-dose decitabine in patients with relapsed or refractory malignancies, including Non-Hodgkin'lymphoma, Hodgkin'lymphoma, gastrointestinal cancers, hepatocellular carcinoma, breast cancer, ovarian cancer or lung cancer or renal-cell cancer or pancreatic cancer or bile duct cancer.
详细描述
Primary objective: To assess the feasibility and safety for Anti-PD-1 antibody alone or in combination with decitabine and/or chemotherapy administered every 3 weeks to subjects with relapsed or refractory malignancies.
Secondary objectives: 1) To assess the antitumor activity of Anti-PD-1 antibody alone or in combination with decitabine and/or chemotherapy in subjects with relapsed or refractory malignancies. 2) To characterize the immunological effects of Anti-PD-1 antibody alone or in combination with decitabine and/or chemotherapy. 3) To characterize the immunological effects of Anti-PD-1 antibody alone or in combination with decitabine and/or chemotherapy.
Exploratory objectives: 1) To analysis of potential biological parameters correlated to clinical response and toxicities. 2) To search predictive biomarkers to guide the choose of patients undergoing the treatment of Anti-PD-1 antibody alone or in combination with decitabine and/or chemotherapy.
Safety Evaluation: Adverse events will be assessed continuously during the study and for 100 days post last treatment, and will be evaluated according to the NCI CTCAE Version 4.0.
Efficacy Evaluation: 1) Treatment response to lymphoma was defined using the International Workshop to Standardize Response Criteria for Lymphomas; 2) Treatment response to solid tumors was defined using Response Evaluation Criteria in Solid Tumors (RECIST1.1).
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
- 12 Years 至 75 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects must have histological confirmation of relapsed or refractory malignancies,including Non-Hodgkin'lymphoma, Hodgkin'lymphoma, gastrointestinal cancers, hepatocellular carcinoma, breast cancer, ovarian cancer or lung cancer or renal-cell cancer or pancreatic cancer or bile duct cancer.
- •12 to 75 years of age.
- •ECOG performance of less than
- •Life expectancy of at least 3 months.
- •Subjects with lymphoma must have at least one measureable lesion >1 cm as defined by lymphoma response criteria; with solid tumors must have at least one measureable lesion >1 cm per RECIST1.
- •Subjects must have received at least two prior chemotherapy regimen, and must be off therapy for at least 4 weeks prior to Day
- •Subjects with autologous hematopoietic stem-cell transplantation are eligible which must be more than 3 months.
- •Subjects must have adequate bone marrow, live, renal, lung and heart functions.
- •Absolute neutrophil count greater than or equal to 1,000/μL.
- •Platelet count greater than or equal to 70,000/µL.
- •Serum bilirubin level less than or equal to 1.5 x upper limits of normal (ULN).
- •Serum creatinine less than or equal to 1.5 x ULN.
- •Alanine aminotransferase [ALT or SGPT] and aspartate aminotransferase [AST or SGOT] less than or equal to 2.5 x ULN.
排除标准
- •Subjects with any autoimmune disease or history of syndrome that requires corticosteroids or immunosuppressive medications.
- •Serious uncontrolled medical disorders or active infections, pulmonary and intestinal infection especially.
- •Active alimentary tract hemorrhage or history of alimentary tract hemorrhage in 1 month .
- •Prior organ allograft.
- •Women who are pregnant or breastfeeding.
- •Subjects who are compulsorily detained for treatment of either a psychiatric or physical (eg, infectious disease) illness.
研究组 & 干预措施
Anti-PD-1 antibody+decitabine
Decitabine will be administrated at 10mg/d on day1 to 5, followed by Anti-PD-1 antibody 200mg on day8 IV Q3 weeks until progression.
干预措施: Anti-PD-1 antibody (Drug)
Anti-PD-1 antibody+decitabine
Decitabine will be administrated at 10mg/d on day1 to 5, followed by Anti-PD-1 antibody 200mg on day8 IV Q3 weeks until progression.
干预措施: Decitabine (Drug)
Anti-PD-1 antibody
Anti-PD-1 antibody 200mg IV Q3 weeks until progression.
干预措施: Anti-PD-1 antibody (Drug)
Anti-PD-1 antibody+chemotherapy
Chemotherapy will be given depends on the cancer type and treatment regimen before enrollment. Chemotherapy was administrated on day1 , followed by Anti-PD-1 antibody 200mg on day2 IV Q3 weeks until progression.
干预措施: Anti-PD-1 antibody (Drug)
Anti-PD-1 antibody+chemotherapy
Chemotherapy will be given depends on the cancer type and treatment regimen before enrollment. Chemotherapy was administrated on day1 , followed by Anti-PD-1 antibody 200mg on day2 IV Q3 weeks until progression.
干预措施: Chemotherapy (Drug)
结局指标
主要结局
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0.
时间窗: 2 years
次要结局
- Overall survival(3 years)
- Progression free survival(3 years)
- Objective response by Response Evaluation Criteria in Solid Tumors (RECIST1.1).(3 years)
- Objective response by the International Workshop to Standardize Response Criteria for lymphomas.(3 years)
研究者
Han weidong
Principal Investigator
Chinese PLA General Hospital