A Phase II Pilot Trial of Nivolumab + Albumin-Bound Paclitaxel + Paricalcitol + Cisplatin + Gemcitabine (NAPPCG) In Patients With Previously Untreated Metastatic Pancreatic Ductal Adenocarcinoma
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 35
- 试验地点
- 1
- 主要终点
- Complete Response Rate
研究概览
简要总结
The purpose of this study is to find out if the study drugs nivolumab, albumin- bound paclitaxel, paricalcitol, cisplatin, and gemcitabine given together are safe and effective when combined to treat advanced 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 of age .
- •Histologically or cytologically confirmed metastatic pancreatic ductal adenocarcinoma.
- •Capable of providing informed consent and complying with Trial procedures.
- •Karnofsky Performance Status (KPS) of ≥ 70%.
- •Life expectancy ≥ 12 weeks.
- •Measurable tumor lesions according to RECIST 1.1 criteria.
- •Women must not be able to become pregnant (e.g. post-menopausal for at least 1 year, surgically sterile, or practicing adequate birth control methods) for the duration of the study. Women of child bearing potential must have a negative serum or urine pregnancy test at the Screening Visit and be non-lactating. Both male and female patients of reproductive potential must agree to use a reliable method of birth control during the study.
排除标准
- •Patients must have received no previous radiotherapy, surgery, chemotherapy or investigational therapy for the treatment of metastatic disease. Prior treatments in the adjuvant setting with gemcitabine and/or 5-FU (5-Fluorouracil) or gemcitabine administered as a radiation sensitizer are allowed, provided at least 6 months have elapsed since completion of the last dose and no lingering toxicities are present.
- •Palliative surgery and/or radiation treatment less than 4 weeks prior to initiation of study treatment.
- •Exposure to any investigational agent within 4 weeks prior to initiation of study treatment.
- •Evidence of central nervous system (CNS) metastasis (negative imaging study, if clinically indicated, within 4 weeks of Screening Visit).
- •History of other malignancies (except cured basal cell carcinoma, superficial bladder cancer or carcinoma in situ of the cervix) unless documented free of cancer for ≥5 years.
- •Laboratory values: Screening serum creatinine > upper limit of normal (ULN); total bilirubin > (ULN); alanine aminotransferase (ALT) and Aspartate transaminase (AST) ≥ 2.5 ULN or ≥ 5.0×ULN if liver metastases are present; absolute neutrophil count <1,500/mm3, platelet concentration <100,000/mm3, hematocrit level <27% for females or <30% for males, or coagulation tests (prothrombin time [PT], partial thromboplastin time [PTT], International Normalized Ratio [INR]) >1.5×ULN unless on therapeutic doses of warfarin.
- •Current, serious, clinically significant cardiac arrhythmias as determined by the investigator.
- •History of HIV infection or active or chronic hepatitis B or C.
- •Active, clinically significant serious infection requiring treatment with antibiotics, anti-virals or anti-fungals.
- •Major surgery within 4 weeks prior to initiation of study treatment.
- •Any condition that might interfere with the patient's participation in the study or in the evaluation of the study results.
- •Any condition that is unstable and could jeopardize the patient's participation in the study.
- •Patient has a transplanted organ.
- •Patients with a history of autoimmune disease.
- •Prior Programmed cell death protein-1 (PD-1) or Programmed death-ligand-1 (PD-L1) therapy.
- •Patients taking any chemo or immunosuppressive steroids (equivalent to > 20 mg hydrocortisone per day).
- •Patients cannot have > Grade 1 pre-existing peripheral neuropathy (per CTCAE).
研究组 & 干预措施
single arm
open label using combination therapy
干预措施: Nivolumab (Drug)
single arm
open label using combination therapy
干预措施: Albumin-bound paclitaxel (Drug)
single arm
open label using combination therapy
干预措施: Paricalcitol (Drug)
single arm
open label using combination therapy
干预措施: Cisplatin (Drug)
single arm
open label using combination therapy
干预措施: Gemcitabine (Drug)
结局指标
主要结局
Complete Response Rate
时间窗: From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 84 months
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete response (CR) rate as defined by CT scan using RECIST 1.1 criteria - disappearance of all target lesions and no new sites or disease-related symptoms confirmed at least 4 weeks after initial documentation and CA 19-9 (or CA 125, or CEA if not expressers of CA 19-9) down to normal limits; Partial Response (PR), at least a 30% decrease in the sum of the diameters of target lesions; Overall Response (OR) = CR + PR. When a complete response is documented, a Positron emission tomography (PET) scan will be obtained to confirm.
次要结局
- Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v4.0(From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 84 months)