NCT05494697暂停2 期
A Phase 2 Randomized Open-Label Controlled Study to Evaluate the Efficacy and Safety of Ampligen in Combination With Standard of Care Versus SOC Alone Following First-Line Therapy in Subjects With Locally Advanced Pancreatic Adenocarcinoma
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 暂停
- 入组人数
- 90
- 试验地点
- 4
- 主要终点
- Progression Free Survival (PFS)
研究概览
简要总结
The purpose of this study is to assess the safety and efficacy of Ampligen in patients with locally advanced pancreatic adenocarcinoma
详细描述
This is a Phase 2, randomized, open-label controlled study to evaluate the efficacy and safety of Ampligen treatment combined with standard of care (SOC) versus SOC alone following First-line therapy in subjects with locally advanced pancreatic adenocarcinoma.
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
- •Histological diagnosis of pancreatic adenocarcinoma confirmed pathologically: Unresectable pancreatic cancer; locally advanced pancreatic cancer.
- •Measurable disease per RECIST v.1.
- •Completion of at least four (4) months of first line therapy, such as FOLFIRINOX and no disease progression per RECIST v.1.1 as confirmed by Computed Tomography (CT) or Magnetic Resonance Imaging (MRI) scan after last first-line therapy and prior to randomization.
- •Subject must meet one of the following criteria for stratification question of 'Is subject planned to receive chemoradiation therapy as SOC? [Yes/No]' A. For subjects to be enrolled under stratification of 'Yes, SOC includes chemoradiation', subjects are planned to receive the following allowable radiotherapy and chemotherapy, with curative intent (i.e., not palliative).
- •Allowable SOC radiotherapy:
- •IMRT (Intensity-Modulated Radiation Therapy)
- •SBRT (Stereotactic Body Radiation Therapy)
- •Allowable SOC chemotherapy:
- •Capecitabine
- •5-Fluorouracil (5-FU) +/- irinotecan B. For subjects to be enrolled under stratification of 'No, SOC does not include chemoradiation', subjects are planned to receive chemotherapy alone or undergo surveillance for disease progression only.
- •Male or non-pregnant, non-lactating female, ≥18 years or age.
- •Negative serum pregnancy test at screening visit for female subjects of childbearing potential. Females of childbearing potential must be willing to use an acceptable method of contraception from screening up until 90 days after last study treatment administration.
- •Acceptable methods of contraception include abstinence, female subject/partner's use of hormonal contraceptive (oral, patch, injectable, depot or vaginal) in conjunction with a barrier method (e.g., diaphragm, cervical cap, condom, spermicide or sponge), or female subject/partner's use of an implantable device (implantable rod or intrauterine device).
- •Female subject/partners of non-childbearing potential are defined as surgically sterile (e.g., bilateral tubal ligation, hysterectomy) or two years postmenopausal at time of screening.
- •All male subjects (excluding men who have been sterilized) with female partners of child-bearing potential must agree to consistently and correctly use a condom from screening up until 90 days after last study treatment administration. In addition, subjects may not donate sperm for the same time period.
- •Provide signed written informed consent and willingness, ability to comply with study requirements.
- •Minimum weight of 40kg at screening.
- •Karnofsky Performance Status of 80 or higher at screening.
- •Subject must have a projected life expectancy of ≥ 3 months in the opinion of the Investigator.
- •Subject has adequate organ function by the following laboratory assessments at screening (after the last dose of first-line therapy treatment and prior to randomization):
- •Hematologic:
- •Platelets ≥ 100×10^9/L Hemoglobin ≥ 9.0 g/dL Absolute Neutrophil Count (ANC) ≥ 1.5×10^9/L WBC ≥ 3 x 10^9/L Neutrophil/Lymphocyte (N/L) ratio < 4.5
- •AST/ALT ≤ 3×ULN (if liver metastases are present, ≤ 5×ULN) Alkaline phosphatase ≤ 2.0×ULN (if liver metastases are present, ≤ 5×ULN) Total bilirubin ≤ 1.5×ULN Albumin ≥ 3.0 g/dL
- •Creatinine clearance ≥ 60 mL/min using the Cockcroft-Gault formula.
- •Coagulation:
- •PT, aPTT and INR within normal limits
排除标准
- •Diagnosis of islet neoplasm acinar cell carcinoma, non-adenocarcinoma (i.e., lymphoma, sarcoma), adenocarcinoma originating from the biliary tree, or cystadenocarcinoma.
- •Subjects who have surgically resectable locally advanced pancreatic adenocarcinoma following treatment with first-line therapy, such as FOLFIRINOX.
- •Subject has received prior treatment with Ampligen®.
- •Therapy with investigational drugs within 6 weeks of beginning study medication.
- •History of prior malignancy, except for adequately treated in situ cancer, basal cell, squamous cell skin cancer, or other cancers (e.g., breast, prostate) for which the subject has been disease-free for at least 3 years. Subjects with prior cancer that is adequately controlled per the judgement of the Investigator will not be excluded from the study.
- •Any serious medical condition, laboratory abnormality, psychiatric illness, or comorbidity that, in the judgment of the Investigator, would make the subject inappropriate for the study.
- •Serious systemic fungal, bacterial, viral, or other infection that is not controlled or requires intravenous (IV) treatment for infection(s).
- •Known history of positivity (regardless of immune status) for human immunodeficiency virus (HIV).
- •Known history of, chronic active, or active viral hepatitis A, B, or C infection
- •Clinically significant bleeding within 2 weeks prior to Randomization (e.g., gastrointestinal [GI] bleeding, intracranial hemorrhage).
- •Pregnant or lactating women.
- •Myocardial infarction within the last 6 months prior to Randomization, symptomatic congestive heart failure (New York Heart Association Classification > Class II), unstable angina, or unstable cardiac arrhythmia requiring medication.
- •Subjects with abnormal electrocardiogram (ECG) at screening with QTc interval >470 ms (calculated using both the Bazett's and Fridericia's corrections).
- •Clinically significant ascites defined as requiring ≥ 1 paracentesis every 2 weeks.
- •Major surgery, defined as any surgical procedure that involves general anesthesia and a significant incision (i.e., larger than what is required for placement of central venous access, percutaneous feeding tube, or biopsy), within 28 days prior to Randomization or anticipated surgery during the study period.
- •Prior history of receiving immune checkpoint inhibitors (anti-CTLA4, anti-PD1, anti-PD- L1).
- •Inability to return for scheduled treatment and assessments.
结局指标
主要结局
Progression Free Survival (PFS)
时间窗: Randomization until disease progression, death, or end of study up to 182 weeks
PFS is defined as the time, in months, from date of randomization to date of the first documentation of definitive disease progression as per RECIST v1.1 and iRECIST (the initial progressive disease (PD)) or death due to any cause.
Progression Free Survival (PFS) [Time Frame: Visit 2/ First Treatment until disease progression, death, or end of study up to 42 months] PFS is defined as the time, in months, from date of Visit 2/ First Treatment to date of the first documentation of definitive disease progression as per RECIST v1.1 (the initial progressive disease (PD)) or death due to any cause.
Progression Free Survival (PFS) [Time Frame: Visit 2/ First Treatment until disease progression, death, or end of study up to 42 months] PFS is defined as the time, in months, from date of Visit 2/ First Treatment to date of the first documentation of definitive disease progression as per RECIST v1.1 (the initial progressive disease (PD)) or death due to any cause.
次要结局
- Overall Survival (OS)(Randomization to death due to any cause, or end of study up to 182 weeks.)
- Overall Survival (OS) at 1 year(Randomization to death due to any cause.at 1 year)
- Objective Response Rate (ORR)(Randomization until disease progression, death, or end of study up to 182 weeks)
- Duration of Response (DoR)(Randomization until disease progression, death, or end of study up to 182 weeks)
研究者
研究点 (4)
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