NCT02009397已完成1 期
A Phase I/II Open-Label Study of Ipilimumab and GM-CSF Administered to Unresectable Stage IIIC and Stage IV Melanoma Patients
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 27
- 试验地点
- 1
- 主要终点
- Change in Immune-related Overall Response Rate (irORR)
研究概览
简要总结
The purpose of this study is to test the combination of Ipilimumab and GM-CSF. Both ipilimumab and GM-CSF are intended to work with the body's own immune system to attack melanoma cells in the body. This study will also demostrate how safe the combined drugs are when used to treat patients with Stage 3 or Stage 4 melanoma (metastatic melanoma), which cannot be removed by surgery.
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
- •Patients may be entered in the study only if they meet all of the following criteria.
- •Male or female patients ≥18 years of age;
- •Patients with histological confirmed melanoma (Stage IIIC or Stage IV, American Joint Commission on Cancer);
- •Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0 to 2;
- •Life expectancy ≥3 months;
- •At least 1 site of radiographically measurable disease by immune-related response criteria (irRC);
- •Adequate hematologic, renal, and liver function as defined by laboratory values performed within 42 days prior to initiation of dosing:
- •Absolute neutrophil count (ANC) ≥1.0 x 109/L;
- •Platelet count ≥50 x 109/L;
- •Hemoglobin ≥8 g/dL;
- •Serum creatinine ≤3 x upper limit of normal (ULN)
- •Total serum bilirubin ≤2 x ULN;
- •Serum aspartate transaminase (AST/SGOT) or serum alanine transaminase (ALT/SGPT) ≤2x ULN, and ≤3 x ULN if liver metastases are present.
- •Fertile males should use an effective method of contraception during treatment and for at least 3 months after completion of treatment, as directed by their physician;
- •Pre-menopausal females and females <2 years after the onset of menopause should have a negative pregnancy test at Screening. Pre-menopausal females must agree to use an acceptable method of birth control from the time of the negative pregnancy test up to 90 days after the last dose of study drug. Females of non-childbearing potential may be included if they are either surgically sterile or have been postmenopausal for ≥1 year;
- •Before study entry, written informed consent must be obtained from the patient prior to performing any study-related procedures.
排除标准
- •Patients will not be entered in the study for any of the following:
- •Treatment with Denileukin Diftitox within 42 days prior to the start of Ipilimumab;
- •Prior treatment with Ipilimumab;
- •Known hypersensitivity to Ipilimumab or any of its components
- •Received radiotherapy for non CNS disease within the 2 weeks prior to commencing study treatment or have not recovered from side effects of all radiation-related toxicities to Grade ≤1, except for alopecia;
- •Steroids within one week prior to initiation of Ipilimumab.
- •Pre-existing autoimmune colitis.
- •Patients with an allograft requiring immunosuppression;
- •Known positive human immunodeficiency virus (HIV)
- •Pregnant, breast-feeding, or refusing double barrier contraception, oral contraceptives, or avoidance of pregnancy measures;
- •Have any other uncontrolled infection or medical condition that could interfere with the conduct of the study.
研究组 & 干预措施
Ipilimumab and GM-CSF
Experimental
IV ipilimumab followed by subcutaneous GM-CSF, for up to 4 cycles
干预措施: Ipilimumab (Drug)
Ipilimumab and GM-CSF
Experimental
IV ipilimumab followed by subcutaneous GM-CSF, for up to 4 cycles
干预措施: GM-CSF (Drug)
结局指标
主要结局
Change in Immune-related Overall Response Rate (irORR)
时间窗: assessed at baseline and at 4 weeks (±1 week) following the last administration of Ipilimumab
次要结局
未报告次要终点
研究者
Jason Chesney
Director, James Graham Brown Cancer Center
University of Louisville
研究点 (1)
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