A Phase II Open-Label Study of Ipilimumab Administered to Stage IIIC and Stage IV Melanoma Patients After Regulatory T Cell Depletion With Denileukin Diftitox
概览
- 阶段
- 2 期
- 干预措施
- Ipilimumab
- 疾病 / 适应症
- Metastatic Melanoma
- 发起方
- University of Louisville
- 入组人数
- 2
- 试验地点
- 1
- 主要终点
- Change From Baseline Using Immune-related Response Criteria (irRC)
- 状态
- 终止
- 最后更新
- 4年前
概览
简要总结
This is an open-label, clinical efficacy study of Ipilimumab in patients with Stage IIIC and Stage IV melanoma who have recently been treated with Denileukin Diftitox. Approximately 42 patients with radiographically measurable melanoma who have received at least one cycle of Denileukin Diftitox will be enrolled and treated in the study.
详细描述
This is an open-label, clinical efficacy study of Ipilimumab in patients with Stage IIIC and Stage IV melanoma who have recently been treated with Denileukin Diftitox. Approximately 42 patients with radiographically measurable melanoma who have received at least one cycle of Denileukin Diftitox will be enrolled and treated in the study.
研究者
Jason Chesney
Director, James Graham Brown Cancer Center
University of Louisville
入排标准
入选标准
- •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;
- •Treatment with Denileukin Diftitox within 42 days prior to first dose of Ipilimumab;
- •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 ≥100 x 109/L;
- •Hemoglobin ≥8 g/dL;
排除标准
- •Prior treatment with Ipilimumab;
- •Known hypersensitivity to Ipilimumab or any of its components;
- •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
IV ipilimumab
干预措施: Ipilimumab
结局指标
主要结局
Change From Baseline Using Immune-related Response Criteria (irRC)
时间窗: baseline, 12 weeks, 24 weeks, 36 weeks, 48 weeks
no outcomes available, Study was Terminated due to low subject enrollment \[r/t requirement of prior treatment with denileukin diftitox\] Data was not analyzed