NCT01611558已完成2 期
A Phase II Safety and Efficacy Study of Ipilimumab Monotherapy in Recurrent Platinum Sensitive Ovarian Cancer Subjects
Bristol-Myers Squibb17 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2012年8月21日最近更新:
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 17
- 主要终点
- Number of Participants With Drug-related Adverse Events (AEs) of Grade 3 or Higher
研究概览
简要总结
To assess the incidence of drug-related adverse events of Grade 3 or higher and the overall response associated with ipilimumab treatment
详细描述
Condition: Ovarian Cancer, Second line, Third line, or Fourth line
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
- Female
- 接受健康志愿者
- 否
入选标准
- •For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com.
- •Key Inclusion Criteria
- •Ovarian cancer that is not refractory or resistant to platinum-based therapy (refactory=progression while receiving any previous platinum regimen; resistant=progression within 6 months of any previous platinum regimen)
- •Recipients of platinum/taxane-based chemotherapy as frontline regimen for ovarian cancer
- •An Eastern Cooperative Oncology Group performance status ≤1
- •Up to 4 prior lines of therapy for ovarian cancer
- •Two groups are eligible:
- •Women who have not met the criteria for progressive disease following their most recent chemotherapeutic regimen were required to have:
- •Demonstrated partial response or stable disease following the most recent chemotherapy regimen
- •Evaluable or measurable disease, detected by baseline computed tomography (CT) or magnetic resonance imaging (MRI) scan
- •Received the last dose of their most recent chemotherapeutic regimen for ovarian cancer within 4 to 12 weeks of the first administration of ipilimumab Group 2: Women with disease progression while receiving or following the last dose of the most recent chemotherapeutic regimen were required to have:
- •Measurable disease on a CT or MRI scan performed within 28 days of first dose of ipilimumab.
- •Received the last dose of their most recent chemotherapeutic regimen for ovarian cancer at least 4 weeks prior to the first administration of ipilimumab.
排除标准
- •Histologic diagnosis of borderline, low malignant potential epithelial carcinoma
- •For Group 1, women with complete response on the most recent ovarian carcinomatherapy
- •Presence of known brain metastases
- •Second malignancy active within the past 5 years, with the exception of locally curable cancers that have no need for subsequent therapy
- •Documented history of severe autoimmune or immune-mediated symptomatic disease requiring prolonged systemic immunosuppressive treatment
- •History of motor neuropathy considered to be of autoimmune origin or the of grade 2 or higher peripheral neuropathy
- •History of toxic epidermal necrolysis
- •Prior therapies with immunosuppressive agents within the last 2 years (excluding low-dose corticosteroids) and prior therapies with cytotoxic drugs within 4 weeks
- •Chronic use of systemic immunosuppressive drugs, ongoing use of immunotherapy or biologic therapy for the treatment of cancer, or prior use of ipilimumab or any immune-stimulating agent.
研究组 & 干预措施
Arm: Ipilimumab, 10 mg/kg
Experimental
Participants received 10 mg/kg of ipilimumab administered intravenously once every 3 weeks for 4 doses (Induction Phase). Then, once every 12 weeks (Maintenance Phase), until disease progression or unacceptable toxicity occurs.
干预措施: Ipilimumab (Biological)
结局指标
主要结局
Number of Participants With Drug-related Adverse Events (AEs) of Grade 3 or Higher
时间窗: Day 1, first dose, to within 90 days of last dose in Induction Phase
AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. Treatment-related=having certain, probable, possible, or missing relationship to study drug. Grade 1=Mild, Grade 2=Moderate, Grade 3=Severe, Grade 4=Potentially Life-threatening or disabling.
次要结局
- Best Overall Response Rate (BORR)(From first dose of study drug to unacceptable toxicity or progressive disease (to a maximum of 3 years))
- Number of Participants Who Died and With Serious Adverse Events (SAEs), Drug-related SAEs, Drug-related AEs, AEs Leading to Discontinuation, and Drug-related AEs Leading to Discontinuation(From first dose to within 90 days of last study dose)
研究者
研究点 (17)
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