NCT00362713已完成1 期
A Phase 1b Safety and Dose-Assessment Study of Neoadjuvant Ipilimumab Monotherapy in Patients With Urothelial Carcinoma Undergoing Surgical Resection
Bristol-Myers Squibb1 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2007年3月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Safety of two dose levels of ipilimumab, given prior to surgery, in this patient population.
研究概览
简要总结
The purpose of this study is to learn if ipilimumab can be given safely at two different doses given to patients with urothelial cancer who are going to have surgery as part of their treatment. The immunological effectiveness of ipilimumab will also be studied.
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
- •Previously untreated urothelial cancer requiring surgery for treatment
- •Ineligible for chemotherapy
- •Adequate hematologic, kidney and liver function
排除标准
- •Sexually active and fertile individuals or partners of these individuals who are unwilling or unable to use an acceptable method of birth control for the entire trial and up to 4 weeks after the study
- •Women who are pregnant or breastfeeding
- •Women with a positive pregnancy test on enrollment prior to study drug administration
- •Prior treatment with ipilimumab or other anti-CTLA4 antibody, or a CD137 agonist
- •Concurrent malignancy, with the exception of adequately treated and cured basal or squamous cell skin cancer, or carcinoma in situ of the cervix (previous malignancy without evidence of disease for 5 years will also be allowed to enter trial)
- •Autoimmune disease: subjects with a documented history of inflammatory bowel disease (including Crohn's disease and ulcerative colitis) are excluded from this study as are patients with a history of symptomatic disease (e.g., rheumatoid arthritis, systemic progressive sclerosis [scleroderma], Systemic Lupus Erythematosus, autoimmune vasculitis [e.g., Wegener's Granulomatosis]). Subjects with motor neuropathy considered of autoimmune origin (e.g., Guillain-Barre Syndrome) are excluded from this study
- •Patients deemed ineligible for surgery
- •Any non-oncology vaccine therapy used for prevention of infectious diseased in the past month
- •Concomitant therapy with any of the following: IL-2, interferon or other non-study immunotherapy regimens, chemotherapy; immunosuppressive agents; other investigation therapies; or chronic use of systemic corticosteroids (used in the management of cancer or non-cancer related illnesses)
- •Prior radiation therapy for urothelial cancer
- •Positive screening tests for or any prior history of HIV, Hepatitis B or Hepatitis C
研究组 & 干预措施
A
Experimental
3 mg/kg or 10 mg/kg
干预措施: Ipilimumab (Drug)
结局指标
主要结局
Safety of two dose levels of ipilimumab, given prior to surgery, in this patient population.
时间窗: assessed throughout the study
次要结局
- To evaluate anti-cancer immunological activity in blood and tissue samples compared to pre-treatment or control samples.(assessed throughout the study)
研究者
研究点 (1)
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