NCT01455103撤回1 期
A Phase I Study of the Biologic Effects of BMS-936559 Treatment in Subjects With Unresectable Stage III or IV Melanoma
Bristol-Myers Squibb0 个研究点开始时间: 2011年11月最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 发起方
- 主要终点
- Evidence of immunomodulatory effects of BMS-936559 as measured by changes from baseline in biomarkers assessed 1) peripheral blood assays including flow cytometry and soluble factors and 2) tumor based assays including immunohistochemistry
研究概览
简要总结
The purpose of this study is to evaluate pharmacodynamic changes of BMS-936559 treatment on the biomarkers measured in the peripheral blood and tumor tissues of subjects with unresectable Stage III or IV Melanoma.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 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
- •Men and women ≥ 18 years
- •Eastern Cooperative Oncology Group (ECOG) status = 0 to 1
- •Subjects with unresectable Stage III or IV Melanoma who are either refractory or intolerant to, or have refused standard therapy for treatment of metastatic Melanoma
- •Subject must have histologic or cytologic confirmation of advanced Melanoma
- •Subjects must have at least one measurable lesion at baseline by computed tomography (CT) or magnetic resonance imaging (MRI) as per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria
- •Subjects must have at least 1 tumor site that can be biopsied at acceptable clinical risk and must consent to pre- and post-treatment biopsies
排除标准
- •Active or progressing brain metastases
- •Other concomitant malignancies (with some exceptions per protocol)
- •Active or history of autoimmune disease
- •Positive test for human immunodeficiency virus (HIV) 1&2 or known acquired immunodeficiency syndrome (AIDS)
- •History of any hepatitis
- •Prior therapy with any antibody/drug that targets the T cell coregulatory proteins, including but not limited to, anti Programmed cell death 1 (PD-1), anti Programmed cell death ligand 1 (anti-PD-L1), anti-PD-L2, anti-CD137, anti-OX-40, anti-CD40 or anti Cytotoxic T lymphocyte-associated antigen 4 (anti-CTLA-4) antibodies
结局指标
主要结局
Evidence of immunomodulatory effects of BMS-936559 as measured by changes from baseline in biomarkers assessed 1) peripheral blood assays including flow cytometry and soluble factors and 2) tumor based assays including immunohistochemistry
时间窗: Baseline and within the first 24 weeks of study participation
次要结局
- Safety and tolerability of BMS-936559 as measured by the incidence of adverse events (AEs), serious AEs, laboratory test abnormalities, and changes in vital signs(Every 2 weeks until 70 days after last treatment)
- Antitumor Activity of BMS-936559 as measured by the objective response rate, disease control rate, duration of response, and progression free survival(Every 6 weeks for 1 year, every 12 weeks thereafter until confirmed disease progression)
- Immunogenicity of BMS-936559 as measured by the frequency of subjects with an increase in anti-drug antibody levels from baseline(Baseline, Week 6, Week 12, and then every 12 weeks until follow-up)
- Pharmacodynamic activity of BMS-936559 as measured by changes from baseline of the tetramer assay in HLA-A*0210 positive subject only(Predose (screening) and Cycle 3 Day 1)
研究者
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