NCT03536780Unknown2 期
Phase II Trial of Avelumab in Combination With Gemcitabine in Advanced Leiomyosarcoma as a Second-line Treatment
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 入组人数
- 38
- 试验地点
- 6
- 主要终点
- Overall Response Rate
研究概览
简要总结
A Phase 2 trial of avelumab plus gemcitabine in advanced leiomyosarcoma as a second line treatment
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
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Unresectable, advanced or metastatic histologically confirmed leiomyosarcoma
- •Progression during or after first-line doxorubicin-based chemotherapy (relapse within 6 months of completion of adjuvant/neoadjuvant chemotherapy containing doxorubicin-based regimen could be considered as first-line therapy.)
- •ECOG PS 0-2
- •At least one measurable lesion according to RECIST v1.1
- •Adequate organ function
- •Life expectancy >= 3 months
- •Negative serum or urine pregnancy test at screening for women of childbearing potential
排除标准
- •Prior treatment history of anti-PD-1/PD-L1 or anti-CTLA4 treatment
- •Receipt of 2 or more prior systemic treatments for advanced leiomyosarcoma
- •Active or untreated brain metastases or spinal cord compression
- •Prior treatment with gemcitabine
- •History of major surgery within 4 weeks prior to enrollment
- •Chemotherapy or radiotherapy within 3 weeks prior to the study drug commencement
- •Previous malignant disease other than leiomyosarcoma within the last 5 years with the exception of basal or squamous cell carcinoma of skin or carcinoma in situ (bladder, cervical, colorectal, breast)
- •Pregnant or lactating women
- •HIV, HBV, or HCV infection
- •Severe hypersensitivity or anaphylaxis to monoclonal antibody, or uncontrolled bronchial asthma
- •Current use of immunosuppressive agent (exclusion : less than prednisone 10 mg/day or equivalent)
- •Active autoimmune disease
- •Clinically significant cardiovascular disease
- •Clinically significant interstitial pneumonitis or pulmonary fibrosis
- •Vaccination within 4 weeks of the first dose of avelumab and while on trial is prohibited except for administration of inactivated vaccines
研究组 & 干预措施
Avelumab and Gemcitabine
Experimental
干预措施: Avelumab and Gemcitabine (Drug)
结局指标
主要结局
Overall Response Rate
时间窗: 3 years
response rate according to RECIST v1.1
次要结局
未报告次要终点
研究者
Young Saing Kim
Associate Professor
Gachon University Gil Medical Center
研究点 (6)
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