EUCTR2019-002980-81-AT进行中（未招募）1 期
IO-1: A Phase 1b/2, Open-Label Study to Evaluate the Safety and Efficacy of Lucitanib in Combination With Nivolumab in Patients With An Advanced, Metastatic Solid Tumor - LIO-1
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 161
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- Female
入选标准
- •= 18 years of age
- •Adequate organ function
- •Life expectancy = 3 months
- •Women of childbearing potential must have a negative plasma or serum
- •pregnancy test
- •Advanced/metastatic solid tumor
- •Availability of tumor tissue at screening
- •ECOG performance status of 0 to 1
- •Measurable disease (RECIST v1.1)
- •Advanced, recurrent, or metastatic gynecological solid tumor
- •Willing and able to provide an additional biopsy after 4 weeks of
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 97
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 64
排除标准
- •Prior treatment with lucitanib
- •Active second malignancy
- •Active central nervous system brain metastases
- •Pre-existing duodenal stent or any gastrointestinal disorder
- •Known history of HIV or AIDS; positive result of hepatitis B or C
- •Evidence of interstitial lung disease, active pneumonitis,
- •myocarditis, or history of myocarditis
- •Active, known, or suspected autoimmune disease (e.g.,
- •autoimmune hepatitis)
- •Condition requiring systemic treatment with corticosteroids or
- •other immune suppressive medications
- •Unstable or uncontrolled hypertension
- •(greater than 140/90 mmHg)
- •Prior treatment with a VEGFR-tyrosine kinase inhibitor
- •NOTE: Bevacizumab is permitted in the first line and second line
- •treatment (including maintenance) of advanced ovarian cancer as first
- •line treatment of metastatic or recurrent cervical cancer in combination
- •with chemotherapy (including maintenance), or as first-line and secondline
- •treatment in combination with chemotherapy (including
- •maintenance) or as single-agent for recurrent or metastatic endometrial
- •cancer. An EMA- or FDA-approved biosimilar is an acceptable substitute
- •for bevacizumab.
- •History of life-threatening toxicity related to prior immune therapy
- •(eg, anti CTLA 4 or anti PD 1/PD L1 treatment or any other antibody or
- •drug specifically targeting T cell co stimulation or immune checkpoint
- •pathways) except those that are unlikely to re-occur with standard
- •countermeasures (eg, hypothyroidism).
研究者
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