EUCTR2021-003229-31-BE招募中1 期
Integration of the PD-L1 inhibitor atezolizumab and WT1/DC vaccination into platinum/pemetrexed-based first-line treatment for epithelioid malignant pleural mesothelioma - Immuno-MESODEC
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 15
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •- Signed informed consent
- •- Diagnosis with histologically proven epithelioid unresectable MPM (stage I-IV)
- •- Aged =18 years at the time of signing the informed consent form
- •- World Health Organization (WHO) performance status: grade 0-1
- •- Adequate hematologic and end-organ function
- •- Negative viral serology for Human Immunodeficiency Virus (HIV), Hepatitis B Virus (HBV) or Hepatitis C Virus (HCV)
- •- Willing and able to comply with the study protocol, as judged by the treating physician
- •- Women of childbearing potential must have a negative serum or urine pregnancy test at the time of screening
- •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 3
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 12
排除标准
- •- History of another malignancy within the last three years (except for malignancies with a negligible risk of metastasis or death)
- •- Symptomatic, untreated, or actively progressing central nervous system metastases
- •- Active or history of autoimmune disease or immune deficiency
- •- Severe infection within 4 weeks prior to initiation of study treatment
- •- Prior treatment for MPM
- •- Prior allogeneic stem cell or solid organ transplantation
- •- Major surgical procedure, other than for diagnosis, within 4 weeks prior to initiation of study treatment, or anticipation of need for a major surgical procedure during the study
- •- Use of any investigational agent within 28 days before study enrollment
- •- Recent treatment with systemic immunostimulatory agents or systemic immunosuppressive medication
- •- Pregnant or breastfeeding
- •- Any other condition, either physical or psychological, or reasonable suspicion thereof on clinical or special investigation, which contraindicates the use of atezolizumab, pemetrexed, cisplatin/carboplatin and/or WT1/DC vaccines, or may negatively affect patient compliance, or may place the patient at higher risk of potential treatment complications.
研究者
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