Integration of the PD-L1 inhibitor atezolizumab and WT1/DC vaccination into platinum/pemetrexed-based first-line treatment for epithelioid malignant pleural mesothelioma
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 15
- 试验地点
- 3
- 主要终点
- Feasibility: the proportion of patients who completed study treatment schedule (i.e. administration of four platinum/pemetrexed-based chemotherapy cycles in combination with four atezolizumab treatments and four WT1/DC vaccinations
研究概览
简要总结
To investigate the feasibility and safety of adding atezolizumab and WT1/DC vaccination to first-line platinum/pemetrexed-based chemotherapy in patients with epithelioid MPM
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 是
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
排除标准
- •History of another malignancy within the last three years (except for malignancies with a negligible risk of metastasis or death)
- •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
- •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
结局指标
主要结局
Feasibility: the proportion of patients who completed study treatment schedule (i.e. administration of four platinum/pemetrexed-based chemotherapy cycles in combination with four atezolizumab treatments and four WT1/DC vaccinations
Feasibility: the proportion of patients who completed study treatment schedule (i.e. administration of four platinum/pemetrexed-based chemotherapy cycles in combination with four atezolizumab treatments and four WT1/DC vaccinations
Safety, based on the occurrence of reported AEs and SAEs during investigational treatment administration and during follow-up: (A) Proportions of patients that experienced (S)AEs possibly, probably or definitely related to pemetrexed and/or cisplatin/carboplatin and/or atezolizumab and/or WT1/DC vaccination (B) Number and grade of AEs and SAEs
Safety, based on the occurrence of reported AEs and SAEs during investigational treatment administration and during follow-up: (A) Proportions of patients that experienced (S)AEs possibly, probably or definitely related to pemetrexed and/or cisplatin/carboplatin and/or atezolizumab and/or WT1/DC vaccination (B) Number and grade of AEs and SAEs
次要结局
- Clinical efficacy, including: (A) Best overall response (BOR), duration of response (DOR), disease control rate (DCR), objective response rate (ORR) and progression free survival (PFS), (B) Overall survival (OS)
- Immunogenicity: Functional WT1-specific T cell responses
研究者
Center for Cell Therapy and Regenerative Medicine
Scientific
Antwerp University Hospital