A Randomized, Open-Label Phase II/III Study With Dendritic Cells Loaded With Allogeneic Tumour Cell Lysate (PheraLys) in Subjects With Mesothelioma as Maintenance Treatment (MesoPher) After Chemotherapy. - DENIM (DENdritic Cell Immunotherapy for Mesothelioma)

AMPHERA BV0 个研究点目标入组 230 人开始时间: 2020年11月4日最近更新: 2021年7月21日

适应症

试验速览

阶段: 1 期
状态: 进行中（未招募）
发起方: AMPHERA BV
入组人数: 230

研究概览入排标准研究者记录与标识符相似试验

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: All

入选标准

•1. Signed informed consent form (ICF) indicating an understanding of the purposes, risks, and procedures required for the study and willingness and ability to participate in the study.
•2. Subjects with a histologically confirmed diagnosis of pleural malignant mesothelioma, who are non-progressive (so CR, PR or SD) after 4 to 6 cycles with first line chemotherapy with antifolate/platinum (as determined by CT scanning). Subjects retreated with antifolate/platinum after a disease-free interval of 12 months after the first
•chemotherapeutic treatment are eligible. Concurrent bevacizumab during chemotherapy is allowed but patients who receive bevacizumab will only be eligible if they stop bevacizumab due to non-tolerance before or by the end of the chemotherapy period. Patients who benefit from bevacizumab use may continue treatment with bevacizumab and will consequently not be eligible for the study .
•3. Subject must have signed informed consent within 8 weeks of their last chemo and the date of their informed consent must be such that all per protocol required procedures can be done in such a timeframe that the first treatment can be given within 9 and 13 weeks after their last chemotherapy.
•4. Measurable disease has to be assessed by modified RECIST criteria on CT scanning by radiologic imaging. Even in the absence of measurable disease patients can be included in the study. In such case CT scanning will also be done to evaluate the disease.
•5. Subjects must be at least 18 years old.
•6. Subjects must have WHO-ECOG performance status of 0 or 1.
•7. Subjects must have adequate organ function and adequate bone marrow reserve at screening:
•- creatinine <= 1.5 × upper limit of normal [ULN] or glomerular filtration
•rate> = 50mL/min
•- ALT, AST, bilirubin< = 1.5 × ULN
•- Absolute neutrophil count >=1.5 x 1000000000/L, platelet coun>t =100 x
•1000000000/L, and Hb =9.0g/dL.
•8. Women of childbearing potential must have a negative serum pregnancy test at screening and a negative urine pregnancy test just prior to the first study drug administration on Day 1, and must be willing to use an effective contraceptive method (intrauterine devices, hormonal contraceptives, contraceptive pill, implants, transdermal patches, hormonal vaginal devices, infusions with prolonged release) or true abstinence (when this is in line with the preferred and usual lifestyle)*
•during the study and for at least 12 months after the last study drug administration.
•9. Men must be willing to use an effective contraceptive method (e.g. condom, vasectomy) during the study and for at least 12 months after the last study drug administration.
•10. Subjects must be willing and able to follow the protocol requirements and must be willing and able to return to the study center for adequate follow-up visits.
•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 100
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 130

排除标准

•1. Subject with any concurrent medical, psychological or psychiatric disease or condition that is likely to interfere with study procedures or results, or that in the opinion of the investigator would constitute a hazard for participating in this study.
•2. Subject with any serious intercurrent chronic or acute illness such as cardiac (New York Heart Association [NYHA] Class III or IV) or hepatic disease or other serious concomitant disease considered by the investigator to constitute an unwarranted high risk for investigational dendritic cell treatment.
•3. Subject with any known active serious infection, including human immunodeficiency virus (HIV) and hepatitis B or C virus or syphilis infection.
•4. Subject with a history of autoimmune disease, except for diabetes mellitus type I or other conditions, where patient can be eligible following discussion with medical monitor.
•5. Subject who has received an organ allograft.
•6. Subject with any previous malignancy except adequately treated basal cell or squamous cell skin cancer, superficial or in-situ cancer of the bladder or other cancer for which the subject has been disease-free for at least 3 years.
•7. Subject with a known allergy to shell fish (may contain KLH).
•8. Pregnant women, nursing mothers, lactating women, and women of child-bearing potential who are unwilling to use effective contraceptive methods (intrauterine devices, hormonal contraceptives, contraceptive pill, implants, transdermal patches, hormonal vaginal devices, infusions with prolonged release) during the study and for at least 12 months after the last study drug administration.
•9. Subject with inadequate peripheral vein access to perform leukapheresis.
•10. Use of >10 mg of steroids (or other immunosuppressive agents) during the past 6 weeks before the first study drug administration and throughout the study. Prophylactic usage of dexamethasone during chemotherapy is excluded from this 6-week interval. Inhaled or topical steroids, and adrenal replacement steroid 11. Treatment with any investigational product within 4 weeks or 5 halflives (whichever is longer) before the first study drug administration or concomitant participation in another clinical study.
•12. Subject who is unwilling or unable to follow the protocol requirements, including availability for follow-up assessment.

研究者

发起方

AMPHERA BV

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