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) - DENIM (DENdritic Cell Immunotherapy for Mesothelioma)

Amphera B.V.0 个研究点目标入组 164 人开始时间: 2017年10月13日最近更新: 2022年8月8日

适应症

试验速览

阶段: 1 期
状态: 进行中（未招募）
发起方
入组人数: 164

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

•Subjects will be enrolled in this study only if they meet all of the following criteria:
•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. Disease free interval is defined as the time between the administration of the last chemotherapy cycle and the date of disease progression.
•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 estimated glomerular filtration rate = 50mL/min
•- ALT, AST, bilirubin = 1.5 × ULN
•- Absolute neutrophil count =1.5 x 1000000000/L, platelet count =100 x 1000000000/L, and Hb =9.0g/dL.
•NOTE: borderline isolated result in any of the above parameters may be acceptable subject to review and discussion between the Investigator and Medical monitor.
•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 treatment 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 treatment administration. *True abstinence is acceptable when this is in line with the preferred and usual lifestyle of the subject. Periodic abstinence (such as calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception.
•9. Men must be willing to use an effective contraceptive method (eg, condom, vasectomy) during the study and for at least 12 months after the last study treatment 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

排除标准

•Subjects will not be enrolled in this study if they meet any of the following criteria:
•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), 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 treatment administration.
•9. Subject with inadequate peripheral vein access to perform leukapheresis.
•10. Use of >10 mg of prednisolone or equivalent/day and/or other immunosuppressive agents during the 6 weeks before the first study treatment anticipated D1 date 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. Patient treated with colony stimulating factors (e.g. G-CSF) in the 14 days of screening and in the period between screening and date of leukapheresis.
•12. Treatment with any investigational product within 4 weeks or 5 half-lives (whichever is longer) before the first study treatment administration or concomitant participation in another clinical study. Simultaneous participation in another study may be permitted, but prior written permission by the medical monitor is required.
•13. Subject who is unwilling or unable to follow the protocol requirements, including availability for follow-up assessment.

研究者

发起方

Amphera B.V.

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