NL-OMON52234已完成不适用
Dendritic Cells loaded with allogeneic tumor lysate (MesoPher) in combination with a CD40 agonist (Mitazalimab) in metastatic pancreatic disease (REACtiVe-2 Trial) - REACtiVe-2
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
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
- 年龄范围
- 18 至 99（—）
入选标准
- •In order to be eligible to participate in this study, a subject must meet all
- •of the following criteria:
- •Metastatic pancreatic cancer as defined by the presence of radiologically
- •suspect metastatic lesions.
- •Inclusion <= 4 weeks after stopping FOLFIRINOX chemotherapy.
- •No more than 1 line of chemotherapy for metastatic disease is allowed. Prior
- •FOLFIRINOX for locally advanced disease if given within 1 year before screening
- •will be counted as first-line treatment. Any FOLFIRINOX given in the curative
- •intent setting if more than a year before screening will not be considered
- •first line therapy.
- •An accessible metastasistic lesion for histological tissue collection.
- •Patients must be at least 18 years old and must be able to give written
- •informed consent.
- •WHO performance status 0-1.
- •Patients must have normal organ function and adequate bone marrow reserve:
- •absolute neutrophil count > 1.0 x 109/l, platelet count > 100 x 109/l, and Hb >
- •6.0 mmol/l (as determined during screening). Transfusion in the 2 weeks
- •preceding screening is not allowed.
- •Laboratory tests: ASAT/ALAT <5xULN (upper limit of normal), bilirubine
- •<1.5xULN, Creatinine value <1.5xULN, Lactate dehydrogenase value <= ULN and
- •albumin value >= LLN (lower limit of normal).
- •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.
- •*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, postovulation methods) and withdrawal are not
- •acceptable methods of contraception.
- •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.
- •Ability to return to the hospital for adequate follow-up as required by this
- •Written informed consent according to ICH-GCP.
排除标准
- •A potential subject who meets any of the following criteria will be excluded
- •from participation in this study:
- •Medical or psychological impediment to probable compliance with the protocol.
- •Abdominal ascites.
- •Current or previous use of a CD40 antibody and/or anti-tumor vaccinations.
- •Current use of steroids (or other immunosuppressive agents). Patients must
- •have had 6 weeks of discontinuation and must stop any such treatment during the
- •time of the study. Prophylactic usage of dexamethasone during chemotherapy is
- •excluded from this 6 weeks interval.
- •Prior 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 patient has undergone curative intent treatment and has been disease-free
- •for two years.
- •Serious concomitant disease, or active infections.
- •History of autoimmune disease, organ allografts or active acute or chronic
- •infection, including but not limited to HIV and viral hepatitis.
- •Serious intercurrent chronic or acute illness such as pulmonary disease
- •(asthma or COPD), cardiac disease (NYHA class III or IV), hepatic disease or
- •other illness considered by the study coordinator to constitute an unwarranted
- •high risk for the investigational treatment.
- •Known allergy to shell fish (may contain keyhole limpet hemocyanin (KLH)).
- •Pregnant or lactating women.
- •Inadequate vein access to perform leukapheresis.
- •Concomitant participation in another clinical intervention trial (except
- •participation in a biobank study).
- •An organic brain syndrome or other significant psychiatric abnormality which
- •would compromise the ability to give informed consent, and preclude
- •participation in the full protocol and follow-up.
研究者
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