EUCTR2017-002179-24-DK进行中（未招募）1 期
T-cell therapy in combination with checkpoint inhibitors for patients with advanced ovarian-, fallopian tube- and primary peritoneal cancer.
Center for Cancer Immune Therapy0 个研究点目标入组 6 人开始时间: 2017年6月15日最近更新:
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 6
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.Histological proven advanced ovarian-, fallopian tube or primary peritoneal cancer with the possibility of surgical removal of tumor tissue of > 1 cm3. All histologies can be included.
- •2.Progressive or recurrent resistant disease after platin-based chemotherapy (platinum resistant) or progressive or recurrent disease after second line or additional chemotherapy.
- •3.Age: 18 – 70 years.
- •4.ECOG performance status of =1.
- •5.Life expectancy of > 6 months.
- •6.At least one measurable parameter in accordance with RECIST 1.1 –criteria’s.
- •7.No significant toxicities or side effects (CTC = 1) from previous treatments, except sensoric- and motoric neuropathy (CTC = 2) and/or alopecia (CTC = 2).
- •8.Sufficient organ functions.
- •9.Women in the fertile age must use effective contraception. This applies from inclusion and until 6 months after treatment. Birth control pills, spiral, depot injection with gestagen, subdermal implantation, hormonal vaginal ring and transdermal depot patch are all considered safe contraceptives.
- •10.Signed statement of consent after receiving oral and written study information
- •11.Willingness to participate in the planned controls and capable of handling toxicities.
- •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 10
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 2
排除标准
- •1.A history of prior malignancies. Patients treated for another malignancy can participate if they are without signs of disease for a minimum of 5 years after treatment.
- •2.Known hypersensitivity to one of the active drugs or one or more of the excipients.
- •3.Severe medical conditions, such as severe asthma/COLD, significant cardiac disease, poorly regulated insulin dependent diabetes mellitus among others.
- •4.Creatinine clearence < 70 ml/min*.
- •5.Acutte/chronic infection with HIV, hepatitis, syphilis among others.
- •6.Severe allergies or previous anaphylactic reactions.
- •7.Active autoimmune disease, such as autoimmune neutropenia/thrombocytopenia or hemolytic anemia, systemic lupus erythematosis, Sjögren’s syndrome, sclerodermia, myasthenia gravis, Goodpasteur’s disease, Addison’s disease, Hashimotos thyroiditis, active Graves disease.
- •8.Pregnant women and women breastfeeding.
- •9.Simultaneous treatment with systemic immunosuppressive drugs (including prednisolone, methotrexate among others)**.
- •10.Simultaneous treatment with other experimental drugs.
- •11.Simultaneous treatment with other systemic anti-cancer treatments.
- •12.Patients with active and uncontrollable hypercalcaemia.
- •* In selected cases it can be decided to include a patient with a GFR < 70 ml/min with the use of a reduced dose of chemotherapy.
- •** In selected cases a systemic dose of =10 mg prednisolone or a transient planned treatment that can be stopped before TIL therapy can be tolerated.
研究者
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