EUCTR2020-002738-34-DK进行中（未招募）1 期
T-cell Therapy in Combination with Nivolumab, Relatlimab, and Ipilimumab for Patients with Advanced Ovarian-, Fallopian Tube- and Primary Peritoneal Cancer
ational Center for Cancer Immune Therapy0 个研究点目标入组 18 人开始时间: 2020年7月2日最近更新:
适应症
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
- 18
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
- Female
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 – 75 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 18
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 6
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 3 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 ( Except for anti-hormonal treatment. Physician’s evaluation is needed)
- •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
相似试验
进行中（未招募）
1 期
Cell based treatment combined with standard therapy for skin cancer.EUCTR2014-001419-38-DKCenter for Cancer Immune Therapy12
招募中
2 期
eo-adjuvant T-VEC + Nivolumab combination therapy for resectable early metastatic (stage IIIB/C/D-IV M1a) melanoma with injectable disease.skin cancerMelanomaNL-OMON49074Antoni van Leeuwenhoek Ziekenhuis24
进行中（未招募）
1 期
CombinatiOn of NivolumAb plus Relatlimab in patients with Advanced or metastatic soft-tissue Sarcoma: a proof-of-concept randomized phase II studyAdvanced soft-tissue sarcomaMedDRA version: 20.0 Level: SOC Classification code 10029104 Term: Neoplasms benign, malignant and unspecified (incl cysts and polyps) System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 20.0 Level: LLT Classification code 10039494 Term: Sarcoma NOS System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2019-002332-81-FRInstitut Bergonié67
已完成
1 期
A phase Ib study of Nivolumab plus Trastuzumab with S-1/Capecitabine plus Oxaliplatin for HER2 positive advanced gastric cancerHER2 positive advanced or unresectable gastric cancerJPRN-UMIN000034222The Cancer Institute Hospital of JFCR45
Unknown
1 期
Combined Therapy of Nivolumab and Adoptive T Cell Therapy in Metastatic Melanoma PatientsMelanomaNCT03374839Nantes University Hospital11