EUCTR2016-004527-23-DK进行中（未招募）1 期
Combination therapy with Nivolumab and PD-L1/IDO peptide vaccine with Montanide to patients with metastatic malignant melanoma
Center for Cancer Immune Therapy0 个研究点目标入组 30 人开始时间: 2017年1月11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
- 30
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.Age = 16
- •2.The patient has unrespectable or metastatic melanoma with progressive, persistent or recurrent disease on or following treatment with standard of care agents.
- •3.The patient is candidate for Nivolumab monotherapy.
- •4.At least one measurable parameter according to RECIST 1.1.
- •5.The patient has an ECOG Performance status of 0 or 1.
- •6.The patient is a female of childbearing potential with negative pregnancy test.
- •7.Women agreement to use contraceptive methods with a failure rate of < 1 % per year during the treatment period and for at least 120 days after the treatment.
- •8.For men: agreement to use contraceptive measures and agreement to refrain from donating sperm.
- •9.The patient has met the following hematological and biochemical criteria::
- •a.AST and ALT =2,5 X ULN or =5 X ULN with liver metastases
- •b.Serum total bilirubin =1,5 X ULN or direct bilirubin = ULN for patient with total bilirubin level > 1,5 ULN
- •c.Serum creatinine =1,5 X ULN
- •d.ANC (Absolute Neutrophil Count) =1,000/mcL
- •e.Platelets = 75,000 /mcL
- •f.Hemoglobin = 9 g/dL eller = 5.6 mmol/L
- •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 25
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 25
排除标准
- •1.The patient has previously received monotherapy Nivolumab.
- •2.The patient has not recovered to grade 0-1 from adverse events due to prior chemotherapy, radioactive or biological cancer therapy.
- •3.The patient has not recovered from surgery or is less than 4 weeks from major surgery.
- •4.The patient has a history of life-threatening or severe immune related adverse events on treatment with another immunotherapy and is considered to be at risk of not recovering.
- •5.The patient is expected to require any other form of systemic antineoplastic therapy while receiving the treatment.
- •6.The patient has a history of severe clinical autoimmune disease.
- •7.The patient has a history of pneumonitis, organ transplant, human immunodeficiency virus positive, active hepatitis B or hepatitis C.
- •8.The patient requires systemic steroids for management of immune-related adverse events experienced on another immunotherapy.
- •9.The patient has active CNS metastases and/or carcinomatous meningitis. However patients with subclinical brain metastases < 1 cm can be included (maximum of 4 metastases < 1 cm). (Patients with previously treated brain metastases may participate provided they are clinically stable. Patients with untreated brain metastasis will be excluded).
- •10.The patient has any condition that will interfere with patient compliance or safety (including but not limited to psychiatric or substance abuse disorders).
- •11.The patient is pregnant or breastfeeding.
- •12.The patient is unable to voluntarily agree to participate by signed informed consent or assent.
- •13.The patient has an active infection requiring systemic therapy.
- •14.The patient has received a live virus vaccine within 30 days of planned start of therapy.
- •15.Known side effects to Montanide ISA-51.
- •16.Significant medical disorder according to investigator; e.g. severe asthma or chronic obstructive lung disease, dysregulated heart disease or dysregulated diabetes mellitus.
- •17.Concurrent treatment with other experimental drugs.
- •18.Any active autoimmune diseases e.g. autoimmune neutropenia, thrombocytopenia or hemolytic anemia, systemic lupus erythematosus, scleroderma, myasthenia gravis, autoimmune glomerulonephritis, autoimmune adrenal deficiency, autoimmune thyroiditis etc.
- •19.Severe allergy or anaphylactic reactions earlier in life.
研究者
相似试验
已完成
1 期
Combination Therapy With Nivolumab and PD-L1/IDO Peptide Vaccine to Patients With Metastatic MelanomaMetastatic MelanomaNCT03047928Inge Marie Svane48
进行中（未招募）
1 期
Nivolumab and Ipilimumab in Combination With Immunogenic Chemotherapy for Patients With Advanced NSCLCAdvanced NSCLCNCT04043195Hatim Husain30
招募中
2 期
Tovorafenib for Treatment of Craniopharyngioma in Children and Young AdultsCraniopharyngioma, ChildRecurrent CraniopharyngiomaCraniopharyngiomaNCT05465174Sabine Mueller, MD, PhD57
已完成
2 期
O LIMIT StudyJPRN-jRCT2080225304Hisato Kawakami (Coordinating Investigator)28
进行中（未招募）
1 期
A Study of Nivolumab and Ipilimumab Combined with Chemotherapy Compared to Chemotherapy by Itself as the First Treatment Given for Stage IV Non-Small Cell Lung Cancer (NSCLC) (CheckMate 9LA)Stage IV Non-Small Cell Lung Cancer (NSCLC)MedDRA version: 20.0Level: PTClassification code 10029522Term: Non-small cell lung cancer stage IVSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2017-001195-35-ESBristol-Myers Squibb International Corporation504