EUCTR2005-000727-42-DE进行中（未招募）不适用
A Phase IIa Study to Evaluate Safety, Tolerability, and Immunogenicity of a Melan-A-VLP Vaccine in HLA-A2 Positive Patients with stage III/IV Malignant Melanoma
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
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
- •- Able to provide written informed consent
- •- Able to complete all protocol requirements
- •- Age: 18 years and older
- •- Histologically confirmed stage III or IV melanoma (per American Joint Committee on
- •- HLA-A*0201 haplotype (serological and genomic typing)
- •- Expected survival of at least 6 months
- •- ECOG performance status of 0 or 1
- •- At least one and no more than two previous systemic therapies for metastatic melanoma.
- •- Adequate organ and bone marrow functions
- •- All AEs from prior anticancer therapy have resolved to >= Grade 1
- •-Sexually active males should use adequate contraception throughout the study and 3 months therafter
- •- Females of child bearing potential should use adequate contraception that can be oral contraception or a double-barrier local contraception (intra-uterine device plus condom or spermicidal gel plus condom) and have a negative serum pregnancy test within 4 weeks prior to the first dose of the vaccine
- •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
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •- Pregnant or nursing
- •- Use of an investigational drug within 30 days before enrolment
- •- Known or suspected brain metastases
- •- Current use of an immunosuppressive drug or any concomitant medication that could potentially interfere with the study drug
- •- Presence of significant cardiovascular, renal, pulmonary, endocrine, infectious, or neurological disorders
- •- Serum tests positive for HIV, HBV, HCV
- •- Active autoimmune diseases or severe allergies
- •- Current diagnosis or history of relevant and severe psychiatric disorder
- •- Blood donation or loss of >400mL within 8 weeks prior to inclusion
- •- Abuse of alcohol or other recreational drugs.- Smokers consuming >20 cigarettes per day
- •- Previous participation in a clinical trial with a Qb based vaccine (DerQb, NicQb, TNFQb, AngQb, GhrQb, QbG10, AllQbG10)
研究者
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