Adjuvant Antigen Specific Immunotherapy in Patients With Advanced Renal Cell Carcinoma Using Tumor Associated Peptides
试验速览
- 阶段
- 1 期
- 入组人数
- 40
- 主要终点
- Tolerability
研究概览
简要总结
Clinical Phase I/II study to investigate the feasibility and tolerability of synthetic adjuvant peptide immunisation in combination with immune adjuvants (granulocyte macrophage colony stimulating factor; Montanide ISA-51) in patients with advanced renal cell cancer (RCC).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Advanced renal cell carcinoma clinical stage T3 or T4, N0, M0
- •M1 (after complete metastasectomy)
- •ECOG performance status 0 or 1
- •age >18 years
- •at least 4 weeks since last administration of radiation- or chemotherapy
- •Serum levels of bilirubin <2 mg/dl, creatinine<2mg/dl
排除标准
- •detectable distant metastasis in radiological imaging (M1)
- •patients unable to consent
- •severe cardiopulmonary disorder (NYHA >= 3)
- •presence of secondary malignancy
- •Immunosuppressive medication (last application of glucocorticoids > 4 weeks)
- •pregnancy
- •simultaneous participation in other active or passive immunisation treatment
研究组 & 干预措施
Study Arm 1
Intradermal application of peptide vaccine in combination with Granulocyte Macrophage Colony Stimulating Factor (GM-CSF)
干预措施: peptide vaccine (Biological)
Study Arm 1
Intradermal application of peptide vaccine in combination with Granulocyte Macrophage Colony Stimulating Factor (GM-CSF)
干预措施: Granulocyte Macrophage Colony Stimulating Factor (Drug)
Study Arm 2
Intradermal application of peptide vaccine with Montanide ISA-51
干预措施: peptide vaccine (Biological)
Study Arm 2
Intradermal application of peptide vaccine with Montanide ISA-51
干预措施: Montanide ISA-51 (Drug)
结局指标
主要结局
Tolerability
时间窗: Day 0-365
Tolerability, as measured by number of Participants with Adverse Events
次要结局
- Immune Response(Day 0-365)
- All Cause Mortality(60 Months)
- Progression-free Survival(36 Months)