Open Label, Randomized, Phase I/II Study of a Long Peptide Vaccine Plus TLR Agonists for Resected Stage IIb-IV Melanoma. (MEL60)
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 4
- 主要终点
- T Cell Response in Peripheral Blood Over Duration of Study Participation
研究概览
简要总结
The purpose of this study is to learn what effects (good and bad) an experimental vaccine (LPV7) plus tetanus peptide and other substances called polyICLC, resiquimod, and Montanide ISA-51 have on you and your melanoma. We will also look at whether the experimental vaccine and these drugs cause any changes in your immune system.
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
- •Histologically or cytologically proven Stage IIB - IV melanoma rendered clinically free of disease by surgery, other therapy, or spontaneous remission within 6 months prior to registration.
- •Patients may have had melanoma from a cutaneous, mucosal or unknown primary site
- •Patients with small radiologic or clinical findings may be eligible
- •Patients with treated brain metastases may be eligible if the following are true:
- •Total number of brain metastases ever is less than or equal to 3
- •The brain metastases have been completely removed by surgery or have been treated completely with stereotactic radiotherapy
- •There has been no evident growth of any brain metastases since treatment
- •No treated brain metastases is greater than 2 cm at the time of protocol entry
- •Patients must have at least 1 intact axillary and/or inguinal lymph node basin
- •ECOG performance status of 0-1
- •Lab parameters as follows:
- •HLA-A1, A2, A3, B35, or B51
- •ANC > 1000/mm3 and Platelets > 100,000/mm3 and Hemoglobin > 9 g/dL
- •AST and ALT up to 2.5 x ULN
- •Bilirubin up to 2.5 x ULN
- •Alkaline Phosphatase up to 2.5 x ULN
- •Creatinine up to 1.5 x ULN
- •HGBA1C level ≤ 7.5%
排除标准
- •Patients with melanoma from a uveal or ocular primary site
- •Patients currently receiving any systemic therapy within 4 weeks of study registration. Gamma knife or stereotactic radiosurgery must not be administered within 1 week prior to study registration. Patients who are currently receiving nitrosoureas within the preceding 6 weeks.
- •Patients who have received CTLA-4, PD-1, PD-L1, CD137, or CD27 within the prior 12 months.
- •Patients with known or suspected allergy to any component of the vaccine
- •HIV positive or active Hepatitis C virus
- •Patients receiving any of the following medications within 4 weeks are excluded:
- •Agents with immunomodulating activity (with the exception of non-steroidal anti-inflammatory agents and topical steroids)
- •Allergy desensitization injections
- •Systemic corticosteroids, administered parenterally or orally. Inhaled steroids (e.g. Advair, Flovent, Azmacort) are not permitted. Topical corticosteroids are acceptable including steroids with very low solubility administered nasally for local effects only (e.g. Nasonex)
- •Any growth factors (e.g. GM-CSF, G-CSF, erythropoietin).
- •Interferon therapy
- •Interleukin-2 or other interleukins
- •Other investigational drugs or investigational therapy if currently receiving or have received within 1 month
- •Pregnancy or the possibility of becoming pregnant during the study. And women who are breastfeeding.
- •Must not have had prior autoimmune disorders requiring cytotoxic or immunosuppressive therapy, or autoimmune disorders with visceral involvement. The following are not exclusionary:
- •Presence of laboratory evidence of autoimmune disease (e.g. positive ANA titer) without symptoms
- •Clinical evidence of vitiligo
- •Other forms of depigmenting illness
- •Mild arthritis requiring NSAID medications
- •Patients with a medical contradiction or potential problem with complying with the protocol, in the opinion of the investigator
- •Patients with Class III or IV heart disease (according to NYHA classification)
- •Patients with a body weight < 110 lbs.
结局指标
主要结局
T Cell Response in Peripheral Blood Over Duration of Study Participation
时间窗: 6 months
Levels of peptide-reactive CD8+ T cells in the peripheral blood: number of participants with T cell response to minimal epitope for CD8 T cells. This was assessed by direct (ex vivo) IFN-gamma ELIspot assay for reactivity to known minimal epitopes. To be considered positive, there had to be an increase compared to the maximum negative control target by at least 2-fold and by at least 20 IFN-gamma secreting cells per 100,000 CD8 T cells evaluated.
Number of Participants With Treatment-related Adverse Events Per Study Arm
时间窗: 6 months
Safety and toxicity following vaccination with 7 long peptides in melanoma patients with and without TLR agonists. Patients are evaluated by safety labs and physical exams to assess for toxicity.
次要结局
- T Cell Response and Function in Peripheral Blood(6 months)
研究者
Craig L Slingluff, Jr
Professor, Department of Surgery
University of Virginia