Pilot Study of a Prophylactic Cancer Peptide Vaccine in Advanced ALK+ NSCLC
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- Incidence of treatment-related adverse events
研究概览
简要总结
The purpose of this study is to evaluate the safety of a cancer peptide vaccine to prevent or delay acquired resistance in advanced ALK+ lung cancer patients currently on ALK targeted therapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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 confirmed diagnosis of stage IV NSCLC (or recurrent NSCLC not a candidate for definitive multimodality therapy)
- •Documented ALK rearrangement as detected by: (1) fluorescence in situ hybridization (FISH), (2) immuno-histochemistry (IHC), (3) tissue next-generation sequencing (NGS), or (4) circulating tumor DNA (ctDNA) NGS
- •Ongoing treatment with crizotinib, ceritinib, alectinib, brigatinib, or lorlatinib with at least stable disease ≥ 4 months
- •No known presence of the specific ALK acquired resistance alterations targeted by the study vaccine
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1
- •Males or females at least 18 years old
排除标准
- •Known additional malignancy that is progressing or has required active treatment within the past 3 years. Adequately resected non-melanoma skin cancer, curatively treated in-situ disease, and other solid tumors treated with potentially curative therapy are allowed.
- •Cytotoxic chemotherapy within 14 days of first dose of study vaccine or concurrent with study vaccine
- •Anti-neoplastic immunotherapy within 28 days of first dose of study vaccine or concurrent with study vaccine
- •Systemic immune suppression:
- •Use of chronic oral or systemic steroid medication (topical or inhalational steroids are permitted)
- •Other clinically relevant systemic immune suppression
- •Symptomatic central nervous system (CNS) metastasis. Asymptomatic CNS disease requiring increasing dose of corticosteroids within 7 days prior to study enrollment is also not permitted
- •Current spinal cord compression (symptomatic or asymptomatic and detected by radiographic imaging). Patients with leptomeningeal disease and without cord compression are allowed
研究组 & 干预措施
Advanced ALK+ NSCLC
All patients will receive the intervention
干预措施: Peptide vaccine (Biological)
结局指标
主要结局
Incidence of treatment-related adverse events
时间窗: Up to 2 years
The safety of administering the ALK peptide vaccine will be assessed by the occurrence of the following adverse events: * Grade 3 or above drug-related toxicities * Drug-related toxicity by grade * Vaccine site reactions after vaccine injections * Immune-related adverse events (AEs) * Unacceptable toxicities * Treatment-emergent changes from normal to abnormal values in key laboratory parameters
Vaccine-specific immune response
时间窗: Up to 2 years
Vaccine-specific response will be evaluated by the fold change in interferon-producing mutant-ALK-specific CD8 and CD4 T cells in the peripheral blood.
次要结局
未报告次要终点