ACTRN12619000769189招募中1 期
A pilot study to evaluate the safety and immunogenicity of a personalised tumour neo-antigen peptide vaccine strategy in patients with completely resected non-small cell lung cancer.
niversity of Western Australia0 个研究点目标入组 6 人开始时间: 2019年5月23日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 6
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Non-randomised trial
- 主要目的
- Treatment
入排标准
- 年龄范围
- 18 Years 至 o limit（—）
- 性别
- All
入选标准
- •1. Pathologically established diagnosis of NSCLC
- •2. Localised disease amenable to complete surgical resection
- •3. > 18 years of age
- •4. Eastern Cooperative Oncology Group (ECOG) performance status =1.
- •5. Life expectancy of >24 weeks
- •6. Patients who may require adjuvant chemotherapy are eligible
- •7. History of prior malignancy is eligible if the following criteria are met for a cancersurvivor:
- •7.1. has undergone potentially curative therapy for all prior malignancies,
- •7.2. has been considered disease free for at least 2 years
- •8. Women of reproductive potential must agree to use adequate contraception (two barrier methods or barrier method plus hormonal method of birth control; abstinence) prior to study entry and for the duration of study participation.
- •9. Males who are sexually active with women of reproductive potential must agree to use adequate contraception (two barrier methods or abstinence) prior to study entry and for the duration of study participation.
- •10. Able to provide written informed consent.
- •11. Must be willing and able to comply with scheduled visits, treatment schedule, and laboratory testing.
- •Pre-Registration
- •12. Complete resection with margins negative for disease.
- •13. If required. Completed adjuvant platinum doublet chemotherapy as per standard oncological management
- •14. Adequate organ and marrow function no more than 14 days prior to registration as defined below:
- •Haemoglobin = 90g/L
- •WBC > 2 x 109/L
- •absolute neutrophil count > 1.5 x 109/L
- •platelets > 100 x 109/L
- •total bilirubin < 1.5 x ULN
- •ALT < 3.0 x ULN
- •creatinine < 1.5 x ULN
- •15. Adequate number of accessible tumour cells from resection.
排除标准
- •1. Received chemotherapy, radiotherapy, or biologic therapy or other investigational therapeutic agent(s) within the last 21 days
- •2. Ongoing adverse effects from chemotherapy that have not resolved to = grade 1 (except haemoglobin= 90g/L is allowed)
- •3. Known allergy, or history of serious adverse reaction to vaccines such as anaphylaxis, urticaria, or respiratory difficulty.
- •4. Uncontrolled significant intercurrent illness of major organ systems, or has psychiatric illness/social situation that would limit compliance with study requirements.
- •5. Prior or currently active significant autoimmune disease. Subjects with Type I diabetes mellitus, hypothyroidism requiring only hormone replacement are permitted to enroll.
- •6. Subjects with a condition requiring systemic corticosteroids or other immunosuppressive medications within 14 days of study treatment. Inhaled steroids and adrenal replacement steroids are permitted in the absence of active autoimmune disease.
- •7. Pregnant or breastfeeding. A negative serum pregnancy test is required in women of childbearing
- •potential no more than 7 days before registration.
- •8. Known HIV-positive status.
- •9. Any positive test result for Hepatitis B virus or hepatitis C virus indicating the presence of virus, e.g. Hepatitis B surface antigen (HBsAg) positive, or Hepatitis C antibody (anti-HCV) positive (except if HCV-RNA negative).
- •10. Known medical condition that, in the investigator’s opinion, would increase the risk associated with study participation or study drug administration or interfere with the interpretation of safety results.
- •11. Subjects in whom the ability to observe possible local reactions at the eligible injection sites is, in the
- •opinion of the investigator, unacceptably obscured due to a physical condition or permanent body art.
- •12. Therapeutic or traumatic metal implant in the skin or muscle of eligible injection sites.
- •13. Prisoners or subjects who are involuntarily incarcerated.
- •14. Subjects who are compulsorily detained for treatment of either a psychiatric or physical illness
研究者
相似试验
尚未招募
不适用
Malaria vectored vaccines and EPI co-administration trial (VAC 058)MalariaPACTR201402000749217THE JENNER INSTITUTE, UNIVERSITY OF OXFORD65
进行中（未招募）
1 期
Investigating a vaccine against plaguePlagueInfections and InfestationsISRCTN41077863niversity of Oxford36
进行中（未招募）
1 期
A first-in-human study to assess the safety of an MVA-based vaccine for Crimean-Congo Haemorrhagic Fever (MVA-CCHF) and the vaccine's ability to generate an immune responseCrimean-Congo Haemorrhagic FeverInfections and InfestationsISRCTN14935155niversity Hospital Southampton NHS Foundation Trust18
未知
1 期
DNK-651-1JPRN-jRCT2080223171DENKA SEIKEN CO.,LTD.
进行中（未招募）
1 期
A clinical trial to assess the safety, immune response, and protection against infection of novel malaria vaccines.Plasmodium falciparum infectionEUCTR2017-001049-28-GBniversity of Oxford, CTRG18