A Phase II Clinical Trial of Candida Therapeutic Vaccine in Head and Neck Cancer Patients to Reduce Recurrence
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 9
- 主要终点
- Assessment of clinical efficacy
研究概览
简要总结
This is a Phase II randomized, double-blind, placebo controlled, multi-site study of Candin. It is designed to show the efficacy and safety of a 7-dose regimen of Candin over a two-year period in terms of reducing cancer recurrence rate by comparing the recurrence rates between the Candin and the placebo arm. The ratio of the number of subjects who will receive Candin versus placebo will be 3:1. Up to 100 subjects will be screened until 80 subjects are eligible for injection.
详细描述
This is a Phase II study to evaluate the efficacy and safety of a therapeutic vaccine called Candin® (Nielsen Biosciences, San Diego, CA) in adults over a two (2) year period. Each subject will be receiving a total of 7 injections of Candin (0.5 mL per dose) or placebo (saline) at a 3:1 ratio in a randomized double-blinded design. Subjects will receive one injection every 3 weeks until they receive 4 injections. Then, subjects will receive one injection every 3 months until they receive a total of 7 injections. Subjects will have 2 more visits approximately 6 months apart after the last injection. Immunological assessment T-cell repertoire analysis and by fluorescent activated cell sorter analysis (FACS) will be made at 4 time points (Visits 1, 5, 7, and 8). Stool and oral wash samples will be collected at the Screening Visit, Visit 5, Visit 7 and Visit 8 for microbiome diversity analysis.
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
- Triple (Participant, Care Provider, Investigator)
盲法说明
Each study site will received a separate randomization scheme, and the research pharmacy at each site will implement and maintain randomization schedule.
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Able to provide informed consent
- •Male or female 18 years of age or older
- •Squamous cell carcinoma of the head and neck who have completed curative therapy (surgery and/or radiation and/or chemotherapy and/or immunotherapy) within the 120 days prior to the screening visit
- •No Evidence of Disease (NED) based on clinical and radiographic evaluations
- •Willing and able to comply with the requirements of the protocol
排除标准
- •Positive urine pregnancy test for women of childbearing potential
- •Being pregnant or attempting to be pregnant with the period of study participation
- •Women who are breast feeding or plan to breast feed within the period of study participation
- •Patients who are allergic to Candin®
- •If in the opinion of the PIs or other Investigators, it is not in the best interest of the patient to enter or continue in this study
研究组 & 干预措施
Candin vaccine
Seven Candida (Candin). The route of administration is intradermal injection at subject's limbs at 0.5 mL/injection. The schedule is 1 injection every three weeks for the first 4 injections, and then one injection every 3 months until a total of 7 injections has been given.
干预措施: 0.5 mL Candin®/injection (Biological)
Placebo
Seven placebo injections (sterile 0.9% Normal Saline). The route of administration is intradermal injection at subject's limbs at 0.5 mL/injection. The schedule is 1 injection every three weeks for the first 4 injections, and then one injection every 3 months until a total of 7 injections has been given.
干预措施: Placebo: 0.5 mL Intravenous 0.9% NaCl solution (Saline) (Other)
结局指标
主要结局
Assessment of clinical efficacy
时间窗: Through study completion, up to 2 years
Studying the efficacy of Candida and the schedule in which this protocol specifically outlines the clinical response (i.e., reduced cancer recurrence rate) of subjects is the primary endpoint.
次要结局
- Assessment of adverse events(Regularly throughout the study, up to 2 years)