A Phase I/II Clinical Trial of PepCan in Head and Neck Cancer Patients in Remission to Reduce Recurrence Regardless of HPV Status
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 17
- 试验地点
- 1
- 主要终点
- Adverse Events - Evaluate Safety of a 7-injection Regimen of PepCan.
研究概览
简要总结
This study has been designed to evaluate the safety and efficacy of giving seven injections of PepCan or placebo over approximately a 24-month period in subjects with head and neck cancers who achieved remission. PepCan may prove to be beneficial in treating many stages of HPV-related malignancies starting from infection to cancer. Safety, efficacy in terms of reduced cancer recurrence, immunological responses and profiles, and gut microbiome changes will be assessed.
详细描述
This is a Phase I/II study to evaluate the efficacy and safety of an HPV therapeutic vaccine called PepCan (HPV-16 E6 peptides) in adults over a two (2) year period. Each subject will be receiving a total of 7 injections of PepCan (50 µg per peptide 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 by enzyme-linked immunospot (ELISPOT) assay will be made at 4 time points (Visits 1, 5, 8, and 9), and by fluorescent activated cell sorter analysis will be made at times points at Visits 1, 3, 5, 6, 7, 8, and 9. Oral wash samples and stool 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
- Double (Participant, Investigator)
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) therapy within the previous 120 days
- •Performance status of Eastern Cooperative Oncology Group (ECOG) 0-2
- •No Evidence of Disease (NED) based on clinical and/or radiographic evaluations
- •Vital Signs recorded
- •Blood pressure (≤160/95 mm Hg acceptable)
- •Heart rate (50-100 beats per min acceptable)
- •Respiratory rate (≥ 12 ≤25 breaths per min acceptable)
- •Temperature (≤100°F acceptable)
- •Blood work done at Screening Visit
- •White count (≥3x109/L acceptable)
- •Hemoglobin (≥ 7 g/dL acceptable)
- •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 within 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® or yeast
- •History of severe asthma requiring emergency room visit or hospitalization within the past 5 years
- •Patients who have previously received PepCan
- •History of recurrence of squamous cell carcinoma of the head and neck
- •If in the opinion of the Principal Investigator 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
PepCan
Four injections (one every 3 weeks) of PepCan, then three injections (one every 3 months) of PepCan for a total of 7 injections.
干预措施: PepCan (Biological)
Placebo
Four injections (one every 3 weeks) of placebo, then three injections (one every 3 months) of placebo for a total of 7 injections.
干预措施: Placebo (Biological)
结局指标
主要结局
Adverse Events - Evaluate Safety of a 7-injection Regimen of PepCan.
时间窗: 2 years
To evaluate the safety of a 7-injection regimen of PepCan, adverse events will be captured and assessed per NCI CTCAE Version 5.0 whether they are treatment-related or not by a physician.
次要结局
- Cancer Recurrence Rate - Efficacy of a 7-injection Regimen of PepCan(Study completion, approximately 24 months after enrollment)
- Efficacy Analysis (Intention to Treat) - PepCan(Study completion, approximately 24 months after enrollment)
- Efficacy Analysis (Intention to Treat) - Placebo(Study completion, approximately 24 months after enrollment)
- Efficacy Analysis (Per Protocol) - PepCan(Study completion, approximately 24 months after enrollment)
- Efficacy Analysis (Per Protocol) - Placebo(Study completion, approximately 24 months after enrollment)