Long-term Safety Outcomes in Patients Treated With Replimune Oncolytic Immunotherapy Products
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Evaluate the long-term safety of patients treated with an RPx product
研究概览
简要总结
This is a noninterventional, observational, long-term follow-up (LTFU) study. Patients in this study will be followed for 5 years from enrollment on this study to assess potential delayed risks of RPx products. Eligible participants for this LTFU study include patients who received at least 1 dose of an RPx product under the interventional parent study. Patients will be rolled over into this LTFU study after completion of the Replimune-sponsored parent study (ie, either completion of the LTFU in the parent study or withdrawal from the parent study). All patients in ongoing RPx studies will be asked to participate in this LTFU study so that the Sponsor can evaluate potential delayed risks.
详细描述
Long-term outcomes include detection of delayed adverse event(s) for any new malignancy(ies), new incidence or exacerbation of a pre-existing neurologic disorder, rheumatologic or other autoimmune disorder, hematologic disorder, new incidence of infection related to RPx product and new incidence of herpetic-like infection. Patients with a suspected herpetic infection will be asked to provide a sample of the area of the suspected infection (using a swab), and also may be asked to provide additional biological samples (eg, a blood or urine sample to determine presence of RPx.) No study interventions will be administered in this observational study. Patients will be contacted by telephone every 3 months (Q3M) for 5 years from enrollment on this study. Participant visits may occur in person, over the phone, by video conference, or other technology.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Patients are eligible for inclusion in the study only if they meet all of the following criteria:
- •Patient has received at least 1 dose of an RPx product and has completed or discontinued participation in the parent study.
- •Patient or patient's legal guardian has provided signed informed consent (or assent) as , which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.
排除标准
- •Patients are excluded from the study if the following criterion applies:
- •1. Cannot comply with the requirements of the study.
研究组 & 干预措施
Patients who received at least 1 dose of an RPx [RP1, RP2, RP3]
This is an observational study and there will be no clinical interventions.
干预措施: Observational study with no interventions (Other)
结局指标
主要结局
Evaluate the long-term safety of patients treated with an RPx product
时间窗: Every 3 months (Q3M) (± 30 days) for 5 years from enrollment on this study to assess potential delayed risks
Identify any delayed adverse event(s) related to treatment with an RPx product
时间窗: Every 3 months (Q3M) (± 30 days) for 5 years from enrollment on this study to assess potential delayed risks
Identify systemic HSV-1 infection related to treatment with an RPx product
时间窗: Every 3 months (Q3M) (± 30 days) for 5 years from enrollment on this study to assess potential delayed risks
次要结局
未报告次要终点