Immunological variables associated to ICI toxicity in cancer patients
概览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- Institut Jules Bordet
- 入组人数
- 441
- 试验地点
- 1
- 主要终点
- Modification(s) in the immune blood markers including serum autoantibody level of treated subjects at three different time points during the treatment by ICI (early, mid time and late) and at the occurrence of irAEs as described below compared to baseline. Safety will be assessed: by the investigator(s) by using the adverse events reported during the study in accordance with the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0.
概览
简要总结
The main objective of this pilot study is to explore the value of immune markers present in blood in the purpose of identifying biomarkers for immune-related toxicities of checkpoint inhibitors.
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 是
入选标准
- •Age ≥ 18 years old
- •ECOG performance status ≤ 1
- •Must have histologically or cytologically confirmed solid tumour, eligible fortreatment with ICI as standard-of-care alone or in combination with another ICI (cohort 1), ICI with chemotherapy (cohort 2), or ICI with targeted therapy (cohort 3) with no restrictions on number of prior systemic therapies
- •All prior anti-cancer treatment-related toxicities (except alopecia) must be ≤ Grade 1 according to the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 at the time of enrolment
- •Serum pregnancy test (for subjects of childbearing potential) negative within 15 days prior to study medications administration
- •Women of childbearing potential must agree to use one highly effective method of contraception prior study entry, during the course of the study and at least 7 months after the last administration of study treatments
- •Men with childbearing potential partner must agree to use condom during the course of this study and for at least 6 months after the last administration of the study treatments
- •Completion of all necessary screening procedures within 14 days prior to enrolment
- •Signed Informed Consent form (ICF) obtained prior to any study related procedure
排除标准
- •Subject with a significant medical, neuro-psychiatric, or surgical condition, currently uncontrolled by treatment, which, in the principal investigator's opinion, may interfere with completion of the study
- •Participation in another clinical trial
- •Pregnant and/or lactating women
- •Patients already receiving ICI
结局指标
主要结局
Modification(s) in the immune blood markers including serum autoantibody level of treated subjects at three different time points during the treatment by ICI (early, mid time and late) and at the occurrence of irAEs as described below compared to baseline. Safety will be assessed: by the investigator(s) by using the adverse events reported during the study in accordance with the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0.
Modification(s) in the immune blood markers including serum autoantibody level of treated subjects at three different time points during the treatment by ICI (early, mid time and late) and at the occurrence of irAEs as described below compared to baseline. Safety will be assessed: by the investigator(s) by using the adverse events reported during the study in accordance with the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0.
次要结局
未报告次要终点
研究者
Clinical Trial Support Unit
Scientific
Institut Jules Bordet