Elderly Cancer PatIents Treated for Advanced or Metastatic Melanoma or NSCLC, Safety and qualiTy of Life Under immunOtheraPies: a Phase IV Trial
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 发起方
- 入组人数
- 40
- 试验地点
- 9
- 主要终点
- Number of participants adverse events as assessed by CTCAE v5.0
研究概览
简要总结
The co-primary objectives will be to assess the safety and quality of life under treatment.
详细描述
The co-primary objectives will be to assess the safety and quality of life under treatment. Secondary objectives will be evaluations of geriatric data modifications under treatment, efficacy (progression-free survival and overall survival), correlation between toxicity and efficacy, and comparison of the safety profiles between various immunotherapy regimens.
Another secondary objective will be the comparison between patients and clinicians symptom reporting. The investigators will also perform a pharmacokinetics analysis on PD1-monoclonal antibodies to improve the understanding of PD-1 inhibitors pharmacokinetics for the elderly population.
Finally, toxicity and efficacy will be compared to immunological parameters such as the description of tumor infiltrating lymphocytes, markers of immunosenescence and inflammation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 70 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients eligible to start a treatment including immune checkpoint inhibitors (Nivolumab, Ipilimumab, Pembrolizumab, and so on…)
- •Diagnosis of advanced or metastatic melanoma or NSCLC (All treatment lines will be allowed)
- •Age ≥ 70 years
- •Having personally signed and dated informed consent
- •Patient affiliated to the ''National security'' regimen or beneficiary of this regimen
排除标准
- •Immune checkpoint inhibitor therapy initiated before study enrolment
- •Concomitant participation in other investigational clinical trials involving an immune checkpoint inhibitor
- •Immune checkpoint inhibitor treatment in a context of other solid tumours
- •Immune checkpoint inhibitor treatment in a context of haematological malignancies
- •Being unable or unwilling to comply with the requirements of the protocol, as assessed by the investigator
- •Patient in urgency situation, adult under legal protection, or unable to give his consent
研究组 & 干预措施
treatment including immune checkpoint inhibitors
All patients included in this study will receive approved immune-checkpoint inhibitors therapies, such as CTLA-4, PD-1, and PD-L1 inhibitors.
干预措施: immune-checkpoint inhibitors therapies (Drug)
结局指标
主要结局
Number of participants adverse events as assessed by CTCAE v5.0
时间窗: From treatment initiation to 18 weeks after treatment initiation. (up to 24 months)
Description of adverse events' type, incidence, severity (CTCAE v.5.0), timing, seriousness, and relatedness. This endpoint will be based on the rate of grade ≥ 3 adverse events 18 weeks after treatment initiation, defined as medical assessment of safety including adverse events' type, incidence, severity (graded by the CTCAE\] v. 5.0), timing, seriousness, and relatedness. This will include clinical as well as biological toxicities such as liver and endocrine dysfunctions. All high grade adverse events will be taken into account.
European Organization for Research and Treatment of Cancer Quality of Life Core Questionnaire (QLQ-C30) and Elderly Cancer Patients module (QLQ - ELD14), combined to compute a total score (between 44 and 128 points)
时间窗: From inclusion until 24 weeks after treatment initiation (up to 24 months)
Quality of life will be evaluated using the EORTC QLQ-C30 and QLQ-ELD14 questionnaires collected at inclusion and at every treatment cycles during the first 6 weeks, then every 6 weeks until treatment discontinuation. The proportion of patients with a decrease superior or equal to 10% for their global score between baseline and at 24 weeks after treatment initiation will be estimated.
次要结局
- correlation between toxicity and efficacy(time from treatment beginning to radiological or clinical progression of the disease, or death of any cause. (up to 24 months))
- geriatric data modifications under treatment(From inclusion until treatment discontinuation (up to 24 months))
- rate of grade 3 to 5 adverse events 18 weeks after treatment initiation(From treatment initiation to 18 weeks after treatment initiation.(up to 24 months))
- Progression-free survival(time from treatment beginning to radiological or clinical progression of the disease, or death of any cause. (up to 24 months))
- compare patients and clinician symptoms reporting(From treatment initiation to 18 weeks after treatment initiation.(up to 24 months))
- Overall Survival(time from treatment beginning to death of any cause (up to 24 months))