TNF in Melanoma Patients Treated With Immunotherapy (MELANFα)
This trial is a translational proof-of-concept, open-label, prospective cohort study of 60 patients aiming to identify the clinical markers and/or biomarkers associated with therapeutic response to immune checkpoints inhibitors, in patients with advanced melanoma.
The study will be conducted on a population of patients treated with ICI in the context of routine care, separated in two subgroups:
- Subgroup 1: patients treated with anti-PD-1 alone (nivolumab or pembrolizumab)
- Subgroup 2: patients treated with the combined treatment anti-PD-1+anti-CTLA-4 (nivolumab + ipilimumab)
For each included patient, blood samples will be collected during baseline visit and during treatment period (at Week 6 Day 1 and Week 12 Day 1).
If feasible, tumor biopsy (of primary tumor or metastasis) will be performed during baseline and on Week 12 Day 1 visit (predose). If tumor biopsy is not feasible, available archived tumor specimen (frozen or FFPE block) may be collected for the study.
All included patients will be followed-up for tumor status and/or survival status every 3 months until a maximum duration of 1 year from the first study dose.
研究概览
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
-
-
-
Lille、法国
- CHRU Claude Huriez
-
Montpellier、法国
- CHU Montpellier Saint-Eloi
-
Toulouse、法国、31059
- Institut Universitaire du Cancer de Toulouse - Oncopole
-
-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Age ≥18 years at the time of study entry.
- Patient with histologically-proven metastatic and/or unresectable melanoma (stage IIIc-IV, M1a-c as per AJCC 2009), including mucosal melanoma.
- Patient for which a treatment with immune checkpoint inhibitor (nivolumab alone, pembrolizumab alone or nivolumab + ipilimumab) has been decided.
- Subjects are included regardless of BRAFV600 mutation status. BRAFV600 mutation status must be documented.
- Patient must be naïve to immune checkpoint inhibitor treatment for locally advanced and/or metastatic disease (i.e., no prior treatment with ICI and current treatment with ICI not yet started).
- ECOG Performance status 0-2.
- Life expectancy of at least 3 months.
- Patient able to participate and willing to give informed consent prior to performance of any study-related procedures and to comply with the study protocol.
- Patient affiliated to a Social Health Insurance in France.
Exclusion Criteria:
- Patient pregnant, or breast-feeding.
- Uveal melanoma.
- Any condition contraindicated with sampling procedures required by the protocol.
- Any psychological, familial, geographic or social situation, according to the judgment of investigator, potentially preventing the provision of informed consent or compliance to study procedure.
- Any current severe or uncontrolled disease, including, but not limited to ongoing or active infection.
- Patient who has forfeited his/her freedom by administrative or legal award or who is under guardianship.
学习计划
研究是如何设计的?
设计细节
- 主要用途:其他
- 分配:非随机化
- 介入模型:并行分配
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
---|---|
其他:Subgroup 1
Patients treated with anti-PD-1 alone (nivolumab or pembrolizumab)
|
Tumor biopsy specimens (if feasible) and blood samples will be collected at Baseline, Week 6 Day 1 (blood sample only) and Week 12 Day 1.
|
其他:Subgroup 2
Patients treated with the combined treatment anti-PD-1+anti-CTLA-4 (nivolumab + ipilimumab)
|
Tumor biopsy specimens (if feasible) and blood samples will be collected at Baseline, Week 6 Day 1 (blood sample only) and Week 12 Day 1.
|
研究衡量的是什么?
主要结果指标
结果测量 |
大体时间 |
---|---|
主要终点是使用 RECIST V1.1 标准评估的预测 12 周进展的判别能力。
大体时间:每位患者 12 周
|
每位患者 12 周
|
次要结果测量
结果测量 |
大体时间 |
---|---|
将在第 12 周使用 RECIST V1.1 标准定义客观反应(即完全或部分反应)。
大体时间:每位患者 12 周
|
每位患者 12 周
|
反应持续时间定义为从客观反应到根据研究者判断出现进展或死亡的时间。
大体时间:每个病人 12 个月
|
每个病人 12 个月
|
无进展生存期定义为根据研究者判断从纳入到进展或死亡(以先发生者为准)的时间。
大体时间:每个病人 12 个月
|
每个病人 12 个月
|
Immune related adverse event will be evaluated using National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 4.03.
大体时间:12 weeks per patient
|
12 weeks per patient
|
合作者和调查者
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.