NCT05307289招募中不适用
Study of Alterations in Tumor Metabolism Associated With the Development of Immunotherapy Resistance in Melanoma
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Change from baseline pyrimidine metabolism at 4 years
研究概览
简要总结
Among the mechanisms responsible for resistance to immunotherapy, metabolism seems to play a major role. A better understanding of tumor metabolism appears to be absolutely necessary in order to propose efficient therapeutic alternatives to target tumor cells without exerting a deleterious effect on the cells responsible for the anti-tumor immune response. The main objective is to evaluate metabolism modulations in melanoma cells extracted from metastases of patients sensitive and resistant to immunotherapies (anti-PD1 or anti-PD1+anti-CTLA4).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
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
- •Female or male, 18 years of age or older
- •Stage III unresectable or histologically confirmed stage IV cutaneous melanoma (melanoma of unknown origin is accepted), treatment naïve (metastatic stage) and for which immunotherapy will be started
- •Performance Status ≤1
- •BRAF status available; BRAF status determination is required but patient will be eligible regardless of BRAF status
- •For women of childbearing potential, effective contraception must be initiated during the study.
- •Patient affiliated to social security plan
- •Patient having signed informed consent
排除标准
- •Breastfeeding or pregnant patients: for women of childbearing age, a urine pregnancy test will be performed
- •Patients with ocular or mucosal melanoma of metastatic ocular melanoma
- •Patients with metastatic melanoma not treated with immunotherapy (i.e. treated with a combination of targeted therapies).
- •Contraindication to the initiation of immunotherapy: HIV and/or HCV and/or HBV positive, active autoimmune disease (chronic inflammatory bowel disease such as ulcerative colitis, Crohn's disease, vasculitis, etc.), patients with autoimmune motor neuropathy (such as Guillain Barré syndrome).
- •Vulnerable patients: minors, adults under guardianship or curatorship, deprived of liberty
- •Vulnerable persons (minors, patients under guardianship or curatorship, deprived of liberty, under court protection, etc.).
- •A psychiatric or addiction history that will compromise the patient's ability to consent and follow the proper protocol procedures
- •Any other clinical finding that, in the opinion of the principal investigator, could interfere with the results of the study or pose a risk to the patient during the study.
结局指标
主要结局
Change from baseline pyrimidine metabolism at 4 years
时间窗: At inclusion visit and 4 years
Investigation of modulations of pyrimidine metabolism using isotopically labelled glutamine
次要结局
- Overall Survival(At inclusion visit and 4 years)
研究者
研究点 (2)
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