Timing of Immunotherapy in Melanoma (TIME-NL): Dancing to the Beat of the Circadian Rhythm
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 170
- 试验地点
- 5
- 主要终点
- Best overall response rate
研究概览
简要总结
The TIME-NL trial is a multicenter, randomized, open-label clinical trial in the Netherlands to assess the effect of the timing of the first administration of standard-of-care intravenous combination immunotherapy (early morning versus afternoon) in patients with metastatic melanoma. Patients will be randomized 1:1 to start standard-of-care ICI administration either before 10am (early morning arm; arm A) or after 1pm (afternoon arm; arm B). Patients will be stratified according to performance status and study center. The randomized clinical trial will be part of a hybrid design in which data from the randomized clinical trial will be combined with observational data.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 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
- •Histologically or cytologically confirmed cutaneous melanoma, classified as irresectable (stage III) or metastatic (stage IV) disease.
- •At least 18 years of age.
- •World Health Organization (WHO) Performance Status 0-
- •Measurable disease according to RECIST 1.
- •Starting treatment with standard-of-care combination immunotherapy (ipilimumab+nivolumab) as first line treatment.
- •Signed informed consent form
排除标准
- •Uveal or mucosal melanoma (unknown primary melanoma is allowed).
- •Use of systemic immunosuppressive medications. Inhaled or topical steroids are permitted.
- •Use of adrenal replacement medications, e.g. hydrocortisone.
- •Use of melatonin agonists.
- •Prior systemic therapy for irresectable/metastatic melanoma (prior T-VEC is allowed)
- •Prior systemic therapy for resectable melanoma in the last 6 months (neo-adjuvant and adjuvant treatment is allowed if at least 6 months ago).
- •Use of investigational drugs.
研究组 & 干预措施
A: early morning immunotherapy
Standard-of-care immune checkpoint inhibition with ipilimumab + nivolumab with the first administration starting before 10am
干预措施: Timing of first administration (early morning) (Other)
B: afternoon immunotherapy
Standard-of-care immune checkpoint inhibition with ipilimumab + nivolumab with the first administration starting after 1pm
干预措施: Timing of immunotherapy (afternoon) (Other)
结局指标
主要结局
Best overall response rate
时间窗: from enrollment to 1year
Best overall response rate (radiological complete or partial response according to RECIST 1.1)
次要结局
未报告次要终点