NL-OMON55748招募中不适用
Safe Stop Trial: observational study of the STOP & GO strategy of PD-1 blockade in advanced melanoma patients upon achieving a complete or partial response - Safe Stop Trial Melanoma
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 200
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •- advanced or metastatic melanoma
- •- current treatment with first-line nivolumab or pembrolizumab for advanced or
- •metastatic melanoma; previous systemic treatment, including immunotherapy, in
- •(neo)adjuvant setting for resectable melanoma is allowed
- •- documented diagnostic CT at start of PD-1 blockade with nivolumab or
- •pembrolizumab
- •For patients with CR on a diagnostic CT at response evaluation, a low dose-CT
- •(which is usually part of 18FDG-PET/CT) is allowed at baseline
- •For patients with PR on a diagnostic CT at response evaluation, a low dose-CT
- •(which is usually part of 18FDG-PET/CT) is allowed if sufficient target lesions
- •are measurable for response evaluation according to RECIST v1.1 criteria. In
- •this specific case the sponsor should be consulted.
- •- documented tumor response evaluation every 12 (±1) weeks according to RECIST
- •v1.1 (34) using a diagnostic CT as per standard practice
- •- presence of MRI brain for the screening of brain metastases (prior to
- •discontinuation of PD-1 blockade)
- •- willingness to discontinue nivolumab or pembrolizumab within 6 (+1) weeks
- •weeks after
- •confirmation of CR or PR before the full period of 2 years therapy
排除标准
- •Concomitant systemic therapies with other anti-cancer agents, e.g.
- •BRAF-inhibitor, anti-CTLA4 (e.g. ipilimumab), or other PD-1 blockade than
- •nivolumab or pembrolizumab
研究者
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