Abscopal Effect of Radiotherapy and Nivolumab in Relapsed Hodgkin Lymphoma After Anti-PD1 Therapy
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 26
- 试验地点
- 1
- 主要终点
- Abscopal response rate (ARR-6)
研究概览
简要总结
The aim of the trial is to improve efficacy of nivolumab in patients with relapsed or refractory HL who recently progressed on anti-PD1 therapy. Nivolumab is highly effective and well tolerated in rrHL, nevertheless CR-rates are low and a considerable proportion of patients suffers from progressive disease. Localized RT induces an immunogenic effect which might work synergistically and facilitate augmented systemic (i.e. abscopal) responses in combination with nivolumab.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Progression of refractory or relapsed cHL during treatment with an anti-PD1 agent
- •At least two distinct FDG-avid HL-lesions with at least 5 cm distance between them, and one of them considered eligible for irradiation with 20Gy based on localization and prior RT exposure
- •Age at registration ≥ 18 years
排除标准
- •Nodular-lymphocyte predominant HL (NLPHL) or composite/greyzone lymphoma
- •Lymphoma involving the central nervous system
- •Naïve to treatment with anti-PD1 targeting antibodies
结局指标
主要结局
Abscopal response rate (ARR-6)
时间窗: 12 weeks
Abscopal response rate (ARR-6) with abscopal response centrally confirmed as restaging result after RT to a single lesion and at least four but not more than six nivolumab infusions (RE-6 result)
次要结局
未报告次要终点
研究者
Dr. Paul Broeckelmann
Dr.
University of Cologne