NCT02665650已完成1 期
A Phase 1b Dose Escalation Study to Assess the Safety of AFM13 in Combination With Pembrolizumab in Patients With Relapsed or Refractory Classical Hodgkin Lymphoma (KEYNOTE- 206)
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Affimed GmbH
- 入组人数
- 30
- 试验地点
- 34
- 主要终点
- Number of participants experiencing dose limiting toxicity (DLT) during combination treatment
研究概览
简要总结
The purpose of this study is to establish a dosing regimen for the combination therapy of AFM13 and pembrolizumab (MK-3475) in patients with relapsed or refractory (R/R) Hodgkin Lymphoma (HL) and to assess the safety and tolerability of this combination therapy.
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
- •Diagnosis of CD30+ classical Hodgkin lymphoma reconfirmed by histopathology. Note: where reconfirmation is not possible, patients will still be eligible where they have confirmation clearly documented in their medical records.
- •Relapsed or refractory disease after standard therapy including brentuximab vedotin (Adcetris®).
- •Completion of, if applicable, radiotherapy, chemotherapy, antibodies and immunoconjugates including brentuximab vedotin and/or another investigational drug which could interact with this trial not less than 4 weeks (or 5 half-lives of the drug, whichever occurs later) prior to first dose of study drug. Cessation of small molecule tyrosine kinase inhibitors must be at least 7 days prior to first dose of study drug.
- •Completion of, if applicable, an autologous stem cell transplantation (ASCT) at least 3 months prior to first dose of study drug.
- •Eastern Cooperative Oncology Group (ECOG) performance score (PS) <
排除标准
- •Is currently participating and receiving study therapy or has participated in a study of an investigational agent and received study therapy or used an investigational device within 4 weeks of the first dose of treatment.
- •Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent or if the patient has previously participated in MK-3475 clinical trials.
- •Has received a live-virus vaccination within 30 days of planned treatment start. Note: Seasonal flu vaccines that do not contain live virus are permitted.
- •Prior allogeneic stem cell transplantation (SCT) within the last 5 years.
- •Major surgery within 4 weeks prior to first dose of study drug.
研究组 & 干预措施
AFM13 + Pembrolizumab
Experimental
Participants receive AFM13 in escalating doses intravenously (IV) for up to 25 weeks, pembrolizumab as a fixed dose intravenously (IV) for up to 52 weeks.
干预措施: AFM13 (Biological)
AFM13 + Pembrolizumab
Experimental
Participants receive AFM13 in escalating doses intravenously (IV) for up to 25 weeks, pembrolizumab as a fixed dose intravenously (IV) for up to 52 weeks.
干预措施: Pembrolizumab (Biological)
结局指标
主要结局
Number of participants experiencing dose limiting toxicity (DLT) during combination treatment
时间窗: Up to 9 months
次要结局
- Number and frequency of adverse events(Up to 30 months)
- Objective response rate (ORR)(Up to 30 months)
研究者
研究点 (34)
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