An Open-label Phase Ib/II, Multi-center Study of 4SC-202 in Combination With Pembrolizumab in Patients With Unresectable Stage III/Metastatic Stage IV Cutaneous Melanoma Primary Refractory/Non-responding to Prior Anti-PD-1 Therapy
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 4SC AG
- 入组人数
- 40
- 试验地点
- 7
- 主要终点
- Incidence of Adverse Events [Safety and Tolerability]
研究概览
简要总结
Phase Ib/II open-label, multi-center study with a priming cycle of 4SC-202 to evaluate the safety, tolerability and preliminary efficacy of combination treatment with 4SC-202 and Pembrolizumab. A dose expansion cohort at the Recommended Phase Two Dose (RPTD) will be added.
Adult patients with advanced (unresectable or metastatic) cutaneous melanoma primary refractory or non-responding to anti-PD-1 therapy as most current systemic anti-cancer therapy and for whom no standard therapy is available, will be enrolled. The last administration of anti-PD-1 therapy must have been performed within 6 months prior to screening.
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
- •Patients with unresectable stage III or stage IV cutaneous melanoma, as per American Joint Committee on Cancer (AJCC) (Version 8) staging system (must have been histologically confirmed at least once during course of disease). Patients with metastatic tumor of unknown primary site and histology of melanoma are eligible.
- •Patients must be primary refractory or non-responding to anti-PD-1 therapy (either as monotherapy or in combination with Ipilimumab)
- •Measurable disease by computer tomography (CT) or Magnetic resonance imaging (MRI) per immune-related response evaluation criteria in solid tumors (irRECIST) 1.1 criteria, with longest diameter for non-nodal lesions ≥ 10 mm and ≥ 15 mm in short axis for nodal lesions
- •At least one tumor site (either primary site or metastasis) must be accessible for sequential biopsies and patient must consent to the 2 mandatory biopsies. This requirement is not applicable for continuous dosing schedules and may be waived by the sponsor in other individual cases.
排除标准
- •Patients who achieved a CR or PR, during or after prior anti-PD-1 mono- or anti-CTLA-4/anti-PD-1 combination therapy
- •Patients with symptomatic brain metastases/central nervous system (CNS) involvement
- •Patients with inadequate organ function
- •Therapy with agents known to prolong the QT interval and increase the risk for Torsades de Pointes
研究组 & 干预措施
4SC-202 + Pembrolizumab
Single arm study of 4SC-202 in combination with Pembrolizumab
干预措施: 4SC-202 in combination with Pembrolizumab (Drug)
结局指标
主要结局
Incidence of Adverse Events [Safety and Tolerability]
时间窗: Up to 114 weeks
Safety and tolerability of the combination of 4SC-202 and Pembrolizumab will be assessed from adverse events.
次要结局
- Best Overall Response (BOR)(Up to 102 weeks)
- Time to Progression (TTP)(Up to 102 weeks)
- Objective Response Rate (ORR)(Up to 102 weeks)
- Disease Control Rate (DCR)(Up to 102 weeks)
- Progression Free Survival (PFS)(Up to 102 weeks)
- Overall Survival (OS)(Up to 102 weeks)
- Duration of Response (DOR)(Up to 102 weeks)