A Phase 2 Study of Nivolumab Plus Ipilimumab in Previously Treated Classical Kaposi Sarcoma (CKS)
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- ORR
研究概览
简要总结
A Phase 2 study of nivolumab plus ipilimumab in previously treated classical Kaposi Sarcoma (CKS)
详细描述
A prospective, single arm, interventional study. All patients will receive IV nivolumab 3mg/kg every two weeks and ipilimumab 1mg/kg every 6 weeks. Patients will be treated until disease progression or intolerable toxicity for a maximal period of two years, with an option to re-initiate therapy upon progression in patients with prior documented response to investigational therapy (unless treatment was held for progression of disease).
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
- •Pathologically confirmed KS
- •Age > 18
- •ECOG PS < 2
- •At least one prior treatment modality (palliative radiation or chemotherapy)
- •Measurable disease as defined by RECIST version 1.1 by physical exam and/or PET-CT (previously irradiated lesions should not be counted as target lesions).
排除标准
- •Patients with HIV-related KS or HIV positive serology.
- •Ongoing immunosuppressive therapy
- •Active autoimmune disease. Subjects with type I diabetes mellitus, hypothyroidism only requiring hormone replacement, skin disorders (such as vitiligo, psoriasis, or alopecia) not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enroll.
研究组 & 干预措施
nivolumab plus ipilimumab
nivolumab 240mg every 2 weeks plus ipilimumab 1 mg/kg every 6 weeks
干预措施: Ipilimumab (Drug)
nivolumab plus ipilimumab
nivolumab 240mg every 2 weeks plus ipilimumab 1 mg/kg every 6 weeks
干预措施: Nivolumab (Drug)
结局指标
主要结局
ORR
时间窗: 6-months
overall response rate (ORR)
次要结局
- Tolerability - treatment related adverse events (AEs) that caused study drug interruption and discontinuation(during the study, through study completion, an average of 1 year)
- PFS rate(6-months)
- Safety - Incidence of Treatment-Emergent Adverse Events according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events, Version 4.0 (CTCAE v4)(during the study, through study completion, an average of 1 year)
研究者
Alona Zer
Senior Physician
Rabin Medical Center