Extended Follow-up of Patients With Melanoma Treated With Fianlimab Plus Cemiplimab in Expansion Cohorts From Study R3767-ONC-1613
试验速览
- 阶段
- 2 期
- 状态
- Enrolling By Invitation
- 入组人数
- 48
- 试验地点
- 15
- 主要终点
- Death from any cause starting at time of initial treatment with fianlimab and cemiplimab in study R3767-ONC-1613
研究概览
简要总结
This study is researching the long-term effects of a combination of experimental drugs called fianlimab and cemiplimab. The study is being conducted in patients with advanced skin cancer (melanoma) who had previously been treated with fianlimab and cemiplimab in the study called R3767-ONC-1613 (NCT03005782).
The aim of the current study is to see how safe and effective the study drugs are in a long-term follow-up. No study drug will be given during this study. Cancer status will be monitored, in addition to routine care. The study is also collecting information about general health status, and other treatments that may have been received since participation in study R3767-ONC-1613 (NCT03005782).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 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
- •1. Participants with melanoma who enrolled in cohorts 6, 15, or 16 of study R3767-ONC- 1613 (NCT03005782)
排除标准
- •Note: Other protocol-defined Inclusion/ Exclusion criteria may apply
研究组 & 干预措施
No Progressive Disease at Enrollment
干预措施: Fianlimab+cemiplimab (Drug)
With Disease Progression at Enrollment
干预措施: Fianlimab+cemiplimab (Drug)
结局指标
主要结局
Death from any cause starting at time of initial treatment with fianlimab and cemiplimab in study R3767-ONC-1613
时间窗: Up to 4 years
次要结局
- Progressive-Free Survival (PFS)(Up to 4 years)
- Objective Response Rate (ORR)(Up to 4 years)
- Duration of Response (DOR)(Up to 4 years)
- Disease Control Rate (DCR)(Up to 4 years)
- Incidence of Serious Adverse Events (SAEs)(Up to 4 years)
- Severity of SAEs(Up to 4 years)
- Incidence of treatment-related AEs(Up to 4 years)
- Severity of treatment-related AEs(Up to 4 years)
- Incidence of anti-cancer therapies received since end of treatment with fianlimab and cemiplimab in study R3767-ONC-1613(Up to 4 years)