Cemiplimab Survivorship Epidemiology (CASE) Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 287
- 试验地点
- 47
- 主要终点
- Objective response rate (ORR)
研究概览
简要总结
The objectives of the study are:
- To describe the effectiveness of cemiplimab 350 mg administered every 3 weeks (Q3W) for treatment of patients with advanced (defined as locally advanced or metastatic [nodal or distant]) cutaneous squamous cell carcinoma (CSCC) and patients with advanced (defined as locally advanced or metastatic [nodal or distant]) basal cell carcinoma (BCC) in real-world clinical settings
- To evaluate the safety of cemiplimab based on incidence of treatment related immune-related adverse events (irAEs), infusion related reactions (IRRs), and treatment related serious adverse reactions (TSARs) in patients with advanced CSCC and patients with advanced BCC receiving cemiplimab treatment in real world clinical settings
- To describe patient experience, including patient reported quality of life (QOL) and functional status, and clinician reported performance status in a real-world setting for patients with advanced CSCC and patients with advanced BCC
- To describe baseline characteristics that could potentially be associated with health-related outcomes for patients with advanced CSCC and patients with advanced BCC undergoing treatment with cemiplimab
- To describe patients who receive cemiplimab as treatment for CSCC or BCC in a real-world setting
- To describe real-world use patterns of cemiplimab for CSCC and BCC
- To investigate the long-term effects and effectiveness of cemiplimab in patients with advanced CSCC or advanced BCC
- To describe the effectiveness of cemiplimab in immunosuppressed and immunocompetent patients with advanced CSCC or advanced BCC, regardless of etiology, per available data
- To describe the effectiveness of cemiplimab after prior exposure to radiation therapy for CSCC per available data
- To describe the effectiveness of cemiplimab as a first-line (1L) or later systemic treatment in patients with advanced CSCC, regardless of etiology, per available data
- To describe the effectiveness of cemiplimab in patients with advanced BCC based on treatment patterns (reason for discontinuation, treatment exposure, etc) of prior Hedgehog inhibitor (HHI) usage
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Eligible for treatment with and prescribed cemiplimab for advanced CSCC or advanced BCC in accordance with approved prescribing information as described in the protocol
排除标准
- •Receiving cemiplimab for an indication other than advanced CSCC or advanced BCC
- •Any condition that, in the opinion of the investigator, may interfere with patient's ability to participate in the study
- •Patients concurrently participating in any study including administration of any investigational drug (including cemiplimab) or procedure (including survival follow up)
- •Note: Other protocol defined Inclusion/Exclusion Criteria apply
研究组 & 干预措施
Group 1
This group will enroll patients with advanced (defined as locally advanced or metastatic [nodal or distant]) CSCC.
干预措施: cemiplimab (Drug)
Group 2
This group will enroll patients with advanced (defined as locally advanced or metastatic [nodal or distant]) BCC.
干预措施: cemiplimab (Drug)
结局指标
主要结局
Objective response rate (ORR)
时间窗: Up to 36 months
The rate of complete responses (CR) or partial responses (PR), as assessed by investigators
Disease control rate (DCR)
时间窗: Up to 36 months
Percentage of patients who have achieved CR, PR or stable disease (SD) to cemiplimab as assessed by investigators
Duration of response (DOR)
时间窗: Up to 36 months
Time from the time of initial response until documented tumor progress, death, or initiation of non-cemiplimab CSCC or BCC treatment
Time to response
时间窗: Up to 36 months
Time from date of first admission of cemiplimab to the initial response
Disease specific death (DSD)
时间窗: Up to 36 months
Rate of death cause by or related to underlying CSCC or BCC as assessed by investigators
Infusion related reactions (IRRs)
时间窗: Up to 36 months
NCI-CTCAE v5
Treatment related serious adverse reactions (SARs)
时间窗: Up to 36 months
Progression free survival (PFS)
时间窗: Up to 36 months
Time from the date of first administration of cemiplimab to progression or death from any cause, whichever occurs first
Overall Survival (OS)
时间窗: Up to 36 months
Time from the date of first administration of cemiplimab to the date of death due to any cause
Number of patients with metastatic vs locally advanced cancer summarized every three weeks
时间窗: Up to 36 months
Pattern of recurrence
Time to treatment failure (TTTF)
时间窗: Up to 36 months
Time from date of first administration of cemiplimab to treatment discontinuation for disease progression, treatment toxicity, or death
Immune related adverse events (irAEs)
时间窗: Up to 36 months
Per the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5
次要结局
未报告次要终点