NCT06585410招募中3 期
A Phase 3 Randomized Study of Intralesional Cemiplimab Versus Primary Surgery in Participants With Early Stage Cutaneous Squamous Cell Carcinoma (CSCC)
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 369
- 试验地点
- 84
- 主要终点
- Event-Free Survival (EFS) as assessed by the investigator
研究概览
简要总结
This study will test a study drug called cemiplimab to see if it can help treat early-stage Cutaneous Squamous Cell Carcinoma (CSCC), a type of skin cancer. Cemiplimab works by helping the immune system to kill cancer cells. It binds to a protein called Programmed cell Death-1 (PD-1) on the surface of certain immune cells.
The main purpose of this study is to compare how well cemiplimab works compared to surgery, when injected into the lesion.
The study is looking at:
- The side effects cemiplimab might cause
- How well cemiplimab works compared to surgery
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •Participants who have a histologically confirmed invasive CSCC TL, as described in the protocol
- •Participants who have CSCC TL ≥1 cm and ≤2.0 cm (longest diameter) prior to biopsy and >0.7 cm to ≤2.0 cm after biopsy, located in either the Head or Neck (HN), hand, or pre-tibial surface, as described in the protocol
- •Participants who are judged to be eligible for surgical resection of their CSCC TL and the method of planned surgical resection would be Micrographically oriented histographic surgery (Mohs) or other surgical method of Complete Margin Assessment (CMA). Participants for whom the planned surgery is surgical excision without margin control are not eligible
- •Eastern Cooperative Oncology Group (ECOG) performance status (PS) ≤1
- •Adequate hepatic, renal and bone marrow functions, as described in the protocol
排除标准
- •Participant in which the TL is a keratoacanthoma (KA), adenosquamous carcinoma, desmoplastic carcinoma, sarcomatoid carcinoma, basal cell carcinoma, basosquamous carcinoma, Bowen's disease, or CSCC in situ without an invasive component. (Note: For participants with invasive CSCC with a minor basaloid component, the patient may be eligible after discussion with the sponsor medical director.)
- •Ongoing or recent (within 5 years) evidence of significant autoimmune disease that required treatment with systemic immunosuppressive treatments, which may suggest risk for immune-mediated Adverse Events (imAEs), as described in the protocol
- •History of non-infectious pneumonitis within the last 5 years
- •TL (lesion planned for intralesional therapy) or other non-target CSCC lesion in dry red lip (vermillion), oral cavity, or nasal mucosa
- •NOTE: Other protocol defined inclusion / exclusion criteria apply.
研究组 & 干预措施
Control Arm
Other
干预措施: Standard of care (Procedure)
Experimental Arm
Experimental
干预措施: Cemiplimab (Drug)
结局指标
主要结局
Event-Free Survival (EFS) as assessed by the investigator
时间窗: Up to 1 year
EFS as assessed by the investigator
时间窗: Up to 3 years
次要结局
- Severity of TEAEs(Up to 3 years)
- Composite Complete Response (CCR) for Target Lesion (TL)(At week 13)
- Non-Target Lesions (NTLs) in the Region of the Target Lesion (ROTL)(Baseline and at week 13)
- Size of surgical defect(At week 13)
- Incidence of Treatment Emergent Adverse Events (TEAEs)(Up to 3 years)
- Size of biopsy defect(At week 13)
研究者
研究点 (84)
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