A Phase 1 Study of Pre-Operative Cemiplimab (REGN2810), Administered Intralesionally, for Patients With Cutaneous Squamous Cell Carcinoma (CSCC) or Basal Cell Carcinoma (BCC)
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 97
- 试验地点
- 18
- 主要终点
- Incidence and severity of TEAEs graded according to the NCI CTCAE v5
研究概览
简要总结
This study is researching an experimental drug called cemiplimab. The study is focused on Cutaneous Squamous Cell Carcinoma (CSCC) and Basal Cell Carcinoma (BCC).
The aim of the study is to evaluate the safety and tolerability (how your body reacts to the drug) of cemiplimab (also known as REGN2810).
The first part of the study tested several different doses of cemiplimab given weekly for 12 weeks.
The study is also looking at several other research questions, including:
- What side effects may happen from taking the study drug
- To see effect of cemiplimab on the tumor
- How much study drug is in the blood at different times
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
- •Dose Escalation: History of recurrent resectable CSCC or BCC (Cohort C and I only) that satisfies conditions as defined in the protocol
- •Patients must have measurable disease in the index lesion, defined as 1-2 cm in the longest diameter
- •Eastern Cooperative Oncology Group (ECOG) performance status ≤1
排除标准
- •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)
- •Prior treatment with an agent that blocks the programmed cell death 1 (PD-1)/ programmed cell death 1 ligand (PD-L1) pathway.
- •Prior treatment with other systemic immune modulating agent as defined in the protocol
- •M1 or N1, N2 (a, b, or c), or N3 CSCC or BCC. Patients with history of metastatic CSCC (distant or nodal), or metastatic BCC (distant or nodal) are excluded unless the disease-free interval is at least 3 years
- •Concurrent malignancies, other than those with negligible risk of metastasis or death. Patients with hematologic malignancies, including chronic lymphocytic leukemia (CLL), are excluded.
- •Patients with a history of solid organ transplant
- •Has received a Coronavirus induced disease of 2019 (COVID-19) vaccination (initial series and booster) within 1 week of planned start of study medication
- •Note: Other protocol defined Inclusion/Exclusion criteria apply.
研究组 & 干预措施
Cemiplimab
Three dose cohorts are planned and will follow a 3 + 3 dose-escalation design with cohort expansion. After completion of the above, three additional cohorts (A, B and C) of patients will be evaluated. Cohorts D, H and I may open after completion of Cohort B.
Note: Cohort E through G will not be opened for participation.
干预措施: Cemiplimab (Drug)
结局指标
主要结局
Incidence and severity of TEAEs graded according to the NCI CTCAE v5
时间窗: From the first dose up to 90 days after the last dose
Incidence, nature, and severity of dose limiting toxicities (DLTs) (if any) graded according to the National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI CTCAE) v5
时间窗: From the first dose through day 28
Dose levels 1-3
Incidence, nature, and severity of treatment-emergent adverse events (TEAEs) graded according to the National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI CTCAE) v5
时间窗: From the first dose to 90 days after the last dose
Dose levels 1-3
The incidence and severity of injection site reactions (ISRs)
时间窗: From the first dose to 90 days after the last dose
次要结局
- Pathologic complete response rate (or end of treatment biopsies, for patients who decline surgery) in index lesion(At time of surgery)
- Major pathologic response rate (or end of treatment biopsies, for patients who decline surgery) in index lesion(At time of surgery)
- Cemiplimab concentration in serum over time(From the first dose up to 90 days after the last dose)
- Incidence of anti-drug antibody (ADA) titers for cemiplimab(Up to 90 days after last dose)
- Objective response rate (ORR) of index lesion(At baseline and at Week 13)
- Selection of the recommended dose of cemiplimab for further study based on clinical and pharmacokinetic (PK) observations(Up to 90 days after last dose)