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A Study Comparing Cemiplimab-based Treatments for Adult Participants With Locally Advanced Basal Cell Skin Cancer (laBCC)

2026年9月1日 更新者：Regeneron Pharmaceuticals

Phase 2 Platform Trial of Combination Therapies for Participants With Locally Advanced Basal Cell Carcinoma: Master Protocol With Cemiplimab Monotherapy as Comparator Arm

This study will test an experimental Regeneron drug called cemiplimab ("study drug") given alone or in combination with other anti-cancer drugs ("combination treatment") to see if they can help treat laBCC.

The study is looking at:

  • What side effects cemiplimab, alone or in a combination treatment, might cause
  • How well cemiplimab, alone or in a combination treatment, works
  • How cemiplimab, alone or in a combination treatment could affect the immune system, which can help researchers understand why cemiplimab, alone or in a combination treatment, works better in some participants than others

研究概览

地位

尚未招聘

条件

干预/治疗

研究类型

介入性

注册 (估计的)

135

阶段

  • 阶段2

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

不

描述

Key Inclusion Criteria:

  1. Histologic confirmation of BCC by local board-certified pathologist, as described in the protocol
  2. At least one lesion that is measurable by study criteria, defined as ≥ 1cm in at least one dimension, as assessed by radiology and/or digital medical photography, as described in the protocol
  3. The treating physician must document that the participant is not appropriate for curative-intent surgery or curative-intent radiation
  4. The treating physician must document that the participant does not wish to receive a hedgehog pathway inhibitor (HHI) or is not a candidate for an HHI
  5. Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1

Subsequent Therapy Arm - specific inclusion criteria:

  1. Documentation of histopathologic diagnosis of basal cell carcinoma - NOT necessary
  2. Submission of tumor or blood for exploratory correlative research - NOT necessary

Key Exclusion Criteria:

  1. Metastatic disease to lymph node(s) or distant site(s) (Note: involvement of lymph node due to direct invasion from overlying cutaneous BCC is still considered laBCC, and is not excluded)
  2. History or current evidence of significant cardiovascular disease, as described in the protocol
  3. Exposure to any prior systemic therapy (eg, HHI or an immune checkpoint inhibitor) or locally injectable agent for laBCC, as described in the protocol
  4. Current participation OR past participation in another investigational trial in which an investigational intervention (eg, drug, vaccine, invasive device) was administered within 4 weeks before planned first dose of study intervention in this clinical trial.

Subsequent Therapy Arm - specific exclusion criteria:

1. Receipt of any anti-cancer therapy (including HHIs, radiation, surgery, or other systemic therapy) for BCC, AFTER treatment on Arms A, B, or C.

NOTE: Other protocol defined inclusion/exclusion criteria apply

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：无（打开标签）

武器和干预

参与者组/臂
干预/治疗
实验性的：手臂A
药品：西米普利单抗
根据协议进行管理
其他名称：
  • REGN2810
  • Libtayo®
实验性的：B臂
药品：西米普利单抗
根据协议进行管理
其他名称：
  • REGN2810
  • Libtayo®
药品：Vidutolimod
Administered per the protocol
其他名称：
  • CMP001
实验性的：C臂
药品：西米普利单抗
根据协议进行管理
其他名称：
  • REGN2810
  • Libtayo®
药品：菲安利单抗
根据协议进行管理
其他名称：
  • REGN3767
实验性的：Subsequent Therapy Arm
药品：西米普利单抗
根据协议进行管理
其他名称：
  • REGN2810
  • Libtayo®
药品：菲安利单抗
根据协议进行管理
其他名称：
  • REGN3767
药品：Vidutolimod
Administered per the protocol
其他名称：
  • CMP001

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Objective Response Rate (ORR) by blinded independent central review (BICR) per Composite Response Criteria
大体时间：Up to approximately 3 years
Composite Response Criteria integrates radiology findings [Response Evaluation Criteria in Solid Tumors (RECIST) 1.1] and external lesion assessments from digital photography [modified World Health Organization (WHO) criteria].
Up to approximately 3 years

次要结果测量

结果测量
大体时间
Duration of Response (DOR) by BICR per Composite Response Criteria
大体时间：Up to approximately 3 years
Up to approximately 3 years
Time to Response (TTR) by BICR per Composite Response Criteria
大体时间：Up to approximately 3 years
Up to approximately 3 years
Best Overall Response (BOR) of Complete Response (CR) by BICR per composite Response Criteria
大体时间：Up to approximately 3 years
Up to approximately 3 years
Progression-Free Survival (PFS) by BICR per Composite Response Criteria
大体时间：Up to approximately 3 years
Up to approximately 3 years
Objective Response by investigator review per Composite Response Criteria
大体时间：Up to approximately 3 years
Up to approximately 3 years
DOR by investigator review per Composite Response Criteria
大体时间：Up to approximately 3 years
Up to approximately 3 years
TTR by investigator review per Composite Response Criteria
大体时间：Up to approximately 3 years
Up to approximately 3 years
Complete Response (CR) by investigator review per Composite Response Criteria
大体时间：Up to approximately 3 years
Up to approximately 3 years
PFS by investigator review per Composite Response Criteria
大体时间：Up to approximately 3 years
Up to approximately 3 years
Occurrence of Treatment-Emergent Adverse Events (TEAEs)
大体时间：Up to approximately 3 years
Up to approximately 3 years
Severity of TEAEs
大体时间：Up to approximately 3 years
Up to approximately 3 years

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Regeneron Pharmaceuticals

调查人员

  • 研究主任：Clinical Trial Management、Regeneron Pharmaceuticals

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (估计的)

2026年10月15日

初级完成 (估计的)

2030年11月13日

研究完成 (估计的)

2030年11月13日

研究注册日期

首次提交

2026年9月1日

首先提交符合 QC 标准的

2026年9月1日

首次发布 (实际的)

2026年9月9日

研究记录更新

最后更新发布 (实际的)

2026年9月9日

上次提交的符合 QC 标准的更新

2026年9月1日

最后验证

2026年7月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • CMP001-ONC-2607

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

是的

IPD 计划说明

All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing

IPD 共享时间框架

When Regeneron has:

  • received marketing authorization from major health authorities (e.g., FDA, European Medicines Agency (EMA), Pharmaceuticals and Medical Devices Agency (PMDA), etc.) for the product and indication or has globally discontinued development of the product for all indications on or after April 2020 and has no plans for future development
  • made the study results publicly available (e.g., scientific publication, scientific conference, clinical trial registry)
  • the legal authority to share the data, and
  • ensured the ability to protect participant privacy.

IPD 共享访问标准

Qualified researchers can submit a proposal for access to individual patient or aggregate level data from a Regeneron-sponsored clinical trial through Vivli. Regeneron's Independent Research Request Evaluation Criteria can be found at: https://www.regeneron.com/sites/default/files/Regeneron-External-Data-Sharing-Policy-and-Independent-Research-Request-Evaluation-Criteria.pdf

IPD 共享支持信息类型

  • 研究方案
  • 树液
  • 国际碳纤维联合会
  • 分析代码
  • 企业社会责任

药物和器械信息、研究文件

研究美国 FDA 监管的药品

是的

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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