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皮肤癌患者放射治疗和 Cemiplimab 的研究

2026年11月9日 更新者：Memorial Sloan Kettering Cancer Center

放疗和 CeMiPlimAb 的 II 期、多中心、单臂临床试验：局部晚期、不可切除的皮肤鳞状细胞癌的 Rwlc 免疫疗法：RAMPART

The purpose of the study is to see if the combination of radiation therapy and cemiplimab immunotherapy is an effective treatment for people with locally advanced, unresectable CSCC.

研究概览

地位

主动，不招人

条件

干预/治疗

研究类型

介入性

注册 (实际的)

34

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。

学习地点

  • 美国
    • Colorado
      • Aurora、Colorado、美国、80045
        • University of Colorado (Data Collection Only)
    • Florida
      • Tampa、Florida、美国、33612
        • Moffitt Cancer Center (Data Collection Only)
    • New Jersey
      • Basking Ridge、New Jersey、美国、07920
        • Memorial Sloan Kettering Cancer Center at Basking Ridge (All Protocol Activities)
      • Middletown、New Jersey、美国、07748
        • Memorial Sloan Kettering Monmouth (All Protocol Activities)
      • Montvale、New Jersey、美国、07645
        • Memorial Sloan Kettering Bergen (All protocol activities)
    • New York
      • Commack、New York、美国、11725
        • Memorial Sloan Kettering Suffolk-Commack (All Protocol Activities)
      • Harrison、New York、美国、10604
        • Memorial Sloan Kettering Westchester (All Protocol Activities)
      • New York、New York、美国、10065
        • Memorial Sloan Kettering Cancer Center (All Protocol Activities)
      • Rockville Centre、New York、美国、11553
        • Memorial Sloan Kettering Nassau (All protocol activities)
    • Ohio
      • Cleveland、Ohio、美国、44195
        • Cleveland Clinic (Data Collection Only)
    • Pennsylvania
      • Philadelphia、Pennsylvania、美国、19111
        • Fox Chase Cancer Center (Data Collection Only)
    • South Carolina
      • Charleston、South Carolina、美国、29425
        • Medical University of South Carolina
    • Washington
      • Seattle、Washington、美国、98109
        • University of Washington (Data Collection Only)

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

18年 及以上 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

描述

Inclusion Criteria:

  • Biopsy proven cutaneous squamous cell carcinoma which is locally advanced

    • Mixed histology tumors that are predominantly squamous cell carcinoma are eligible
    • Locally advanced primary tumor is T3-T4 and/or N+ by AJCC and/or UICC 8th edition clinical criteria

  • T3-T4 primary tumor characteristics noted below:

    • Non-eyelid tumor >4 cm in maximum dimension or with bone erosion or invasion, perineural invasion of nerve 0.1 mm or larger, or invasion beyond subcutaneous fat or >6 mm from granular layer of adjacent normal epidermis
    • Eyelid tumor >2 cm or invading adjacent ocular, orbital or facial structures

  • ≥18 years old

  • Unresectable or medically inoperable according to local multidisciplinary consensus for reasons such as:

    • Tumor or regional lymph node metastases that has recurred despite ≥2 prior surgical procedures, with another curative resection unlikely
    • Tumor or nodal disease with significant local invasion that precludes complete resection
    • Tumor or nodal disease in anatomically challenging area where surgery may result in significant disfigurement or dysfunction (amputation of nose, ear, eye, digit, limb, etc)
    • Medical contraindication to surgery
    • Patient refusal of surgery due to anticipate morbidity

  • ECOG ≤2

  • Adequate bone marrow and metabolic function (by blood tests)

    • Total bilirubin ≤1.5 x upper limit of normal
    • Aspirate aminotransferase (AST) ≤3 x upper limit of normal
    • Alanine aminotransferase (ALT) ≤3 x upper limit of normal
    • Alkaline phosphatase ≤2.5 x upper limit of normal
    • Serum creatinine ≤1.5 x upper limit of normal or estimated creatinine clearance >30 mL/min according to Cockcroft-Gault formula
    • Hemoglobin >9 g/dL
    • Absolute neutrophil count ≥1.5 x10^9/L
    • Platelet count ≥75 x10^9/L

  • Able to provide informed consent

  • Acceptable candidate for curative intent radiotherapy and Cemiplimab immunotherapy, in opinion of radiation and medical oncologist, respectively

  • Life expectancy >18 months

Exclusion Criteria:

  • Primary tumor originating on the mucosal (non-hair bearing) lip or nose, anogenital (penis, scrotum, vulva, perianal) area

  • Iatrogenic immunosuppression (>prednisone 10 mg/day or equivalent within 14 days of initiation of treatment)

  • Women of child bearing potential unwilling or unable to use effective contraception while receiving treatment with cemiplimab and for 4 months thereafter

  • Distant metastases

  • Clinically significant autoimmune disease that requires iatrogenic immunosuppression

    o For example, severe rheumatoid arthritis requiring disease modifying antirheumatic drugs, such as methotrexate

  • Current or previous hematopoietic malignancy (leukemia, lymphoma)

  • Prior allogeneic transplant of solid organ or bone marrow

  • Concurrent malignancies with >10% risk of metastasis or death within 2 years

  • Prior aPD1 immunotherapy or PI3Kδ inhibitor use

  • Prior radiotherapy for the cutaneous squamous cell carcinoma requiring treatment

  • Other ongoing cancer therapy

    o Adjuvant endocrine therapy is permitted for patients with prostate or breast cancer

  • Uncontrolled HIV or infectious hepatitis (viral load detectable in patient with known infection)

  • Pregnancy or breastfeeding

  • Comorbid or diagnostic abnormalities within the last year that would interfere with interpretation of study results

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：不适用
  • 介入模型：单组作业
  • 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：Participants with locally advanced, unresectable cutaneous squamous cell carcinoma/CSCC

Participants have locally advanced, unresectable cutaneous squamous cell carcinoma/CSCC
药品：Cemiplimab

Participants will undergo baseline imaging, followed by two doses of neoadjuvant cemiplimab at a dose of 350 mg intravenously over 30 minutes every 3 weeks (+/-3 days). Then, participants will receive concurrent cemiplimab 350 mg intravenously over 30 minutes every 3 weeks (+/-3 days) concurrently with RT to 70 Gy in 35 fractions over 7 weeks. Thereafter, participants will receive 38 weeks of cemiplimab 350 mg intravenously over 30 minutes every 3 weeks (+/-3 days) for a cumulative total of 12 months of cemiplimab.

辐射：Radiotherapy

Participants will receive radiotherapy to 70 Gy in 35 fractions over 7 weeks concurrently with cemiplimab

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
Event Free Survival
大体时间：18 months

The primary endpoint for this study is event free survival at 18 months (week 78 +/- 3 weeks) after starting cemiplimab.
18 months

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

Memorial Sloan Kettering Cancer Center

调查人员

  • 首席研究员：Christopher Barker, MD、Memorial Sloan Kettering Cancer Center

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

有用的网址

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 (实际的)

2022年10月6日

初级完成 (估计的)

2027年10月6日

研究完成 (估计的)

2027年10月6日

研究注册日期

首次提交

2022年10月6日

首先提交符合 QC 标准的

2022年10月6日

首次发布 (实际的)

2022年10月10日

研究记录更新

最后更新发布 (实际的)

2026年11月10日

上次提交的符合 QC 标准的更新

2026年11月9日

最后验证

2026年11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

  • 22-090

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

Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.

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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