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Pembrolizumab and Lenvatinib in Mismatch Repair Proficient Recurrent Endometrial Cancer After Failure of First-Line Therapy With Platinum-based Doublet and Immunotherapy

2026年8月24日 更新者：Navya Nair, M.D., M.P.H、University of Miami

Phase 2 Open-Label Trial Investigating the Efficacy and Safety of Pembrolizumab and Lenvatinib in Mismatch Repair Proficient Recurrent Endometrial Cancer After Failure of First-Line Therapy With Platinum-based Doublet and Immunotherapy

The purpose of this study is to determine the efficacy and safety of Pembrolizumab in combination with Lenvatinib in recurrent, mismatch repair-proficient endometrial cancer after failure of first-line therapy with a platinum-based doublet chemotherapy and immunotherapy.

研究概览

地位

招聘中

条件

干预/治疗

研究类型

介入性

注册 (估计的)

46

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

研究联系人备份

  • 姓名：Abdulrahman Sinno, MD
  • 电话号码：305-243-2233
  • 邮箱：axs3193@miami.edu

学习地点

  • 美国
    • Florida
      • Miami、Florida、美国、33146
        • 招聘中
        • University of Miami
        • 接触：
        • 接触：
        • 首席研究员：
          • Navya Nair, MD, MPH

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

Inclusion Criteria:

  1. Histologically confirmed recurrent endometrial carcinoma, including serous, endometrioid, carcinosarcoma, clear cell subtypes, with measurable disease per RECIST 1.1 criteria.
  2. Mismatch repair (MMR) proficient status confirmed by IHC (Immunohistochemistry) or molecular testing.
  3. Patients must have failed first-line therapy with platinum based doublet with prior immunotherapy.
  4. Patient must have completed next-generation sequencing on either primary or recurrent tumor.
  5. Eastern Cooperative Oncology Group (ECOG) performance status of 0 - 3.
  6. Age ≥ 18 years.
  7. Female participants must be of non-childbearing potential or for females of child bearing potential (FOCBPs), must agree to use contraception as described in Section 5.6. FOCBPs must not be pregnant or breastfeeding.
  8. At least one measurable lesion according to RECIST 1.1.

  9. Adequate organ function, including:

    • Hemoglobin ≥ 8 g/dL (blood transfusions are permitted)
    • Absolute neutrophil count ≥ 1000
    • Platelet count ≥ 100 x 10⁹/L
    • Glomerular filtration rate (GFR) ≥ 30 mL/min
    • Bilirubin ≤ 1.5 x ULN (upper limit of normal)
  10. Written informed consent obtained from the patient.
  11. At least 3 weeks must have elapsed from any prior therapy

Exclusion Criteria:

  1. Uterine sarcoma
  2. Active central nervous system metastases or leptomeningeal disease.
  3. History of severe allergic reactions to pembrolizumab, lenvatinib, or any components of the formulations.
  4. Active autoimmune disease requiring chronic systemic steroids for > 3 months in the last 6 months prior to enrollment.
  5. Pregnancy or breastfeeding at the time of enrollment.
  6. Previous treatment with lenvatinib or other VEGFR inhibitors.
  7. Concurrent treatment with other investigational drugs or anti-cancer therapies except for adjuvant hormonal therapy for breast cancer.
  8. Uncontrolled concurrent illness, such as active infections that could interfere with study participation.
  9. Blood pressure >160 systolic or >110 diastolic averaged over last 3 documented measurements.
  10. History of significant cardiovascular events within 12 months prior to enrollment, including myocardial infarction, unstable angina, or congestive heart failure (NYHA Class III or IV).
  11. History of organ transplant or immune suppressive therapy that would interfere with the efficacy or safety of the investigational drugs.
  12. Other malignancies within the past 2 years except for non-melanoma skin cancer.

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：Pembrolizumab in combination with Lenvatinib

Participants will receive Pembrolizumab in combination with Lenvatinib after failure of first-line therapy with a platinum-based doublet chemotherapy in combination with immunotherapy. Participants may receive treatment for a total of up to approximately 24 months, or until participants have progression of disease or experience a Grade 4 or higher severe adverse event (SAE).

Total participation duration is approximately 26 months.
药品：Pembrolizumab
Participants will receive 200mg of Pembrolizumab intravenously on Day 1 of every 21 day cycle, as per standard of care and as per institutional guidelines.
其他名称：
  • 可瑞达
药品：Lenvatinib
Participants will self-administer Lenvatinib orally at a daily dose of 20mg or every 21 day cycle, as per standard of care and as per institutional guidelines.
其他名称：
  • 乐卫玛

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
Clinical Benefit Rate
大体时间：Baseline, Up to 18 weeks
Clinical benefit rate (CBR) is defined as the proportion of participants achieving complete response (CR), partial response (PR) or sustained stable disease (SD), as the best response as assessed using Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria.
Baseline, Up to 18 weeks

次要结果测量

结果测量
措施说明
大体时间
Objective Response Rate (ORR)
大体时间：Up to 26 months
Objective Response Rate (ORR) is defined as the proportion of participants achieving complete response (CR) or partial response (PR) as the best response assessed using Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria.
Up to 26 months
Progression-Free Survival (PFS)
大体时间：Up to 26 months
Progression-Free Survival (PFS) is the elapsed time in months from date of treatment initiation until progression or death from any cause. Patients who are alive and without documented disease progression will be censored at the date of their last disease assessment.
Up to 26 months
Overall Survival (OS)
大体时间：Up to 26 months
Overall Survival (OS) is the elapsed time in months from date of treatment initiation until death from any cause. Alive patients will be censored at the last date known to be alive.
Up to 26 months
Duration of Response (DOR)
大体时间：Up to 26 months
Duration of Response (DOR) is the elapsed time in months from date of first documentation of complete response (CR) or partial response (PR) until first documentation of progression or death from any cause for responders. Patients who are alive and without documented disease progression will be censored at the date of their last disease assessment.
Up to 26 months
Number of Participants Experiencing Treatment-Related Toxicity: Serious Adverse Events (SAEs)
大体时间：Up to 26 months
The safety and tolerability of combination Pembrolizumab and Lenvatinib therapy will be reported as the number of participants experiencing treatment-related serious adverse events (SAEs). SAEs will be assessed using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.
Up to 26 months
Number of Participants Experiencing Treatment-Related Toxicity: Adverse Events (AEs)
大体时间：Up to 26 months
The safety and tolerability of combination Pembrolizumab and Lenvatinib therapy will be reported as the number of participants experiencing treatment-related adverse events (AEs). AEs will be assessed using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.
Up to 26 months
Health-Related Quality of Life Scores: Patient-Reported Outcomes via EORTC QLQ-17
大体时间：Up to 26 months
Participant quality of life will be assessed using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 17 (EORTC QLQ-17), a validated 17-item questionnaire measuring global health status and functional domains relevant to cancer patients. Items are scored using standardized Likert scales and converted to 0-100 domain scores according to EORTC scoring guidelines. Higher scores indicate better functioning and overall quality of life.
Up to 26 months
Health-Related Quality of Life Scores: Patient-Reported Social Isolation via Social Provisions Scale - 10 items (SPS-10)
大体时间：Up to 26 months
Social isolation will be measured using the 10-item short form of the Social Provisions Scale, a validated instrument assessing perceived social support and relational connectedness. Each item is rated on a 4-point Likert scale (1 = Strongly Disagree, 2 = Disagree, 3= Agree, 4 = Strongly Agree), yielding a total score ranging from 10 to 40, with higher scores indicating greater perceived social support (lower social isolation).
Up to 26 months
Health-Related Quality of Life Scores: Patient-Reported Social Needs via Health Leads 10-Item Screening Tool
大体时间：Up to 26 months
Unmet social needs will be assessed using the 10-item Health Leads Social Needs Screening Tool, a validated questionnaire identifying needs such as food insecurity, housing instability, transportation barriers, and utility challenges. Each item is coded as 1 (unmet need present) or 0 (no unmet need). Total scores represent the count of unmet social needs (range 0-10), with higher scores indicating greater social needs burden.
Up to 26 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

University of Miami

调查人员

  • 首席研究员：Navya Nair, MD, MPH、University of Miami

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)

2026年8月6日

初级完成 (估计的)

2031年8月31日

研究完成 (估计的)

2031年8月31日

研究注册日期

首次提交

2026年5月11日

首先提交符合 QC 标准的

2026年5月11日

首次发布 (实际的)

2026年5月18日

研究记录更新

最后更新发布 (实际的)

2026年8月26日

上次提交的符合 QC 标准的更新

2026年8月24日

最后验证

2026年8月1日

更多信息

与本研究相关的术语

其他相关的 MeSH 术语

其他研究编号

  • 20251180

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

不

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

在美国制造并从美国出口的产品

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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