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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

2026년 8월 24일 업데이트: 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.

연구 개요

상태

모병

정황

개입 / 치료

연구 유형

중재적

등록 (추정된)

46

단계

  • 2 단계

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 연락처

연구 연락처 백업

  • 이름: Abdulrahman Sinno, MD
  • 전화번호: 305-243-2233
  • 이메일: axs3193@miami.edu

연구 장소

  • 미국
    • Florida
      • Miami, Florida, 미국, 33146
        • 모병
        • University of Miami
        • 연락하다:
        • 연락하다:
        • 수석 연구원:
          • Navya Nair, MD, MPH

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

  • 성인
  • 고령자

건강한 자원 봉사자를 받아들입니다

아니

설명

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.

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 치료
  • 할당: 해당 없음
  • 중재 모델: 단일 그룹 할당
  • 마스킹: 없음(오픈 라벨)

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: 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.
의약품: 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.
다른 이름들:
  • 키트루다
의약품: 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.
다른 이름들:
  • 렌비마

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Clinical Benefit Rate
기간: 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

2차 결과 측정

결과 측정
측정값 설명
기간
Objective Response Rate (ORR)
기간: 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)
기간: 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)
기간: 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)
기간: 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)
기간: 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)
기간: 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
기간: 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)
기간: 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
기간: 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

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

University of Miami

수사관

  • 수석 연구원: Navya Nair, MD, MPH, University of Miami

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2026년 8월 6일

기본 완료 (추정된)

2031년 8월 31일

연구 완료 (추정된)

2031년 8월 31일

연구 등록 날짜

최초 제출

2026년 5월 11일

QC 기준을 충족하는 최초 제출

2026년 5월 11일

처음 게시됨 (실제)

2026년 5월 18일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 8월 26일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 8월 24일

마지막으로 확인됨

2026년 8월 1일

추가 정보

이 연구와 관련된 용어

추가 관련 MeSH 약관

기타 연구 ID 번호

  • 20251180

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

아니요

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

예

미국 FDA 규제 기기 제품 연구

아니

미국에서 제조되어 미국에서 수출되는 제품

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

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