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Pembrolizumab and Lenvatinib for Recurrent Endometrial Cancer

This study is testing a combination of two drugs, Pembrolizumab and Lenvatinib, for women with recurrent endometrial cancer that has not responded to previous treatments (platinum-based chemotherapy and immunotherapy). The cancer must also be "mismatch repair proficient" (MMR proficient), which is a specific characteristic of the cancer cells. Researchers want to see how well this drug combination works and if it is safe. The study aims to enroll 46 participants and will measure the "Clinical Benefit Rate" (how many people experience a positive response to the treatment) up to 18 weeks. The current recruitment status is unclear.

Study design
This is an interventional study with an enrollment goal of 46 participants. It is testing the combination of Pembrolizumab and Lenvatinib.
What's involved
Participants will receive Pembrolizumab intravenously every 21 days and self-administer Lenvatinib orally every day.
Compensation
Not stated in the trial record.
Follow-up
The primary outcome, Clinical Benefit Rate, will be measured up to 18 weeks.

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NCT07594015

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

Recruiting
PHASE2Ages 18+InterventionalTreatment
University of Miami
~46 participants
Updated 2026-08-26 on ClinicalTrials.gov
What's tested:PembrolizumabLenvatinib

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Clinical Benefit Rate
Measured over Baseline, Up to 18 weeks

Conditions

Recurrent Endometrial Cancer

Explore related trials

Endometrial CarcinomaMRC1 wt Allele

Where it's being run

1 sites across 1 states
Florida1

Study leadership

  • Navya Nair, MD, MPH · PRINCIPAL_INVESTIGATOR · University of Miami

Who to contact

Navya Nair, MD, MPH
[email protected]
305-243-2233
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Eligibility criteria

Inclusion

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

What this trial measures

  • Clinical Benefit RateBaseline, 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.