New combo shows promise for Tough-to-Treat uterine cancer
NCT ID NCT07594015
First seen Jun 27, 2026 · Last updated Aug 27, 2026 · Updated 4 times
Summary
This study tests two drugs, pembrolizumab and lenvatinib, in people with a type of uterine cancer that has come back after initial treatment. The cancer must be mismatch repair proficient, meaning it has a specific genetic feature. The goal is to see if this drug combination can shrink or stabilize the tumor. About 46 adults will take part.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 46 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Aug 2026
- Expected to finish
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Aug 2031
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Female participants only
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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University of Miami
RECRUITINGMiami, Florida, 33146, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- New drug combo aims to stall endometrial cancer in High-Risk patients
- New antibody combo aims to fight back against recurrent ovarian cancer
- Experimental cancer drug ART0380 trial halted early